NRC FORM 313 \02-2016;

U.S. NUCLEAR REGULATORY COMMISSION APPROVED BY OMB: NO. 3160--0120 EXPIRES: 02129/2016

10 C!R 30. 32 33 :l4 35 30 3! 39 and <O

APPLICATION FOR MATERIALS LICENSE

Es~mat&d burden oer response to comply wilh !his mandatory collec1ion request: 4.3 hours, Submittal of the application is necessary to deterrrnne mat the applicant is qualif<e<i and lhal adequate procedures exist lo protect the public nealth and sa1ety, Send conments regardm<J burden esbmate to the FOIA. Privacy, and ln'orrnation Collections Branch (T-5 F53) U.S. Nuclear Re9ulatory Commission, Washi~ton. DC 20555-0001. 0< by e-mail to lnfocollects.Resourr...e@nn::.gov, and to the Desk Officer. Office of lnf0<mation and Requlatory Affa1fs. NEOB-10202. (3150-0120). Office of Management and Budget Washmgton DC 20503. If a means used to impose an informaoon collecton ooes not dtS!)lay a currenUy valid OMB control number the NRC may not conduct or sponsor, and a person is not reqwred to respond to, the information collection.

INSTRUCTIONS: SEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPLICATION. SEND TWO COPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW. 'AMENDMENTS/RENEWALS THAT INCREASE THE SCOPE OF THE EXISTING LICENSE TO A NEW OR HIGHER FEE CATEGORY WILL REQUIRE A FEE.

APPLICATION FOR DISTRIBUTION OF EXEMPT PRODUCTS FILE APPLICATIONS WITH:

MATERIALS SAFETY LICENSING BRANCH DIVISION OF MATERIAL SAFETY. STATE, TRIBAL AND RULEMA.KING P~OGR/•MS OFFICE OF NUCLEAR MATERIALS SAFETY AND SAFEGUARDS U.S NlJCLEAR REGULATORY COMMISSION WASHINGTON DC 20555-0001

ALL OTHER PERSONS FILE APPLICATIONS AS FOLLOWS:

IF YOU ARE LOCATED IN:

IF YOU ARE LOCATED IN:

ILLINOIS, INDIANA, IOWA, MICHIGAN, MINNESOTA. MISSOURI, OHIO, OR WISCONSIN. SEND APPLICATIONS TO:

MATERIALS LICENSING BRANCH U.S ~lUCLEAR REGULATORY COMMISSION, REGION Ill 2443 WARRENVILLE ROAD SUITE 210 LISLE. IL 60532-4352

ALABAMA, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, ALASKA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, HAWAII, IDAHO, KANSAS, KENTUCKY. MAINE, MARYLAND, MASSACHUSETTS, NEW HAMPSHIRE, NEW JERSEY, LOUISIANA, MISSISSIPPI, MONTANA, NEBRASKA, NEVADA, NEW MEXICO. NORTH NEW YORK. NORTH CAROLINA, PENNSYLVANIA, PUERTO RICO, RHODE ISLAND, SOUTH DAKOTA, OKLAHOMA, OREGON, PACIFIC TRUST TERRITORIES, SOUTH DAKOTA, TEXAS. CAROLINA, TENNESSEE. VERMONT, VIRGINIA, VIRGIN ISLANDS. OR WEST VIRGINIA. UTAH, WASHINGTON, OR WYOMING,

SEND APPLICATIONS TO:

LICENSING ASSISTANCE TEAM DIVISION or NJCLEAR MA TE RIALS SAFETY US. NUCLEAR REGULA TORY COMMISSION REGION I 2100 RENAISSANCE BOULEVARD. SUITE 100 KING OF PRUSSIA, PA 19406-2713 3

SEND APPLICATIONS TO:

NUCcEAR MATERIALS LICENSING BRANCH U.S NUCLEAR REGULA TORY COMMISSIO'~ REGION IV 1600 E LAMAR BOULEVARD ARLINGTON, TX 76011-4511

PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE U.S. NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSESS AND USE LICENSED MATERIAL IN STATES SUBJECT TO U.S.NUCLEAR REGULATORY COMMISSION JURISDICTIONS.

1 THIS IS AN APPLICATION FOR (Check 8ppropnate item)

D A NEW LICENSE

0 8 AMFNDMeNT TO LICE°'ISE NUMBER

D c R[NEV\'AL OF .lCENSE NUMBER

07-1215.1-02

3 AD1DRLSS 'M•E.'<E LICENSED MATERIAL \'\Le BE USED OR POSSESSED

There is no change to the facilities where licensed material may be used or stored as in the current license (conditions item I 0 ).

2. NAME AND MAILING ADDRESS OF APPLICANT (Include ZIP code)

Christiana Care Health Services. Inc. Management Suite - Room 1270 4755 Ogleto\\n-Stanton Road Newark, Delaware 19718

4. NAME OF PERSON TO BE CONTAC"ED ABOUT THIS .APPLICATION

Xiaoqian Wen

BUSINESS TELEPHONE NUMBER

(302) 623-3839

BUSINESS EMAIL ADDRESS

xiaoqian.wen@christianacarc.org

BUSINESS CELLULAR TELEPHONE NUMBER

(484) 633-0035

SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11" PAPER THE TYPE AND SCOPE OF INFORMATION TO BE PROVIDED IS DESCRIBED IN THE LICENSE APPLICATION GUIDE.

RADIOAC1 IVE MATERIAL

a. Element and mass number. b. chem1ca! and/or phys1eaJ rorm. ano c ma)l;1murn amount which will be possessed at any one time.

TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS

'0 RADIATION SAFETY PROGRAM.

12 LICENSE FEES 1i=ees reQuired onJ1 fO! new appl1catioos w1:h few exceptions•; (See 10CF.R 170andSect;on 170J1)

6. PURPOSE(SI FOR WHICH LICENSED MATERIAL WILL BE USED.

7. INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE

9. FACILITIES AND EQUIPMENT

11. WASTE MANAGEMENT

FEE CATEGORY I AMOUNT I ENCLOSED $

\3 CERTIFICATIOfl (Mustoe comp/eled by app!1canr1 THE APPLICANT 'JNOERSTANOS THAT ALL STATEMENTS ANO REPRESENTATIONS MADE IN THIS APPLICATION ARE BINDING UPON THE APPL !CANT

THE APPdCAN! AND ANY Ol'FICIAL EXEClJTING THIS CERTIFICA ! ION ON BEHALF OF THE A?PLICANT NAMED IN ITEM 2 CERTIFY THAT THTS APPLICATION IS PREPARED IN CONFOHMITY Wl'H TITLE '0. CODE OF FEDERAL REGULATIONS. PARTS 30. 32. 33. 34 35 36. 37 39, AND 40. AND TH-' TALL INFORMATION CONT At-. ED HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIR KNOWLEDGE AND BELIEF WARNING 18 U.S.C. SECT ION 1001 ACT OF JUNE 25, 1948 62 STAT, 749 MAKES Ir A CRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTME'lT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER l"llTHIN ITS JURISDICTION.

CERTIFYING OFFICER -TYPED/PRINTED NAME AND TITLE SIGNATURE CATE

Xiaoqian Wen ~ J I

~ \, \.;' :l/1 8 (.10 I G

l'iRC FORM 313 \02-2016,

SII\J>X Certificate of Completion

presented to:

Samuel Putnam, MD

We certify that the above named individual has been appointed by Sirtex as an official Proctor as a result of their clinical expertise in the use of SIR-Spheres® microspheres and has successfully completed all rl{w requirements of the program.

David Liu Medical Director

May 10, 2013 Date

SI

January 25, 2016

Re: DA YID MASON

Dear Sir/Madam:

Sirtex Medical Inc. 300 Unicom Park Drive

Woburn, MA 01801

Telephone: (781 )721-3838 Fax: (781 )-658-2701

Web: www.sirtex.com

I am writing to confirm that the employee is currently employed by Sirtex Medical. Sirtex Medical provides the medical device Sir-Spheres® microspheres which are used for the treatment of unresectable liver tumors.

This Jetter is to confirm that the employee has been trained to the following effective 112112016:

• HIPPA • AdvaMed and Ethics • Sir-Spheres® microspheres • Bloodborne Pathogens

If you have any questions, please feel free to contact me directly at 781.721-3838.

Regards,

Ashley Castillo Human Resources

SIR.:ThX Certificate of Completion

presented to:

Mark Westcott, MD

We certify that the above named individual has been appointed by Sirtex as an official Proctor as a result of their clinical expertise in the use of SIR-Spheres® microspheres and has successfully completed all

/' ~ ;f requirements of the program.

rl(itt,,tM-l May 10, 2013

David Liu Date Medical Director

SIR-Spheres® is a registered trademark ofSirtex SIR- Spheres Pty. Ltd.

presented to:

Rahul Patel, MD

We certify that the above named individual has been appointed by Sirtex as an official Proctor as a result of their clinical expertise in the use of SIR-Spheres® microspheres and has successfully completed all

(. / requirements of the program.

(y~~ David Liu

Medical Director

May 10, 2013 Date

Wen, Carol

From: Sent: To: Subject: Attachments:

Carol,

David Mason <dmason@sirtex.com> Sunday, January 03, 2016 11:18 PM Wen, Carol RE: Carol Wen's contact information Christiana Care Health Services Kevin Lie 3715 2.pdf; Christiana Care Health Services Christopher Grilli 71015 l.pdf

Attached please find the proctor forms for Dr. Hung Dam. For some administrations a Sirtex Physician proctor was present. For other administrations I certify that I was present to support and proctor the case (per NRC guidelines for Microsphere Brachytherapy Sources and Devices, (B) Pathway 2).

3/27 /15 (proctor form attached) 5/4/15 (supervised by Dave Mason, Sirtex) 5/29/15 (supervised by Dave Mason, Sirtex) 7 /10/15 (proctor form attached)

Best Regards, Dave

Dave Mason Regional Sales Manager

Cell: 609 577-8520 Fax: 609-259-0275 e-mail: drnason@s1rtex.com web: www.sirtex.com

300 Unicorn Park Drive

Woburn, MA 01801

From: Wen, Xiaoqian [mailto:Xiaogian.Wen@Chd.filia.na~9~] Sent: Thursday, December 17, 2015 9:20 AM To: David Mason Subject: Carol Wen's contact information

Hi Dave,

It was a pleasure talking with you over the phone. Here is my contact information. Feel free to contact me if you need anything or have any questions for me in the future.

Carol

Xiaoqian (Carol) Wen, M.S., CHP Radiation Safety Officer Christiana Hospital, Room 1127 (map 2)

4755 Ogletown-Stanton Rd Newark, DE 19718 Tel: 302-623-3839 Fax: 302-623-3865 Xiaoqian.Wen@ChristianaCare.org

This email message and any accompanying attachments may contain information that is confidential and 1s subject to legal privilege. If you are not Uie intended 1·ec1p1ent, do not read, use, disseminate, distribute or copy this message or attachments. If you have received this :riessage in error, please notify the sender immediately and delete this message. /\ny views expressed in this email and any attachments are riot those ot S1rtex, except wl1ere the sender expressly, and witt1 authority, states them to represent the views of Sirtex. Before opening any dttachments, please check them for viruses and defects.

2

·' Junod, Rebecca

From: Sent:

Wen, Carol <Xiaoqian.Wen@ChristianaCare.org> Monday, January 04, 2016 8:34 AM

To: Weidner, Tara Cc: Subject:

Manzone, Timothy A; Eppehimer, Michael S; Grady, Erin E; Dam, Hung Q [External_Sender] RE: NRC amendment/notification request

Attachments: Dam 3-27-15.pdf; Dam 5-4-15 and 5-19-15 Email from Dave Mason.pdf; Dam 7-10-15.pdf; Grady 1-28-15 First Proctored Case.pdf; Grady 3-6-15 Second and Third Proctored Case.pdf

Good morning Tara!

Hope you have enjoyed the holidays and had a relaxing time with families and friends!

I have just received the documentations from SirTex regarding the three proctored cases for Dr. Dam and Dr. Grady and attached them to this email. Please review and let me know if you have any questions.

Also I am wondering if you could provide us an update on our most recent license amendment request.

Thank you very much for all your help and I am looking forward to hearing back from you!

Carol

Xiaoqian (Carol) Wen, M.S., CHP Radiation Safety Officer Christiana Hospital, Room 1127 (map 2) 4755 Ogletown-Stanton Rd Newark, DE 19718 Tel: 302-623-3839 Fax: 302-623-3865 Xiaoqian.Wen@ChristianaCare.org

From: Weidner, Tara [mailto:Tara.Weidnercmnrc.gov] Sent: Tuesday, December 01, 2015 2:57 PM To: Eppehimer, Michael S Subject: NRC amendment/notification request

License No. 07-12152-02 DocketNo. 03001303 Control No. 589404

********************************PLEASE CONFIRM RECEIPT OF THIS E-MAIL *****************************************

Mr. Eppehimer,

In the letter dated November 4, 2015 you notified us that Timothy Manzone, M.D., J.D. completed the three proctored cases for Y-90 SIRspheres. In addition, it was stated that, "This should complete the proctored case requirement for our 3 Authorized Users for this agent." I have reviewed the documentation provided by

1

.....

Christiana Care since Y-90 SIRspheres have been added to the license and I have not been able to locate documentation that Ors. Dam and Grady have completed the three proctored cases. Please provide confirmation from Sirtex that Ors. Dam and Grady have completed the casework, then I will be able to agree that the three authorized users have met the requirement.

Finally, I need to take care of some administrative items. Would you provide your fax number and the telephone, fax, and e-mail address of the newly appointed Radiation Safety Officer, Xiaoqian Wen?

I will continue the review of your amendment request as soon as I receive the additional information. If you have any questions, feel free to contact me via e-mail or at 610-337-5272.

Tara L. Weidner Senior Health Physicist US NRC

2

Document ID:--··-----­(;Uloc.ll:ed by Sirte.:1:)

SIR-Spheres® Mkrosi;1hcres Treatment: J~rocb:arin.g Evaluation U'ormm . -

. . erzanl with the "S/R..Splteres Microspheres Users

.Pcss __ l~viitlur.l;fan ltt:r11 1. m. has receivedar!dtS oouv

__ ,_V<_auual" -----

::nt to perfo1m satisfoi:torV'·;iscE!L_~ngio!tranhy ~.. Hospital reso_u_r~_ .. _s __ _

,__ ___ a....,. J.:1..9.!i>hal hU! e~iI!!U ,_.. __ _.b ..... 9 ... ua=l!;;.,/,tf of hc:p~ ffl0.1trams ·-·--+. QWer mJe. e

~)!~.fil!.,lde ...... ..,,_ .....

1edz..!9cludin&_Y,~,!i.1!!!!...& aberrant vessf:ls

• p •. ~ d -n!ifi ->"--3. Hos1>ital h11s apnro2riat::::

I'--"'-•rsonnel assigned to the treatment team

M

a. M~i?J Physi~.is! ....... ---· b. Radiation safe!,.v o cer(RSO}

I/nuclear medicine or Interventional raclioiogist <Arn --ffi

00!_ c. Radi&tion 012~!0

-· 4. d. Nursin~ slaff.'pati coordinator --·

Pati~nt se•ection & pre·t tmcnt wcrk-ue a. Histo1.tl:.physicu ;amination fir.dinw reviewed b. Rel~yant le.l>orato

ent rea le rv as lS

i1u rt; ku

results reviewed (L..l:Ts/bilirubin2 blood exam., etc.} c. Triolu ph~c C!£:ntr d. Hepati~ an~~ar.1

i enhcnced CT scan of chest/abdo/celvis reviewed & vnriar.t o~ aberrant vessel~_correctly !dentjfied

e. r!1AA-Tc99 lang s nt study performed & correcttx intc!:ereted -f. Patient sel:ctec.! fo · eatment is an ap~ro~;'iate candid~~ g. Pre-treatment w9r p is satisfactory

·•·

.

Nctes: (1.) T/11~ i•mctor111g Emi""tior. Form 1;r11st iJe completed by the Proctor followbtg the proctoring of a SIR..Splteres mkrrw."'eres treatMent a."U/ fo:ward~'tl. 10 Sirtex

(2) Please add reason and/or commei tts below 10 Section 5

SIR-Spheres ... ' is n aegistered Trnd:im.nrl: or Slnex SIR.Spheres i'ty Ud

--

·-

-

form 102 Proctoring Eval11a1ion Reference: QSOPOB

Revisio11 #: 4 (CRI432) lss1~.:d: 30 lrfay 2012 Pagel ofJ

·.

~].wRTo ~X' ··- •. 1.~ .•

Document ro: ~~~~~~~~-

(All o cn !.ed by Sirtex)

2. Dose Preparatlort: S!gn-Ofr by Strtox Field perso1met

rn ' ~

.!ii'tt mu; on rem -uss •n

1. r~uclear medicine hot ·iab p;;$onnel have the policies and procedures in ....

' --~~!2._tt:cepl_~i.~~·:t?. the SIR~§P.!H!!'C.1...f!licrosollcl'es dose 2. Nuclear medicine hot lab personuel can verify and document quantity of

r I f 1·

SIR-Srd!!rr..~ microsphcres nctivit~elive1'Cd to the patient ~·""--3. Nuclt:ar medicine hot lab pcrscnnel understand radiation safety and

decontamination 1'rocedures

J. Treatment Pli.n

. < •• - •

,_l~R-S~res rrdcrospht..Tes ~S.~ ci:te:ntiEtio!J is satisfactory ·---· ,. 2. Treatment dan is satisfactorv t'whole liver vs. lobar vs. seJUncntal)

3. Hetmtic artert~.Limeiantation site(sl of SIR-S12heres microspheres is satisfactory 4. Phvsiciar1(s} involv:::d um!erstanc;:

a. Disease ~cess ·--·-~· TheiU!?.!:.in tile delivery of SIR-Spheres microso:1eres

c. Possible comlllications and treatment d. Trealmznt oicnninrr (whole liver vs. lobar vs. segmenta11 e. Dos~met1y calculatior.s _

.____ f. Optimal C!thete• Jilitcemenh_ i,~ i. Need foi' embulization of ODA. RG, other variants and aberrants

---U. Correct positioning of e&theter -... ..,,,_

.....__. iii. Adegunte radiation shielding in place I!. Satisfactory nurning care availabl" during and nfter 1?rocedure

.J - - -. L f'eri-orocedu~l ca~ & sucoortive therapy/medicatioris understood

follow·uE understood 2. Post-treatment ~e_~ 3. Post-treatm~n!.~!Pon s:: assessment and imarJ.ng {Cf /PET) schedale un<lerstood

5. Cormneuts (attaci1 additional sheets if necess~ry)

Comments

Form 102 - Proctodng E1'tll11ation Refertmce: QSOPOB

Revisio11 #: 4 (CR/432) Issued: 30 May 2012

..

. I

Pass I

I

cnt SI rtexo. : ..

--

Deficient . .

Poge2ofJ

S l. ·1:{ Tr-\ .,X'/ '-···~·

Document ID: (Allocated by S!rt·:ix)

________ .,_.,_

6u. Approvid for Pc"GCtoted Coses

First Proctored ~se D ,·-y

Second Proctored Cas-: t-.:::

Third Proctored Case 0

If Pre-trained please complete section 6b

Plense complete section 6b

6b. Appro·vnl £01~ li'utu.re tJ~e or SIR-Spheres Mlcraspherw

/ Ir. my opinion, the hospital ha!!~lt.trastructurc in place to receive and to safely treat plltients with SIR· Spheres :nicrosr-iieres: YES L-:r NO 0

In my opinion, t,he lrm:rv~ntional Radiolosist proctored is qualified to implant SIR-Spheres microspheres iil coopera7tio,.y~~1ith th~ Authorized Use;· am.l does not requ!rc additional proctoring: YES Q NO 0

In :ny opinion, the IntervcnLional Radfol~~~~roctored requires at least one cdditional proctoring session: YES 0 NOT NECESSARY Ej

In my opinion, tr.~ Auth•Jrhed-Oser pi'OCtored is qualified to imj>lant SIR-Spheres microsphel'es in cooperation with the Inte!)•~ionrJ Radiolog!st and does not require additional proctoring: YES [J NO f.:j"

In my ~i~i~uthoiized User proctored retlui:es at least one additional proctoring session: YES ~3' NOT :NECESSARY 0

Frcztor: Plerui·~ fax ::ompleted Proctoring f£ynlmu:hrn Form to Sirte:.: Regional Administrator at the following numbers:

US: + 1 (978) 229 9585 EU: +49 228 1840 735 I~: +61 2 9964 8410

Form 102 Proctoring Evaluation Ref::rence: QSOPOB

Revision#: 4 (CR1432) l1s11td: 30 May 2012 Page3cif3

Document ID: _______ _ (Allocated by Sirtex)

SIR~Spheres Microspheres Treatment: Proctoring Evaluation Form<l)

Proctored Physicians and Institution Information

Interventional Radiologist (IR): Kevin Lie Authorized User (AU): Erin Grady Institution: Christiana Medical Center Date Proctored: January 28. 2015 Proctor: Rahul Patel, MD

1. Pre-Treatment Evaluation

Evaluation Item 1. IR has received and is conversant with the "SIR-Spheres Microspheres Users

Manuar' 2. Hospital resources

a. Hospital has equipment to perform satisfactory visceral angiography b. Quality of hepatic angiograms

i. Power injected ii. Anatomy identified, including variant & aberrant vessels

3. Hospital has aonropriate personnel assigned to the treatment team a. Medical physicist b. Radiation safety officer ffi.SO) c. Radiation oncologist/nuclear medicine or Interventional radiologist (AU) d. Nursing staff/patient coordinator

4. Patient selection & pre-treatment work-up a. History & physical examination findings reviewed b. Relevant laboratory results reviewed (LFTs/bilirubin, blood exam., etc.) c. Triple phase contrast enhanced CT scan of chest/abdo/pelvis reviewed d. Henatic angiograms & variant or aberrant vessels correctly identified e. MAA-Tc99 lung shunt study performed & correctly interpreted f. Patient selected for treatment is an appropriate candidate g. Pre-treatment work up is satisfactory

Pass Deficieufll x

x x x x

x x x x

x x x x x x x

Notes: (1) The Proctoring Evaluation Form must be completed by the Proctor fol/oM;ing the proctoring of a SIR-Spheres mtcrospheres treatment and forwarded to Sirtex

(2) Please add reason and/or comments below to Section 5

SIR-Spheres is a Registered Trademark of Sirtex SIR-Spheres Pty Ltd

Form I 02 - Proctoring Evaluation Reference: QSOPOB

Revision#: 4 (CRJ432) Issued: 30 May 2012 Page I of3

DocumentID:~~~~~~~­(Allocated by Slrte1)

2. Dose Preparation: Sign-Off by Sirtex Field personnel

E I ti It va ua on em p ass D fi i e 1c ent s· 1rtex Si II!: 1. Nuclear medicine hot lab personnel have the policies and procedures in

place to accept and prepare the SIR-Spheres microspheres dose 2. Nuclear medicine hot lab personnel can verify and document quantity of

SIR-Spheres microspheres activity delivered to the patient 3. Nuclear medicine hot lab personnel understand radiation safety and

decontamination procedures

3. Treatment Plan

Evaluation Item 1. SIR-Spheres microspheres dose determination is satisfactory 2. Treatment plan is satisfactory (whole liver vs. lobar vs. segmental) 3. Hepatic arterial implantation site(s) of SIR-Spheres microspheres is satisfactory 4. Phvsician(s) involved understand:

a. Disease process b. Their role in the delivery of SIR-Spheres microspheres c. Possible complications and treatment d. Treatment plannin£ (whole liver vs. lobar vs. segmental) e. Dosimetrv calculations f. Optimal catheter placement, including

i. Need for embolization ofGDA, RG, other variants and aberrants ii. Correct positioning of catheter iii. Adequate radiation shielding in place

g. Satisfactory nursing care available during and after procedure

4. Peri-Procedural Care & Post-Treatment Follow-up

Evaluation Item 1. Peri-procedural care & supportive therapy/medications understood 2. Post-treatment care & follow-up understood 3. Post-treatment response assessment and imaging (CT/PET) schedule understood

5. Comments (attach additional sheets if necessary)

Item# Comments rrou!!h case but was able to oroblem solve wav through

Form 102- Proctoring Evaluation Reference: QSOP08

Revision#: 4 (CRJ432) Issued: 30 May 2012

Pass Deficient x x x

x x x x x x x

i x x x

Pass Deficient x x x

Page2of3

6a. Approval for Proctored Cases

First Proctored Case [}

Second Proctored Case D

Third Proctored Case 0

Document ID: (Allocated by Slrtex)

If Pre-trained please complete section 6b

Please complete section 6b

6b. Approval for Future Use of SIR-Spheres Microspheres

In my opinion, the hospital has the infrastructure in place to receive and to safely treat patients with SIR-Spheres microspheres: YES 0 NO D

In my opinion, the Interventional Radiologist proctored is qualified to implant SIR-Spheres microspheres in cooperation with the Authorized User and does not require additional proctoring: YES 0 NO 0

In my opinion, the Interventional Radiologist proctored requires at least one additional proctoring session: YES 0 NOTNECESSARY 0

In my opinion, the Authorized User proctored is qualified to implant SIR-Spheres microspheres in cooperation with the Interventional Radiologist and does not require additional proctoring: YES 0 NO 0

In my opinion, the Authorized User proctored requires at least one additional proctoring session: YES 0 NOTNECESSARY 0

7. Signatures

Proctor name (print): Rahul S Patel_.. __ ...:__

Proctor Signature: __ , Date: February 2, 2015

Proctor: Please fax completed Proctoring Evaluation Form to Sirtex Regional Administrator at the following numbers:

US: + l (978) 229 9585 EU: +49 228 1840 735 AP: +6129964 8410

Form 102- Proctoring Evaluation Reference: QSOP08

Revision#: 4 (CR/432) issued: 30 May 2012 Page3 o/3

!

SI Te''-Document ID: -------­

(Allocated by Sirtex)

SIR-Spheres® Microspheres Treatment: Proctoring Evaluation Form(l)

Proctored Physicians and Institution Information

Interventional Radiologist (IR) =D~a~n~L=e~t=m""g~, ~M=D~-----­Authorized User (AU): _.E~· r_,,in"--"G"'"-ra=d,,_y,__,·,--"M~D=--------­Institution: Christiana Hospital, Newark, DE Date Proctored: -=3"-'/6"'"/.:::.20"-1~5,__ ___________ _ Proctor: Samuel Putnam MD

I. Pre-Treatment Evaluation

Evaluation Item ----··------------·-

l. TR has received and is conversant with the "SIR-Spheres Microspheres Users Manual"

-·

2 Hospital resources

Pass Deficient<2>

x

~-

a. Hospital has equipment to perform satisfactory visceral angiography x b. Quality of hepatic angjogi:ams ------ ----

i. Power injected x i ii Anatomy identified, including variant & aberrant vessels x

3. Hospital has appropriate personnel assigned to the treatment !_e_<l:!ll _____ I ---,----·

a_ Medical physicist x b. Radiation safety officer (RSO) x

~ c. Radiation oncologist/nuclear medicine or Interventional radiologist (AU) x d. Nursing staff/patient coordinator x - -

4. Patient selection & ore-treatment work-up

I a. Historv & ['.hysical examination findings reviewed x b. Relevant laboratory results reviewed (LFTs/bilirubin, blood exam, etc.) __ x '

~-I

c. Triple phase contrast enhanced CT scan of chest/ab~o/pelvis reviewed x d. Hepatic angiograms & variant or aberra_nt vessels correctlv identified x I e. MAA-Tc99 lung shunt study performed & cor~terpreted

I x I

I x i f Patient selected for treatment i_s an appropri~~..E._~ndidate I I r---- ' -

Notes. ( lj The Proctoring Evaluation Form mus/ be complered by the Proctor.following the proctoring r!fa SIR-Spheres microspheres 1realmen1 a11djo11varded to Sinex

(2) Please add reason am/'or comments below to Section 5

SlR-Sphcres"' is a Registered Trademark of Sirtex SIR-Spheres Pty Ltd

Form 102 - Proctoring Evaluation Reference· QSOP08

Revision#.· 4 (CR/432) Issued: 30 May 2012 Page I of 3

SI 1-e '" DocumentlD:~~~~~~~~­

(Allocated by Sirtex)

2. Dose Preparation: Sign-Off by Sirtex Field personnel

Evaluation Item Pass Deficient s s· , irtex 1

l Nuclear medicine hot lab personnel have the policies and procedures in x OM place to accept and oreoare the SIR-Spheres microspheres dose

2 Nuclear medicine hot lab pers01mel can verify and document quantity of x OM SIR-Spheres microspheres activitv delivered to the patient i

3 Nuclear medicine hot lab personnel understand radiation safety and ! x OM

decontamination Erocedures I

3. Treatment Plan

Evaluation Item Pass Deficient -

I i. SIR-SQheres micros12heres dose determination is satisfactory x 2. Treatment Qian is satisfactory (whole liver vs. lobar vs. segmental) x 3. Hepatic arterial implantation site(s) ofSIR-Sphercs microspheres is satisfactorv x 4. Physician(s) involved understand:

a. Disease process x b. Their role in the delivt'._iy_().f..STR-Soheres microspheres x c. Possible como!ications and treatment x d. Treatment planning (whole liver vs. lobar vs. segmental) x e. Dosimet!}'· calculatiol}<> x

·-

f 012timal ca!het~r 2Jacement, including ·---i. Need for embolizat1on ofGDA, RG, other variants and aberrants x

~-· ii. Correct nositioning of catheter x iii. Adeguatc radiation shielding in place x

g. Satisfactory nursing care available during and after procedure x

4. Peri-Procedural Care & Post-Treatment Follow-up

Evaluation Item Pass Deficient --~-·

l. Peri-procedural care & suoportive therapy/medications understood x 2. Post-treatment care & follow-up understood x 3. Post-treatment response assessment and imaging (CT/PET) sched~le ;;~derstood x

5. Comments (attach additional sheets if necessary)

Item# Comments Dosimetrv performed bv Nuclear Medicine AU, 2"~ and 3rd proctoring for her; siimed off. Did need to address non-target vessels not seen_ on mapping procedure.

fwo cases done todav, IR needs one more oroctored case.

Form 102- Proctoring Evaluation Reference.· QSOP08

Revision#.· 4 (CRl432) Issued.·]() May20l2 Page 2 of3

--

SI Te'\_ Document ID: -------­

(Allocated by Sirtex)

6a. Approval for Proctored Cases

First Proctored Case If Pre-trained please complete section 6b

Second Proctored Case ~

Third Proctored Case Wfor AU only Please complete section 6b

6b. Approval for Future Use of SIR-Spheres Microspheres

In my opinion, the hospital has the infrastructure in place to receive and to safely treat patients with SIR-Spheres microspheres: YES @ NO D

In my opinion, the Interventional Radiologist proctored is qualified to implant SIR-Spheres microspheres in cooperation with the Authorized User and does not require additional proctoring: YES 0 NO ~

In my opinion, the lnterventional Radiologist proctored requires at least one additional proctoring session: YES I]] NOT NECESSARY 0

In my opinion, the Authorized User proctored is qualified to implant SIR-Spheres microspheres in cooperation with the Interventional Radiologist and does not require additional proctoring YES G NO 0

In my opinion, the Authorized User proctored requires at least one additional proctoring session: YES 0 NOTNECESSARY IX]

7. Signatures

Proctor name (print): Samuel Putnam MD

Date: 3/6/2015

Proctor Please fax completed Proctoring Evaluation Form to Sirtex Regional Administrator at the following numbers:

US: +I (978) 229 9585 EU +49 228 1840 735 AP +61 2 9964 8410

Form 102- Proctoring Evaluation Reference. QSOP08

Revision#: 4 (CR 1432) Issued: 30 May 2012 Page 3 of3

Document ID: __ , ___ _ (Allocated by Sirtn)

SIR-Spher~s® It/Hcrospheres T:reannen~: P;;-octoring Evafo~tfon Form<1)

Proctored Pbysidans and Institution Information

lntervent10nal Radiologist (IR) Christopher Grill_i,J)O ____ _ Authorized User (AU): ""'H'""un""""'g-=D'-"'a=m=,-=-MD=--------­lnstitution: Christiana Hospital, Newark, DE Date Proctored: _,7"'--/1'""'0""'/2=0'-'1"""'5 ___________ _ Proctor: Samuel Putnam MD

1. Pre-Treatment Evaluation

Evaluation item l. IR has received and is conversant with the "SIR-Spheres Microspheres Users

Manual" 2. Hospital resources

a. Hospital has eoup!Jlent to perform satisfactory visceral angiography b. Qualitv of hepatic angiograms

i. Power in1ected ii. Anatomy identified, including variant & aberrant vessels

3. Hoseital has a1212ro12riate 12ersonnel assigned to the treatment team a. Medical physicist b. Radiation safety officer (RSO) c. Radiation oncologist/nuclear medicine or lnterventional radiologist (AU) d. Nursing staffi'Ratient coordinator

4. Patient selection & pre-treatment work-up -·-····-

Pass Deficiellt<2>

x

x

x x

x x x x

x _fi· History & physical examination findings reviewed ------b Relevant laboratory results reviewed {LFTs/bilirubin, blood exam::>_ etc.) x c. Triple phase contrast enhanced CT scan of_~hestJabdo/pelvis reviewed x

i--· d. Hcoatic angiograms & variant or abenant vessels correctly identified x e. MAA-Tc99 Jung shunt study performed & correctlv interpreted x f. Patient selected for treatment is an appropriate candidate x g. Pre-treatment work up is satisfactory x

Notes: (I) The Proctoring Eval11ation Form must be comple!ed by the Proctor following the proctoring of a SIR-Spheres mfcrospheres treatment and forwarded to Sirtex

(2) Please add reason and/or comments below to Section 5

SIR-Spheres® is a Registered Trademark of Sirtex SIR-Spheres Pty Ltd

--

Form 102- Proctoring Evaluation Reference: QSOP08

f?pvision #. 4 (CR.1./32) issued: 30 May 2012 Page I of3

..

1e"-Docm:aent ID:

~~~~~~~~~

(Allocated by Sirtcx)

2. Dose Preparation: Sign-Off by Sir~ex Field ptrsonn"I

I Evaluation tem Pass D fi . t 1cient 1. Nuclear medicine hot lab P"crsonncl have the policies and procedures in x

place to accept and prenare the SIR-Spheres microspheres dose 2. Nuclear medicine hot lab personnel can verify and document quantity of x

SIR-Sphere~ micros£_heres ac:!ivi!J delivered to the_p~tient 3. Nuclear medicine hot lab personnel understand radiation safety and x

dec<?ntami n~ti on procedures

3. Treatment Plan

Eva!u~tion Hem Pass 1. SlR-Spheres microsphcres dose determination is satisfu...c:~<?!)' x 2. Treatment plan i~_:5atisfactorv (whole liver vs. lobar vs. segmental) x 3 Hepatic arterial implantation site(s) ofSIR-Snhercs microsnheres is satisfactorv x 4. Physician(s) involved understand:

a. Disease process x b. Their role in the delivery of SIR-Spheres microspheres x c. Possible complications and treatment x d. Treatment planning (whole liver vs. lobar vs. segmental) x --e Dosimetry calculations x f Optima] catheter placement, including

i. Need for embohzation ofGDA, RG, other variants and aberrants x -·--ii. Correct pos._itioning of catheter x

iii. Adequate radiation shielding in place x g Satisfactory nursing care available during and after procedure i x --

4. Peri-Procedural CtJre & Post-Treatment F'ollow-up

Evaluatiolfl Item Pass -....... _ I. Peri-procedural care & supportive therapy/medications understood }{

2. Post-treatment care & foll()w-up und~IS.!()?.d _____ x 3 Post-treatment response assessment and imaging (CT/PET) schedule understood x

5. Comments (attach additional sheets if necessary)

Item# Comments Dosimetry performed by Nuclear Medicirie AU, 3rd proctoring for Dr. Dam; signed off.

First proctored case for Dr. Grilli, IR.

-·---.-··

Form 102-Pmctormg Evalualwn Reference. QSOP08

Reviswn ii: 4 (CRl432) Issued: 30 May 2012

s· 1rteit s· l2

DM

OM

DM

Ddicient

Deficie~t

Page2uf3

('1 ~--'Ji

Document ID:--------­(Alloc:.itcd by Sirtex)

6a. Approval for Proctored Cases

First Proctored Case 0 for Dr. Grilli If Pre-trained please complete section 6b

Second Proctored Case 0

Third Proctored Case lli}for AU only Please complete section 6b

6b. Approval for Future Use of SIR-Spheres Microspberes

In my opinion, the hospital bas the infrastructure in place to receive and to safely treat patients with SIR-Sphcres microspheres: YES (R) NO 0

In my opinion, the Interventional Rad1o!ogist proctored is qualified to implant SIR-Spheres microspheres in cooperation with the Authorized User and does not require additional proctoring: YES 0 NO []

In my opinion, the lnterventional Radiologist proctored requires at least one additional proctoring session: YES (]) NOT NECESSARY 0

In my opin1on, the Authorized User proctored is qualified to implant SIR-Spheres microspheres in cooperation with the lntcrvcntional Radiologist and does not require additional proctoring: YES G} NO 0

Jn my opinion, the Authonzed User proctored requires at least one additional proctoring session: YES 0 NOT NECESSARY l2i:]

7. Signatures

Proctor name (print): Samuel Putnam, MD

... / ' ~--.--:'< ~> ·-;. Proctor Signature: --"If"',~'-·_,'~'-!('-"'.:-' 1_._._,,./"-'M:..=-·/..._1""(.,_.{~·'-..,,_/_..[~.,.-"'"''-,,..--

\ ' Date 7 /10/20 J 5

Proctor: Please fax completed ?roctoriog Evaluation .Form to Sirtex Regional Administrator at the following numbers:

us + 1 (978) 229 9585 EU +49 228 1840 735 AP: +6129964 8410

Form 102- Proctonng Evaluat1011

Reference: QSOP08 Revision#.· 4 (CRI432) ls.med: 30 May 2012 Page3 o/3

This is to acknowledge the receipt of your Jette application ated

J..\ \K\ J..O l lo , and to inform you that the initial processing which includes an admini&trative review has been performed.

~ TheN.£i-J~fa~d1f.~ve C9.J.~, 1<?o!/..t,,,;£g.)., "";gned to a technical reviewer. Please note that the technical review may identify additional omissions or require additional information.

O Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee & Accounts Receivable Branch, who will contact you separately if there is a fee issue involved.

Your action has been assigned Mail Control Number 5:103( r . When calling to inquire about this action, please refer to this control number. You may call us on (610) 337-5398, or 337-5260.

NRC FORM 532 (RI)

(6-96)

Sincerely, Licensing Assistance Team Leader