questions? contact fda/cdrh/oce/did at cdrh … fda/cdrh/oce/did at [email protected] or...

Records processed under FOIA Request 2013-5334; Released 2/6/14

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Traditional 510(k) PREMARKET NOTIFICATION Sonendo Endotherapy System

APPLICANT

Sonendo, Inc. 26061 Merit Circle, Suite 101

Laguna Hills, CA 92653

OFFICIAL CORRESPONDENT

Dan W. Miller Phone: 949.766.3636 x 544

FAX: 949.348.1866 (b)(4)



Sonendo, Inc. Sonendo Endotherapy System

Page 2 of 85 Premarket Notification

SONENDO ENDOTHERAPY SYSTEM TRADITIONAL 510(K) PREMARKET NOTIFICATION

TABLE OF CONTENTS

SECTION PAGE TABLE OF CONTENTS ..........................................................................................................2 1. MEDICAL DEVICE USER FEE COVER SHEET (FORM FDA 3601) ............................ 4

2. CERTIFICATION OF COMPLIANCE WITH CLINICALTRIALS.GOV FDA FORM 3674 5

3. STANDARDS DATA REPORT FDA FORM 3654 ......................................................... 6

4. COVER LETTER ......................................................................................................... 7

5. INDICATIONS FOR USE STATEMENT ....................................................................... 10

6. 510(K) SUMMARY .................................................................................................... 11

7. TRUTHFUL AND ACCURATE STATEMENT ............................................................... 13

8. CLASS III SUMMARY AND CERTIFICATION ............................................................ 14

9. FINANCIAL CERTIFICATION OR DISCLOSURE STATEMENT ................................... 15

10. DECLARATION OF CONFORMITY & SUMMARY REPORTS ..................................... 16

11. EXECUTIVE SUMMARY ........................................................................................... 17

Device Description .................................................................................................. 17

Indications for Use .................................................................................................. 18

Predicate Devices .................................................................................................... 18

Performance Testing ............................................................................................... 19

12. DEVICE DESCRIPTION ............................................................................................. 20

12.1 CONSOLE ........................................................................................................ 21

12.2 MOLAR PROCEDURE KIT ................................................................................ 31

12.3 DEVICE OPERATION ........................................................................................ 35

13. SUBSTANTIAL EQUIVALENCE DISCUSSION ............................................................ 38

14. PROPOSED LABELING ............................................................................................. 45

14.1 SONENDO ENDOTHERAPY MOLAR PROCEDURE KIT INSTRUCTIONS FOR USE . 45

14.2 SONENDO ENDOTHERAPY SYSTEM CONSOLE INSTRUCTIONS FOR USE ........... 46

14.3 PRIMARY LABELING ....................................................................................... 47

15. STERILIZATION AND SHELF LIFE ........................................................................... 52

15.1 STERILITY ....................................................................................................... 52





15.2 SHELF LIFE ..................................................................................................... 53

16. BIOCOMPATIBILITY ................................................................................................ 55

17. SOFTWARE .............................................................................................................. 65

18. ELECTROMAGNETIC COMPATIBILITY AND ELECTRICAL SAFETY ........................ 73

19. PERFORMANCE TESTING ........................................................................................ 74

20. PERFORMANCE TESTING- ANIMALS ...................................................................... 84

21. CLINICAL DATA ...................................................................................................... 85

APPENDICES

(b)(4)



Section 1 Medical Device User Fee cover Sheet



1. Medical Device User Fee Cover Sheet (Form FDA 3601) (see attached)



12/27/12 Site: null

1/2

Form Approved: OMB No 0910-511 Expiration Date: February 28, 2013 See Instructions for OMB Statement

DEPARTMENT OF HEALTH AND HUMANSERVICES FOOD AND DRUG ADMINISTRATION MEDICAL DEVICE USER FEE COVERSHEETA completed cover sheet must accompany each original application or supplement subject tofees. If payment is sent by U.S. mail or courier, please include a copy of this completed formwith payment. Payment and mailing instructions can be found at:http://www.fda.gov/oc/mdufma/coversheet.html

1. COMPANY NAME AND ADDRESS(include name, street address, city state,country, and post office code)

SONENDO INCSonendo, Inc.26061 Merit CircleSuite 10126061 Merit CircleLaguna Hills CA 92653US

1.1 EMPLOYER IDENTIFICATION NUMBER(EIN)

*****1718

2. CONTACT NAME Dan Miller2.1 E-MAIL ADDRESS

2.2 TELEPHONE NUMBER (include Areacode)

949-766-3636

2.3 FACSIMILE (FAX) NUMBER (IncludeArea code)

949-305-5201

3. TYPE OF PREMARKET APPLICATION (Select one of the following in each column; if youare unsure, please refer to the application descriptions at the following web site:http://www.fda.gov/oc/mdufmaSelect an application type: 3.1 Select a center [X] Premarket notification(510(k)); except for third party [X] CDRH [ ] 513(g) Request for Information [ ] CBER [ ] Biologics License Application (BLA) 3.2 Select one of the types below [ ] Premarket Approval Application (PMA) [X] Original Application [ ] Modular PMA Supplement Types: [ ] Product Development Protocol (PDP) [ ] Efficacy (BLA) [ ] Premarket Report (PMR) [ ] Panel Track (PMA, PMR, PDP) [ ] Annual Fee for Periodic Reporting (APR) [ ] Real-Time (PMA, PMR, PDP) [ ] 30-Day Notice [ ] 180-day (PMA, PMR, PDP)

4. ARE YOU A SMALL BUSINESS? (See the instructions for more information on determiningthis status) [ ] YES, I meet the small business criteria and havesubmitted the required qualifying documents to FDA

[X] NO, I am not a small business

4.1 If Yes, please enter your Small Business Decision Number:

(b)(4)

(b)(4)



12/27/12 Site: null

2/2https://userf ees.f da.gov /OA_HTML/mduf maCScdCf gItemsPopup.jsp?v cname=Dan Miller&v cmpname…

"Close Window" Print Cover sheet

5. FDA WILL NOT ACCEPT YOUR SUBMISSION IF YOUR COMPANY HAS NOT PAID ANESTABLISHMENT REGISTRATION FEE THAT IS DUE TO FDA. HAS YOUR COMPANYPAID ALL ESTABLISHMENT REGISTRATION FEES THAT ARE DUE TO FDA? [X] YES (All of our establishments have registered and paid the fee, or this is our first device,and we will register and pay the fee within 30 days of FDA's approval/clearance of this device.) [ ] NO (If "NO," FDA will not accept your submission until you have paid all fees due to FDA.This submission will not be processed; see http://www.fda.gov/cdrh/mdufma for additionalinformation)

6. IS THIS PREMARKET APPLICATION COVERED BY ANY OF THE FOLLOWING USERFEE EXCEPTIONS? IF SO, CHECK THE APPLICABLE EXCEPTION.

[ ] This application is the first PMA submitted by aqualified small business, including any affiliates

[ ] The sole purpose of the application isto support conditions of use for a pediatricpopulation

[ ] This biologics application is submitted undersection 351 of the Public Health Service Act for aproduct licensed for further manufacturing use only

[ ] The application is submitted by a stateor federal government entity for a devicethat is not to be distributed commercially

7. IS THIS A SUPPLEMENT TO A PREMARKET APPLICATION FOR WHICH FEES WEREWAIVED DUE TO SOLE USE IN A PEDIATRIC POPULATION THAT NOW PROPOSESCONDITION OF USE FOR ANY ADULT POPULATION? (If so, the application is subject to thefee that applies for an original premarket approval application (PMA). [ ] YES [X] NO

PAPERWORK REDUCTION ACT STATEMENT Public reporting burden for this collection of information is estimated to average 18 minutesper response, including the time for reviewing instructions, searching existing data sources,gathering and maintaining the data needed, and completing and reviewing the collection ofinformation. Send comments regarding this burden estimate or any other aspect of thiscollection of information, including suggestions for reducing this burden, to the address below.

Department of Health and Human Services, Food and Drug Administration, Office of ChiefInformation Officer, 1350 Piccard Drive, 4th Floor Rockville, MD 20850 [Please do NOT return this form to the above address, except as it pertains to comments onthe burden estimate.]

8. USER FEE PAYMENT AMOUNT SUBMITTED FOR THIS PREMARKETAPPLICATION

27-Dec-2012

Form FDA 3601 (01/2007)

(b)(4)



Section 2 Certification of Compliance- ClinicalTrials.gov



2. Certification of Compliance with ClinicalTrials.gov FDA Form 3674 (see attached)



Section 3 Standards Data Report Form(s)



3. Standards Data Report FDA Form 3654 (see attached)



Section 5 Indications for Use Statement

5. Indications for Use Statement

INDICATIONS FOR USE STATEMENT 510(k) Number (if known): ___________ Device Name: Sonendo Endotherapy System Indications for Use: The Sonendo Endotherapy System is intended to prepare, clean and irrigate 1st and 2nd molar teeth indicated for root canal therapy.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ________________________________________________________________________

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page __ of ___

Prescription Use __X___

AND/OR Over-The-Counter Use_____

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)



Section 6 510(k) Summary



6. 510(k) Summary This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT: Sonendo, Inc.

DATE PREPARED: December 29, 2012

CONTACT PERSON: Dan W. Miller Sonendo, Inc. 26061 Merit Circle, Suite 101 Laguna Hills, CA 92653 Phone: (949) 766.3636 x 544

TRADE NAME: Sonendo Endotherapy System

CLASSIFICATION NAME:

Ultrasonic Scaler

DEVICE CLASSIFICATION:

Class 2, per 21 CFR 872.4850

PRODUCT CODE ELC

PREDICATE DEVICES: EMS Piezon Master 700 (K093000) Sonic Air MM 1500+ (MID) (K081268)

Substantially Equivalent To: The Sonendo Endotherapy System is substantially equivalent in intended use, principal of operation and technological characteristics to the EMS Piezon Master 700 (K093000) and the Sonic Air MM 1500+ (MID) (K081268). Description of the Device Subject to Premarket Notification: The Sonendo Endotherapy System is a medical device intended to prepare, clean and irrigate root canals. The Sonendo Endotherapy System is comprised of a Console, Foot Pedal and Molar Procedure Kit with a Handpiece. Indication for Use: The Sonendo Endotherapy System is intended to prepare, clean and irrigate 1st and 2nd molar teeth indicated for root canal therapy. Technical Characteristics: The Sonendo Endotherapy System has similar physical and technical characteristics to the predicate devices. These characteristics are tabulated below:



Section 6 510(k) Summary



Performance Data:

(b)(4)

(b)(4)



Section 7 Truthful & Accurate Statement



7. Truthful and Accurate Statement Pursuant to 21 CFR 807.87(j) I certify that in my capacity as Vice President, Quality/Regulatory/Clinical Affairs for Sonendo, Inc., I believe to the best of my knowledge, that all data and information submitted in this premarket notification are truthful and accurate and that no material fact has been omitted.

_________________________________________ ________________ Dan W. Miller Date Sonendo, Inc.



Section 8 Class III Summary and Certification



8. Class III Summary and Certification The Sonendo Endotherapy System is a Class II medical device under 21 CFR 872.4850. The Class III Summary and Certification requirement as described in 21 CFR §807.87(j) and §807.94 do not apply to this device and submission.



Section 9 Financial Certification or Disclosure Statement



9. Financial Certification or Disclosure Statement The requirement for financial certification or disclosure requirement as described in 21 CFR §807.87(i) does not apply to this submission.



Section 10 Declaration of Conformity & Summary Reports



10. Declaration of Conformity & Summary Reports This submission is a traditional 510(k) submission. The requirement for a declaration of conformity and a summary report of testing does not apply.



Section 11 Executive Summary



11. Executive Summary (b)(4)



Section 11 Executive Summary



(b)(4)



Sonendo Endotherapy System

Molar Procedure Kit DRAFT

Instructions for Use

Federal law restricts this device to sale by or on the order of licensed dental professional

26061 Merit Circle, Suite 101 Laguna Hills, CA 92653 PH: 949-766-3636 FAX:949-348-1866



Section 15 Sterilization & Shelf Life



15. Sterilization and Shelf Life

Sterilization Validation

(b)(4)

(b)(4)






(b)(4)






.

(b)(4)



Section 16 Biocompatibility



16. Biocompatibility (b)(4)



(b)(4) Biocompatibility DataRecords processed under FOIA Request 2013-5334; Released 2/6/14


Section 17 Software



17. Software (b)(4)



Section 19 Performance Testing- Bench



19. Performance Testing (b)(4)



Appendices

Sonendo, Inc.

Sonendo Endotherapy System Page 1

Premarket Notification

Appendix 2 Sonendo Endotherapy System Technical Drawings

(see attached)



(b)(4) Records processed under FOIA Request 2013-5334; Released 2/6/14


Appendices

Sonendo, Inc.



Appendix 3 Sonendo Endotherapy System Biocompatibility Reports

(see attached)



CONFIDENTIAL Sonendo ®

Title Software Risk/Hazard Analysis

Sonendo ® | Page 1 of 19

Software Risk/Hazard Analysis

(b)(4)



Appendices

Sonendo, Inc.



Appendix 11 Sonendo Endotherapy System Electromagnetic Compatibility Test

Report

(see attached)



Appendices

Sonendo, Inc.



Appendix 13 , Thermal Safety Experiment Report

(see attached)

(b)(4)



SONENDO Inc –Confidential (b)(4)



Appendices

Sonendo, Inc.



Appendix 17 Imaging of Cavitation Clouds

(see attached)



CONFIDENTIAL Sonendo™

(b)(4)

(b)(4)

(b)(4)



Appendix I

Optical Analysis via Stereo Microscope (8x)

Thirteen specimens imaged at 8x magnification


(b)(4)

(b)(4)



SONENDO Inc.–Confidential

Appendix II

Optical Analysis via Stereo Microscope (8x)

Five specimens imaged at 8x magnification

EMS Piezon Master 700

(b)(4)

(b)(4)



Appendix III

Optical Analysis via Scanning Electron Microscope

Four canals imaged at 50x and 200x magnification


(b)(4)

(b)(4)



SONENDO Inc.–Confidential

Appendix IV

Optical Analysis via Scanning Electron Microscope

Four canals imaged at 50x and 200x magnification

EMS Piezon Master 700

(b)(4)

(b)(4) (b)(4)



of 6 Pages

Supplement

CDRH PREMARKET REVIEW SUBMISSION COVER SHEET

Form Approval OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on page 5.

Date of Submission

(If Yes, please complete Section I, Page 5)

Division Name (if applicable) Phone Number (including area code)

Street Address FAX Number (including area code)

City

Contact Name

Contact E-mail Address

Company / Institution Name

Contact Title

ZIP/Postal CodeState / Province

Division Name (if applicable) Phone Number (including area code)

Street Address FAX Number (including area code)

City

Contact Name

Contact E-mail Address

Evaluation of Automatic Class III Designation

(De Novo)

APPLICATION CORRESPONDENT (e.g., consultant, if different from above)

FORM FDA 3514 (1/13)

PMA PMA & HDE Supplement

Establishment Registration Number (if known)

Original Submission

PDP 510(k)

Other SubmissionHumanitarian Device Exemption (HDE)

Amendment

Class II Exemption Petition

Original SubmissionAdditional Information

Original Submission Original Submission

Additional InformationOriginal Submission

Amendment

No

Supplement

SUBMITTER, APPLICANT OR SPONSOR

IDE

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

Report Amendment

TYPE OF SUBMISSION

State / Province ZIP Code Country

Country

Additional Information

Other (describe submission):

Contact Title

FDA Submission Document Number (if known)User Fee Payment ID Number

513(g)

Notice of CompletionAmendment to PDP

Original PDPRegular (180 day)SpecialPanel Track (PMA Only)30-day Supplement30-day Notice135-day SupplementReal-time Review

Abbreviated (Complete section I, Page 5)

SpecialTraditional

Original Submission:

Modular Submission

Other

AmendmentReportReport Amendment

Premarket Report

Licensing Agreement Third Party

Amendment to PMA & HDE Supplement

Company / Institution Name

Have you used or cited Standards in your submission?

Report

Yes

December 29, 2012 MD6066279-956733 K130025

Sonendo, Inc

NA 949-766-3636

26061 Merit Circle, Suit 101 949-305-5201

Laguna HIlls CA 92653 USA

Dan Miller

Vice President of Regulatory/Clinical Affairs, and Quality Assurance [email protected]

SECTION A

SECTION C

SECTION B

PSC Publishing Services (301) 443-6740 EF

Request for Feedback

Informational Meeting

Study Risk Determination

Pre-Submission

Day 100 MeetingAgreement MeetingDetermination Meeting

Submision Issue Meeting

Other (specify):



of 6 Pages

Additional or Expanded Indications

Request for Applicant Hold

Withdrawal

Post-approval Study Protocol

Request to Remove or Add Manufacturing Site

Request for Extension

Request for Removal of Applicant Hold

New Device

Manufacturing PackagingSterilization

Other (specify below)

Post-approval Study

Packager

Process change:

Response to FDA correspondence: Change of Applicant Address

Location change:

SterilizerManufacturer

New Indication

Request Hearing

Other Reason (specify):

Adverse ReactionDevice DefectAmendment

Change in design, component, or specification:

Report Submission:Annual or Periodic

Color AdditiveMaterial

Software / Hardware

Change in OwnershipChange in Correspondent

SpecificationsOther (specify below)

Labeling change:Indications

Performance CharacteristicsInstructions

Shelf LifeTrade NameOther (specify below)


Change in TechnologyNew Device

REASON FOR APPLICATION - PMA, PDP, OR HDE

REASON FOR SUBMISSION - 510(k)

FORM FDA 3514 (1/13)

REASON FOR APPLICATION - IDE

New Device

Expansion / Extension of StudyIRB Certification

Addition of Institution

Termination of StudyWithdrawal of Application

Continued Access

Unanticipated Adverse Effect

Compassionate Use RequestTreatment IDE

Notification of Emergency Use

Change in:

Design / DeviceInformed Consent

Correspondent / Applicant

Manufacturer

Protocol - FeasibilityProtocol - Other

Manufacturing Process

Response to FDA Letter Concerning:

Sponsor

Deemed ApprovedDeficient Final Report

Conditional Approval

Site Waiver Report

Current InvestigatorAnnual Progress Report

Report submission:

Deficient Progress Report

DisapprovalRequest Extension of Time to Respond to FDA

Deficient Investigator Report

Request Meeting

Final


Additional or Expanded Indications

March 12, 2013: First Round Deficiencies Notification, Dr. Belani

SECTION D1

SECTION D3

SECTION D2



of 6 Pages

Trade or Proprietary or Model Name510(k) Number

Product codes of devices to which substantial equivalence is claimed

5

Manufacturer

Information on devices to which substantial equivalence is claimed (if known)

1

PRODUCT INFORMATION - APPLICATION TO ALL APPLICATIONS

2

PRODUCT CLASSIFICATION - APPLICATION TO ALL APPLICATIONS

Common or usual name or classification name

Trade or Proprietary or Model Name for This Device

3

Model Number

3

FDA document numbers of all prior related submissions (regardless of outcome)

8

2

9

3

10

Data Included in SubmissionLaboratory Testing Animal Trials Human Trials

Device ClassProduct Code C.F.R. Section (if applicable)

Classification Panel

Indications (from labeling)

Class I Class II

Class III Unclassified

Summary of, or statement concerning, safety and effectiveness information

510 (k) summary attached510 (k) statement

ADDITIONAL INFORMATION ON 510(K) SUBMISSIONS

FORM FDA 3514 (1/13)

7

3

4

8

4

2

3

6

2

7

1

11

5

12

6

3

1 1

4

5

6

4

5

6

2

3

1

4

5

6

4

1

2

5

4

1

2

5

ELC

K093000 EMS Piezon Master 700 EMS Electro Medical Systems SA

K081268 Sonic Air MM 1500+ (MID) Micro-Mega S.A.

Ultrasonic Scaler


Sonendo Endotherpay Molar Handpiece Kit

109-0008-001

109-0006-001

K130025

ELC 21 CFR 872.4850

The Sonendo Endotherapy System is intended to prepare, clean and irrigate 1st and 2nd molar teeth indicated for root canal therapy.

SECTION F

SECTION G

SECTION ERecords processed under FOIA Request 2013-5334; Released 2/6/14


Note: Submission of the information entered in Section H does not affect the need to submit device establishment registration.

FDA Document Number (if known)

MANUFACTURING / PACKAGING / STERILIZATION SITES RELATING TO A SUBMISSION

K130025

SECTION H(b)(4)



of 6 Pages

UTILIZATION OF STANDARDS

FORM FDA 3514 (1/13)

Standards Organization

Please include any additional standards to be cited on a separate page.

The burden time for this collection of information is estimated to average 0.5 hour per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW.*

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff 1350 Piccard Drive, Room 400 Rockville, MD 20850

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

7

Note: Complete this section if your application or submission cites standards or includes a "Declaration of Conformity to a Recognized Standard" statement.

1

2

3

4

5

6

DateStandards No. Standards Title Version













ISO 10993-1 International Organization for Standardization

Biological Evaluation of Medical Device- Part 1 Evaluation and Testing

4

01/01/2009

ISO 10993-5 International Organization for Standardization

Biological Evaluation of Medical Device- Part 5 Tests for In Vitro Cytotoxicity

3

01/01/2009

ISO 10993-10International Organization for Standardization

Biological Evaluation of Medical Device- Part 10 Tests for Irritation and Delayed Hypersensitivity

3

01/01/2010


Biological Evaluation of Medical Device- Part 11 Tests for Systemic Toxicity

2

01/01/2006


Sterilization of Health Care Products- Radiation- Part 1 Requirements for Development of Validation

1

01/01/2006


Sterilization of Health Care Products- Radiation- Part 2 Establishing Sterilization Dose

2

01/01/2006

IEC 60601-1-1-2 International Electrotechnical Commission

Medical electrical equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests 3

01/01/2007

SECTION I Records processed under FOIA Request 2013-5334; Released 2/6/14


FDA FORM 3514 K130025: Section I Utilization of Standards (continued)

# Standards No.


Standards Title Version Date

8 IEC 60601-1 International Electrotechnical Commission

Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995

3 01/01/2006

9 ISO 11607-1 International Organization for Standardization

Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems

1 01/01/2006

Page 1 of 1



Section 19 Performance Testing- Bench

19. Performance Testing

(b)(4)



questions? contact fda/cdrh/oce/did at cdrh … fda/cdrh/oce/did at [email protected] or...

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