A DIFFERENT APPROACH TO TONSILLECTOMYA procedural solution from the Valleylab™ energy portfolio, the BiZact™ device is designed for tonsillectomy

TABLE OF CONTENTS

Product Information

Introduction 3

Technology Overview 4

Device Features 5

Device Performance 6

Materials Management Information

Indications for Use 7

Product Request Form 8

Ordering Information 9

References 9

510(k) Clearance 10

3 | Introduction

LESS BLEEDING.1,†

FASTER PROCEDURES.1-3 ‡ MORE IDEAL OUTCOMES.We believe there is a better tonsillectomy procedure — for surgeons and patients entrusted in their care. It’s now possible with the BiZact™ tonsillectomy device, in surgeons’ hands.

The BiZact™ tonsillectomy device has been shown to:

∙ Result in no measurable intraoperative bloodloss, based on a prospective study with 48 adult patients1,†

∙ Provides faster setup and more efficient procedures1-4,‡,§

In some studies, technology similar to the BiZact™ device helped tonsillectomy patients experience less pain.5,Ω

It’s one of the latest surgical innovations from the Valleylab™ energy portfolio, borne out of our commitment to continually advance patient care, together.

† Adults 22 and older in the United States and 18 and older in the European Union. Compared to conventional techniques and Coblation™*.

‡ Used in 48 cases, including adults (22+) US (18+) EU. Average procedure time for the BiZact™ tonsillectomy device was 6 min. compared to published literature stating 14.8 (pediatric) and 20.5 (adult) min. [Lee] for Electrocautery and 27.3 min. [Omrani] for Coblator™*

§11 out of 12 surgeons 13 out of 15 nurses surveyed agreed.ΩCompared to conventional techniques. BiZact™ was not a part of this meta-analysis

LOW ENERGY LEVELS. HIGH CLINICAL VALUE.The BiZact™ device is powered by Valleylab™ energy platforms that deliver consistent and reliable seals

The BiZact™ device uses advanced bipolar energy to permanently seal vessels up to and including 3 mm.6 It’s powered by Valleylab™ energy platforms that:

∙ Continuously measure impedance of clamped tissue

∙ Appropriately adjust energy levels — in real time — to maintain the desired tissue effect

∙ Automatically stop energy delivery when the seal is complete

The clinical result is seals withstand three times normal systolic blood pressure,8,† and minimal thermal damage to tissue.9,‡

BiZact™ device vs. monopolar electrosurgery7

Mid-seal

Post-seal

4 | Technology Overview

†Based on internal bench testing, probability of burst ≥ 360 mm Hg is ≥ 96.1%. ‡The average thermal spread of the BiZact™ device is less than 1 mm.

5 | Device Features

DESIGNED FOR TONSILLECTOMY Seal and divide tonsil tissue in one step

Ergonomic handle

ensures comfort in either hand

12 cm shaft

provides optimal access

Curved jaw

follows the shape of tonsil bed

In-line activation

facilitates intuitive control and efficient sealing and transection

FAST EASY SETUP4,†

†12 out of 12 surgeons and 13 out of 15 nurses surveyed agreed.

‡Feedback provided March 2017 after 30 procedures.

Simple setup contributes to procedural efficiency — and it’s easier than the Coblator™* device.4

“Nurses are very happy with it.”‡

Dr. Eng Ooi

Head of Otolaryngology Head and Neck Surgery Unit at Flinders Medical Centre and Associate Professor, Flinders University, Adelaide, Australia

Picrosirius Red (PSR) Stained Images13,§

BiZact™ device

BiZact™ device

Monopolar electrosurgery

Monopolar electrosurgery

Coblator™* device

Coblator™* device

Hematoxylin and Eosin (H&E) Stained Images

Vessel is completely occluded

Vessel is completely occluded

Damaged tissue and incomplete seal

Damaged tissue and incomplete seal

§Damaged tissue is dark red and undamaged tissue is gold.

Vessel is not occluded

Vessel is not occluded

6 | Device Performance

DIFFERENT TECHNIQUE. BETTER RESULTS.Compared to the Coblator™* device, the BiZact™ tonsillectomy device:

∙ Offers easier setup4,†

∙ Reduces intraoperative bleeding10–12,‡

Compared to an electrosurgical pencil, the BiZact™ tonsillectomy device provides:

∙ Less bleeding during surgery10–12,‡

∙ Significantly lower maximum external jaw temperature7

∙ Significantly faster jaw cooldown time to 60 C7

†12 out of 12 surgeons and 13 out of 15 nurses surveyed agreed.‡ Average intraoperative bleeding in 17 cases was 7.3 mL for BiZact™ device, compared to published

literature results for Coblator™* device (10.83 mL) and electrocautery (27.08 mL)6 and cold knife (73 mL).7

EFFICIENT AND EFFECTIVE

Dr. Ron J. Karni

Chief, Division of Head & Neck Surgical Oncology; Associate Professor, Department of Otorhinolaryngology – Head & Neck Surgery

University of Texas Medical School at Houston

Feedback provided March 2017 after 30 procedures

“ The removal is so efficient in terms of vessel sealing that it’s quite rare for us to have to actually do anything once the tonsil’s removed.”

§Damaged tissue is dark red and undamaged tissue is gold.

INDICATIONS FOR USEThe BiZact™ device is a bipolar instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.

The tissue fusion function of the device can be used on vessels(arteries and veins) and lymphatics up to and including 3 mm diameter. The BiZact™ device is indicated for use in open general surgical procedures.

It is also indicated for adult and adolescent ENT procedures (12 years of age and above), including tonsillectomy, for the ligation and division of vessels, tissue bundles and lymphatics 2-3 mm away from unintended thermally sensitive structures.

The BiZact™ device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use for these procedures.

5920 Longbow DriveBoulder, CO 80301

800.722.8772 medtronic.com/covidien

© 2018 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. ™* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. 11/2018 – US170492(1) – [WF# 1601715]

PRODUCT REQUEST FORMI’m requesting the following instrument to convert my practice to the BiZact™ tonsillectomy technique:

BiZact™ tonsillectomy device (BZ4212A)

The BiZact™ device:

∙ Resulted in non-measurable intraoperative blood loss, based on a prospective study including 48 adults patients1,†

∙ Provides efficiency throughout the procedure1–3,‡

With a 3 mm vessel-sealing indication4 and curved jaws that follow the shape of the tonsil bed, the BiZact™ device is designed specifically for tonsillectomy procedures.

In some studies, technology similar to the BiZact device helped tonsillectomy patients experience less pain.5,§

Thank you for reviewing this information. Please feel free to contact me if you have any questions.

Sincerely,

Additional comments:

BiZact™ device seals withstand 3X normal systolic blood pressure6,Ω

†Adults 22 and older in the United States and 18 and older in the European Union.‡ Used in 48 cases, including adults (22+) US (18+) EU. Average procedure time for the BiZact™

tonsillectomy device was 6 min. compared to published literature stating 14.8 (pediatric) and 20.5 (adult) min. [Lee] for Electrocautery and 16.32 min. [Omrani] for Coblator™*”.

§Compared to conventional techniques. BiZact™ was not a part of this meta-analysis.ΩBased on internal bench testing, probability of burst ≥ 360 mmHg is ≥ 96.1%.

References1. Karni, R., Attner, P. . A prospective, multi-center, single arm, non-comparative pilot study of BiZact™ on

adults undergoing tonsillectomy. Data on file. Study sponsored by Medtronic. ClinicalTrials.gov Identifier: NCT02876575; 2018.

2. Lee SW, Jeon SS, Lee JD, Lee JY, Kim SC, Koh YW. A comparison of postoperative pain and complications in tonsillectomy using BiClamp™* forceps and electrocautery tonsillectomy. Otolaryngol Head Neck Surg. 2008;139(2):228-234.

3. Omrani M, Barati B, Omidifar N, Okhovvat AR, Hashemi SA. Coblation™* versus traditional tonsillectomy: A double blind randomized controlled trial. J Res Med Sci. 2012;17(1):45-50.

4. BiZact™ Tonsillectomy Device [instructions for use]. Boulder, CO: Medtronic; 2018.5. Alexiou VG, Salazar-Salvia MS, Jervis PN, Falagas ME. Modern technology-assisted vs conventional

tonsillectomy: A meta-analysis of randomized controlled trials. Arch Otolaryngology Head Neck Surg. 2011;137(6):558-570.

6. Based on internal test report #RE00077022, Porcine testing. Jan. 9–10, 2017.

Ordering Information

5920 Longbow DriveBoulder, CO 80301

800.722.8772 medtronic.com/covidien

© 2018 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. ™* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. 12/2018 – US170492(1) – [WF# 1601715]

Photo credit Getty Images

References

1. Karni, R., Attner, P. A prospective, multi-center, single arm, non-comparative pilot study of BiZact™ on adults undergoing tonsillectomy. Data on file. Study sponsored by Medtronic. ClinicalTrials.gov Identifier: NCT02876575; 2018.

2. Lee SW, Jeon SS, Lee JD, Lee JY, Kim SC, Koh YW. A comparison of postoperative pain and complications in tonsillectomy using BiClamp™* forceps and electrocautery tonsillectomy. Otolaryngol Head Neck Surg. 2008;139(2):228-234.

3. Omrani M, Barati B, Omidifar N, Okhovvat AR, Hashemi SA. Coblation™* versus traditional tonsillectomy: A double blind randomized controlled trial. J Res Med Sci. 2012;17(1):45-50.

4. Based on internal test report #RE00073873 and #RE00079704, Independent surgeon and nurse feedback collected during Medtronic-sponsored labs. January and February 2017.

5. Alexiou VG, Salazar-Salvia MS, Jervis PN, Falagas ME. Modern Technology-Assisted vs Conventional Tonsillectomy: A Meta-analysis of Randomized Controlled Trials. Arch Otolaryngology Head Neck Surg. 2011;137(6):558-570.

6. BiZact™ Tonsillectomy Device [instructions for use]. Boulder, CO: Medtronic; 2018.7. Based on internal test report #RE00011247, Benchtop testing comparing the BiZact™ tonsillectomy device with the E1551X Valleylab™ Hex-locking blade

electrode. March 23, 2017. 8. Based on internal test report #RE00077022, Porcine testing. Jan. 9–10, 2017.9. Based on internal test report #RE00015788, Tissue testing. March 23, 2017.10. Based on internal test report #RE00003687, Data collected during 17 procedures for product introduction. April–June 2017.11. Roje Z, Racić G, Dogas Z, Pisac VP, Timms M. Postoperative morbidity and histopathologic characteristics of tonsillar tissue following coblation tonsillectomy in

children: a prospective randomized single-blinded study. Coll Antropol. 2009;33(1):293–298.12. Lachanas VA, Prokopakis EP, Bourolias CA, et al. LigaSure™ versus cold knife tonsillectomy. Laryngoscope. 2005;115(9):1591–159413. Based on internal test report #RE00089921, Histological image collection with BiZact™ BZ4212, a monopolar electrosurgical device E1551X, and the Coblator™*

Surgery System. March 30 and April 11, 2017.

LET’S OPTIMIZE TONSILLECTOMY PROCEDURES

Contact your Medtronic sales representative today to trial the BiZact™ tonsillectomy device

Ordering informationBZ4212A, six per case800-722-8772medtronic.com/bizact

510(k) CLEARANCE

U.S. Food & Drug Administration 10903 New Hampshire Avenue D o c I D # 0 4 0 Silver Spring, MD 20993 www.fda.gov

Covidien, LLC Rebecca Clark Senior Regulatory Affairs Specialist 5920 Longbow Drive Boulder, CO 80301 Re: K182451

Trade/Device Name: BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider

Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 6, 2018 Received: September 7, 2018

Dear Rebecca Clark: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

510(k) CLEARANCE

K182451 - Rebecca Clark Page

2

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health