LOSE THE CORD. GAIN SAFETY, & EFFICIENCY. · Competitive Cross-Reference 8 Material Management 510(k) Clearance 12 Indications for Use 14 Product Request Form 15 Ordering Information

LOSE THE CORD.GAIN SAFETY, MOBILITY & EFFICIENCY. Performance, safety, and value come together with our ultrasonic portfolio

Sonicision™ System

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CONTENTS

Introduction 3

Product Information

Features & Benefits 4

Portfolio Description 6

Clinical Performance 7

Competitive Cross-Reference 8

Material Management

510(k) Clearance 12

Indications for Use 14

Product Request Form 15

Ordering Information 16

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INTRODUCTION

VALUE ANDVERSATILITYWITH NO STRINGS ATTACHED.Our advanced energy portfolio meets all your ultrasonic dissection needs and — with its cordless design — contributes to a safer OR1

Imagine an OR free of cords. No tripping hazards, effortless instrument exchanges, and fewer distractions that take focus off the patient.

That vision for a safer2, more efficient OR inspired the first and only cordless ultrasonic device, the Sonicision™ system.

More experience. More choice. More opportunity to save.Surgical solutions built over more than 50 years of collaboration with healthcare professionals, to advance patient care and solve clinical challenges. So you get more choice and more opportunity to save through standardization.

FEATURES & BENEFITS

SAFETY. SIMPLICITY.EFFICIENCY.

14.5 mm active blade reliably seals vessels up to 5 mm5

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Setup requires only one person, and can occur within the sterile field

Generator can be reused up to 100 times4

Advanced lithium battery can be reused up to 100 times

Shaft comes in four lengths — and there’s no other ultrasonic pistol grip device on the market with a shorter or longer option

13 cm

26 cm

39 cm

48 cm

Self-contained system saves space and can be used in any OR

Doesn’t require software upgrades

Single energy activation button — with two power settings — improves focus on the procedure2,3

Integrated LED provides device feedback

Cordless design improves freedom of movement and contributes to a safer OR and patient experience1

Uses 5 mm trocar

Unlimited rotation

Sonicision™ Cordless Ultrasonic Dissector

FEATURES & BENEFITS

YOU’RE NOWFREE TO MOVE ABOUT THE OR.

Discover the powerful benefits of the first — and only — cordless ultrasonic dissector

GOLD WINNER2 0 1 3

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We’re making the OR safer for healthcare professionals and the patients entrusted in their care. Because our ultrasonic dissection system not only reliably seals vessels3, its one-of-a-kind cordless design2,3:

∙ Reduces cords and potential tripping hazards

∙ Improves freedom of movement

∙ Makes it easier to pass the device

Groundbreaking innovationSeveral leading medical technology organizations have recognized the Sonicision™ cordless ultrasonic dissector for its design, including:

∙ Medical Design Excellence Awards (MDEA), 2013 Gold Winner

∙ Excellence in Surgical Products Award, 2013 Best in Show (second place)

∙ Design Zentrum Nordrhein, 2014 Red Dot Award Winner

PORTFOLIO DESCRIPTION

STANDARDIZE. SIMPLIFY. SAVE.

A complete portfolio that meets all your ultrasonic dissection needs

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FREEDOM OF MOVEMENT COMES STANDARD. YOU PICK YOUR SIZE.

Consolidating to the Sonicision™

system portfolio qualifies your facility for a preferred tier pricing. And:

∙ Reduces SKU inventory management

∙ Reduces cost burden compared to traditional capital equipment

∙ Reduces the number of suppliers

13 cm

26 cm

39 cm

48 cm

CLINICAL PERFORMANCE

SPEED.SAFETY.RELIABILITY.

The Sonicision™ device outperforms competitive devices in key areas

27% FASTER dissection than Harmonic Ace™* device5†

18.3% FASTERactive blade cool down to 60 C than Harmonic Ace™* device6

5x LESS PLUME than Harmonic Ace™* device7

The Sonicision™ device also has less lateral thermal spread and lower maximum jaw temperature than the Thunderbeat™* device.8,9 And is comparable to the Harmonic Ace™* and Harmonic Ace+™* devices in the following performance areas:

∙ Seal time5,9

∙ Seal burst pressure5,10

∙ Peak active blade temperature9,11

∙ Thermal spread5,8

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† Comparing Harmonic Ace™* and Sonicision™ cordless ultrasonic dissector in an in vivo porcine model to coagulate 189 arteries up to 5 mm.

COMPETITIVE CROSS-REFERENCE

SONICISION™ DEVICE 13 CM

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Company Description Product Code Shaft Length (cm)

Shaft Diameter (mm)

Generator

Medtronic Sonicision™ Ultrasonic Dissector

SCD13 13 5 SCG Cordless Reusable Generator

Ethicon Harmonic Focus™* Curved Shears

FCS9 9 N/A Ethicon Endo-Surg Gen11

Ethicon Harmonic Focus™* + Curved Shears

HAR9F 9 N/A Ethicon Endo-Surg Gen11

Ethicon Harmonic Focus™* Long Shears


Ethicon Harmonic Focus™* + Long Shears


Olympus Thunderbeat™* Inline Grip Instrument

TB-0510IC 10 5 USG-400 Ultrasonic Generator / ESG-400 Electrosurgery Generator



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Shaft Diameter (mm)

Generator



Ethicon Harmonic Focus™* Long Curved Shears


Ethicon Harmonic Focus™* + Long Shears


Ethicon Harmonic Ace™* Curved Shears

ACE23E 23 5 Ethicon Endo-Surg Gen11

Ethicon Harmonic Ace™* + Shears

HAR23 23 5 Ethicon Endo-Surg Gen11

Ethicon Harmonic Ace™* +7 Shears with advanced hemostasis

HARH23 23 5 Ethicon Endo-Surg Gen11

Ethicon Harmonic™* HD1000i Shears HARHD20 20 5 Ethicon Endo-Surg Gen11





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Shaft Diameter (mm)

Generator



Ethicon Harmonic Ace™* with Ergonomic Grip


Ethicon Harmonic Ace™* Shears

HAR36 36 5 Ethicon Endo-Surg Gen11

Ethicon Harmonic Ace™*+7 shears with advanced hemostasis


Ethicon Harmonic™* HD 1000i shears

HARHD36 36 5 Ethicon Endo-Surg Gen11

Olympus Thunderbeat™* Front-Actuated Grip

TB-0535FC 35 5 USG-400 Ultrasonic Generator/ ESG-400 Electrosurgery Generator

Olympus Thunderbeat™* Pistol Grip Instrument

TB-0535PC 35 5 USG-400 Ultrasonic Generator/ ESG-400 Electrosurgery Generator


TB-0535IC 35 5 USG-400 Ultrasonic Generator/ ESG-400 Electrosurgery Generator

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Shaft Diameter (mm)

Generator



Ethicon Harmonic Ace™* Curved Shears


Ethicon Harmonic Ace™* +7 shears with advanced hemostasis


Olympus Thunderbeat™* Front-Actuated Grip

TB-0545FC 45 5 USG-400 Ultrasonic Generator / ESG-400 Electrosurgery Generator

Olympus Thunderbeat™* Pistol Grip Instrument

TB-0545PC 45 5 USG-400 Ultrasonic Generator / ESG-400 Electrosurgery Generator





510(K) CLEARANCE

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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center – WO66-G609 Silver Spring, MD 20993-0002

March 28, 2016

Covidien LLC Ms. Nancy Sauer Principal Regulatory Affairs Specialist 5920 Longbow Drive Boulder, Colorado 80301

Re: K153371 Trade/Device Name: Sonicision Cordless Ultrasonic Dissection Device Regulation Name: Instrument, Ultrasonic Surgical Regulatory Class: Unclassified Product Code: LFL Dated: February 24, 2016 Received: February 26, 2016

Dear Ms. Sauer:

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. 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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

510(K) CLEARANCE

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Page 2 – Ms. Nancy Sauer

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. DirectorDivision of Surgical DevicesOffice of Device EvaluationCenter for Devices and Radiological Health

Enclosure

Jennifer R. Stevenson -A

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INDICATIONS FOR USE

FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.

510(k) Number (if known)K153371

Device NameSonicision™ Cordless Ultrasonic Dissection Device

Indications for Use (Describe)The Sonicision Cordless Ultrasonic Dissection Device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to 5 mm in diameter. The Sonicision 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

The burden time for this collection of information is estimated to average 79 hours 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:

Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) [email protected]

“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 number.”

I am requesting the following instruments be stocked in our facility so that I have consistent access to them for my cases:

F Sonicision™ Cordless Ultrasonic Dissector 13 cm (SCD13)




The first and only cordless dissector, the Sonicision™ device:

∙ Contributes to a safer OR and patient experience1

∙ Reliably seals vessels up to 5 mm2

∙ Comes in four lengths — including the longest and shortest pistol grip available in the market — to accommodate all your procedural needs

∙ Improves OR efficiency with a simplified setup

We believe that the Sonicision™ device will add value for our patients and our hospital. Consolidating to the Sonicision™ system portfolio also qualifies our facility for a preferred tier pricing. And:

∙ Reduces SKU inventory management

∙ Reduces cost burden compared to traditional capital equipment

∙ Reduces the number of suppliers

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

Sincerely,

Additional Comments:

1. Brogmus G, Leone W, Butler L, Hernandez E. Best practices in OR suite layout and equipment choices to reduce slips, trips, and falls. AORN J. 2007;86(3):384–394.

2. Tsirline VB, Lau KN, Swan RZ, et al. Evaluation of an innovative, cordless ultrasonic dissector. Surg Innov. 2013;20(5):524–529.

PRODUCT REQUEST FORM

5920 Longbow DriveBoulder, CO 80301

800.722.8772 medtronic.com/covidien

© 2017 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together aretrademarks of Medtronic. All other brands are trademarks of a Medtronic company. 11/2017 – US161203a – [WF# 1298489]

Code Description Quantity

SCD13 13 cm ultrasonic dissector Six (one torque wrench included with each dissector)




SCB Reusable battery One

SCG Reusable generator One

CBC Battery charger (four bays) One

SCST Sterilization tray (U.S. customers only) One

SCST1 Sterilization tray (outside U.S. customers only) One

ORDERING INFORMATION

Get the energy you need — without the cord. Contact your local Medtronic sales representative for more information or visit medtronic.com/covidien.

1. Brogmus G, Leone W, Butler L, Hernandez E. Best practices in OR suite layout and equipment choices to reduce slips, trips, and falls. AORN J. 2007;86(3):384–394.

2. Based on internal test report # R0014853 Rev A, Usability validation report surgical evaluation of Milwaukee: independent surgeon feedback collected during internally-sponsored cadaver and porcine labs. April 2010 and May 2010.

3. Based on internal test report #R0018532, Validation of Milwaukee USG1, 5 mm cordless laparoscopic ultrasonic shears: independent surgeon feedback collected during internally-sponsored cadaver and porcine labs. April 2010 and May 2010.

4. Sonicision™ Cordless Ultrasonic Dissection System User's Guide. Part No. PT00014583 [package insert]. Minneapolis, MN: Medtronic, 2016.

5. Tsirline VB, Lau KN, Swan RZ, et al. Evaluation of an innovative, cordless ultrasonic dissector. Surg Innov. 2013;20(5):524–529.

6. Based on internal test report #R0022948, Compact blade cool down – 60 degrees C – P4 vs. ACE36E: done on maximum power through 15 cm of porcine mesentery. July 16, 2010.

7. Kim FJ, Sehrt D, Pompeo A, Molina WR. Comparison of surgical plume among laparoscopic ultrasonic dissectors using a real-time digital quantitative technology. Surg Endosc. 2012;26(12):3408-3412.

8. Based on internal test report #R0047634 Rev A, Comparison of various competitor devices vs. Sonicision™ dissector, LigaSure™ LF1637, and LigaSure™ LF1737 devices in an acute porcine study, comparing the Thunderbeat™* (seal and cut mode) and Sonicision™ (min. mode) on isolated vessels. Nov. 18, 2013.

9. Based on internal test report #R0047122 Rev A, Thermal profile study of various competitor devices vs. Sonicision™ dissector, LigaSure™ LF1637, and LigaSure™ LF1737 devices conducting one seal/cut cycle on mesentery tissue. Dec. 12, 2013.

10. Based on internal test report #R0047124 Rev A, Comparison of the renal artery seal burst pressure of various competitor devices vs. Sonicision™ dissector, LigaSure™ LF1637, and LigaSure™ LF1737 devices using minimum mode on isolated vessels. Dec. 12, 2013.

11. Based on internal test report #R0014725 Rev B, Verification tissue test report – Milwaukee, done on maximum power through 15 cm of porcine mesentery. May 17, 2010.

5920 Longbow DriveBoulder, CO 80301

800.722.8772 medtronic.com/covidien

© 2017 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together aretrademarks of Medtronic. ™* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. 11/2017 – US161203 – [WF# 1298489]

Photo credit Thinkstock

http://www.medtronic.com/covidien

Documents

LOSE THE CORD. GAIN SAFETY, & EFFICIENCY. · Competitive Cross-Reference 8 Material Management 510(k) Clearance 12 Indications for Use 14 Product Request Form 15 Ordering Information