HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY

K121550 · Ethicon Endo-Surgery, LLC · LFL · Aug 22, 2012 · SU

Device Facts

• Record ID: K121550
• Device Name: HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY
• Applicant: Ethicon Endo-Surgery, LLC
• Product Code: LFL · SU
• Decision Date: Aug 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended Use

The HARMONIC ACE® Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

Device Story

Ultrasonic surgical instrument for coagulation and mechanical transection of soft tissue; used in open and laparoscopic procedures. Device features shaft with rotatable tissue effector; hand-actuated or foot-switch activated. Incorporates Adaptive Tissue Technology: generator monitors blade frequency to detect thermal condition changes; compares data against EEPROM-stored parameters to identify minimal tissue presence between blade and pads. Upon detection, generator reduces power (current) and emits secondary higher-pitched activation tone. Benefits include reduced thermal injury and effective vessel sealing up to 5 mm. Operated by surgeons in OR settings. Output is mechanical ultrasonic energy for tissue cutting/coagulation; healthcare provider observes tissue effect and audible generator tones to guide procedure.

Clinical Evidence

Bench testing and animal model studies (acute and 30-day chronic survival) in thoracic procedures. Results demonstrate device effectively cuts/coagulates soft tissue and seals vessels up to 5 mm in situ, comparable to predicate performance.

Technological Characteristics

Ultrasonic surgical instrument; 55.5 kHz blade frequency; 5.5 mm shaft diameter; curved blade geometry. Coated ultrasonic blade. EEPROM memory chip for device ID, usage tracking, and algorithm parameters. Power provided by Generator G11. Sterilized via Ethylene Oxide (SAL 10^-6). Single-use.

Indications for Use

Indicated for soft tissue incisions in patients undergoing general, plastic, pediatric, gynecologic, urologic, thoracic, or orthopedic (spine/joint space) open or endoscopic procedures where bleeding control and minimal thermal injury are required.

Predicate Devices

• HARMONIC ACE® Shears + Adaptive Tissue Technology (K120729)
• SonoSurg Short Curved Scissors 5 mm O.D., HF Series, Pistol and Inline Grip (K050885)
• HARMONIC Scalpel 5 mm Instruments (K060245)

Submission Summary (Full Text)

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K121550

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AUG 222 2012

## 510(k) Summary of Safety and Effectiveness

Company

Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969

Contact Marcia Arentz Regulatory Affairs Portfolio Leader Ethicon Endo-Surgery. Inc. Telephone: [phone] Fax: [phone] Email: [e-mail]

Date Prepared: May 24, 2012

#### Device Name:

Trade Name: HARMONIC ACE® Shears + Adaptive Tissue Technology Common Name: Instrument, Ultrasonic Surgical

#### Classification Name:

Instrument, Ultrasonic Surgical (Unassigned, Product Code LFL)

### Predicate Devices:

| K120729: HARMONIC ACE® Shears + Adaptive Tissue Technology |
|----------------------------------------------------------------------|
| K050885: SonoSurg Short Curved Scissors 5 mm O.D., HF Series, Pistol |
| and Inline Grip submitted as part of the Olympus Ultrasonic |
| Surgical System SonoSurg |
| K060245: HARMONIC Scalpel 5 mm Instruments by Ethicon Endo- |

- Surgery
## Device Description:

The Ethicon Endo-Surgery HARMONIC ACE® Shears + Adaptive Tissue Technology are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate, and transect soft tissue with a single instrument. The devices are hand-actuated with a shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with an optional generator foot switch.

## Indications for Use Statement:

The HARMONIC ACE® Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

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K121550

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Technological Characteristics: Both the Ethicon Endo-Surgery HARMONIC ACE® Shears + Adaptive Tissue Technology and the predicate devices operate using ultrasonic technology to cut and coagulate soft tissues. The Ethicon Endo-Surgery HARMONIC ACE® Shears + Adaptive Tissue Technology incorporate an ergonomic handle and tapered blade geometry. The instruments have a coated ultrasonic blade and an EEPROM memory chip that stores device identification, usage tracking, and operating parameters for use by the Generator G11 that provides power for the HARMONIC ACE® Shears + Adaptive Tissue Technology.

Adaptive Tissue Technology refers to the power output algorithm that is utilized by the devices. During use the Adaptive Tissue Technology algorithm parameters stored on the device EEPROM are read by the generator and used to reduce the power (current) to the instrument and provide a secondary, higher pitched generator activation tone when there is little or no tissue between the instrument blade and tissue pads. To do this the generator monitors the frequency of the instrument blade and determines when there is a change in the thermal condition of the blade during device activation. This thermal condition of the blade is compared to the values stored on the EEPROM to determine when this minimal tissue condition is present and the Adaptive Tissue Technology features are activated.

| Device<br>Characteristic | HARMONIC ACE<br>Shears + Adaptive<br>Tissue Technology<br>(subject devices) | SonoSurg Short Curved<br>Scissors 5 mm O.D.,<br>(predicate K050885) | Ethicon Endo-surgery<br>HARMONIC Scalpel<br>5 mm Instruments<br>(predicate K060245) |
|----------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Technology | Ultrasonic | Ultrasonic | Ultrasonic |
| Procedures | Open and laparoscopic | Open and laparoscopic | Open and laparoscopic |
| Patient Use | Single Use | Reusable | Single Use |
| Sterilization<br>Method | Ethylene Oxide<br>sterilized<br>(provided sterile to<br>customer) | Steam<br>(autoclave by end user) | Ethylene Oxide<br>sterilized<br>(provided sterile to<br>customer) |
| SAL | $10^{-6}$ | n/a | $10^{-6}$ |
| Shaft Diameter | 5.5 mm | 5.5 mm | 5.5 mm |
| Shaft Length | 23 & 36 cm | 19 cm | 32 cm |
| Blade Frequency | 55.5 kHz | 47 kHz | 55.5 kHz |
| Maximum Blade<br>Amplitude<br>(MAX Power<br>Level) | 91.2 microns (HAR36)<br>85.9 microns (HAR23) | 81 microns | 100 microns |
| Blade Shape | Curved | Curved | Curved |
| Energy<br>Activation<br>Method | Foot or Hand Switch | Footswitch | Foot or Hand Switch |
| Seals vessels up<br>to diameter of | 5 mm | 5 mm | 3 mm |

#### Technological Comparison:

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Performance Data: Bench testing and laboratory evaluations of thoracic procedures in an animal model including acute and 30-day chronic survival studies were conducted to demonstrate that the HARMONIC ACE® Shears + Adaptive Tissue Technology perform as intended.

Conclusion: The results of the bench top and animal model testing demonstrate that the HARMONIC ACE® Shears + Adaptive Tissue Technology are as safe and as effective as the predicate device in cutting and coagulating soft tissue and sealing vessels up to 5 mm in diameter, as measured in situ, in thoracic surgical procedures. This testing supports the substantial equivalence of the HARMONIC ACE® Shears + Adaptive Tissue Technology to the legally marketed predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.

#### Public Health Service

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

Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Incorporated Ms. Marcia Arentz Regulatory Affairs Portfolio Leader 4545 Creek Road Cincinnati, Ohio 45242

AUG 222 2012

Re: K121550

Trade/Device Name: HARMONIC ACE® Shears + Adaptive Technology Regulatory Class: Unclassified Product Code: LFL Dated: July 18, 2012 Received: July 19, 2012

Dear Ms. Arentz:

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

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## Page 2 - Ms. Marcia Arentz

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

yours,

Melkerson

Mark N. Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ethicon Endo-Surgery, LLC

Premarket Notification (Traditional) HARMONIC ACE Shears + Adaptive Tissue Technology - Thoracic Indication

# Indications for Use

510(k) Number (if known): K121550

Device Name: HARMONIC ACE® Shears + Adaptive Tissue Technology

Indications for Use:

The HARMONIC ACE® Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil R.P. Ogden

(Division Sign-Off) (Division Sign Sign Sical, Orthopedic, and Restorative Devices

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510(k) Number K121550

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