HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P

K042777 · Ethicon Endo-Surgery, Inc. · LFL · Dec 1, 2004 · SU

Device Facts

• Record ID: K042777
• Device Name: HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: LFL · SU
• Decision Date: Dec 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended Use

The Harmonic ACE™ Curved Shears with Hand Control is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, pediatric, gynecologic, urologic and other open and endoscopic procedures.

Device Story

Harmonic ACE™ Curved Shears is a sterile, single-patient-use electrosurgical instrument; features pistol grip housing with integrated hand control buttons (MIN/MAX power levels) and audible/tactile feedback for trigger closure. Device includes rotating shaft, curved blade, and clamp arm; compatible with 5 mm trocars or open incisions. Operated by surgeons in OR/clinical settings; provides ultrasonic energy for tissue cutting and coagulation. Serves as adjunct/substitute for traditional electrosurgery, lasers, or steel scalpels. Benefits include precise tissue incision with reduced thermal injury and effective hemostasis.

Clinical Evidence

Bench testing and pre-clinical laboratory evaluations performed to demonstrate device performance. No clinical data provided.

Technological Characteristics

Electrosurgical cutting and coagulation device; ultrasonic energy source. Features pistol grip with hand-actuated power controls (MIN/MAX). Available in 23 cm and 36 cm lengths; 5.5 mm shaft diameter; 15 mm active blade length. Sterile, single-patient-use.

Indications for Use

Indicated for soft tissue incisions requiring bleeding control and minimal thermal injury. Applicable for general, pediatric, gynecologic, urologic, and other open or endoscopic surgical procedures.

Predicate Devices

• UltraCision® Harmonic Scalpel® Curved Shears (LCS) (K993054)
• UltraCision® Harmonic Scalpel® Hand Switching Adaptor (K002906)

Submission Summary (Full Text)

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# DEC = 1 2004

# Harmonic ACE™ Curved Shears 510(k) Summary of Safety and Effectiveness

#### Company

Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242

#### Contact

Kimberly Shoemaker Manager, Regulatory Affairs

## Date Prepared:

October 4, 2004

### Name of Device

Trade Name: Harmonic ACE™ Curved Shears with Hand Control Classification Name: Electrosurgical Cutting and Coagulation Device

#### Predicate Devices:

UltraCision® Harmonic Scalpel® Curved Shears (LCS) cleared under K993054 on 12/09/1999 and UltraCision® Harmonic Scalpel® Hand Switching Adaptor cleared under K002906 on 12/15/2000

#### Device Description

The Harmonic ACE™ Curved Shears with Hand Control is a sterile, single patient use instrument consisting of a pistol grip housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum power level) on both sides of the grip housing. The grip housing has an integrated audible/tactile mechanism for indicating full trigger closure. The instrument has a rotating shaft with a curved blade and clamp arm and is designed to work through a 5 mm trocar, through a 5 mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The instrument is available in 23 cm and 36 cm lengths with a shaft diameter of 5.5 mm and a 15 mm active blade length.

#### Indications for Use

The Harmonic ACE™ Curved Shears with Hand Control is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, pediatric, gynecologic, urologic and other open and endoscopic procedures.

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K042777 2/2

## Technological Characteristics

The Harmonic ACE™ is similar to the predicate devices with respect to design and intended use.

## Performance Data

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Bench testing and pre-clinical laboratory evaluations were performed to demonstrate that the device performs as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 1 2004

Ms. Kimberly Shoemaker Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K042777

Trade/Device Name: Harmonic ACE™ Curved Shears with Hand Control Regulatory Class: Unclassified Product Code: LFL Dated: October 5, 2004 Received: October 6, 2004

Dear Ms. Shoemaker:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it nay be subject to such 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); 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.

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Page 2 - Ms. Kimberly Shoemaker

This letter will allow you to begin marketing your device as described in your Section 510(k) rran reket notification. The FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

iriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): KOYSדרר Harmonic ACE™ Curved Shears with Hand Control Device Name: Indications for Use:

The Harmonic ACE™ Curved Shears with Hand Control is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, pediatric, gynecologic, urologic and other open and endoscopic procedures.

× Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Division of General, Restorative. and Neurological Devices

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510(k) Number_Ko42777