HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P

K051036 · Ethicon Endo-Surgery, Inc. · LFL · Jun 2, 2005 · SU

Device Facts

• Record ID: K051036
• Device Name: HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: LFL · SU
• Decision Date: Jun 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended Use

The Harmonic ACE™ Curved Shears with Pistol Handle and 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. The Harmonic ACE™ Curved Shears with Scissor Handle and 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

Sterile, single-patient-use electrosurgical cutting and coagulation instrument; features grip housing with hand control buttons (MIN/MAX power levels) and audible/tactile trigger closure indicator. Rotating shaft includes curved blade and clamp arm; compatible with 5 mm trocars or direct incision. Operated by surgeons in OR settings for open or endoscopic procedures. Functions as adjunct/substitute for lasers, steel scalpels, and traditional electrosurgery. Provides precise tissue incision and coagulation; minimizes thermal injury to surrounding tissue.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Electrosurgical cutting and coagulation device; 5.5 mm shaft diameter; 15 mm active blade length; available in 14 cm, 23 cm, and 36 cm lengths. Features hand-controlled power levels (MIN/MAX) and integrated audible/tactile feedback mechanism. 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. No specific age or gender contraindications provided.

Predicate Devices

• Harmonic ACE with Hand Control (K042777)

Submission Summary (Full Text)

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Ethicon Endo-Surgery, Inc.

Ethicon Endo-Burger 3, the 510(t) I renal Rev Notheduon ACE™ Curved Shears with Scissor Handle and Hand Control

K051036

# Harmonic ACETM Curved Shears with Pistol Handle and Hand Control and Harmonic ACE™ Curved Shears with Scissor Handle and Hand Control 510(k) Summary of Safety and Effectiveness

### Company

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

#### Contact

Rachel D. Austin Associate I, Regulatory Affairs

### Date Prepared:

April 22, 2005

#### Name of Device

Trade Name: Harmonic ACE™ Curved Shears with Pistol Handle and Hand Control and Harmonic ACE™ Curved Shears with Scissor Handle and Hand Control

Classification Name: Electrosurgical Cutting and Coagulation Device

#### Predicate Devices:

Harmonic ACE with Hand Control cleared under K042777 on 12/01/2004

#### Device Description

The Harmonic ACE™ Curved Shears with Pistol Handle and Hand Control and Harmonic ACE™ Curved Shears with Scissor Handle and Hand Control are a sterile, single patient use instrument consisting of a grip housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum power level). The grip housing has an integrated audible/tactile mechanism for indicating full trigger closure. The instruments have 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 instruments are available in 14 cm (scissor handle only), 23 cm and 36 cm lengths with a shaft diameter of 5.5 mm and a 15 mm active bladc length.

#### Indications for Use

The Harmonic ACE™ Curved Shears with Pistol Handle and 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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Ethicon Endo-Surgery, Inc.

Ethicon Endo-Surgery, Inc.
510(k) Premarket Notification for Harmonic ACE™ Curved Shears World Cantre 510(K) Premarket Notification of Harmonic A C

K051036

page 2 of 2

The Harmonic ACE™ Curved Shears with Scissor Handle and Hand Control is indicated The Harmonte ACE - Ourved blessing control and minimal thermal injury are desired. The instrument can be used as adjunct to or substitute for electrosurgery, lasers, and I he instrument van be abou as an agynecologic, urologic and other open and endoscopic procedures.

# Technological Characteristics

The Harmonic ACE™ Curved Shears with Pistol Handle and Hand Control and The Trainonic ACE™ Curved Shears with Scissor Handle and Hand Control are similar to the predicate devices with respect to design and intended use.

## Performance Data

I er ormance Data
Bench testing was performed to demonstrate that the devices perform as intended.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the circumference of the circle.

JUN 2 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Rachel D. Austin Associate I, Regulatory Affairs Ethicon Endo-Surgery Incorporated 4545 Creek Road Cincinnati, Ohio 45242-2839

Re: K051036

Trade/Device Name: Harmonic Ace™ Curved Shears with Pistol Handle and Hand Control and the Harmonic Ace™ Curved Shears with Scissor Handle and Hand Control Regulatory Class: Unclassified

Product Code: LFL Dated: April 22, 2005 Received: April 25, 2005

Dear Ms. Austin:

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 may 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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Page 2 - Ms. Rachel D. Austin

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D. Acting 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):

Device Name:

Harmonic ACE™ Curved Shears with Pistol Handle and Hand Control and the Harmonic ACE™ Curved Shears with Scissor Handle and Hand Control

Indications for Use:

The Harmonic ACE™ Curved Shears with Pistol Handle and 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.

The Harmonic ACE™ Curved Shears with Scissor Handle and 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 enoscopic 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)

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