CAUTERY CLAMP AND BATTERY PACK POWER SUPPLY

K992460 · Starion Instruments · GEI · Oct 5, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992460
• Device Name: CAUTERY CLAMP AND BATTERY PACK POWER SUPPLY
• Applicant: Starion Instruments
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Simultaneous cutting and cauterization of soft tissue during surgery.

Device Story

Thermal cautery device consisting of hand-held surgical clamp and disposable battery-powered supply. Device uses heater at instrument tip to conduct heat to tissue; enables simultaneous cutting and cauterization. Used by surgeons in various surgical disciplines to manage soft tissue. Benefits include efficient tissue cutting and hemostasis during surgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hand-held surgical clamp with disposable battery pack power supply. Thermal cautery principle via heater at instrument tip. Class II device (21 CFR 878.4400, 886.4115).

Indications for Use

Indicated for simultaneous cutting and cauterization of soft tissue during surgery in patients across all major surgical disciplines.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Cautery Forceps & Battery Pack Power Supply (K990728)

Submission Summary (Full Text)

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OCT 5 1993

K992460

Image /page/0/Picture/2 description: The image shows the logo for "Starion Instruments". The logo consists of a circular graphic with a star inside on the left, followed by the text "Starion Instruments" in a stylized font. A line is present underneath the text.

22900 Congress Springs Road, Saratoga, California 95070 408.741-8773 fax [phone]

## Attachment 1

## 510(K) SUMMARY

Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Blvd. Rockville, MD 20850

This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR §807.92.

Starion intends to introduce into commercial distribution the Cautery Clamp & Battery Pack Power Supply. The equivalent predicate device is the Cautery Forceps & Battery Pack Power Supply (#K 990728) by Starion Instruments Corporation.

The FDA has classified electrically powered surgical instruments for cutting tissue and controlling bleeding as Class II devices (e.g. 21CFR 878-4400, 886-4115). Starion's Clamp is a Class II medical device. The common name for Starion's device is a thermal cautery device -- clamp.

The Cautery Clamp, a hand-held surgical instrument, is powered by a disposable Battery Pack Power Supply. The Cautery Clamp consists of two components that are sold separately: a reusable Surgical Clamp, and a disposable Clamp Insert with power cord. The Cautery Pack Power Supply is intended for the simultaneous cutting and cauterization of soft tissue during surgery, to be used in essentially all major surgical disciplines. Starion's cautery Clamp is substantially equivalent in terms of intended use, principles of operation, basic technological characteristics and target population of surgical disciplines.

The principle of operation is that heat is conducted to the tissue via a small heater located at the tip of a hand-held, surgical instrument to provide cutting/cauterization. The need to provide cutting and cauterization of tissue is present in virually all surgical specialties. The device the widespread, multispecialty use of these cutting/cauterization devices in essentially all disciplines of surgerv.

George D. Herman 7/24/99

George Hermann date Regulatory Affairs Starion Instruments Corporation

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 5 1999

Mr. George Hermann Regulatory Affairs Starion Instruments 22900 Congress Springs Road Saratoga, California 95070

Re: K992460

> Trade Name: Thermal Cautery Device, Clamp Regulatory Class: II Product Code: GEI, HQP Dated: September 10, 1999 Received: September 13, 1999

Dear Mr. Hermann:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 – Mr. George Hermann

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Pcolle/B

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

Enclosure

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K992460 510(k) Number (if Known):___

Device Name: Thermal Cautery Device, Clamp

Indications for Use:

Simultaneous cutting and cauterization of soft tissue during surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

pcollepta

(Division Sign-Off)
Division of General Restorative Devices K992460
510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)