THERMAL CAUTERY DEVICE, FORCEPS

K990728 · Starion Instruments · HQP · Jun 3, 1999 · Ophthalmic

Device Facts

• Record ID: K990728
• Device Name: THERMAL CAUTERY DEVICE, FORCEPS
• Applicant: Starion Instruments
• Product Code: HQP · Ophthalmic
• Decision Date: Jun 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4115
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Simultaneous cutting and cauterization of soft tissue during surgery.

Device Story

Device consists of single-use cautery forceps and battery pack power supply. Principle of operation involves conduction of heat to tissue via small heater located at tip of hand-held surgical instrument. Used by surgeons in major surgical disciplines to simultaneously cut and coagulate soft tissue. Device provides thermal cauterization to control bleeding and cut tissue during surgical procedures. Benefits include efficient tissue management and hemostasis.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Thermal cautery device (forceps). Single-use. Energy source: battery pack power supply. Principle: resistive heating 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 requiring surgical intervention across major surgical disciplines.

Regulatory Classification

Identification

A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.

Predicate Devices

• Hemostatic Surgical System (K902307)
• Accu-Temp disposable hot wire surgical cautery device (preamendment)

Submission Summary (Full Text)

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3 1000 JUN

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K990728

22900 Congress Springs Road. Saratoga, California 408.741-8773 fax 408.74

## Attachment 1

510(K) SUMMARY

Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 1390 Piccard Drive 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 Forceps and Battery Pack Power Supply. The equivalent predicate devices are the Hemostatic Surgical System (#K 902307) by Hemostatic Surgery Corporation and the Accu-Temp disposable hot wire surgical cautery device (preamendment) by Concept, Inc.

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 Cautery Forceps is a Class II medical device. The common name for Starion's device is a thermal cautery device -- forceps.

Starion's Cautery Forceps and Battery Pack Power Supply are single use devices that are intended for the simultaneous cutting and coagulation of soft tissue during surgery, to be used in essentially all major surgical disciplines. Starion's Cautery Forceps are 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 virtually all surgical specialties. The device labeling supports the widespread, multispecialty use of these cutting/cauterization devices in surgery.

George D. Human 3/3/99

date George Hermann Regulatory Affairs Starion Instruments Corporation

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 1999

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

Re: K990728 Trade Name: Cautery Forceps Battery Pack Power Supply Regulatory Class: II Product Code: HQP and GEI Dated: March 3, 1999 Received: March 5, 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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,

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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510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Thermal Cautery Device, Forceps

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) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | K990728 |
| 510(k) Number | |

Prescription Use ✓
(Per 21 CFR 801.109) OR Over-The-Counter Use ____

(Optional Format 1-2-96)

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