CAUTERY GRASPER/DISSECTOR

K994019 · Starion Instruments · HQP · Jan 20, 2000 · Ophthalmic

Device Facts

• Record ID: K994019
• Device Name: CAUTERY GRASPER/DISSECTOR
• Applicant: Starion Instruments
• Product Code: HQP · Ophthalmic
• Decision Date: Jan 20, 2000
• 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

Single-use, hand-held surgical instrument; used for simultaneous cutting and cauterizing soft tissue. Surgeon positions distal jaws around target tissue; squeezes handle and depresses finger switch to activate internal heating element. Heat conducts to tissue between jaws to achieve cutting and cauterization. Used in surgical settings by physicians. Benefits include combined tissue management in one device.

Clinical Evidence

No clinical data provided; device relies on bench testing and substantial equivalence to a previously cleared predicate.

Technological Characteristics

Single-use, hand-held thermal cautery instrument. Features distal jaws with integrated heating element. Energy source: thermal (electrosurgical). Form factor: grasper/dissector. No software or complex electronics described.

Indications for Use

Indicated for simultaneous cutting and cauterization of soft tissue during surgery. Prescription use only.

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

• Starion Instruments thermal cautery forceps (K990728)

Submission Summary (Full Text)

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## JAN 2 0 2000

510(k) Summary Subject:

Starion Instruments Thermal Cautery Grasper/Dissector Product:

## Summary:

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

The Starion Instruments thermal cautery grasper/dissector is a single use, hand-held surgical instrument intended for simultaneously cutting and cauterizing soft tissue during surgery. The general and plastic surgery panel of the Food and Drug Administration has classified electrosurgical cutting and coagulating devices and accessories as Class II devices (21 CFR 878.4400).

Instruments thermal cautery grasper/dissector The Starion is substantially equivalent in terms of intended use, target population, energy source, and principles of operation to the Starion Instruments thermal cautery forceps, a legally marketed predicate device which has been granted marketing clearance via K990728.

The Starion Instruments thermal cautery grasper/dissector contains handle controls that allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. While squeezing the handle, the surgeon depresses a finger switch, which activates a heating element in the jaws. This heat is conducted to the tissue between the jaws to provide cutting/cauterization.

Brian Higgins

Brian Grigsby - Submitter/Contact Person Starion Instruments Corporation 20665 Fourth Street Saratoga, CA 95070 Phone [phone] Fax [phone]

11 (24 (99 Date

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Public Health Service

## JAN 2 0 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Brian Grigsby Vice President, Quality and Regulatory Affairs Starion Instruments 20665 Fourth Street Saratoga, California 95070

K994019 Re: Trade Name: Cautery Grasper/Dissector Regulatory Class: II Product Code: HQP and GEI Dated: November 24, 1999 Received: November 26, 1999

Dear Mr. Grigsby:

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 (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.

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.

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Page 2 - Mr. Brian Grigsby

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,

Stupt Rhodes
James E. Dillard III

Acting 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): _K 994019

DEVICE NAME: __ Thermal Cautery Device, Grasper/Dissector

INDICATIONS FOR USE:

Simultaneous cutting and cauterization of soft tissue during surgery.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Stephen Rourke

(Division Sign-Off) Division of General Restorative Devices K994019 510(k) Number _

Prescription Use √
(Per 21 CFR 901.109)

OR

Over-The-Counter Use _ (Optional Format 1-2-96)