KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR

K971341 · Kirwan Surgical Products, Inc. · GEI · May 22, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971341
• Device Name: KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR
• Applicant: Kirwan Surgical Products, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KIRWAN MODEL 28 1000 Generator is a general purpose solid state bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.

Device Story

Kirwan Model 28 1000 Bipolar Generator is a solid-state electrosurgical unit providing RF energy to handpieces for soft tissue coagulation. Device features 0-50 digital power display (+/- 5 watts at 100 ohms) and bar graph output current monitor. Handswitch operates on isolated 7 Vdc power supply. Designed for clinical use by medical professionals. Monitors provide audio/visual feedback during activation. Safety compliance includes IEC 601-1-2 and ANSI HF-18 standards for isolated body-floating bipolar coagulators. Device intended to manage varying tissue impedances during surgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Solid-state bipolar RF generator. Features digital power display (0-50 scale) and bar graph current monitor. Isolated 7 Vdc power supply for handswitch. Complies with IEC 601-1-2 and ANSI HF-18 safety standards for isolated (body floating) bipolar coagulators.

Indications for Use

Indicated for use as a general purpose solid-state bipolar generator to supply RF signals to electrosurgical handpieces for soft tissue applications across various tissue types, patient conditions, and load impedances.

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.

Submission Summary (Full Text)

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S. Food and Drug Administration 0K Document Mail Center HFZ-401 Center for Medical Devices 1390 Piccard Drive Rockville, Maryland 20850

MAY 2 2 1997

K 971341

To: Document Control Clerk

This summary of 510K safety and effectiveness for the Kirwan 28 1000 Coagulator is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807,92.

A 0-50 digital display power setting indicator provides the operator a parallax free reading of the power setting (+/- Swatts, full scale (@ 100 ohms).

A bar graph display output current monitor provides the operator a relative measure of the output current amplitude and to denote the presence of output energy during activation.

The handswitch is powered by an independent low voltage (7 Vdc) isolated power supply.

Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines.

IF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) ipolar coagulators.

This device is identical to an existing approved device.

Sincerely,

Kembra Pfahler

Kevin Prario Manager, Regulatiory Affairs Kirwan Surgical Products Inc. 180 Enterprise Drive Box 427 Marshfield, Massachusetts 02050

4/9/97

Date

**Date**

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2 1997

Mr. Kevin Prario Manager, Regulatory Affairs Kirwan Surgical Products, Inc. 180 Enterprise Drive Marshfield, Massachusetts 02050

Re: K971341 Trade Name: Kirwan Model 28 1000 Biopolar Generator Regulatory Class: II Product Code: GEI Dated: April 9, 1997 Received: April 10, 1997

Dear Mr. Prario:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. Kevin Prario

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.

ﺍﻟﻤﺴﺘﻘ

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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Page__________________________________________________________________________________________________________________________________________________________________________

971341 510(k) Number (if known)

Device Name: KIRWAN MODEL 28 1000 BIPOLAR GENERATOR

Indications for use:

The KIRWAN MODEL 28 1000 Generator is a general purpose solid state bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Divisier) Stan-
Division of General Restorative Devices (471341
510(k) Number

Prescription Use
X(Per 21 CFR 801.109)

OR

Over The Counter Use

(Optional Format 1-2-96)

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