MODEL 20 BIPOLAR COAGULATOR

K972311 · Boston Surgical Products, Inc. · GEI · Sep 18, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972311
• Device Name: MODEL 20 BIPOLAR COAGULATOR
• Applicant: Boston Surgical Products, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Boston Surgical Products, Inc. Model 20 Coagulation Generator is a solid state bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where low impedance or wetfield conditions exist.

Device Story

Model 20 Bipolar Coagulation Generator; solid-state device supplying RF signals to electrosurgical handpieces. Used for coagulation of soft body tissues in low impedance or wetfield conditions. Powered by independent 7 Vdc isolated power supply. Audio and visual monitors included. Device repackaged version of Kirwan Model 25 1000; intended for clinical use by healthcare professionals.

Clinical Evidence

No clinical data. Bench testing only; device complies with IEC 601-1-2 and ANSI HF-18 guidelines for RF and low-frequency leakage and audio/visual monitoring.

Technological Characteristics

Solid-state bipolar RF generator; 7 Vdc isolated power supply; body-floating output. Complies with IEC 601-1-2 and ANSI HF-18 safety standards for leakage. No software or digital processing described.

Indications for Use

Indicated for use with electrosurgical handpieces on soft body tissues in low impedance or wetfield conditions. Prescription use only.

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

• Kirwan Model 25 1000 (K880863)

Submission Summary (Full Text)

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U.S. Food and Drug Administration 510K Document Mail Center HFZ-401 Center for Medical Devices 1390 Piccard Drive Rockville, Maryland 20850

K972311

## SEP 1 8 1997

To: Document Control Clerk

This summary of 510K safety and effectiveness for the Model 20 generator is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807,92.

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.

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

This device is technically identical to an existing approved device (Kirwan Model 25 1000, 510k K880863) but repackaged in e new style enclosure and relabeled Boston Surgical Products Model 20.

Sincerely,

Charles Vassallo

Charles Vassallo Boston Surgical Supply, Inc. 17 Old Country Road Oxford, Connecticutt 06478 Telephone/FAX [phone]

( 17 JUN 97

Date

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Charles Vassallo Boston Surgical Supply, Inc. 17 Old Country Road Oxford. Connecticut 06478

SFP 1 8 1997

Re: K972311 Trade Name: Model 20 Bipolar Coagulator Regulatory Class: II Product Code: GEI Dated: June 17, 1997 Received: June 20, 1997

Dear Mr. Vassallo:

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 requirements , 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. Charles Vassallo

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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Page____ l_of_____ 1

510(k) Number (if known)

Device Name: Model 20 Bipolar Coagulation Generator

Indications for use:

The Boston Surgical Products, Inc. Model 20 Coagulation Generator is a solid state bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where low impedance or wetfield conditions exist.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

celly

(Division Sign-O

Division of General Restorative Devices K972311
510(k) Number

Prescription Use √
(Per 21 CFR 801.109)

OR

Over The Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)