BERGEN MODEL 500 ELECTROSURGERY GENERATOR by BERGEN MFG.

The Bergen Model 500 Generator is a general purpose solid state 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 Description

An isolated output monopolar electrosurgery generator with independent bipolar electrosurgery generator. The monopolar generator has continuously adjustable 0-150 watts in three cut modes of cut, blend 2 and two coagulation modes 0-75 watts. The bipolar generator is continuously adjustable 0-50. Outputs of both generators are independently controlled and RF isolated from each other.

AI/ML Overview

No, the provided 510(k) summary does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria.

The document is a 510(k) submission for an electrosurgery generator, focusing on demonstrating substantial equivalence to predicate devices based on design and safety standards (e.g., IEC, ANSI) rather than performance metrics derived from clinical studies or specific acceptance criteria for diagnostic accuracy.

Therefore, I cannot provide the following information:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done and the effect size.
If a standalone (algorithm only) performance study was done.
The type of ground truth used.
The sample size for the training set.
How the ground truth for the training set was established.

This type of 510(k) submission primarily addresses engineering specifications, safety standards, and equivalence to existing devices, not clinical performance studies typically required for devices with diagnostic or AI components.

Summary

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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

AUG 27 199

K972299

To: Document Control Clerk

This summary of 510K safety and effectiveness for the Bergen Model 500 electrosurgery generator is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The monopolar electrosurgery generator is similar to the Bergen Model 710 K94586 I but without displays and calibrated to higher power levels. The bipolar generator is similar to the Bergen Model 610 K964736 but without digital power setting display and current monitor.

Each generator handswitch system is powered by independent low voltage (7 Vdc) isolated power supplies.

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

Date

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 similar to existing approved devices each as independent generators and in combination.

Sincerely,

Rogs Costen

Roger Oosten President Bergen Mfg. 9345 Rookery Road New Port Richey, Florida 34654

6/12/97

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AUG 27 1997

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Roger Oosten President Bergen Manufacturing ........ 9345 Rookery Road New Port Richey, Florida 34654

Re: K972299 Trade Name: Bergen Model 500 Electrosurgery Generator Regulatory Class: II Product Code: GEI Dated: June 12, 1997 Received: June 19, 1997

Dear Mr. Oosten:

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 (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

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Page 2 - Mr. Roger Oosten

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.

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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

tosedalz

ia M. Witten, Ph.D., M.D. Ce 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) K972299

Device Name: BERGEN MODEL, 500 ELECTROSURGERY GENERATOR

Indications for use: REVISED 7/30/97

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

tccello

of General Restorative D 510(k) Numbe

Prescription Use
(Per 21 CFR 801.109)

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Over The Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.