ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD by TRANSAMERICAN TECHNOLOGIES INTL.

The ACCU-Surg Bipolar Laparoscopic Electrodes are intended to be used with the ACCU-Surg Suction / Irrigation Cannula. They are surgical tools for cutting and coagulation used for GYN and General Surgery for such procedures as coagulation of endometrium, laparoscopic myomectomy, laparoscopic leiomyoma coagulation (myolysis), bleeding control of pelvic vessels and laparoscopic (**) errors )) bacanth orgeons choice will determine the tip style used.

Device Description

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AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "ACCU-Surg Bipolar Laparoscopic Electrodes." It primarily addresses regulatory aspects and does not contain information about acceptance criteria or a study proving device performance in the context of the requested details (e.g., sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance).

Therefore, based solely on the provided text, I cannot describe the acceptance criteria or a study proving the device meets those criteria with the level of detail requested in your prompt. The document only states that the device is "substantially equivalent" to predicate devices, which is a regulatory determination, not a clinical performance assessment in the manner you're asking for.

The information you are requesting typically comes from detailed clinical trial reports or FDA 510(k) summaries which contain performance data and methodologies, none of which are present in this specific clearance letter.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Allen R. Howes President Transamerican Technologies International 7026 Koll Center Parkway, 207 Pleasanton, California 94566

AUG 20 1997

Re: K971677

Trade Name: ACCU-Surg Bipolar Laparoscopic Electrodes Regulatory Class: II Product Code: GEI Dated: July 23, 1997 Received: July 28, 1997

Dear Mr. Howes:

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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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,

[Image of a signature]

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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STATEMENT OF INDICATIONS FOR USE

Allen R. Howes, President

Date: May 6, 1997

Premarket Notification Number

Prescription Use
(Per 21 CFR 801.109)

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Divis

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.