BICOAG COAGULATING FORCEPS

K971565 · Everest Medical Corp. · HIN · Mar 12, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K971565
• Device Name: BICOAG COAGULATING FORCEPS
• Applicant: Everest Medical Corp.
• Product Code: HIN · Obstetrics/Gynecology
• Decision Date: Mar 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Laparoscopic grasping of tissue. Laparoscopic bipolar coagulation. baparoscopic contraceptive coagulation of the Fallopian tissue and may be used to achieve hemostasis following transection of the Fallopian tube.

Device Story

BiCOAG Coagulating Forceps are laparoscopic surgical instruments used for tissue grasping and bipolar coagulation. Operated by surgeons in a clinical/OR setting, the device utilizes electrical energy to coagulate Fallopian tissue for contraceptive purposes or to achieve hemostasis after tubal transection. The device functions in conjunction with a bipolar generator. By applying controlled electrical current to tissue via the forceps, the device achieves thermal coagulation, aiding in surgical procedures. The device provides surgeons with a tool for precise tissue manipulation and vessel sealing, potentially reducing bleeding and facilitating sterilization procedures.

Clinical Evidence

Clinical studies were conducted to evaluate histological results of tissue coagulation. The studies utilized the Wolf Bipolar generator to demonstrate equivalent effectiveness to the predicate Wolf Kleppinger Forceps.

Technological Characteristics

Laparoscopic bipolar forceps; energy source: bipolar generator; intended for tissue grasping and coagulation.

Indications for Use

Indicated for laparoscopic tissue grasping, bipolar coagulation, and contraceptive coagulation of Fallopian tissue, including hemostasis following Fallopian tube transection.

Regulatory Classification

Identification

A bipolar endoscopic coagulator-cutter is a device used to perform female sterilization and other operative procedures under endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through tissue between two electrical contacts of a probe. This generic type of device may include the following accessories: an electrical generator, probes, and electrical cables.

Special Controls

*Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance 2/12/90 (K-90),” and (iii) “Guidance (‘Guidelines’) for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and Accessories),” (2) International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety,” (3) American National Standards Institute/American Association for Medical Instrumentation's HF-18, 1993, “Electrosurgical Devices,” (4) Labeling: (i) Indication: For female tubal sterilization, and (ii) Instructions for use: (A) Destroy at least 2 centimeters of the fallopian tubes, (B) Use a cut or undampened sinusoidal waveform, (C) Use a minimum power of 25 watts, and (D) For devices with ammeters: continue electrode activation for 5 seconds after the visual endpoint (tissue blanching) is reached or current flow ceases indicating adequate tissue destruction.

Predicate Devices

• Everest Medical laparoscopic BiCOAG forceps (K945975)
• Wolf Kleppinger Forceps (pre-enactment)

Submission Summary (Full Text)

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MARAR | 29,998

K971565
PI91

4/30/97

## 510(k) Summary of Safetv & Effectiveness

This 510(k) Summary of Safety & Effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The device is a Class III medical device. The Tubal Sterilization device is similar to Everest Medical's current laparoscopic BiCOAG® forceps submitted on 510(k) no. K945975 and the pre-ennactment Tubal sterilization Wolf Kleppinger Forceps. Performance testing has been submitted to support the safety and functional performance of the submitted devices. Clinical studies evaluating histological results have been conducted using the same Wolf Bipolar generator to demonstrate equivalent effectiveness to the currently available Tubal sterilization Wolf Kleppinger Forceps.

## CONTACT PERSON: David J. Parins

Vice President, Engineering, Requlatory Affairs, and Quality Assurance Everest Medical Corp. 13755 First Ave. N. Minneapolis, MN 55340

Tel. No. [phone] FAX. No. [phone]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 1998

Mr. David J. Parins Everest Medical® 13755 First Avenue North Minneapolis, Minnesota 55441-5454 Re: K971565 BiCOAG Coagulating Forceps Dated: January 8, 1998 Received: January 12, 1998 Regulatory Class: III 21 CFR 884.4150/Procode: 85 HIN

Dear Mr. Parins:

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 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 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.

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

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K971565

BiCOAG Coagulating Forceps Device Name:

Indications For Use:

Laparoscopic grasping of tissue. Laparoscopic bipolar coagulation. baparoscopic contraceptive coagulation of the Fallopian tissue and may be used to achieve hemostasis following transection of the Fallopian tube.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Satting
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K971565

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)