The bissinger® detachable bipolar coagulation-forceps 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. The device consists of a Forceps Body (grip), Exterior tube (available in three working lengths), Interior tube (sliding tube, available in three working lengths), 1mm Electrode (fluted bit, available in three working lengths), 3mm Electrode (tong-type bit, available in three working lengths), Hirsch-electrode (rippled bar, available in three working lengths), and various types of plugs (Erbe-type, Martin/Berchtold-type, Codman-type, Valleylab-type) to connect to different current generators, and a Cable.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the bissinger® detachable bipolar coagulation-forceps. It addresses the device description, classification, and a comparison to a predicate device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The document specifically states: "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...". This indicates that the approval was based on a demonstration of substantial equivalence to a legally marketed predicate device (WISAP bipolar coagulators), rather than a separate device performance study with acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, sample sizes, ground truth details, or expert information as this data is not present in the provided text.

The text focuses on administrative details of the 510(k) submission, including:

Device Name: bissinger® detachable bipolar coagulation-forceps
Common Name: Coagulation forceps
Classification Name: Bipolar, Coagulator-Cutter, Endoscopic, Bipolar and Accessories
Device Class: Class III (but noted that "No effective date has been established of the requirement for premarket approval. See § 884.3.")
Classification Panel: OB/GYN
Product Code: 85HIN (later updated in the FDA response letter to 85HET and 78KNS)
Predicate Device: WISAP bipolar coagulators from WISAP USA
Intended Use: Bipolar tissue coagulation in Gynecology and Laparoscopic surgical procedures.

The "Feature Comparison Table" (section 7) primarily details physical and material similarities between the device and the predicate, which is typical for demonstrating substantial equivalence for 510(k) submissions. It lists features like intended use, materials, length, forcep style, insulation material, and compliance with UL and ISO standards. All features are marked as "Yes" for "SE?" (Substantial Equivalence). This table does not represent performance acceptance criteria.

Summary

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K970968

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bissinger®

distribute btc

detachable bipolar coagulation-force
Medizintechnik GmbH

Premarket Notification, Section 510(k)

Medizintechnik, GmbH

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

Device Name:

Trade Name:	bissinger® detachable bipolar coagulation-forceps
Common Name:	Coagulation forceps
Classification Name:	Bipolar, Coagulator-Cutter, Endoscopic, Bipolar and Accessories

2. Establishment Name & Registration Number:

Name:	Medizintechnik, GmbH
Number:	Pending

3. Classification:

& 884.4150 Bipolar endoscopic coagulator-cutter and accessories.

(a) 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. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 884.3.

[45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987]

Device Class:	Class III
Classification Panel:	OB/GYN
Product Code:	85HIN

4. Device Description:

Cat. #	Description
xx123	Forceps Body
xx789	Exterior tube (3 lengths)
xx234	Interior tube (3 lengths)
xx567	1mm Electrode (fluted bit) (3 lengths)
xx890	3mm Electrode (tong-type bit) (3 lengths)
xx345	Hirsch-electrode (rippled bar) (3 lengths)
xx678	Erbe-type plug
xx901	Martin/Berchtold-type plug
xx012	Codman-type plug
xx111	Valleylab-type plug
xx222	Cable

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Forceps Body (grip). The handle is the attachment point for the other elements of the coagulation forcep. The exterior tube, internal tube, electrode and the current cable (with or without addapter) attach here.

Exterior tube. Available in three working lengths, 200mm, 340mm and 450mm. Please refer to the graphic representations in Appendix II for additional information.

Interior tube (sliding tube). Available in three working lengths, 200mm and 450mm. Please refer to the graphic representations in Appendix II for additional information.

1mm Electrode (fluted bit). Available in three working lengths, 200mm, 340mm and 450mm to match the interior and exterior tube length selected. Please refer to the graphic representations in Appendix II for additional information.

3mm Electrode (tong-type bit). Available in three working lengths, 200mm, 340mm to match the interior and exterior tube length selected. Please refer to the graphic representations in Appendix II for additional information.

Hirsch-electrode (rippled bar). Available in three working lengths, 200mm and 450mm to match the interior and exterior tube length selected. Please refer to the graphic representations in Appendix II for additional information.

Erbe-type plug. Used to connect the bissinger detachable bipolar coagulation-forceps to an Erbe brand current generator. Please refer to the graphic representations in Appendix II for additional information.

Martin/Berchtold-type plug. Used to connect the bissinger® detachable bipolar coagulationforceps to an Martin/Berchtold brand current generator Please refer to the graphic representations in Appendix II for additional information.

Codman-type plug. Used to connect the bissinger® detachable bipolar coagulation-forceps to a Codman brand current generator. Please refer to the graphic representations in Appendix II for additional information.

Valleylab-type plug. Used to connect the bissinger detachable bipolar coagulation-forceps to a Valleylab brand current generator. Please refer to the graphic representations in Appendix II for additional information.

Cable. Provides the flexible insulated cable to connect the instrument to the current generator.

5. Cleaning/Sterilization/Re-sterilization:

The surgical instruments required to properly use the device are supplied clean only and must be sterilized prior to each use. Remove all shipping and packaging materials before sterilization. Wash all instruments thoroughly prior to sterilization. For the instruments, the recommended method is steam autoclave sterilization. The recommended sterilization cycle is based on AAMI guidelines. The cycle is saturated steam at 270° F for 15 minutes.

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6. Equivalence:

Based on the materials, intended uses, design and clinical technique, the bissinger detactions bipolor coogulation-forceps are substantially equivalent to the referenced legally marketed WISAP bipolar coagulators available from WISAP USA.

7. Feature Comparison Table:

FEATURE	bissinger®	WISAP - USA	SE?
Intended Use:			Yes
Materials:	PEEK, PTFE, stainless steel,Silicone, Pa	Polyethylene, stainlesssteel,	Yes
Length:	200mm, 340mm & 450mm	330mm & 450mm	Yes
Forcep Style:	1mm Electrode (fluted bit)3mm Electrode (tong-type bit)Hirsch-electrode (rippled bar)	WISAP - #7585, 7585-1WISAP - #7585, 7585-1WISAP - #7585-4, 7585-5	Yes
Insulation Material:	PTFE	PTFE	Yes
UL Compliant:	UL-544	UL-544	Yes
ISO Compliant:	ISO-9001	ISO-9001	Yes
Manufacturer:	Medizintechnik, GmbH	WISAP USA	Yes
K-Number	Pending	Unknown	Yes

952

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 lagg

Mr. David W. Schlerf Medizintechnik, GMBH c/o Buckman Company, Inc. 1000 Burnett Avenue, Suite 450 Concord, CA 94520

Re. K970968

Bissinger® Detachable Bipolar Forceps Dated: August 20, 1997 Received: February 20, 1998 Regulatory Class: II 21 CFR 884.1720/Procode: 85 HET 21 CFR 876.4300/Procode: 78 KNS

Dear Mr. Schlerf:

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, narket the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, issing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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 Admisstration (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

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 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiliance at (301) 594-4613. Additioually, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (30) ) 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/dsmaldsmamain.html".

Sincerely vours,

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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Page 1 __ of _ 1

K970968 510(k) Number:

Device Name: bissinger® detachable bipolar coagulation-foresps

Indications For Use:

Bipolar tissue coagulation in: Gynecology and Laparascopic surgical procedures

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thos h. Seymour

(Division Sign-Off) Division of Reproductive, Abdominal, ENT. and Radiological Devices 4776 510(k) Number

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Prescription Use ✓

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

(Optional format 1-2-96)

Regulation Number and Section

§ 884.1720 Gynecologic laparoscope and accessories.

(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.