The Bissinger bipolar cable/cord is intended for use in electrosurgical procedures to provide transmission of electrical power from the bipolar output of an electrosurgical generator to a bipolar foot-activated instrument.

This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

Device Description

Bissinger cables are a line of non-sterile, reusable bipolar foot activated cables fitting Erbe, Martin, Valleylab, Aesculap GK50, Codman CMC II, and other ES units.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (Bissinger Cables), not a study report detailing acceptance criteria and performance. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not present in the provided text.

However, based on the context of a 510(k) submission, the "acceptance criteria" can be inferred as substantial equivalence to predicate devices. The "study that proves the device meets the acceptance criteria" is the comparison to predicate devices presented in the document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria in the format typically used for a performance study (e.g., sensitivity, specificity, accuracy thresholds). Instead, the "acceptance criteria" for a 510(k) are met by demonstrating "substantial equivalence" to legally marketed predicate devices. The "reported device performance" is a comparison of characteristics to those predicates.

Here's an adaptation of the requested table format, using the substantial equivalence comparison:

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (Bissinger Bipolar Cable)
Intended Use: Transmission of electrical power from an electrosurgical generator to a bipolar foot-activated instrument	Transmission of electrical power from an electrosurgical generator to a bipolar foot-activated instrument
Material of Outer Cable Insulation: Silicone	Silicone
Reusable/Single Use? Reusable	Reusable
Provided Sterile? No	No
Length of Cable: Comparable to predicates (e.g., 3.05m, 3.66m)	3 meters, 5 meters
Connector Types (Instrument End): For standard American two-pin type plugs or standard European flat plug	Two types: either for instruments with standard American two-pin type plugs, or for instruments with the standard European flat plug
Connector Types (Generator End): Compatible with various ES units (e.g., Martin, Erbe, Valleylab, Aesculap GK50, Codman CMC II)	Martin, Erbe, Valleylab, Aesculap GK50, Codman CMC II, standard type fitting all generators utilizing the standard receivers for "Banana" inserts

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable. This document describes a comparison of device specifications, not a clinical or performance study with a "test set" in the context of data analysis. No patient or sample data is involved.
Data Provenance: Not applicable. The "data" here refers to the device's technical specifications and intended use, which are provided by the manufacturer (Günter Bissinger Medizintechnik GmbH) from Germany.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no "test set" and no "ground truth" in the clinical or diagnostic sense within this 510(k) submission. The FDA reviews the provided information to determine substantial equivalence based on accepted regulatory standards and the comparison to predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no "test set" requiring adjudication in this technical comparison.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a 510(k) submission for an electrosurgical cable, not an AI-powered diagnostic device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the direct sense of diagnostic "ground truth." The "ground truth" for a 510(k) in this context is established by the accepted specifications and performance of the legally marketed predicate devices and compliance with relevant industry standards (IEC, ANSI, AAMI).

8. The sample size for the training set

Not applicable. There is no machine learning or AI training set involved.

9. How the ground truth for the training set was established

Not applicable. There is no machine learning or AI training set involved.

Summary

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છે નિર્દ 6 1998

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510(k) Summary of Safety and Effective 2. Günter Bissinger Medizintechnik GmbH

As required by Section 807.92(c)

Submitted by:

Günter Bissinger Medizintechnik GmbH Tel. Gottlieb-Daimier-Straße 5 Fax D-79331 Teningen/ Baden eMail Germany

01149 (7641) 9 14 33 0 01149 (7641) 5 49 84 BissingerM@aol.com

Contact Person:

Dagmar Mäser FDA Liaison Amstel 320-l 1017 AP Amsterdam The Netherlands

01131 (20) 428-9591 Tel. 01131 (20) 428-9429 Fax bsi(@xs4all.nl eMail

Date Summary Prepared:

May 26, 1998

Name of the Device:

Bissinger Cables Proprietary Name: Bipolar Cable/Cord Common/Usual Name: Electrosurgical Cutting and Coagulation Classification Name: Device and Accessories (per 21 CFR 878.4400)

Description:

Bissinger cables are a line of non-sterile, reusable bipolar foot activated cables fitting Erbe, Martin, Valleylab, Aesculap GK50, Codman CMC II, and other ES units.

Intended Use:

This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

Industry Standards:

Bissinger certifies to comply with the required IEC. ANSI, and AAMI standards for manufacture, cleaning, sterilization and for the validation of these processes.

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Predicate Devices: g)

Olsen Electrosurgical Inc. Bipolar Cables Valleylab Reusable Cords/Connectors

Predicate Comparison: h)

ate Comparing the Bissinger Bipolar Cables to predicate devices is attached.

Bissinger Bipolar Cables Substantial Equivalence Comparison to Predicate Devices:

Manufacturer	Bissinger	Olsen	Valleylab
Device	Bipolar cable	Bipolar cable	Bipolar cable
Model(s)	80100xx	870,871,872	E0019
Intended Use	Transmission ofelectrical power froman electrosurgicalgenerator to a bipolarfoot activatedinstrument	Transmission ofelectrical power froman electrosurgicalgenerator to a bipolarfoot activatedinstrument	Transmission ofelectrical power froman electrosurgicalgenerator to a bipolarfoot activatedinstrument
Length of Cable	3 meters, 5 meters	10 foot (3.05m)	12 foot (3.66m)
Material of OuterCable Insulation	Silicone	Silicone	Silicone
Reusable/SingleUse?	Reusable	Reusable	Reusable
Provided Sterile?	No	No	No
Connector TypesInstrument End	Two types: either forinstruments withstandard Americantwo-pin type plugs, orfor instruments withthe standardEuropean flat plug	Two types: either forinstruments withstandard Americantwo-pin type plugs, orfor instruments withthe standardEuropean flat plug	For instruments withstandard Americantwo-pin type plugs
Connector TypesGenerator End	Martin, Erbe,Valleylab, AesculapGK50, Codman CMCII, standard typefitting all generatorsutilizing the standardreceivers for"Banana" inserts	Martin (872), Eder(872), Wolf (872),standard type fittingall generators utilizingthe standardreceivers for"Banana" inserts(870,871)	Valleylab

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 6 1998

Ms. Dagmar S. Maser Günter Bissinger Medizintechnik GmbH FDA Liaison Business Support, International Amstel 320-I 1017 AP Amsterdam - The Netherlands

Re: K981919

Trade Name: Bissinger Cables, Catalog Number 801000XX Regulatory Class: II Product Code: GEI Dated: May 27, 1998 Received: June 1, 1998

Dear Ms. Maser:

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 requirement, 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 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 - Ms. Dagmar S. Maser

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,

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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Günter Bissinger Medizintechnik GmbH

510(k) Number:

K98/9/9

Device Name:

Bipolar Cable/Cord

Classification Name:

Electrosurgical Cutting and Coagulation Device & Accessories

Product Code:

79 GEI Class II 21 CFR 878.4400

INDICATIONS FOR USE:

This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. 1981919

Prescription Use
(Per 21 CFR 801.109)

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.