BISSINGER CABLES, CAT. NO. 801000XX

K981919 · Guenter Bissinger Medizintechnik GmbH · GEI · Aug 6, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981919
• Device Name: BISSINGER CABLES, CAT. NO. 801000XX
• Applicant: Guenter Bissinger Medizintechnik GmbH
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Bissinger bipolar cables are reusable, non-sterile electrosurgical accessories; function as electrical conduits between bipolar electrosurgical generators and foot-activated bipolar instruments. Cables feature silicone outer insulation; available in 3-meter and 5-meter lengths; include various connector configurations for compatibility with multiple generator brands (e.g., Erbe, Martin, Valleylab, Aesculap, Codman). Operated by qualified medical personnel in clinical settings; cables facilitate power delivery for cutting and coagulation. Benefit includes standardized connectivity for diverse electrosurgical equipment.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Reusable bipolar electrosurgical cables; silicone outer insulation; 3m and 5m lengths; connector interfaces for standard American two-pin plugs, European flat plugs, and various generator-specific 'banana' inserts. Complies with IEC, ANSI, and AAMI standards for manufacture, cleaning, and sterilization.

Indications for Use

Indicated for use by qualified medical personnel trained in electrosurgery to transmit electrical power from a bipolar electrosurgical generator to a bipolar foot-activated instrument during electrosurgical procedures.

Regulatory Classification

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.

Predicate Devices

• Olsen Electrosurgical Inc. Bipolar Cables
• Valleylab Reusable Cords/Connectors

Submission Summary (Full Text)

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છે નિર્દ 6 1998

Image /page/0/Picture/1 description: The image shows a close-up of an eye on the left side of the image. The eye has a dark pupil and a visible lower eyelid. On the right side of the image, there is a series of handwritten numbers that appear to be "1981919". The numbers are written in a cursive style and are slightly slanted.

## 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 [e-mail]

## 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:

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.

## 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 of<br>electrical power from<br>an electrosurgical<br>generator to a bipolar<br>foot activated<br>instrument | Transmission of<br>electrical power from<br>an electrosurgical<br>generator to a bipolar<br>foot activated<br>instrument | Transmission of<br>electrical power from<br>an electrosurgical<br>generator to a bipolar<br>foot activated<br>instrument |
| Length of Cable | 3 meters, 5 meters | 10 foot (3.05m) | 12 foot (3.66m) |
| Material of Outer<br>Cable Insulation | Silicone | Silicone | Silicone |
| Reusable/Single<br>Use? | Reusable | Reusable | Reusable |
| Provided Sterile? | No | No | No |
| Connector Types<br>Instrument End | Two types: either for<br>instruments with<br>standard American<br>two-pin type plugs, or<br>for instruments with<br>the standard<br>European flat plug | Two types: either for<br>instruments with<br>standard American<br>two-pin type plugs, or<br>for instruments with<br>the standard<br>European flat plug | For instruments with<br>standard American<br>two-pin type plugs |
| Connector Types<br>Generator End | Martin, Erbe,<br>Valleylab, Aesculap<br>GK50, Codman CMC<br>II, standard type<br>fitting all generators<br>utilizing the standard<br>receivers for<br>"Banana" inserts | Martin (872), Eder<br>(872), Wolf (872),<br>standard type fitting<br>all generators utilizing<br>the standard<br>receivers for<br>"Banana" inserts<br>(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 [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,

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:

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.

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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)

OR

Over-The-Counter Use

V

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