BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS

K970968 · Guenter Bissinger Medizintechnik GmbH · HET · May 21, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K970968
• Device Name: BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS
• Applicant: Guenter Bissinger Medizintechnik GmbH
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: May 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bipolar tissue coagulation in: Gynecology and Laparoscopic surgical procedures

Device Story

Detachable bipolar coagulation forceps used for tissue coagulation during laparoscopic and gynecological surgery. Device consists of a handle (forceps body), exterior/interior tubes, and interchangeable electrodes (fluted, tong-type, or rippled bar). Connects to external high-frequency electrical generators via specialized plugs (Erbe, Martin/Berchtold, Codman, Valleylab) and insulated cables. Operated by surgeons in an OR setting. Principle of operation involves delivering high-frequency electrical current through tissue between two electrical contacts on the probe to achieve coagulation via thermal destruction. Device is supplied clean and requires steam autoclave sterilization prior to use.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and intended use comparisons to the predicate device.

Technological Characteristics

Materials: PEEK, PTFE, stainless steel, silicone, PA. Sensing/Actuation: Bipolar high-frequency electrical current. Form factor: Detachable forceps with 200mm, 340mm, and 450mm working lengths. Connectivity: Wired connection to external electrosurgical generators. Sterilization: Steam autoclave (270°F for 15 minutes). Compliance: UL-544, ISO-9001.

Indications for Use

Indicated for bipolar tissue coagulation during gynecological and laparoscopic surgical procedures.

Regulatory Classification

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.

Predicate Devices

• WISAP bipolar coagulators (WISAP USA)

Submission Summary (Full Text)

{0}

K970968

| Summary of Safety and Effectiveness Information
Premarket Notification, Section 510(k) | bissinger®
detachable bipolar coagulation-forceps
Medizintechnik, GmbH |
| --- | --- |

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

1. 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 |

150

{1}

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, 340mm 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 and 450mm 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, 340mm 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 coagulation-forceps 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.

{2}

152

# 6. Equivalence:

Based on the materials, intended uses, design and clinical technique, the bissinger® detachable bipolar coagulation-forcops 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, stainless steel, | 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, 7585-1
WISAP - #7585, 7585-1
WISAP - #7585-4, 7585-5 | Yes
Yes
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 |

{3}

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

MAY 21 1998

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

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, 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 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 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/dsma/dsmamain.html".

Sincerely yours,


Enclosure

{4}

Page 1 of 1

510(k) Number: K970968

Device Name: L-issinger® detachable bipolar coagulation forceps

Indications For Use:
- Bipolar tissue coagulation in:
- Gynecology and
- Laparoscopic surgical procedures

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David H. Sigmon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number 15970968

Prescription Use ☑ OR Over-The-Counter Use ☐

(Per 21 CFR 801.109) (Optional format 1-2-96)