CLARIS NON-STICK BIPOLAR FORCEPS

K051429 · Guenter Bissinger Medizintechnik GmbH · GEI · Jul 29, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051429
• Device Name: CLARIS NON-STICK BIPOLAR FORCEPS
• Applicant: Guenter Bissinger Medizintechnik GmbH
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bissinger CLARIS NON-STICK bipolar forceps are designed to grasp, manipulate and coagulate selected tissue. It is to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current. The Bissinger CLARIS NON-STICK bipolar forceps has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

Device Story

Bipolar forceps designed for surgical coagulation; utilizes specialized non-stick material on tips to prevent tissue adhesion during electrosurgery. Device connects to standard high-frequency electrosurgical generators via bipolar cable; operator (surgeon) uses forceps to grasp and manipulate tissue while applying bipolar coagulation current. Non-stick properties reduce need for intraoperative cleaning, enabling continuous operation. Device is reusable; requires manual cleaning and validated steam sterilization between uses. Benefits include improved surgical efficiency and reduced instrument maintenance.

Clinical Evidence

Bench testing only. Device performance evaluated against safety standards DIN EN 60601-1, DIN EN 60601-2-2, and ANSI/AAMI HF18-2001.

Technological Characteristics

Bipolar electrosurgical forceps; non-stick tip material; connects to standard high-frequency electrosurgical generators. Complies with DIN EN 60601-1, DIN EN 60601-2-2, and ANSI/AAMI HF18-2001. Sterilization: validated steam-sterilization (137°C, 3 bar, 15 min).

Indications for Use

Indicated for grasping, manipulating, and coagulating tissue during surgery. Contraindicated for tubal sterilization or tubal coagulation 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

• Link Technology, Inc. / Silverglide Surgical Technologies (K992931)

Submission Summary (Full Text)

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JUL 2 9 2005

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CLARIS NON-STICK

510(k) Notification

Annex I, Page 1 of 3

K 051429

Page 1 of (3)

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS IN Accordance with SMDA of 1990

DATE: 2005-05-19

Submitted by:

Guenter Bissinger Medizintechnik GmbH Gottlieb-Daimler-Str. 5 D-79331 Teningen Germany Phone: [phone] Fax: [phone] Email: [e-mail]

Official Correspondent: Matthias Bissinger

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Page ② of ③

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510(k) Notification

CLARIS NON-STICK

Annex I, Page 2 of 3

K 051429

#### 1. Device Name

CLARIS NON-STICK Bipolar Forceps Trade Name: Bipolar Forceps Common Name:

### 2. Classification

| Device: | Device, Electrosurgical, Cutting & Coagulation & Accessories |
|---------------------|----------------------------------------------------------------------|
| Device description: | Electrosurgical cutting and coagulation device and accesso-<br>ries. |
| Medical Specialty: | Part 878, General & Plastic Surgery |
| Product Code: | GEI |
| Regulation Number: | 878.4400 |
| Device Class: | 2 |

#### 3. Substantial Equivalence

CLARIS NON-STICK Bipolar Forceps are substantially equivalent to other legally marketed Bipolar Forceps from different manufacturers, e.g. Link Technology, Inc. / Silverglide Surgical Technologies, K992931.

## 4. Description of the Device

During the coagulation of tissue the coagulated tissue might stick to the tip of the forceps. This undesirable effect can almost completely be avoided by using the new CLARIS NON-STICK bipolar forceps. By applying a material with excellent thermal properties for the forceps, difficult and time-consuming cleaning of the forceps during an operation is no longer necessary and enables non-stop working. The non-stick effect is permanently ensured and will not be reduced, even if subject to frequent sterilization. By using a suitable connecting cable, CLARIS NON-STICK bipolar forceps can be connected to all high-frequency electrosurgical generators generally used.

#### 5. Intended Use

The Bissinger CLARIS NON-STICK bipolar forceps are designed to grasp, manipulate and coagulate selected tissue. It is to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current.

The Bissinger CLARIS NON-STICK bipolar forceps has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

## 6. Performance Standards

DIN EN 60601-1: Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988 + A1:1991 + A2:1995); German version EN 60601-1:1990 + A1:1993 + A2:1995; Version: 01-Mar-1996;

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K051429

Image /page/2/Picture/1 description: The image shows a logo with the word "bissinger" in lowercase letters. Above the word, there is a stylized eye graphic. The pupil of the eye is shaped like the letter "b". The logo is contained within a rectangular border.

510(k) Notification

CLARIS NON-STICK

Page 3 of 3
Annex I, Page 3 of 3

DIN EN 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (IEC 60601-2-2: 1998); German version EN 60601-2-2:2000; Version: 01-Aug-2001;

ANSI/AAMI HF18-2001: Electrosurgical Devices; Version: 01-May-2001.

## 7. Sterilization by User

BiTech Bipolar Scissors are delivered in non-sterile conditions. The user may sterilize these devices by using a validated and applicable sterilization process.

#### Cleaning and Maintenance

Every surgical instrument should be disinfected and thoroughly cleaned after each use. Proper cleaning, inspection and maintenance will help ensure correct function of the surgical instrument. Clean, inspect and test each instrument carefully. Sterilise all instruments before surgery. A good cleaning and maintenance procedure will extend the useful life of the instrument.

Special attention must be paid to slots, stops, ends, hollow tubes and other highly inaccessible Opolar attention mation, cables and connectors for cuts, voids, cracks, tears, abrasions, etc.

Do not use damaged instruments.

Cleaning and rinsing must take place immediately after each use for best effect. Failure to clean promptly may result in adherent particles or dried secretions that may resist cleaning and complicate or resist future sterilisation.

Instruments must be completely cleaned and rinsed of all foreign matter.

Use warm water and a commercially available instrument pre-soak or cleaning agent. Enzymatic cleaners (such as Enzol™) must be used to remove protein deposits. Follow the enzymatic cleaner's instructions; rinse thoroughly.

- · Do not use corrosive cleaning agents (i.e. bleach). Cleaning solutions and rinses at or near a neutral pH (7.0) are best.
- · Do not use abrasive cleaners.
- · Only a soft bristle brush should be used.
- · Immerse the entire device in detergent and clean while soaking. Rinse with sterile deionized water. Can be disinfected in the washing machine up to 203°F (95°C).
- · Rinse thoroughly with distilled water.
- · Prepare for storage and/or sterilisation.

#### Sterilization

Only a validated steam-sterilization process according DIN EN 554 / ISO 11134 that uses a sterilization cycle of 137°C / 280°F, 3 bar, for min. 15 minutes has to be used.

(Note: Contact the manufacturer of your steam autoclave to confirm appropriate temperatures and sterilisation times.)

Caution: Autoclave temperatures should not exceed 280°F (137°C); handles, insulation or other non-metallic parts may be damaged

Do not sterilise with hot air.

Do not use 'Flash' autoclave procedures.

#### 8. Conclusion

Based on the available 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that Bissinger CLARIS NON-STICK bipolar forceps are substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 2005

Guenter Bissinger Medizintechnik GmbH c/o Ms. Christa Heitmann-Franke MEDAGENT, Inc. One Park Avenue, Suite #5G Hampton, New Hampshire 03842

Re: K051429

Trade/Device Name: CLARIS NON-STICK Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 27, 2005 Received: June 10, 2005

Dear Ms. Heitmann-Franke:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### Page 2- c/o Ms. Christa Heitmann-Franke

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Stipt Rhodes

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number: K_ 051429

Device Name: CLARIS NON-STICK Bipolar Forceps

Indications for Use:

. .

The Bissinger CLARIS NON-STICK bipolar forceps are designed to grasp, manipulate The bloomger of and tissue. It is to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current.

The Bissinger CLARIS NON-STICK bipolar forceps has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

Prescription Use X YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use NO (21 SFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hupt Rurdis

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_K051429