Bipolar Micro-Coagulation Forceps

K172368 · Gunter Bissinger Medizintechnik GmbH · GEI · Apr 5, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K172368
• Device Name: Bipolar Micro-Coagulation Forceps
• Applicant: Gunter Bissinger Medizintechnik GmbH
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 5, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bipolar Micro-Coagulation Forceps are intended to remove tissue and control bleeding.

Device Story

Bipolar Micro-Coagulation Forceps are reusable electrosurgical instruments designed for tissue removal and hemostasis. The device consists of forceps with various handle styles and tip designs (0.35–2.8 mm). It connects to an external electrosurgical generator via a bipolar cable to deliver high-frequency electrical energy to the target tissue. Operated by surgeons in clinical settings, the device is supplied unsterile and requires cleaning and sterilization before each use. By applying bipolar current, the forceps coagulate blood vessels and remove tissue, aiding in surgical precision and bleeding control. The device is functionally equivalent to existing bipolar forceps, with performance validated through comparative thermal tissue effect testing and adherence to electrical safety standards.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility evaluation per ISO 10993-1 (cytotoxicity, sensitization, irritation/reactivity), electrical safety testing per IEC 60601-1 and IEC 60601-2-2 (mechanical stability, insulation, leakage current, electrical strength), and comparative thermal tissue effect analysis against the predicate device across three tissue types and various power settings.

Technological Characteristics

Materials: Stainless steel and plastic. Energy: Bipolar high-frequency (HF) electrosurgery. Max peak voltage: 300 Vp. Form factor: Reusable forceps with varying handle/tip designs (0.35–2.8 mm). Connectivity: Wired connection to electrosurgical generator. Standards: IEC 60601-1, IEC 60601-2-2. Sterilization: Validated cleaning and sterilization required by user.

Indications for Use

Indicated for the removal of tissue and control of bleeding in patients requiring electrosurgical intervention. Prescription use only.

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

• Sutter Bipolar Forceps - Calvian (K150959)

Submission Summary (Full Text)

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April 5. 2018

Gunter Bissinger Medizintechnik GmbH Mr. Matthias Bissinger CEO Hans-Theisen-Str. 1 D-79331 Teningen, DE Baden-Wurttemberg, Germany

Re: K172368

Trade/Device Name: Bipolar Micro-Coagulation Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 2, 2018 Received: March 12, 2018

Dear Mr. Bissinger:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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### Page 2 - Mr. Bissinger

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director

Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K172368

Device Name Bipolar Micro-Coagulation Forceps

Indications for Use (Describe)

Bipolar Micro-Coagulation Forceps are intended to remove tissue and control bleeding.

| <span style="text-decoration: underline;"> </span> <span style="font-family: sans-serif;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;"> </span> □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Type of Use (Select one or both, as applicable)

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510(k) Notification

# K172368

# 510(k) Summary

DATE OF APPLICATION: 2017-08-04

| APPLICANT: | Günter Bissinger Medizintechnik GmbH<br>Hans-Theisen-Str. 1<br>D-79331 Teningen<br>Germany<br>Tel.: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail]<br>Internet: www.bissinger.com |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | Matthias Bissinger<br>Managing Director<br>Tel.: [phone]<br>E-Mail: [e-mail] |
| CONTACT PERSON: | Maria Goertz<br>Quality Management Representative<br>Tel.: [phone]<br>E-Mail: [e-mail] |

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510(k) Notification

#### 1. Device Name

| Product code: | GEI |
|----------------------|----------------------------------------------------------------|
| Trade Names: | Bipolar Micro-Coagulation Forceps |
| Common Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |

#### 2. Classification Product Code / Subsequent Code

Bipolar Micro-Coagulation Forceps can be classified according to following device name and product code

| Device | Medical Specialty | Review Panel | Product Code | Device Class | Regulation Number |
|--------------------------------------------------------------|------------------------------|------------------------------|--------------|--------------|-------------------|
| Electrosurgical,<br>Cutting & Coagula-<br>tion & Accessories | General & Plastic<br>Surgery | General & Plastic<br>Surgery | GEI | 2 | 878.4400 |

#### Prior Submissions 3.

There have been no prior submissions of the subject devices so far.

#### 4. Predicate Device

| Predicate Device | 510(k) Number | 510(k) Holder |
|----------------------------------|---------------|----------------------------|
| Sutter Bipolar Forceps - Calvian | K150959 | Sutter Medizintechnik GmbH |

#### Device Description 5.

Bipolar Micro-Coagulation Forceps are electrosurgical tools available with different handles and different tip designs. The Bipolar Micro-Coagulation Forceps can be connected through an appropriate bipolar cable to an electrosurgical generator. The Bipolar Micro-Coagulation Forceps can be disassembled for cleaning and sterilization. The Bipolar Micro-Coagulation Forceps are delivered in unsterile condition and have to be sterilized prior to each use.

#### 6. Indications for Use

The Bipolar Micro-Coaqulation Forceps are intended to remove tissue and control bleeding.

#### Technological Characteristics 7.

The technological characteristics of our Bipolar Micro-Coagulation Forceps are the same as the technological characteristics of the predicate device.

#### 7.1. Device characteristics table

| Company | Günter Bissinger Medizin-<br>technik GmbH | Sutter Medizintechnik GmbH | Result |
|--------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------|
| Device Name | Bipolar Micro-Coagulation For-<br>ceps | Sutter Bipolar Forceps - Calvian | - |
| Regulation Number | 878.4400 | 878.4400 | Substantially Equivalent |
| Code | GEI | GEI | Substantially Equivalent |
| Class | II | II | Substantially Equivalent |
| 510(k) number | - | K150959 | - |
| Indication for Use | Bipolar Micro-Coagulation For-<br>ceps are intended to remove<br>tissue and control bleeding | Sutter Bipolar Forceps - Calvian<br>are intended to remove tissue<br>and control bleeding | Substantially Equivalent |
| Prescription / OTC | Prescription | Prescription | Substantially Equivalent |

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## Bipolar Micro-Coagulation Forceps

| Company | Günter Bissinger Medizin-<br>technik GmbH | Sutter Medizintechnik GmbH | Result |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Device Design | Bipolar Micro-Coagulation For-<br>ceps are electrosurgical tools<br>available with different handles<br>and different tip designs. | Sutter Bipolar Forceps - Calvian<br>is an electrosurgical tool availa-<br>ble in different handle styles and<br>tip sizes. | Substantially Equivalent |
| Material | Stainless Steel<br>Plastic Material | Stainless Steel<br>Plastic Material | Substantially Equivalent |
| Tip size [mm] | 0.35 – 2.8 | 0.7 - 2.5 | Substantially Equivalent |
| Shaft Length [mm] | 15 | 18 | Substantially Equivalent |
| HF-mode | bipolar | bipolar | Substantially Equivalent |
| Maximum peak voltage [Vp] | 300 | 500 | Substantially Equivalent |
| Delivered Condition | unsterile | unsterile | Substantially Equivalent |
| single use | no | no | Substantially Equivalent |
| Meets IEC 60601-2-2 | yes | yes | Substantially Equivalent |

#### 7.2. Summary of technological characteristics

The proposed device is similar in terms of design, operating principles and intended use and has similar technological characteristics as the predicate devices are bipolar forceps with the same intended use. Both devices are available with different handles and different tip sizes. They are both reusable devices which are delivered in unsterile condition. The subjected device as well as the predicate devices meet the requirements of IEC 60601-2-2.

#### 8. Performance Data

Verification and validation results demonstrate that the device performs as intended and that the device is substantially equivalent to the predicate device K150959.

#### 8.1. Biocompatibility

The device has been evaluated for its biological safety according to ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process". Following endpoints have been assessed during the evaluation:

- Cytotoxicity ■
- . Sensitization
- I Irritation or Intracutaneous Reactivity

The evaluation proofs the biological safety of the Bipolar Micro-Coagulation Forceps.

#### Electrical Safety 8.2.

The Bipolar Micro-Coagulation Forceps has been tested according to IEC 60601-1 and IEC 60601-2-2. The test setup included:

- Mechanical stability
- l Insulation of active equipment
- I High frequency leakage current
- l High frequency electrical strength
- I Power frequency (50 Hz)

The device had passed all performed tests.

#### 8.3. Sterilization and Shelf Life

The devices are supplied in non-sterile condition and have to be cleaned prior to the first and every further use. A cleaning procedure as well as a sterilization procedure have been validated.

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## Bipolar Micro-Coagulation Forceps

#### 8.4. Thermal Effects on Tissue

To evaluate the thermal effects on tissue a comparison the Bipolar Micro-Coagulation forceps of Bissinger and the predicate device was performed. Three different tissue types were used. Each tissue type was tested with different power settings. Afterwards the thermal damage was analyzed.

The comparison of the two devices showed that they are both substantially equivalent. Their functions and characteristics did not display any major difference throughout the tests.

#### 9. Substantial Equivalence Summary / Conclusion

Based on available 510(k) information provided herein, Bipolar Micro-Coagulation Forceps are considered substantially equivalent to the predicate devices in terms of indications for use, material, technology, design and performance specifications. The performed tests show that the subjected device is in compliance with the applicable recognized standards. Performed comparison testing with the predicate device shows substantial equivalence to the FDA-cleared predicate device Sutter Bipolar Forceps – Calvian.

There are no differences between the devices which would raise new issues of safety or effectiveness. The Bipolar Micro-Coagulation Forceps is substantially equivalent to predicate device Sutter Bipolar Forceps - Calvian cleared under 510(k) #K150959