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.

AI/ML Overview

This document is a 510(k) premarket notification for the "Bipolar Micro-Coagulation Forceps" by Gunter Bissinger Medizintechnik GmbH. It describes the device and demonstrates its substantial equivalence to a predicate device, K150959, Sutter Bipolar Forceps - Calvian.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative metrics in the provided document, which is typical for a 510(k) for a Class II electrosurgical device where substantial equivalence to a predicate is the primary goal. Instead, equivalence in various characteristics is demonstrated. The "Result" column typically indicates "Substantially Equivalent," implying that the device's performance aligned with the predicate or relevant standards to demonstrate safety and effectiveness.

Criteria Category	Specific Characteristic	Predicate Device Performance / Standard	Reported Device Performance / Compliance	Result
Indications for Use	Intent to remove tissue and control bleeding	Intended to remove tissue and control bleeding	Intended to remove tissue and control bleeding	Substantially Equivalent
Regulation Number	878.4400	878.4400	878.4400	Substantially Equivalent
Product Code	GEI	GEI	GEI	Substantially Equivalent
Device Class	II	II	II	Substantially Equivalent
Prescription / OTC	Prescription	Prescription	Prescription	Substantially Equivalent
Device Design	Electrosurgical tools with different handles & tip designs	Electrosurgical tool with different handle styles & tip sizes	Electrosurgical tools with different handles & different tip designs	Substantially Equivalent
Material	Stainless Steel, Plastic Material	Stainless Steel, Plastic Material	Stainless Steel, Plastic Material	Substantially Equivalent
Tip Size [mm]	0.35 – 2.8	0.7 - 2.5	0.35 – 2.8	Substantially Equivalent
Shaft Length [mm]	15	18	15	Substantially Equivalent
HF-mode	Bipolar	Bipolar	Bipolar	Substantially Equivalent
Maximum peak voltage	300 Vp	500 Vp	300 Vp	Substantially Equivalent
Delivered Condition	Unsterile	Unsterile	Unsterile	Substantially Equivalent
Single Use	No (Reusable)	No (Reusable)	No (Reusable)	Substantially Equivalent
Safety Standard	Meets IEC 60601-2-2	Meets IEC 60601-2-2	Meets IEC 60601-2-2	Substantially Equivalent
Biocompatibility	Complies with ISO 10993-1 (Cytotoxicity, Sensitization, Irritation)	Complies with ISO 10993-1 (Cytotoxicity, Sensitization, Irritation)	Passed (Evaluation proofs biological safety)	Substantially Equivalent
Electrical Safety	Complies with IEC 60601-1 and IEC 60601-2-2 (Mechanical stability, Insulation, HF leakage/electrical strength, Power frequency)	Complies with IEC 60601-1 and IEC 60601-2-2	Passed all performed tests	Substantially Equivalent
Sterilization/Shelf Life	Validated cleaning & sterilization procedures	Validated cleaning & sterilization procedures	Validated cleaning & sterilization procedures	Substantially Equivalent
Thermal Effects	Thermal damage comparable to predicate	Thermal damage comparable to predicate	Functions and characteristics did not display any major difference	Substantially Equivalent

2. Sample Sizes Used for the Test Set and Data Provenance

Sample Size (Test Set): The document mentions that "Three different tissue types were used" for evaluating thermal effects. However, it does not specify the number of samples or repetitions for each tissue type, neither does it mention specific patient data. For the other tests (Biocompatibility, Electrical Safety, Sterilization), the sample size typically refers to the number of devices tested to meet the respective standard, which is not explicitly quantified here beyond stating the tests were performed.
Data Provenance: Not explicitly stated. Given the applicant is in Germany, it's highly likely the testing was conducted in Germany or a location deemed acceptable for gaining regulatory approval. The study type is not specified as retrospective or prospective, but as it involves testing of the physical device it would inherently be "prospective" for the specific tests performed (e.g., electrical safety, thermal effects).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of device submission. The submission is for an electrosurgical tool, not an AI/diagnostic device that requires expert review for ground truth establishment. The ground truth for this device is based on physical performance measurements, compliance with international standards (IEC, ISO), and direct comparison to a legally marketed predicate device.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason mentioned above. Adjudication methods like 2+1 or 3+1 are relevant for studies involving human interpretation (e.g., reading medical images) to establish a consensus ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic tools or AI systems where human readers interpret cases. This submission is for a physical surgical instrument.

6. Standalone Performance Study (Algorithm Only)

This information is not applicable. This device is a physical surgical instrument, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

Compliance with Recognized Standards: Meeting the requirements of IEC 60601-1, IEC 60601-2-2 for electrical safety, and ISO 10993-1 for biocompatibility. These standards define the acceptable performance and safety limits.
Direct Comparison to a Legally Marketed Predicate Device: The key "ground truth" or benchmark here is the performance and characteristics of the Sutter Bipolar Forceps - Calvian (K150959). The study aimed to demonstrate that the proposed device performs "as intended" and is "substantially equivalent" to the predicate.
Laboratory Testing: Directly measuring physical properties, electrical characteristics, and thermal effects in a controlled environment.

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" for this type of medical device as it does not involve machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.

☒ Prescription Use (Part 21 CFR 801 Subpart D)	□ 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 GmbHHans-Theisen-Str. 1D-79331 TeningenGermanyTel.: +49 7641 914330Fax: +49 7641 9143333E-Mail: info@bissinger.comInternet: www.bissinger.com
SUBMITTER:	Matthias BissingerManaging DirectorTel.: +49 7461 914330E-Mail: bissinger@bissinger.com
CONTACT PERSON:	Maria GoertzQuality Management RepresentativeTel.: +49 7461 91433210E-Mail: m.goertz@bissinger.com

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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,Cutting & Coagula-tion & Accessories	General & PlasticSurgery	General & PlasticSurgery	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.

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-technik GmbH	Sutter Medizintechnik GmbH	Result
Device Name	Bipolar Micro-Coagulation For-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-ceps are intended to removetissue and control bleeding	Sutter Bipolar Forceps - Calvianare intended to remove tissueand control bleeding	Substantially Equivalent
Prescription / OTC	Prescription	Prescription	Substantially Equivalent

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Bipolar Micro-Coagulation Forceps

Company	Günter Bissinger Medizin-technik GmbH	Sutter Medizintechnik GmbH	Result
Device Design	Bipolar Micro-Coagulation For-ceps are electrosurgical toolsavailable with different handlesand different tip designs.	Sutter Bipolar Forceps - Calvianis an electrosurgical tool availa-ble in different handle styles andtip sizes.	Substantially Equivalent
Material	Stainless SteelPlastic Material	Stainless SteelPlastic 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

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.