Cables for electrosurgery are designed to conduct electrical power from the output of a high-frequency electrosurgical generator to the electrosurgical instrument. Do not exceed a maximum output of 6250 Vp of your generator.

Device Description

Bissinger monopolar cables are non-sterile, reusable Monopolar Cables fitting Bovie Electrosurgical units. They are designed to conduct electrical power from the output of a high frequency generator to the instrument.

AI/ML Overview

This document is a 510(k) summary for Bissinger Monopolar Cables, seeking clearance from the FDA. It declares substantial equivalence to previously cleared predicate devices. The information provided heavily focuses on describing the device and comparing it to predicates, rather than presenting a detailed study with specific acceptance criteria and performance metrics typically expected for AI/software-as-a-medical-device (SaMD) clearances.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this document, as they are not typically required for a mechanical device like electrosurgical cables that are seeking substantial equivalence based on material, design, and performance conformity to existing standards, rather than a clinical effectiveness study.

However, I can extract the relevant information that is available:

1. A table of acceptance criteria and the reported device performance

The document frames compliance with recognized standards as the performance criteria. The "new device" (Bissinger Monopolar Cables) is compared to predicate devices across several technological characteristics, with the "RE-SULT" column consistently indicating "Substantial Equivlent".

Characteristic	New Device Acceptance Criteria (implied by standards conformity and predicate equivalence)	Reported Device Performance (as demonstrated by testing and comparison)
Primary Safety Standards Met	Conformance to IEC 60601-2-2: 2009 (Electrical Safety Standard for Electrosurgery)	Conforms to IEC 60601-2-2: 2009. Electrical safety testing performed. (Section 7.1)
Sterilization Process	Sterilizable to a sufficient sterility assurance level using standard parameters. Validated according to recognized standards.	Sterilization process validated under recognized standards. Products can be steam sterilized with sufficient sterility assurance level. (Section 7.2)
Reprocessability	Reprocessable according to recognized standards.	Reprocessability tested and validated under recognized standards. (Section 7.3)
Manual Cleaning	Cleaning validated according to recognized standards.	Manual cleaning validation performed under recognized standards. (Section 7.4)
Biocompatibility	Meets all biocompatibility requirements for clinical use, materials with established safe use history (ISO 10993-1).	All biocompatibility requirements met through material composition and established safe use history in other medical devices. (Section 8)
Maximum Output Voltage	Not to exceed 6250 Vp of the generator.	Power maxima 6.250 Vp (consistent with predicate and reference device). (Section 6)
Intended Use	Designed to conduct electrical power from high-frequency electrosurgical generator to instrument.	Matches the stated intended use. (Section 5, Section 6)
Materials	Silicon (consistent with predicate devices).	Material: Silicon. (Section 6)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not detail specific sample sizes for tests. The testing performed is related to electrical safety, sterilization validation, reprocessing, and manual cleaning. These are typically bench tests or validation studies for manufacturing processes, not clinical studies with patient data. Therefore, concepts like data provenance (country of origin, retrospective/prospective) are not applicable in the usual sense for this type of device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The "ground truth" for this device's clearance is conformity to engineering standards (e.g., IEC 60601) and validated manufacturing processes (e.g., sterilization). Expert consensus of clinical data is not a part of this submission type.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are typically for clinical outcome assessments where there might be disagreement in interpretation. For engineering and process validation, the conformity to standards is typically assessed by engineers and quality control personnel.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This is not an AI/SaMD device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is a physical medical device (monopolar cables), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission are the recognized consensus standards (e.g., IEC 60601-2-2:2009 for electrical safety, and other "recognized standards" for sterilization, reprocessing, and biocompatibility). The device performance is assessed against the specifications and requirements outlined in these standards.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

This is not applicable. There is no training set for this device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 20, 2015

Güenter Bissinger Medizintechnik GmbH Matthias Bissinger Managing Director Hans-Theisen-Straße 1 79331 Teningen Baden-Wuerttemberg Germany

Re: K150024

Trade/Device Name: Monopolar Cables Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 1, 2014 Received: January 7, 2015

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 (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -S

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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Indications for Use

510(k) Number (if known) K150024 I

Device Name Monopolar Cables

Indications for Use (Describe)

Cables for electrosurgery are designed to conduct electrical power from the output of a high-frequency electrosurgical generator to the electrosurgical instrument.

Do not exceed a maximum output of 6250 Vp of your generator.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for Bissinger. The logo features a stylized letter 'b' in red, with the center of the 'b' forming the pupil of an eye. Below the eye is the word 'bissinger' in lowercase, with a line underneath the 'er' at the end of the word.

VOLUME 006

510(k) Summary

DATE OF APPLICATION: 2014-12-01

APPLICANT:	Guenter Bissinger Medizintechnik GmbHHans-Theisen-Str. 1,D-79331 Teningen ,GermanyTel.: +1.603.570.2039Fax: +1.603.570.2055E-Mail: info@bissinger.comInternet: www.bissinger.com
CONTACT PERSON:	Matthias BissingerTel.: +49.7461 914330E-Mail: bissinger@bissinger.com

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Image /page/4/Picture/0 description: The image shows a logo for "bissinger". The logo features a stylized letter "b" in red, with a white outline resembling an eye around it. Below the "b", the word "bissinger" is written in a smaller, black, sans-serif font.

1. Device Name

Product code:	GEI
Trade Names:	Bissinger Monopolar Cables
Common Name:	electrosurgical, cutting & coagulation & accessories
Classification Name:	Electrosurgical cutting and coagulation device and accessories

Classification Product Code / Subsequent Code 2.

2.1. Product Code

Device	MedicalSpecialty	Review Panel	Product Code	Device Class	Regulation Number
Electrosurgical cuttingand coagulation de-vice and accessories.	Part 878	General & Plastic Sur-gery	GEI	2	878.4400

Predicate Device 3.

Bissinger's Monopolar Cables are substantially equivalent to the following predicate devices, already cleared by the FDA:

Predicate Device	510(k) Number	510(k) Holder
Hans Hermann Laparoscopes andAccessories	K051610	HANS HERMANN GMBH
Suffer Electrosurgical Cables	K073450	Suffer Medizintechnik GmbH

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Image /page/5/Picture/0 description: The image shows a logo for Bissinger. The logo features a stylized letter 'b' that is shaped like an eye, with a dark red iris and a black pupil. The word 'bissinger' is written in lowercase letters below the eye-shaped 'b'. The font is simple and modern, and the overall design is clean and eye-catching.

Description of the Device 4.

Indications for Use 5.

Cables for electrosurgery are designed to conduct electrical power from the output of a high-frequency electrosurgical generator to the electrosurgical instrument.

Do not exceed a maximum output of 6250 Vp of your generator.

Technological Characteristics 6.

	NEW DEVICE	Predicate Device 1	Predicate Device 2	Reference DEVICE	RE-SULT
510(k)Submitter/Holder	Bissinger MedizintechnikGmbH	HANS HERMANNGMBH	Sutter MedizintechnikGmbH	Jarit Surgical Instru-ments Inc.	NA
TradeName	Bissinger MonopolarCables	Hans Hermann Lapa-roscopes and acces-sories	Sutter ElectrosurgicalCables	Unipolar EndoscopicCoagulator-cutter andAccessories	NA
Device	Bissinger MonopolarCables	Laparoscopes	Sutter ElectrosurgicalCables	JARIT SURGICALINSTRUMENTS	NA
510(k)Number		K051610	K073450	K932456	NA
Intendeduse	Cables for electrosur-gery are designed toconduct electrical powerfrom the output of ahigh-frequency electro-surgical generator to theelectrosurgicalinstru-ment.Do not exceed a maxi-mum output of 6250 Vpof your generator.	The Laparosopes andaccessories areintended for use inproviding access toand visualization ofbody cavities, organs,and canals to performvarious diagnosticand therapeuticsurgical procedures.The arthroscope isindicated for illumina-tion during joint ex-aminations, arthros-copies, biopsies an (diagnosis of jointdisease in minimallyinvasive proceduresof the knee, shoulder,wrist (carpal tunnelsyndrome), temporalmandibular joint,ankle and elbow. Thebipolar electrodes areuse to coagulate andto remove or destroytissue by the use ofbipolar HF current.	To electrically con-nect monopolar/bipolar electrosurgi-cal instruments to anelectrosurgical gen-erator.	For use by, or as di-rected by, a surgeon inendoscopic surgery.Foruse inendoscopicsurgery. For use when arigid endoscopic instru-ment for graspingand/or dissecting if softtissue is determined tobe appropriate by thesurgeon.Monopolarelectrosurgical currentcan be used for coagu-lation and/or cutting asdetermined necessaryand appropriate by thesurgeon.	Sub-stan-tialEquiv-alent
Type	Monopolar Cable	Monopolar siliconeCables	Monopolar siliconeCables	Jarit 600-290	Sub-stan-tialEquivalent

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Image /page/6/Picture/0 description: The image shows a logo with the word "bissinger" in lowercase letters. Above the word is a stylized graphic that combines the letter "b" with an eye. The "b" is colored in a dark red, and the eye is outlined in black with a black pupil. The word "bissinger" is in a simple, sans-serif font.

Monoplar Cables

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	NEW DEVICE	Predicate Device 1	Predicate Device 2	Reference DEVICE	RE-SULT
Design	Length: 3,080 m.Socket: Ø 4 mmPlug Ø 8 mmConnection: Bovie	Length: 3 m,Connector: 4 mmConnection: Erbe,Martin, Berchtold,	Length: 3.5 mtr, 4,5mtr. Connector: 4 mmConnection:Val-leylab,Conmed,Bovie, Bowa, Erbe, K.Storz, R. Wolf, Martin,Berchtold, Aesculap	Length: 3,080 m.Socket: Ø 4 mmPlug Ø 8 mmConnection: Bovie	Sub-stan-tialEquivalent
Materials /Biocom-patibility	Material: SiliconCables do not havedirect contact with thehuman body or only withuninjured skin, so thatbiocompatibility must notbe evaluated.	Silicon	Silicon	Silicon	Sub-stan-tialequiva-lenrt
Sterility	ReusableInstruments.Delivery non sterile.The instruments must besterilized in moist heat(Autoclave).Pre-vacuum Cycle- Temperature: 132°C- Exposure time: 4 min.- Drying time: at least 20min.	ReusableInstru-ments. Delivery nonsterile.The instruments mustbe sterilized in moistheat(Autoclave).Pre-vacuum Cycle- Temperature:132°C, max 137°C- Exposure time: 3min.- Drying time: at least10 min.	Sutter ElectrosurgicalCables are suppliednon-sterile and canbe reused after clean-ing and steam sterili-zation.Steam-sterilize in theautoclave in accord-ance with DIN EN13060 / DIN EN 285.Fractionedpre-vacuum sterilization:Temperature 134 °C(273 °F), 3 minutes;max.Temperature138 °C (280 °F),max. duration20minutes.	Similar: Reusable In-struments	Sub-stan-tialEquivalent
Compati-bility withenviron-ment andotherdevices	Generators: Bovie	Generators: Erbe,Martin, Berchtold,	Generators: Erbe,Martin, Valleylab,Conmed, Berchtold,Bowie, Bowa, Aescu-lap	Generators: Bovie	Sub-stan-tialEquivalent
Standardsmet	IEC 60601-2-2: 2009	IEC 60601-2-2:2009	IEC 60601-2-2:2007	IEC 60601-2-2:2009	Sub-stan-tialEquivalent
Energyapplied	Power maxima 6.250 Vp	Power maxima 6.250Vp	Maximum MonopolarcablesVoltage 10000Vpp	Power maxima 6.250Vp	Sub-stan-tialEquivalent

7. Testing

Testing in order to proof safety and effectiveness of Bissinger's Monopolar Cables has been performed according to recognized consensus Standards and results are conforming to the respective requirements.

Electrical Safety 7.1.

The devices subject to this submission have been tested according to the requirements of IEC 60601 and IEC 60601-2-2:2009.

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7.2. Sterilization

The sterilization process has been validated under consideration of recognized standards. Testing shows that the Products can be steam sterilized with a sufficient sterility assurance level by use of standard sterilization parameters.

7.3. Reprocessing

Reprocessability was tested and validated under consideration of recognized standards.

7.4. Manual cleaning

Manual cleaning validation was performed under consideration of recognized standards.

8. Biocompatibility

All requirements of biocompatibility are met through the composition of the used materials which demonstrate the appropriate levels of biocompatibility for its clinical use. The used materials are also used in many other medical devices and have an established history of safe use and biocompatibility outlined in ISO 10993-1.

Substantial Equivalence Summary / Conclusion 9.

Based on available 510(k) information provided herein, Bissinger Monopolar Cables are considered substantial equivalent to the predicate devices in terms of indications for use, material, technology, design and performance specifications.

There are no differences between the devices which would raise new issues of safety or effectiveness.

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.