Bissinger Monopolar Cables

K150024 · Guenter Bissinger Medizintechnik GmbH · GEI · Feb 20, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K150024
• Device Name: Bissinger Monopolar Cables
• Applicant: Guenter Bissinger Medizintechnik GmbH
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Bissinger Monopolar Cables are reusable, non-sterile cables designed to conduct high-frequency electrical power from an electrosurgical generator to an electrosurgical instrument. The device acts as a passive conduit for electrical energy; it does not process signals or perform automated analysis. Used in clinical settings by surgeons or trained medical staff, the cables facilitate cutting and coagulation during electrosurgical procedures. The device is connected between the generator and the instrument; it does not affect clinical decision-making directly but enables the delivery of energy required for the surgical task. Benefits include reliable power transmission for electrosurgical instruments. The device is reprocessed via steam sterilization (autoclave) between uses.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical safety per IEC 60601 and IEC 60601-2-2:2009, validation of steam sterilization parameters (132°C, 4-minute exposure), and validation of manual cleaning and reprocessing protocols. Biocompatibility is supported by the use of materials with an established history of safe use per ISO 10993-1.

Technological Characteristics

Reusable monopolar cable; silicone construction. Length: 3.080 m; Socket: 4 mm; Plug: 8 mm. Connectivity: Bovie electrosurgical units. Energy source: High-frequency electrosurgical generator (max 6250 Vp). Sterilization: Moist heat (autoclave) at 132°C for 4 minutes. Standards: IEC 60601-2-2:2009, ISO 10993-1.

Indications for Use

Indicated for use in electrosurgical procedures to conduct electrical power from a high-frequency generator to an electrosurgical instrument. No specific patient population, age, or gender restrictions are stated.

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

• Hans Hermann Laparoscopes and Accessories (K051610)
• Suffer Electrosurgical Cables (K073450)

Reference Devices

• Unipolar Endoscopic Coagulator-cutter and Accessories (K932456)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is the logo for the Department of Health and Human Services (HHS). The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion. Inside the circle is a stylized image of three human profiles facing right, with flowing lines extending from the first profile.

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 [phone] or [phone] 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 [phone] or [phone] 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.

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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.

K

# VOLUME 006

# 510(k) Summary

DATE OF APPLICATION: 2014-12-01

| APPLICANT: | Guenter 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 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Matthias Bissinger<br>Tel.: [phone]<br>E-Mail: [e-mail] |

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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 | Medical<br>Specialty | Review Panel | Product Code | Device Class | Regulation Number |
|-------------------------------------------------------------------------|----------------------|--------------------------------|--------------|--------------|-------------------|
| Electrosurgical cutting<br>and coagulation de-<br>vice and accessories. | Part 878 | General & Plastic Sur-<br>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 and<br>Accessories | 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.

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.

#### 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-<br>SULT |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| 510(k)<br>Submitter/<br>Holder | Bissinger Medizintechnik<br>GmbH | HANS HERMANN<br>GMBH | Sutter Medizintechnik<br>GmbH | Jarit Surgical Instru-<br>ments Inc. | NA |
| Trade<br>Name | Bissinger Monopolar<br>Cables | Hans Hermann Lapa-<br>roscopes and acces-<br>sories | Sutter Electrosurgical<br>Cables | Unipolar Endoscopic<br>Coagulator-cutter and<br>Accessories | NA |
| Device | Bissinger Monopolar<br>Cables | Laparoscopes | Sutter Electrosurgical<br>Cables | JARIT SURGICAL<br>INSTRUMENTS | NA |
| 510(k)<br>Number | | K051610 | K073450 | K932456 | NA |
| Intended<br>use | Cables for electrosur-<br>gery are designed to<br>conduct electrical power<br>from the output of a<br>high-frequency electro-<br>surgical generator to the<br>electrosurgical<br>instru-<br>ment.<br>Do not exceed a maxi-<br>mum output of 6250 Vp<br>of your generator. | The Laparosopes and<br>accessories are<br>intended for use in<br>providing access to<br>and visualization of<br>body cavities, organs,<br>and canals to perform<br>various diagnostic<br>and therapeutic<br>surgical procedures.<br>The arthroscope is<br>indicated for illumina-<br>tion during joint ex-<br>aminations, arthros-<br>copies, biopsies an (<br>diagnosis of joint<br>disease in minimally<br>invasive procedures<br>of the knee, shoulder,<br>wrist (carpal tunnel<br>syndrome), temporal<br>mandibular joint,<br>ankle and elbow. The<br>bipolar electrodes are<br>use to coagulate and<br>to remove or destroy<br>tissue by the use of<br>bipolar HF current. | To electrically con-<br>nect monopolar<br>/bipolar electrosurgi-<br>cal instruments to an<br>electrosurgical gen-<br>erator. | For use by, or as di-<br>rected by, a surgeon in<br>endoscopic surgery.For<br>use in<br>endoscopic<br>surgery. For use when a<br>rigid endoscopic instru-<br>ment for grasping<br>and/or dissecting if soft<br>tissue is determined to<br>be appropriate by the<br>surgeon.<br>Monopolar<br>electrosurgical current<br>can be used for coagu-<br>lation and/or cutting as<br>determined necessary<br>and appropriate by the<br>surgeon. | Sub-<br>stan-<br>tial<br>Equiv-<br>alent |
| Type | Monopolar Cable | Monopolar silicone<br>Cables | Monopolar silicone<br>Cables | Jarit 600-290 | Sub-<br>stan-<br>tialEqu<br>ivalent |

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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

## Page 4 of 5

| | NEW DEVICE | Predicate Device 1 | Predicate Device 2 | Reference DEVICE | RE-<br>SULT |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------|
| Design | Length: 3,080 m.<br>Socket: Ø 4 mm<br>Plug Ø 8 mm<br>Connection: Bovie | Length: 3 m,<br>Connector: 4 mm<br>Connection: Erbe,<br>Martin, Berchtold, | Length: 3.5 mtr, 4,5<br>mtr. Connector: 4 mm<br>Connection:<br>Val-<br>leylab,<br>Conmed,<br>Bovie, Bowa, Erbe, K.<br>Storz, R. Wolf, Martin,<br>Berchtold, Aesculap | Length: 3,080 m.<br>Socket: Ø 4 mm<br>Plug Ø 8 mm<br>Connection: Bovie | Sub-<br>stan-<br>tialEqu<br>ivalent |
| Materials /<br>Biocom-<br>patibility | Material: Silicon<br>Cables do not have<br>direct contact with the<br>human body or only with<br>uninjured skin, so that<br>biocompatibility must not<br>be evaluated. | Silicon | Silicon | Silicon | Sub-<br>stan-<br>tialequ<br>iva-<br>lenrt |
| Sterility | Reusable<br>Instruments.<br>Delivery non sterile.<br>The instruments must be<br>sterilized in moist heat<br>(Autoclave).<br>Pre-vacuum Cycle<br>- Temperature: 132°C<br>- Exposure time: 4 min.<br>- Drying time: at least 20<br>min. | Reusable<br>Instru-<br>ments. Delivery non<br>sterile.<br>The instruments must<br>be sterilized in moist<br>heat<br>(Autoclave).<br>Pre-vacuum Cycle<br>- Temperature:<br>132°C, max 137°C<br>- Exposure time: 3<br>min.<br>- Drying time: at least<br>10 min. | Sutter Electrosurgical<br>Cables are supplied<br>non-sterile and can<br>be reused after clean-<br>ing and steam sterili-<br>zation.<br>Steam-sterilize in the<br>autoclave in accord-<br>ance with DIN EN<br>13060 / DIN EN 285.<br>Fractioned<br>pre-<br>vacuum sterilization:<br>Temperature 134 °C<br>(273 °F), 3 minutes;<br>max.<br>Temperature<br>138 °C (280 °F),<br>max. duration<br>20<br>minutes. | Similar: Reusable In-<br>struments | Sub-<br>stan-<br>tialEqu<br>ivalent |
| Compati-<br>bility with<br>environ-<br>ment and<br>other<br>devices | Generators: Bovie | Generators: Erbe,<br>Martin, Berchtold, | Generators: Erbe,<br>Martin, Valleylab,<br>Conmed, Berchtold,<br>Bowie, Bowa, Aescu-<br>lap | Generators: Bovie | Sub-<br>stan-<br>tialEqu<br>ivalent |
| Standards<br>met | IEC 60601-2-2: 2009 | IEC 60601-2-2:2009 | IEC 60601-2-2:2007 | IEC 60601-2-2:2009 | Sub-<br>stan-<br>tialEqu<br>ivalent |
| Energy<br>applied | Power maxima 6.250 Vp | Power maxima 6.250<br>Vp | Maximum Monopolar<br>cablesVoltage 10000<br>Vpp | Power maxima 6.250<br>Vp | Sub-<br>stan-<br>tialEqu<br>ivalent |

## 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.