ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES

K102921 · Bema-GmbH & Co. KG · GEI · Dec 20, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K102921
• Device Name: ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES
• Applicant: Bema-GmbH & Co. KG
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Endoscopic Monopolar Instruments and Accessories are used in laparoscopic and other minimally invasive procedures for cutting, dissection, fixation and taking of biopsy samples, depending on the design of the tip. They are also intended to control bleeding by use of monopolar high-frequency electrical current.

Device Story

Endoscopic Monopolar Instruments and Accessories consist of modular (two-piece or three-piece) and single-piece (Eco-Line) surgical instruments. Devices comprise handles, shafts, and interchangeable tip inserts. Operated by surgeons in laparoscopic or minimally invasive procedures. Instruments function as mechanical tools for tissue manipulation (cutting, dissection, fixation, biopsy) and as electrosurgical electrodes for hemostasis when connected to a monopolar high-frequency electrosurgical generator. Insulated shafts and handles provide electrical safety during use. Reusable design requires steam sterilization between procedures. Output is physical tissue effect (mechanical or thermal coagulation) controlled by the surgeon's manual operation and generator settings.

Clinical Evidence

Bench testing only. Testing characterized thermal spread and mechanical function/robustness to demonstrate performance equivalent to predicate devices.

Technological Characteristics

Materials: Stainless steel, PPSU, Halar, Nylon. Design: Modular (2/3-piece) and single-piece insulated instruments. Energy: Monopolar high-frequency electrical current. Connectivity: None (manual instrument). Sterilization: Steam. Electrical Safety: IEC 60601-1, IEC 60601-2-2 (2006).

Indications for Use

Indicated for use in laparoscopic and other minimally invasive surgical procedures for cutting, dissection, fixation, biopsy sampling, and hemostasis via monopolar high-frequency electrical current.

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

• Endoscopic Tube Shaft Instruments for Monopolar Coagulation (K010192)
• Pajunk Modular Handle Instruments (K033249)
• Aesculap Modular Monopolar Electrodes (K970541)
• Tekno Medical Instruments for Laparoscopy (K003717)

Submission Summary (Full Text)

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DEC 2 0 2011

K102921
pg 1 of 3
ND EFFECTIVENESS

510(k) Summary of Safety and effective

| Date: | December 12, 2011 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | |
| Name: | BEMA GmbH & Co. KG |
| Address: | Rudolf-Diesel-Strasse 12<br>78576 Emmingen<br>Germany |
| Contact Person: | Thomas Becker |
| Telephone: | +49.7465.92990 |
| Fax: | +49.7465.929929 |
| Product: | |
| Trade Name: | Endoscopic Monopolar Instruments and Accessories |
| Common Name: | Electrosurgical Instruments and Accessories |
| Classification Name: | Electrosurgical Cutting & Coagulation Device & Accessories |
| Predicate Device: | <ul><li>K010192 - Endoscopic Tube Shaft Instruments for Monopolar Coagulation</li><li>K033249 - Pajunk Modular Handle Instruments</li><li>K970541 - Aesculap Modular Monopolar Electrodes</li><li>K003717 - Tekno Medical Instruments for Laparoscopy</li></ul> |
| Device Description: | Endoscopic Monopolar Instruments and Accessories comprises three systems: Modular Three-Piece System, Modular Two-Piece System and Eco-Line. The respective components (handle, shaft and tip) of the Three-Piece and Two-Piece Systems can be used interchangeably, while Eco-Line consists of an assortment of insulated, single-piece instruments. All shafts and several modular handles are insulated and may be used with appropriate tip inserts to control bleeding in monopolar electrosurgical procedures. Additional insulated and non-insulated modular handles are intended for general manual (non-electrical) surgical use according to the design of the chosen tip. |
| Indications for Use: | Endoscopic Monopolar Instruments and Accessories are used in laparoscopic and other minimally invasive procedures for cutting, dissection, fixation and taking of biopsy samples, depending on the design of the tip. They are also intended to control bleeding by use of monopolar high-frequency electrical current. |

ENDOSCOPIC INSTRUMENTS AND ACCESSORIES:

.

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K102921- pg 2 of 3

## Technological Characteristics

Bench testing was provided to characterize thermal spread and mechanical functions and robustness of the Endoscopic Monopolar Instruments and Accessories included in this submission. The device has similar technological and performance characteristics as the predicate device cleared under 510(k) K010192, as shown by the following summary:

| Feature | Subject Device<br>Endoscopic Monopolar<br>Instruments and<br>Accessories | Predicate Device<br>Endoscopic Tube Shaft<br>Instruments for<br>Monopolar Coagulation |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Endoscopic Monopolar<br>Instruments and<br>Accessories are used in<br>laparoscopic and other<br>minimally invasive<br>procedures for cutting,<br>dissection, fixation and<br>taking of biopsy samples,<br>depending on the design<br>of the tip. They are also<br>intended to control<br>bleeding by use of<br>monopolar high-<br>frequency electrical<br>current. | These Endoscopic Tube<br>Shaft Instruments are<br>used in laparoscopic and<br>other minimally invasive<br>procedures for cutting,<br>dissection, fixation and<br>the taking of biopsy<br>samples, depending on<br>the design of the working<br>tips. They are further<br>intended to control<br>bleeding by use of<br>monopolar high-<br>frequency electrical<br>current. |
| Materials | Stainless steel, PPSU,<br>Halar S<br>Nylon | Stainless steel, PPSU,<br>Halar S<br>Nylon insulation for an<br>electrosurgical cutting<br>and coagulation modular<br>component has been<br>cleared for marketing by<br>K033249, Pajunk Modular<br>Handle Instruments. |
| Sterility | Non-sterile | Non-sterile |
| Reusability | Reusable | Reusable |
| Sterilization Method | Steam | Steam |
| Electrical Safety | IEC 60601-1, IEC 60601-2-<br>2 (2006) | IEC 60601-2-18 |
| Design | ◯ Two and Three-Piece<br>Modular System<br>◯ Single-Piece<br>Instruments | ◯ Two and Three-Piece<br>Modular System<br>Single-Piece Instruments<br>for electrosurgical<br>cutting and coagulation<br>have been cleared for<br>marketing by K930666,<br>Reusable Laparoscopic<br>Instruments w/<br>Electrocautery |

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10292) pg 3.83

Conclusion:

The information provided in this 510(k) submission provides reasonable assurance that the subject device Endoscopic Monopolar Instruments and Accessories is safe and effective and that it is substantially equivalent to the predicate device with respect to intended use and technological characteristics.

ENDOSCOPIC INSTRUMENTS AND ACCESSORIES Section 6 - 510(k) Summary Submission Applicant: BEMA GmbH & Co. KG

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

DEC 20 2011

Bema-GmbH & Co. Kg % Business Support International Ms. Angelika Scherp Amstel 320-1 Amsterdam, Noord-Holland Netherlands 1017AP

Re: K102921

Trade/Device Name: Endoscopic Monopolar Instruments and Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 09, 2011 Received: December 13, 2011

Dear Ms. Scherp:

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

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## Page 2 - Ms. Angelika Scherp

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely your

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES

## Indications for Use:

Endoscopic Monopolar Instruments and Accessories are used in laparoscopic and other minimally invasive procedures for cutting, dissection, fixation and taking of biopsy samples, depending on the design of the tip. They are also intended to control bleeding by use of monopolar high-frequency electrical current.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) _

AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature Of

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102921

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