SUTTER ELECTROSURGICAL CABLES

K073450 · Sutter Medizintechnik GmbH · GEI · Mar 17, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073450
• Device Name: SUTTER ELECTROSURGICAL CABLES
• Applicant: Sutter Medizintechnik GmbH
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To electrically connect monopolar/bipolar electrosurgical instruments to an electrosurgical generator.

Device Story

Sutter Electrosurgical Cables serve as conductive accessories for electrosurgical systems; they transfer electrical power from an electrosurgical generator to monopolar or bipolar instruments. The cables feature standard connectors compatible with common electrosurgical equipment. Used in clinical settings by healthcare professionals, the cables facilitate the delivery of energy for cutting or coagulation. The device is supplied non-sterile and is designed for reuse following standard cleaning and steam sterilization protocols. By providing a reliable electrical interface, the cables enable the surgeon to perform electrosurgical procedures effectively.

Clinical Evidence

Bench testing only.

Technological Characteristics

Electrosurgical cables for monopolar/bipolar instruments; reusable; compatible with standard generator connectors; steam sterilizable.

Indications for Use

Indicated for use in connecting monopolar or bipolar electrosurgical instruments to an electrosurgical generator for surgical procedures.

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.

Submission Summary (Full Text)

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## 510(k) Premarket Notification Sutter Medizintechnik GmbH Electrosurgical Cables 510(k) Summary

MAR 1 7 2008

November 27, 2007

The 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 1992.

| Subject: | 510(k) Summary of Safety and Effectiveness Information for the Sutter Bipolar<br>Electrosurgical Cable |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Sutter Medezintechnik GmbH<br>Tullastrasse 87<br>79108 Freiburg Germany |
| Proprietary<br>Name: | Sutter Electrosurgical Cables |
| Common<br>Name and<br>Classification: | Electrosurgical Cutting and Coagulation Device and Accessories<br>(79GEI, §878.4400, Class II) |
| Device<br>Description: | Sutter Electrosurgical Cables are electrosurgical accessories designed to<br>transfer electrosurgical power to monopolar and bipolar instruments from an<br>electrosurgical generator. The cables are designed to fit standard<br>monopolar/bipolar instruments and generator connectors. Sutter Electrosurgical<br>Cables are supplied non-sterile, and can be reused after cleaning and steam<br>sterilization. |
| Intended Use: | To electrically connect monopolar/bipolar electrosurgical instruments to an<br>electrosurgical generator. |
| Test<br>Discussion: | Sutter Electrosurgical Cables presented in this submission are substantially<br>equivalent in design concepts, technologies and materials to their predicate<br>devices. Sutter Electrosurgical Cables were validated through testing that<br>supports the compliance of the devices to the Standards mentioned in Section<br>17 of this submission. |
| Test<br>Conclusion: | Sutter Electrosurgical Cables are substantially equivalent to their predicate<br>devices in design concepts, technologies and materials. Testing demonstrates<br>that these devices are as safe, as effective, and perform as well as or better than<br>the legally marketed devices. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 1 7 2008

Sutter Medizintechnik GMBH % Boone Interactive Mr. Thomas A. Boone Consultant 353 Loma Larga Road Corrales, New Mexico 87048

Re: K073450

Trade/Device Name: Sutter Monopolar and Bipolar Electrosurgical Cables Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: II Product Code: GEI Dated: February 21, 2008 Received: February 29, 2008

Dear Mr. Boone:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Thomas A. Boone

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Milkman

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

Enclosure

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K073450

1041 �.

## Indications for Use

| 510(k) Number (if known): | K073450 |
|---------------------------|--------------------------------------------------------------------------------------------------------|
| Device Name: | Sutter Monopolar and Bipolar Electrosurgical Cables |
| Indications for Use: | To electrically connect monopolar/bipolar electrosurgical instruments to an electrosurgical generator. |

Prescription Use X (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)

Nil R P Ogl for rkm
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number_4013450