REPROCESSED ELECTROSURGICAL ELECTRODE

K012684 · Sterilmed, Inc. · JOS · Jan 18, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K012684
• Device Name: REPROCESSED ELECTROSURGICAL ELECTRODE
• Applicant: Sterilmed, Inc.
• Product Code: JOS · General, Plastic Surgery
• Decision Date: Jan 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Reprocessed electrosurgical electrodes are intended for precision cutting or dissecting and cauterizing soft tissue. These devices are most commonly used in surgical procedures for which minimal tissue necrosis, bleeding, and surgical field smoke is desired.

Device Story

Reprocessed monopolar electrosurgical electrodes; used for precision cutting, dissecting, and cauterizing soft tissue. Device consists of tungsten tip, stainless steel housing, and insulation layers. Operated by surgeons in clinical/surgical settings. Device functions by delivering electrosurgical energy to tissue to achieve desired surgical effect (cutting/coagulation) with minimal necrosis and smoke. Reprocessing involves cleaning and sterilization of previously used devices to restore functional state. Healthcare providers use the device to perform surgical procedures; output is the physical effect on tissue during surgery. Benefits include reduced tissue trauma and bleeding during dissection.

Clinical Evidence

Bench testing only. Representative samples underwent functional testing. Process validation performed for cleaning, sterilization, and packaging. Manufacturing process includes 100% visual and functional inspection.

Technological Characteristics

Monopolar electrosurgical instrument. Materials: tungsten tip, stainless steel housing, insulation layers. Energy source: external electrosurgical generator. Form factor: needle-style electrode. Sterilization: validated reprocessing procedures.

Indications for Use

Indicated for precision cutting, dissecting, and cauterizing soft tissue in surgical procedures where minimal tissue necrosis, bleeding, and smoke are desired.

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

• Colorado Micro-Dissection Needle (K000348)

Submission Summary (Full Text)

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## SECTION 2. SUMMARY AND CERTIFICATION

012684

## 510(k) Summary A.

| Submitter: | SterilMed, Inc.. |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patrick Fleischhacker<br>11400 73rd Avenue North<br>Minneapolis, MN 55369<br>Ph: 888-856-4870<br>Fax: [phone] |
| Date Prepared: | August 11, 2001 |
| Trade Name: | SterilMed Reprocessed Electrosurgical Electrodes |
| Classification Name<br>and Number: | Electrosurgical Device, Class II, 21 CFR 878.4400 |
| Product Code: | JOS |
| Predicate Device(s): | SterilMed's Reprocessed electrosurgical electrodes are<br>substantially equivalent to:<br>• The Colorado Micro-Dissection Needle manufactured<br>by Stryker Leibinger / Colorado Biomedical Inc<br>(K000348)<br>• Similar devices from other manufacturers |
| Device Description: | SterilMed's reprocessed electrosurgical electrodes are a<br>monopolar electrosurgical instruments consisting of a<br>tungsten tip, stainless steel housing, and several layers of<br>insulation. |
| Intended Use: | Reprocessed electrosurgical electrodes are intended for<br>precision cutting or dissecting and cauterizing soft tissue.<br>These devices are most commonly used in surgical<br>procedures for which minimal tissue necrosis, bleeding,<br>and surgical field smoke is desired. |
| Functional and<br>Safety Testing: | Representative samples of reprocessed electrosurgical<br>electrodes underwent bench testing to demonstrate<br>appropriate functional characteristics. Process validation<br>testing was done to validate the cleaning and sterilization<br>procedures as well as the device's packaging. In addition, |

:

Premarket Notification

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the manufacturing process includes visual and functional testing of all products produced.

## Conclusion:

The electrosurgical electrodes reprocessed by SterilMed are substantially equivalent to:

- The Colorado Micro-Dissection Needle manufactured . by Stryker Leibinger / Colorado Biomedical Inc. (K000348)
- Similar devices from other manufacturers .

This conclusion is based upon the fact that the subject device is identical to their predicate device in terms of functional design, materials, indications for use, and principles of operation.

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OF HEALTH & HUMAN SERVICES.USA
DEPARTMENT

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2002

Mr. Patrick Fleischhacker Vice President, Regulatory and Quality Control SterilMed, Inc. 11400 73ª Avenue North Maple Grove, Minnesota 55369

Re: K012684

Trade/Device Name: Reprocessed Electrosurgical Electrodes Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 6, 2001 Received: December 7, 2001

Dear Mr. Fleischhacker:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association 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. Patrick Fleischhacker

This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and w yourse ought finding of substantial equivalence of your device to a legally premated 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 and 11 you assile by controlary 21 for in vitro diagnostic devices), please contact the Office of additionally 21 Of It For 4659. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-461 the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general information turers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely, yours,

L. Mark M. Milliken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for use Page

012684

Device Name: Reprocessed electrosurgical electrodes, or reprocessed electrosurgical electrodes.

Indications for Use:

Reprocessed electrosurgical electrodes are intended for precision cutting, dissecting and reprocesson crocirous grounds are most commonly used in surgical procedures for which minimal tissue necrosis, bleeding, and surgical field smoke is desired.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ro Mark N Millersen

Division Sign-Off Division of General, Restorative and Neurological Devices

51(c) Number K012684