REPROCESSED ELECTROSURGICAL ELECTRODES

K012669 · Surgical Instruments Service and Savings, Inc. · GEI · Jun 27, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K012669
• Device Name: REPROCESSED ELECTROSURGICAL ELECTRODES
• Applicant: Surgical Instruments Service and Savings, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 27, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Reprocessed electrosurgical electrodes are intended to remove tissue and control bleeding during surgery by use of electrical current.

Device Story

Reprocessed electrosurgical electrodes; originally single-use devices from various OEMs. Reprocessing involves cleaning, refurbishing, testing, and sterilization to enable multiple uses. Used in surgery by clinicians to remove tissue and control bleeding via electrical current. Device materials, dimensions, and geometry remain identical to original single-use versions. Functionality testing performed during reprocessing; sterility validated. No clinical evaluations conducted.

Clinical Evidence

No clinical data or comparative performance testing provided. Evidence limited to functionality testing of reprocessed units and validation of the sterility protocol.

Technological Characteristics

Electrosurgical electrodes; various materials and geometries identical to original single-use devices. Sterile. Compatible with existing surgical instruments. Functionality testing performed post-reprocessing.

Indications for Use

Indicated for surgical patients requiring tissue removal and hemostasis via electrosurgical 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

• Original manufacturer single-use electrosurgical electrodes (K012669)

Submission Summary (Full Text)

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## JUN 2 7 2002 510(k) SUMMARY

< 012669

Submitter's name: Surgical Instruments Servicing & Savings, Inc. 723 Curtis Court Sisters, OR 97759 [phone]

August 10, 2001 Date summary prepared:

## Device name:

| Proprietary name: | Reprocessed Electrosurgical Electrodes |
|-----------------------|--------------------------------------------------------------------------------------------------------|
| Common or usual name: | Electrodes or probes |
| Classification name: | Electrosurgical cutting and coagulation device and<br>accessories, 878.4400, or Arthroscope, 888.1100. |

Legally marketed device for substantial equivalence comparison:

The predicate device for each reprocessed electrosurgical electrode is the same product as provided by the original manufacturer.

Description of the device:

The devices that are the subject of this submission are used to remove tissue and control bleeding during surgery. They are made of a variety of materials and come in different shapes. They come from several different original equipment manufacturers as single use devices. Reprocessing includes cleaning. refurbishing, testing, packaging, and sterilization. It allows the electrodes to be used several times rather than just once.

Intended use of device:

Reprocessed electrosurgical electrodes are intended to remove tissue and control bleeding during surgery by use of electrical current.

Technological characteristics:

The device features of the reprocessed electrosurgical electrodes and the single use electrodes are very similar. The materials, dimensions, and geometry of individual electrodes are identical. Both sets of products are provided sterile. The technical characteristics, method of use, and compatibility with other surgical instruments are also identical. The only difference is that the original products are sold for single use, while the reprocessed products can be used several times.

Testing conducted:

Each electrosurgical electrode is tested for functionality as part of the reprocessing procedures. Validation of the sterility protocol was also included in the submission.

Performance testing:

Comparative performance testing and clinical evaluations were not included as part of this 510(k).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2002

Surgical Instruments Services and Savings, Inc. c/o Mr. Robert S. McQuate R.S. McQuate & Associates, Inc. 3636 E. Columbine Drive Phoenix, Arizona 85032

Re: K012669

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: April 19, 2002 Received: April 22, 2002

Dear Mr. McQuate:

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. Iisting 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. Robert McQuate

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact 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 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/dsma/dsmamain.html

Sincerely vours.

Styt Rurdu

S. M. Witt, Ph.D., M.D.

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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Reprocessed Electrosurgical Electrodes 510(k) Notification Page 4

## Indications for Use Statement

510(k) Number (if known): __ /< 0 / 2 6 6 9 _________________________________________________________________________________________________________________________________

Reprocessed electrosurgical electrodes Device name:

Reprocessed electrosurgical electrodes are intended to remove Indications for Use: tissue and control bleeding during surgery by use of electrical current.

(Please do not write below this line)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K012669

メ Prescription Use

OR

Over-The-Counter Use

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