OMNITECH RESECTOSCOPE ROLLER ELECTRODE

K981463 · Omnitech Systems, Inc. · KNF · Jul 17, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K981463
• Device Name: OMNITECH RESECTOSCOPE ROLLER ELECTRODE
• Applicant: Omnitech Systems, Inc.
• Product Code: KNF · Obstetrics/Gynecology
• Decision Date: Jul 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Omnitech Resectoscope Roller Device is indicated for ablation/ coagulation of the soft tissue and is intended for the use with compatible resectoscopes. The device will be sold as a sterile product to be used in the Urological and Gynecological fields.

Device Story

Omnitech Resectoscope Roller Electrode is an electrosurgical accessory designed for use with compatible resectoscopes. Device functions by delivering electrical energy to soft tissue to achieve ablation and coagulation. Used in clinical settings by urologists and gynecologists during surgical procedures. Provided as a sterile, single-use device. Output facilitates tissue management during endoscopic surgery, aiding in hemostasis and tissue removal.

Clinical Evidence

Bench testing only.

Technological Characteristics

Electrosurgical roller electrode for use with resectoscopes; sterile; intended for soft tissue ablation and coagulation.

Indications for Use

Indicated for ablation and coagulation of soft tissue in urological and gynecological procedures. For prescription use only.

Regulatory Classification

Identification

A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 17 1998

Mr. Jon D. Barrett Administrative Assistant Omnitech Systems, Inc. 456 S. Campbell Valparaiso, IN 46385

Re: K981463

Omnitech Resectoscope Roller Electrode Dated: March 3, 1998 Received: April 23, 1998 Regulatory Class: II 21 CFR 884.4160/Procode: 85 KNF

Dear Mr. Barrett:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE:

510(k) Number (if Known):

K981463

Device Name:

Omnitech Resectoscope Roller Electrode

Indications For Use:

The Omnitech Resectoscope Roller Device is indicated for ablation/ coagulation of the soft tissue and is intended for the use with compatible resectoscopes. The device will be sold as a sterile product to be used in the Urological and Gynecological fields.

(Please do not write below this line, continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off: Carlyn Y Newbert for R Gatling
Division of Reproductive, Abdominal, ENT, and Radiological Devices.

| 510(k) Number: | K981463 |
|-----------------------------------------------|--------------|
| Prescription Use Per 21 CFR 801.109 | <div>✓</div> |
| Or | |
| Over The Counter Use Optional Format (1-2-96) | |