OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE

K981464 · Omnitech Systems, Inc. · KNF · Jul 10, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K981464
• Device Name: OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE
• Applicant: Omnitech Systems, Inc.
• Product Code: KNF · Obstetrics/Gynecology
• Decision Date: Jul 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Omnitech Resectoscope Cutting Loop Electrode is a surgical accessory used during urological and gynecological procedures. Device functions as an electrosurgical instrument for tissue resection and coagulation. Operated by surgeons in clinical/hospital settings; connects to compatible electrosurgical resectoscope systems. Provides mechanical cutting and electrical coagulation of soft tissue via high-frequency energy. Benefits include precise tissue removal and hemostasis during endoscopic surgery. Supplied sterile for single-procedure use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical cutting loop electrode; sterile, single-use; compatible with standard urological/gynecological resectoscopes; utilizes high-frequency electrical energy for tissue interaction.

Indications for Use

Indicated for resection and coagulation of soft tissue in urological and gynecological surgical procedures. For use by trained clinicians in a sterile surgical environment.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

1998

Food and Drug Administration: 9200 Corporate Boulevard Rockville MD 20850

Mr. Jon Barrett Administrative Assistant Omnitech Systems, Inc. 456 South Campbell, Building C Valparaiso, IN 46383

Re: K981464

Resectoscope Cutting Loop Electrode Dated: March 3, 1998 Received: April 23, 1998 Regulatory Class: II 21 CFR 876.4300/Procode: 85 KNF

Dear Mr. Barrett:

We have reviewed your Section 510(k) notification of intent to market the device referenced alsove 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 (sec above) into either class II (Special Controls) or class III (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 equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 531 through 542 of the Act for devices under the Flectronic 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 ritro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Other of Compliance an [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/cdrb/dsmaldsmam.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) | |
|--------------------------|--|
|--------------------------|--|

K5814644

Device Name:

Omnitech Resectoscone Cutting Loop Electrode

Indications For I Ise:

The Omnitech Resectoscope Cutting Loop Electrode Device is indicated for resection/
coagulation of the soft tissue and is intended for the worse it to coagulation of the soft lissue and is intended for the use with compatible resection/
The device will be sold as a sterile product to the use with compatible resections 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: | Robert R. Oetting |
|--------------------|-------------------|
|--------------------|-------------------|

Division of Reproductive, Abdominal, ENT, and Radiological Devices.

| 510(k) Number: | K981464 |
|----------------|---------|
|----------------|---------|

| Prescription Use Per 21 CFR 801.109 | X | Or | Over The Counter Use Optional Format (1-2-96) |
|-------------------------------------|---|----|-----------------------------------------------|
|-------------------------------------|---|----|-----------------------------------------------|

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