MIDAS TOUCH ELECTROSURGICAL ELECTRODE

K973234 · Iti Medical Technologies, Inc. · GEI · Oct 27, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973234
• Device Name: MIDAS TOUCH ELECTROSURGICAL ELECTRODE
• Applicant: Iti Medical Technologies, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes are intended for use in standard electrosurgical chucks and pencil type accessories wherever standard monopolar electrosurgical cutting and coagulation blade electrodes are used.

Device Story

Midas Touch™ Electrosurgical Electrodes are stainless steel alloy blades used for monopolar electrosurgical cutting and coagulation; compatible with standard electrosurgical chucks and pencil-type accessories. Operated by trained medical practitioners in clinical settings. Device features include various tip lengths/configurations and optional stick-resistant coating. Electrodes are single-use, sterile-packaged. Functionality is equivalent to predicate devices; provides standard electrosurgical performance for surgical procedures.

Clinical Evidence

Bench testing only. Performance evaluations conducted per written protocols compared ITI devices to predicate devices. Results confirmed compliance with design parameters and equivalent or superior performance to predicates. No adverse effects or complications reported.

Technological Characteristics

Stainless steel alloy electrodes; 0.0937-inch diameter connector pin; plastic insulator sheath at transition point. Stick-resistant coating on some models. Complies with ANSI/AAMI HF18-1993 and ANSI/AAMI 11137 (radiation sterilization). Single-use, sterile.

Indications for Use

Indicated for use by trained medical practitioners for monopolar electrosurgical cutting and coagulation in standard electrosurgical chucks and pencil-type accessories.

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

• MegaDyne Medical Products, Inc. (K903302)
• Aaron Medical Industries, Inc. (K913623)

Submission Summary (Full Text)

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# ITI Medical Technologies, Inc.

2452 Armstrong Street Livermore, CA 94550 [phone] FAX [phone]

K973234

# SUMMARY OF SAFETY AND EFFECTIVENESS

August 25, 1997

| Contact Person: | Roger W. Werne, Ph.D., President |
|-----------------------|-----------------------------------------------------------------------------------|
| Common or Usual Name: | Electrosurgical Electrode |
| Proprietary Name: | Midas Touch™ Electrosurgical Electrodes |
| Classification Name: | Unit, Electrosurgical and Coagulation with accessories<br>21 CFR § 878.4400 |
| Class and Panel: | Regulatory Class II<br>Product Code: GEI General and Plastic Surgery 79 |
| Predicate Devices: | MegaDyne Medical Products, Inc. K903302<br>Aaron Medical Industries. Inc. K913623 |

The ITI Medical Technologies, Inc. Midas Touch™ Description of Device: Electrosurgical Electrodes are similar in design to the predicate devices. They weigh about 2 grams, and have an industry standard 0.0937-inch (2.38 mm) diameter x 0.825inch (22.22 mm) connector pin, with various tip lengths and configurations. They are made from a stainless steel metal alloy. Some models are available with a stick resistant coating. The transition point between the shaft and the tip has a protective plastic insulator sheath. Electrodes are packaged individually in sealed pouches, sold sterile, and intended for single use.

Statement of intended use: The ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes are intended for use in standard electrosurgical chucks and pencil type accessories wherever standard monopolar electrosurgical cutting and coagulation blade electrodes are used.

The intended use is identical to that of the predicate devices, i.e. a standard electrosurgical electrode to be used with most standard electrosurgical chucks and pencils by a trained medical practitioner. There are no differences in the devices concerning intended use or the safety or effectiveness when used as labeled.

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# Statement of technological characteristics:

The ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes incorporate no significant change in design, materials, energy source or other technological characteristics than those found in the predicate devices. Their form factors are similar to the predicate devices. They can be used with the same standard Electrosurgical units and accessories as the predicate devices.

The only difference between the Midas Touch™ electrodes and the predicate devices, other than minor configuration differences, is the type of blade coating on some models. The ITI blades are made from a stainless steel alloy with some models having ITI's own stick resistant coating as compared to the predicate devices: 1.) For MegaDyne Medical, stainless steel electrodes with a Teflon™ coating and, 2.) For Aaron Medical, stainless steel electrodes with a "high-tech polymer coating".

Special Controls: Although there are no performance standards established by the FDA for electrosurgical electrode devices, the ITI Medical Technologies, Inc. Electrosurgical Electrodes have been designed to comply with, and are manufactured to pertinent parts of the following standards:

| ANSI/AAMI | American National Standard HF18-1993 Electrosurgical devices |
|-----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ANSI/AAMI | American National Standard 11137 Sterilization of health care<br>products – Requirements for validation and routine control –<br>Radiation sterilization, Third edition. |

In addition, the device and its development process also comply with pertinent parts of:

- FDA, CDRH, ODE DGRD: October 19, 1993, 510(k) Guideline General Surgical . Electrosurgical Devices and;
- FDA, CDRH, ODE DRAERD: August 16, 1995 510(k) Checklist for Endoscopic . Electrosurgical Unit (ESU) and Accessories used in Gastroenterology and Urology.

Data regarding special controls are summarized in the submission, and support the safety and efficacy of the device.

Comparison tests following written protocols were conducted using the ITI devices and the predicate devices. No findings of adverse effects or complications were reported in any of the tests.

The performance evaluations indicate that the ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes met all of the performance requirements, consistently performed within their design parameters; and performed equivalently or superior to the predicate devices, thus demonstrating that they are safe and effective when used as intended.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Roger W. Werne, Ph.D. President ITI Medical Technologies, Inc. 2452 Armstrong Street Livermore, California 94550

OCT 2 7 1997

K973234 Trade Name: Midas Touch TM Electrosurgical Electrodes Regulatory Class: II Product Code: GEI .... Dated: August 25, 1997 Received: August 28, 1997

Dear Dr. Werne:

Re:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 (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 devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Roger W. Werne, Ph.D.

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

If you desire specific advice for your devices 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 devices, 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/dsmamain.html".

**Sincerely yours,**

Sincerely yours,

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

Enclosure

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#### ITI Medical Technologies, Inc. Electrosurgical Electrode PREFACE - Page 3 510(k) Premarket Notification

973234 510(k) Number (if known): _

Device Name: Midas Touch™ Electrosurgical Electrodes

#### Statement of intended use:

The ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes are intended for use in standard electrosurgical chucks and pencil type accessories wherever standard monopolar electrosurgical cutting and coagulation electrodes are used.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use (Per 21 CFR 801.109)

OR

Over - The - Counter - Use

(Optional Format 1-2-96)