ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC

K061878 · E Surgical, LLC · GEI · Oct 24, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061878
• Device Name: ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC
• Applicant: E Surgical, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

E Surgical Coated Electrodes are intended as an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes for use in conventional monopolar electrosurgical accessories. The Coated Electrodes are intended for use in situations where monopolar electrosurgical cutting and coagulation are normally used.

Device Story

E Surgical Coated Electrodes are stainless steel active electrodes featuring a proprietary non-stick coating to reduce tissue and eschar build-up. Available in ball, needle, and blade tip configurations; designed to fit standard monopolar electrosurgical pencils. Used by clinicians in surgical settings for cutting and coagulation. The non-stick surface facilitates easier cleaning during procedures. Device performance is verified by bending tests and biocompatibility assessments.

Clinical Evidence

Bench testing only. Testing included coating integrity (bend testing to 90 degrees, 10 cycles), functional performance at various power settings, ease of cleaning, and biocompatibility per ISO 10993.

Technological Characteristics

Stainless steel active electrodes with proprietary non-stick coating. Tip configurations: ball, needle, blade. Compatible with standard monopolar electrosurgical pencils. Meets ANSI/AAMI HF 18 standards for electrosurgical devices. Materials meet ISO 10993 biocompatibility requirements.

Indications for Use

Indicated for use in patients requiring monopolar electrosurgical cutting and coagulation procedures. Intended for use with conventional monopolar electrosurgical 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

• Valleylab Edge™ Coated Electrodes (K962044)
• New Deantronics, Ltd. Disposable Hand Switching Pencil (K982742)

Submission Summary (Full Text)

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# 510(k) Summary

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E Surgical, LLC 1990 N. California Blvd., Suite 1040 Walnut Creek, CA 94596 925-280-8388 Phone [phone] Fax Contact: Hans Richter

I. Trade Name: E Surgical Coated Electrode: Electrode, Coated Ball Electrode, Coated Blade Electrode, Coated Needle

OCT 2 4 2006

II. Common Name: Active Electrode

III. Classification: 21 CFR 878.4400, Class II, Electrosurgical Cutting and Coagulation Accessory

IV. Product Code: GEI

#### V. Indications for Use

E Surgical Coated Electrodes are intended as an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes for use in conventional monopolar electrosurgical accessories. The Coated Electrodes are intended for use in situations where monopolar electrosurgical cutting and coagulation are normally used.

### VI. Predicate Devices

a. Valleylab Edge™ Coated Electrodes, K962044 b. New Deantronics, Ltd. Disposable Hand Switching Pencil, K982742

#### VII. Device Description

The E Surgical coated electrodes are designed as a standard stainless steel active electrode with a nonstick coating to prevent tissue and char build-up on the electrode. Three models: ball, needle, and blade are included.

#### VIII. Summary of Technological Characteristics

The active electrodes are substantially equivalent to the New Deantronic electrodes in the disposable hand switching pencil, K982742, and the Valleylab Edge™ Coated Electrodes, K962044. The electrodes are a modification to the single-use electrodes of various tip configurations. A proprietary coating provides a non-stick surface for easier cleaning of eschar during use.

The electrodes are intended for use during monopolar electrosurgery. The electrodes fit in currently marketed electrosurgical pencils offered by New Deantronics and other manufacturers.

## IX. Safety and Performance Data

a. Meets safety and performance requirements under ANSI/AAMI HF 18 Electrosurgical Devices.

b. Finished product non-stick coating was bent to 90 degrees ten times without visible cracking of the coating.

c. Cutting or coagulation is initiated immediately at both lower and higher power settings.

- d. Easy to clean properties after use on tissue.
- e. Materials used in the construction of the electrodes meet ISO 10993 Biocompatibility requirements.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three abstract shapes resembling birds in flight. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2006

E. Surgical, LLC % L.W. Ward and Associates, Inc. Mr. Lewis Ward 4655 Kirkwood Court Boulder, Colorado 80301

Re: K061878

Trade/Device Name: E Surgical, Electrodes, Coated Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 4, 2006 Received: October 10, 2006

Dear Mr. Ward:

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, 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. Lewis Ward

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

F. Pdplhn

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko61878

# INDICATIONS FOR USE

510(k) Number (if known):

Device Name: E Surgical, Electrodes, Coated

Indications for Use:

E Surgical Coated Electrodes are intended as an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes for use in conventional monopolar electrosurgical accessories. The Coated Electrodes are intended for use in situations where monopolar electrosurgical cutting and coagulation are normally used.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------|---------|
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | 4061878 |