SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL

K063161 · Leonhard Lang GmbH · GEI · Nov 21, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K063161
• Device Name: SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL
• Applicant: Leonhard Lang GmbH
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 21, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Skintact® Cool Contact Electrosurgical Grounding Plates are designed for use with electrosurgical generators for cutting and coagulation of human tissue.

Device Story

Self-adhesive, single-use, disposable electrosurgical grounding plates; available in various shapes/sizes (adult/pediatric), standard/split, with/without lead wires. Device functions as return electrode for electrosurgical generators during tissue cutting/coagulation. Used in clinical settings; operated by healthcare professionals. NH 04 gel provides conductive interface. Benefits include safe electrical return path, minimizing risk of thermal injury at site. Performance verified via impedance, temperature rise, and adherence testing.

Clinical Evidence

Bench testing only. Testing included biocompatibility (cytotoxicity, skin irritation, sensitization) and performance testing per ANSI/AAMI HF 18:2001: maximum safe temperature rise, electrode contact impedance, and electrode adherence (pull, conformability, and fluid tolerance tests).

Technological Characteristics

Self-adhesive, disposable electrode with NH 04 conductive gel. Conforms to ANSI/AAMI HF 18:2001. Packaging: water-vapor-proof, heat-sealed, aluminized pouches. Shelf-life: 24 months.

Indications for Use

Indicated for use with electrosurgical generators for cutting and coagulation of human tissue in adult and pediatric patients.

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

• Skintact Cool Contact Electrosurgical Grounding Plates (K030362)

Submission Summary (Full Text)

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NOV 2 1 2006

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## 510(k) Summary

| SUBMITTED ON BEHALF OF: | Company Name: | Leonhard Lang GmbH |
|-------------------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| | Address: | Archenweg 56<br>6020 Innsbruck<br>Austria |
| | Telephone: | ++ 43 / 512 / 33 4 25 7 |
| | Fax: | ++ 43 / 512 / 39 22 10 |
| by: | | Elaine Duncan, MS.M.E., RAC<br>President, Paladin Medical, Inc.<br>PO Box 560<br>Stillwater, MN 55082 |
| | Telephone: | 715-549-6035 |
| | Fax: | 715-549-5380 |
| CONTACT PERSON: | Elaine Duncan | |
| DATE PREPARED: | October 13, 2006 | |
| Trade Name: | Skintact® Cool Contact Electrosurgical Grounding Plates<br>with NH 04 gel | |
| Common Name: | Electrosurgical Grounding Plates | |
| Classification Name: | Electrosurgical Grounding Plates | |

SUBSTANTIALLY EQUIVALENT TO: Skintact® Cool Contact Electrosurgical Grounding Plates will now be offered with new gel NH 04, in otherwise the grounding plates are equivalent to the materials of construction used in the Skintact Cool Contact Electrosurgical Grounding Plates (the manufacturer's predicate device) cleared via 510(k) [K030362]. The Skintact® Cool Contact Electrosurgical Grounding Plates with new NH 04 gel include also a range of electrodes with different geometry and area is also equivalent to the Skintact Cool Contact Electrosurgical Grounding Plates (the manufacturer's predicate device) cleared via 510(k) [K030362]. Based upon these similar features and conformance with the recognized standard ANSI/AAMI HF 18:2001, the Leonhard Lang Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 gel are substantially equivalent.

DESCRIPTION of the DEVICE: Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 gel (and as also to be offered for sale under various private label tradenames) are self-adhesive, nonsterile, single use disposable electrodes, available in a comprehensive range of shapes and sizes (adult and pediatric), standard and split, with or without lead wires.

INDICATIONS FOR USE: Skintact® Cool Contact Electrosurgical Grounding Plates are designed for use with electrosurgical generators for cutting and coagulation of human tissue.

SUMMARY of TESTING: Biocompatibility testing confirms the materials are biocompatible and do not introduce any new risks. The following testing showed no adverse results: Cytotoxicity; Skin Irritation; Sensitization. The ANSI/AAMI HF 18:2001 "Electrosurgical devices" was used to define the requirements for Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 gel. All performance and safety tests are according to ANSI/AAMI HF 18:2001 and were conducted by Leonhard Lang GmbH, Archenweg 56, 6020 Innsbruck, Austria, and Dr. Michael Verius and Dr. Ralf Huttary, Univ. Klinik für Radiodiagnostik, Anichstraße 35, 6020 Innsbruck, Austria. The testing conducted was: Maximum safe temperature rise; Electrode contact impedance; Electrode adherence: Pull test, Conformability test, Fluid tolerance test. All Skintact Cool Contact Grounding Plates are packaged in water-vapor-profeed, heatsealed, non-transparent, aluminized pouches. Leonhard Lang has 20 years of experience with this packaging and has met requirements for 24 months shelf-life. No differences were required for packaging the Skintact Cool Contact Electrosurgical Grounding Plates with NH 04 gel compared to the predicate device.

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Image /page/1/Picture/12 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of three human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Leonhard Lang, GmbH % Paladin Medical, Inc. Elaine Duncan, M.S.M.E., RAC President P.O. Box 560 Stillwater, Minnesota 55082-0560

NOV 2 1 2006

Re: K063161

Trade/Device Name: Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 gel Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 7, 2006 Received: November 8, 2006

Dear Ms. Duncan:

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

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Page 2 – Elaine Duncan, M.S.M.E., RAC

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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,

Rum
D. 1924

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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## 510(k) Number (if known)

Device Name: Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 gel

## Indications for Use:

Skintact® Cool Contact Electrosurgical Grounding Plates are designed for use with electrosurgical generators for cutting and coagulation of human tissue.

Prescription Use

OR

Over -The-Counter Use

(Optional Format 1-2

(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