SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES

K030362 · Leonhard Lang GmbH · GEI · Apr 14, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030362
• Device Name: SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES
• Applicant: Leonhard Lang GmbH
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 14, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: 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

Skintact® Cool Contact Electrosurgical Grounding Plates are self-adhesive, single-use, non-sterile electrodes; available in various shapes/sizes (adult/pediatric), standard or split, with/without lead wires. Device functions as patient return electrode for electrosurgical generators during cutting/coagulation procedures. Used in clinical settings by healthcare professionals. Provides electrical return path for high-frequency current; ensures safe current dissipation to prevent thermal injury. Benefits patient by facilitating safe electrosurgical energy delivery.

Clinical Evidence

Bench testing only. Testing conducted per ANSI/AAMI HF 18:2001 included: biocompatibility (cytotoxicity, skin irritation, sensitization), maximum safe temperature rise, electrode contact impedance, and electrode adherence (pull, conformability, and fluid tolerance tests). No adverse results reported.

Technological Characteristics

Self-adhesive, single-use disposable electrodes. Materials biocompatible per ISO/AAMI standards. Conforms to ANSI/AAMI HF 18:2001. Packaging: water-vapor-proofed, heat-sealed, aluminized pouches. No software or electronic components.

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

• ERBE Disposable Patient Return Electrode (K972269)
• Nikopad Electrosurgical grounding plates (K993306)

Submission Summary (Full Text)

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APR 1 4 2003
K030362

## 510(k) Summary

## SUBMITTED ON BEHALF OF:

Company Name: Address:

Leonhard Lang GmbH Archenweg 56 6010 Innsbruck Austria

++ 43 / 512 / 33 4 25 7

++ 43 / 512 / 39 22 10

Telephone: Fax:

by:

Elaine Duncan, MS.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 715-549-6035 715-549-5380

Telephone: Fax:

CONTACT PERSON: DATE PREPARED:

Trade Name: Common Name: Classification Name: Elaine Duncan January 30, 2003

Skintact® Cool Contact Electrosurgical Grounding Plates Electrosurgical Grounding Plates Electrosurgical Grounding Plates

SUBSTANTIALLY EQUIVALENT TO: Skintact® Cool Contact Electrosurgical Grounding Plates are equivalent to the materials of construction and gel used in the ERBE Disposable Patient Return Electrode cleared via 510(k) [K972269] and produced by Leonhard Lang, GmbH. However the Skintact® Electrosurgical Grounding Plates have a different geometry and area. This area and geometry is equivalent to that found with Nikopad Electrosurgical grounding plates, previously cleared by FDA (K993306.) Based upon these similar features and conformance with the recognized standard ANSUAAMI HF 18:2001, the Leonhard Lang Skintact® Electrosurgical Grounding Plates are substantially equivalent.

DESCRIPTION of the DEVICE: Skintact® Cool Contact Electrosurgical Grounding Plates (and as also to be offered for sale under various private label tradenames) are self-adhesive, non-sterile, 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 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. All performance and safety tests are according to ANSI/AAMI HF 18:2001 and were conducted by TÜV Product Service GmbH, Zertifizierstelle, Ridlerstraße 65, 80339 München, Germany. A certification to conformance ANSVA AMI HF 18:2001 with this standard has been provided. The testing conducted was: Maximum safe temperature rise; Electrode contact impedance; Electrode adherence: Pull test, Conformability test, Fluid tolerance test. All Skintact® Grounding Plates are packaged in water-vapor-proofed, heat-sealed, 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 compared to the predicate device.

## Abbreviated 510(k): Skintact® Cool Contact Electrosurgical Grounding Plates

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with flowing lines suggesting hair or clothing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2003

Leonhard Lang GmbH c/o Ms. Elaine Duncan, M.S.M.E., RAC President Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082

Re: K030362

Trade/Device Name: Skintact® Cool Contact Electrosurgical Grounding Plates Regulation Number: 21 CFR 878.4400 Regulation Names: Electrosurgical cutting and coagulation device and accessoreis Regulatory Class: II Product Codes: GEI Dated: January 30, 2003 Received: February 3, 2003

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 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 - Ms. Elaine Duncan, M.S.M.E., RAC

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]. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours.

Sincerely, yours,

Mark N. Mulberan

Celia M. Witten, Ph.D., M.D. 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)

Skintact® Cool Contact Electrosurgical Grounding Plates Device Name:

Indications for Use:

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

(Please Do Not Write Below This Line-Continue On Another Page If Needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over -The-Counter Use _

(Optional Format 1-2-96)

for Mark A. Millner

(Division Sign-Off) Division & General, Restorative and Neurological Devices

510(k) Number K03036