MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)

K051082 · Medtrade Products , Ltd. · KMF · Nov 8, 2005 · General Hospital

Device Facts

• Record ID: K051082
• Device Name: MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)
• Applicant: Medtrade Products , Ltd.
• Product Code: KMF · General Hospital
• Decision Date: Nov 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1

Intended Use

MedTrade Products Skin Protective Barrier Wipe is a liquid intended for use as a film-forming product, that upon application to intact or damaged skin forms a long lasting waterproof barrier, which acts as a protective interface between the skin and bodily wastes, fluids and adhesive products. It is intended as a primary barrier against irritation from body fluids.

Device Story

MedTrade Products Skin Protective Barrier Wipe is a polymeric solution supplied in single-use sterile pouches. Upon application to skin, the solution dries rapidly to form a colorless, transparent, waterproof film. This film acts as a protective interface between skin and external irritants, including bodily wastes, fluids, and adhesives. The device provides oxygen and moisture vapor permeability. It is intended for use on intact or damaged skin to prevent irritation. The device is sterilized via gamma irradiation.

Clinical Evidence

Bench testing only. Biocompatibility testing performed including dermal irritation, dermal sensitization, and cytotoxicity. Sterilization validated per ANSI/AAMI/ISO 11137-1994 and AAMI TIR8-1991 to a sterility assurance level of 10^-6.

Technological Characteristics

Polymeric solution in water-based, non-cytotoxic carrier. Forms a film upon application. Sterile, single-use. Sterilization: Gamma irradiation per ANSI/AAMI/ISO 11137-1994 and AAMI TIR8-1991. Packaging: Paper/poly/foil tri-laminate pouch.

Indications for Use

Indicated for protection of intact or damaged skin from irritation caused by incontinence, digestive juices, wound drainage, and adhesives.

Regulatory Classification

Identification

A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

Predicate Devices

• 3M No-Sting Barrier Film (K955103)
• Smith & Nephew No-sting Skin Prep (K973228)

Submission Summary (Full Text)

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057082

NOV - 8 2005

Safety & Effectiveness: MedTrade Products Skin Protective Barrier Wipe

KMF, 880.5090, Bandage, Liquid Classification Name:

Contact: Jonathan Ranfield - Director, Quality Assurance & Regulatory Affairs

Prepared: April 18, 2005, revised September 6, 2005.

Description: MedTrade Product's Skin Protective Barrier Wipe is a polymeric solution which forms a unique film when applied to the skin. The product is dispersed in a unique non-cytotoxic, water based solution, which dries rapidly.

MedTrade Products Skin Protective Barrier Wipe helps to protect intact or damaged skin from irritation Mou rrade Freadincontinence, digestive juices, wound drainage and adhesives. The film is coloriess, transparent and possesses good oxygen and moisture vapour permeability.

MedTrade Products Skin Protective Barrier Wipe Wipes are supplied sterile in single use pouches. Packaging will consist of a single dressing in a paper / poly / foil tri laminate pouch, the pouches will then be placed in to a sales carton, with an Instructions For Use Leaflet.

Biocompatibility testing including: Dermal Irritation on the components, Dermal Sensitization on the components, and Cytotoxicity, Irritation & Sensitization on the Skin Protective Barrier Wipe Product has been successfully completed.

The sterile packaged product will be sterilised by gamma irradiation in accordance with the Sterilisation of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilisation, 3 Edition (ANSI/AAMI/ISO11137-1994) and Microbiological Methods for Gamma Sterilisation (AAMI TIR8-1991). Qualification will be based on Method 1 for dosimetric release with a sterility assurance level of 10 -6.

MedTrade Product Skin Protective Barrier Wipe is technologically the same as the substantially equivalent products, 3M No-Sting Barrier Film K955103 & Smith & Nephew No-sting Skin Prep K973228.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the seal in a circular fashion. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 2005

Jonathan Ranfield Director, Quality Assurance & Regulatory Affairs MedTrade Products Ltd Electra House Crewe Business Park Crewe, Cheshire CW1 6GL United Kingdom

Re: K051082

Trade/Device Name: MedTrade Products Skin Protective Barrier Wipe Regulation Number: 21 CFR 880,5090 Regulation Name: Liquid bandage Regulatory Class: I Product Code: KMF Dated: September 6, 2005 Received: September 8, 2005

Dear Mr. Ranfield:

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- Jonathan Ranfield

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,

Barbara Buchup

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

Enclosure

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K051082 f.tofs

## Indications for Use

510(k) Number (if known)

Device Name: MedTrade Products Skin Protective Barrier Wipe

Indications for Use:

MedTrade Products Skin Protective Barrier Wipe is a liquid intended for use as a film-forming product, that upon application to intact or damaged skin forms a long lasting waterproof barrier, which acts as a protective interface between the skin and bodily wastes, fluids and adhesive products. It is intended as a primary barrier against irritation from body fluids.

Prescription Use (Per 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)

Barbara Buschm

Division of General, Restorative, and Neurological Devices

510(k) Number K051062