MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS

K022587 · Medtrade Products , Ltd. · MGQ · Aug 22, 2003 · SU

Device Facts

• Record ID: K022587
• Device Name: MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS
• Applicant: Medtrade Products , Ltd.
• Product Code: MGQ · SU
• Decision Date: Aug 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

MedTrade Product's Antiseptic Barrier Hydrogel Dressings are indicated for OTC use on minor cuts & grazes, minor scalds & burns and insect bites. If at any time you are unsure of the above conditions or type of wound consult a health care professional.

Device Story

Antiseptic barrier hydrogel dressing; consists of >70% water-based hydrophilic polymer gel; includes self-adhesive film backing. Provides moist healing environment; absorbs wound fluid; provides antiseptic barrier protection against microbes. Used for minor cuts, grazes, scalds, burns, and insect bites. Applied by patient or caregiver in home/OTC setting. Sterile, single-use, gamma-irradiated. Benefits include cooling effect, fluid absorption, and infection barrier.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing performed per ISO/Tripartite guidelines including dermal irritation, dermal sensitization, cytotoxicity, acute systemic toxicity, and hemocompatibility/hemolysis. Sterilization validated per ANSI/AAMI/ISO 11137-1995 and AAMI TIR8-1991.

Technological Characteristics

High water content (>70%) medical grade hydrophilic polymer hydrogel; self-adhesive film backing with medical grade pressure-sensitive adhesive. Sterile, gamma-irradiated (ANSI/AAMI/ISO 11137-1995). Biocompatible per ISO/Tripartite guidelines.

Indications for Use

Indicated for OTC use on minor cuts, grazes, minor scalds, burns, and insect bites. Contraindicated for third-degree burns.

Predicate Devices

• MedTrade Product's Hydrogel Island Dressings (K002504)

Submission Summary (Full Text)

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AUG 2 2 2003

510k Summary
K022587

H. Safety & Effectiveness: MedTrade Product's Antiseptic Barrier Hydrogel Dressings Classification Name: NAE 878.4022 Bandage Liquid

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

MedTrade Products Ltd, Electra House, Crewe Business Park, Crewe, CW1 6GL. UK. Tel: [phone]. Fax: [phone]

Prepared: August 10, 2002

Description: MedTrade Product's Antiseptic Barrier Hydrogel Dressings consist of an Antiseptic Hydrogel, which is over 70% pure water. Effective antiseptic barrier protection of the dressing against microbes and microbial contamination is provided by the antiseptic barrier hydrogel and adhesive film cover of the dressing is made from a special Antiseptic Barrier hydrogel formulation which not only has a high water activity (a measure of cooling) but is also capable of absorbing substantial quantities of fluid. This makes it especially suitable for use on burns with minimal risk of maceration. The Antiseptic Barrier hydrogel dressings are highly conformable, soft, absorbent, sterile, primary wound dressings of a gelatinous mass which provides a moist healing environment.

MedTrade Product's Antiseptic Barrier Hydrogel Dressings are indicated for OTC use on minor cuts & grazes, minor scalds & burns and insect bites. If at any time you are unsure of the above conditions or type of wound consult a health care professional.

Dressings are supplied sterile in single use pouches. Product is gamma irradiated in accordance with the Sterilisation of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilisation, 300 Edition (ANS/AAMI/ISO11137 - 1995) and Microbiological Methods for Gamma Sterilisation (AAMI TIR8-1991) for qualification for Method 1 for dosimetric release with a sterility assurance level of 10 -Biocompatability testing including: Dermal Irritation, Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity and Hemocompatibility/Hemolysis have been successfully completed per ISO/Tripartite guidelines.

MedTrade Product's Antiseptic Barrier Hydrogel Dressings are substantially equivalent in design, composition and function to MedTrade Product's Hydrogel Island Dressings K002504, with the addition of an antiseptic, to provide an antiseptic barrier hydrogel. A table of comparative features may be found below.

| Characteristics | MedTrade Product's<br>Hydrogel Island Dressing<br>Exempted 510(k) K002504 | MedTrade Product's<br>Antiseptic Barrier Hydrogel<br>Island Dressing |
|------------------------|---------------------------------------------------------------------------|----------------------------------------------------------------------|
| Hydrogel - Composition | High water content medical<br>grade hydrophilic polymer | High water content medical<br>grade hydrophilic polymer |
| Backing | Self Adhesive Film | Self Adhesive Film |
| Adhesive | Medical grade pressure<br>sensitive adhesive | Medical grade pressure sensitive<br>adhesive |
| Adhesive Coverage | 100% on backing | 100% on backing |
| Indications For Use | Minor cuts & grazes<br>Minor scalds & burns<br>Insect Bites | Minor cuts & grazes<br>Minor scalds & burns<br>Insect Bites |
| Packaging | Printed Pouch | Printed Pouch |
| Supplied | Sterile | Sterile |

## ATIVE

Additionally, MedTrade Products Antiseptic Barrier Hydrogel has been shown to have "Antiseptic Barrier activity".

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## AUG 22 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K022587

Trade/Device Name: MedTrade Product's Antiseptic Barrier Hydrogel Dressings Regulatory Class: Unclassified Product Code: MGQ Dated: June 18, 2003 Received: June 20, 2003

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 - Mr. 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/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark N Wilkerson

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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Page 1 of 1

510(k) Number (if known) . KO22587 ............................................................................................

Device Name: MedTrade Product's Antiseptic Barrier Hydrogel Dressings

These dressings are intended for OTC use on wounds such as:

- Minor cuts and grazes .
- Minor scalds and burns .
- Insect bites .

MedTrade Products Antiseptic Barrier Hydrogel Dressings are contraindicated for:

- . Third degree burns
The components do not contain animal ingredients.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.190) | Or | Over The Counter Use | X | (Optional Format 1-2-96) |
|------------------------------------------|----|----------------------|---|--------------------------|
|------------------------------------------|----|----------------------|---|--------------------------|

(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

| 510(k) Number | K022587 |
|---------------|---------|
|---------------|---------|