PRODERMA LIQUID BANDAGE

K063202 · Procurement Technology Systems, LLC · KMF · May 2, 2007 · General Hospital

Device Facts

• Record ID: K063202
• Device Name: PRODERMA LIQUID BANDAGE
• Applicant: Procurement Technology Systems, LLC
• Product Code: KMF · General Hospital
• Decision Date: May 2, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

ProDerma Liquid Bandage is indicated for over-the-counter (OTC) use to cover minor cuts, scrapes and minor irritations of the skin and help protect them from infection.

Device Story

ProDerma is a liquid topical bandage composed of 2-Octyl and N-Butyl Cyanoacrylate monomers, a plasticizer, and D&C violet #2 pigment. Packaged in a single-use 'tear drop' applicator with a polyurethane foam sponge. User applies by folding the packet to release liquid into the sponge, then dabbing onto the skin. The cyanoacrylate polymerizes upon contact with skin to form a protective mechanical bond/film. Used in home/OTC settings by consumers. The film acts as a physical cover for minor wounds and naturally sloughs off as skin cells shed. Benefits include protection of minor wounds from infection during the healing process.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ANSI/AAMI/ISO 10993. Sterilization validation performed in accordance with ANSI/AAMI/ISO 11137 & 11737 to confirm a Sterilization Acceptance Level (SAL) of 10^-6.

Technological Characteristics

Cyanoacrylate-based liquid adhesive (2-Octyl and N-Butyl monomers). Packaging: Laminated film (Pet/AL/Nitrile and Nitrile/PE or Nitrile/PP/PE) with polyurethane foam applicator. Sterilization: Irradiation (SAL 10^-6). Polymerization time: < 2 minutes.

Indications for Use

Indicated for OTC use to cover minor skin cuts, scrapes, and irritations to protect against infection. Contraindicated for use near eyes, on infected or draining wounds, or on major wounds requiring closure.

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

• Liquiderm™ Liquid Adhesive Bandage (K002338)
• LiquiShield™ Liquid Bandage (K031321)
• DERMA+FLEX™ Gel Adhesive (K050757)

Submission Summary (Full Text)

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K063202

# Procurement Technology Syrtem/.

### 510(k) SUMMARY ProDerma - Liquid Bandage

| Submitted By: | Procurement Technology Systems, LLC<br>2375 Hwy 101 South, Bldg A<br>Greer, SC 29651<br>Telephone: [phone]<br>Fax: [phone]<br>Contact Name: Bill Griswold<br>Date Prepared: September 9, 2006 | MAY - 2 200 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device Name: | Trade Name: ProDerma<br>Common Name: Liquid Bandage<br>Product Code: KMF<br>Classification: Class I<br>CFR Section: 880.5090 | |
| Predicate Devices: | Liquiderm™ Liquid Adhesive Bandage – K002338<br>MFG By: Closure Medical Corporation<br>Marketed As: Johnson & Johnson Band-Aid® Liquid Bandage | |
| | LiquiShield™ Liquid Bandage – K031321<br>MFG By: Medlogic Global Ltd<br>Marketed As: LiquiShield™ | |
| | DERMA+FLEX™ Gel Adhesive – K050757<br>MFG By: Chemence Medical Products<br>Marketed As: DERMA+FLEX™ | |
| Description: | ProDerma Liquid Bandage, a formulated Cyanoacrylate adhesive, is a violet tinted, clear liquid topical bandage composed of 2-Octyl and N-Butyl Cyanoacrylate monomers, a plasticizer and D&C violet #2 pigment.<br><br>ProDerma is packaged in a single use applicator containing up to 0.5 grams of product. The single use applicator is constructed in the shape of “tear drop” with the flat bottom side made of a flexible laminated film of Pet/AL/Nitrile and a flexible laminate of either Nitrile/PE or Nitrile/PP/PE formed as a blister on the top side with a polyurethane foam sponge for applying the liquid bandage. Each applicator is individually packaged in a blister with a Tyvek backing. The applicators are packaged in a box with a quantity ranging of 6 to 24 per box depending on the customer's requirements. The applicator is opened by folding over the packet | |

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KO 63202

## Procurement Technology Syrtem

### 510(k) SUMMARY ProDerma - Liquid Bandage

at the narrow end under the foam sponge onto itself. The liquid flows into the foam sponge and is control by the user as pressure is applied to the applicator. ProDerma is then applied to the area in need.

Applicators sterilized to a Sterilization Acceptance Level (SAL) of 10° via commercially available irradiation facilities.

- Indications for Use: ProDerma Liquid Bandage is indicated for Over-The-Counter (OTC) use to cover minor cuts, scrapes and minor irritations of the skin and help protect them from infection.
- ProDerma should not be applied near the eyes. Do not use on Contraindications: areas that are infected or that show signs of infection or drainage. Avoid using ProDerma on major wounds that require wound closure with another device.
- Technological Characteristics: ProDerma Liquid Bandage is applied to the desired area and polymerizes to form a mechanical bond with the skin. The polymerization process time varies based on the amount of ProDerma applied. The polymerization or set time typically occurs within less than 2 minutes. Once the polymerization is complete the resulting film acts as a cover allowing the wound to heal. During the healing process the polymer covering sloughs off naturally, as dead skin cells are shed and replaced with new ones.

Substantial Equivalence: ProDerma - Liquid Bandage is similar to the predicate devices listed in the section named "Predicate Devices" in that all are cyanoacrylate based liquid bandages. They are manufactured in a similar manner using synthesization and distillation methods and blending with other ingredients and sterilized in its finished package.

- Testing Summary: ProDerma - Liquid Bandage has been subjected to the appropriate biocompatibility testing in accordance with ANSI/AAMI/ISO 10993 and the results have confirmed that the product is safe for its intended use. ProDerma has also been subject to the appropriate sterilization validation testing in accordance with ANSI/AAMI/ISO 11137 & 11737 and the results have confirmed that the method of sterilization selected for ProDerma provides a SAL level 10th in the finished individual applicator package.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Procurement Technology Systems, LLC % Mr. Bill Griswold P.O. Box 748 Duncan, South Carolina 29334-0748

Re: K063202

Trade/Device Name: ProDerma - Liquid Bandage Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: I Product Code: KMF Dated: March 20, 2007 Received: March 21, 2007

MAY - 2 2007

Dear Mr. Griswold:

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. Bill Griswold

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

Mark N. Molkersaan

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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### Indications for Use

510(k) Number (if known): _ K 063 202

Device Name: ProDerma - Liquid Bandage

Indications for Use:

ProDerma Liquid Bandage is indicated for over-the-counter (OTC) use to cover minor cuts, scrapes and minor irritations of the skin and help protect them from infection.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pele m

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

510(k) Number L063262

Indications for Use Statement 09-09-06

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