ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL

K070333 · Acrymed, Inc. · FRO · Jul 10, 2007 · SU

Device Facts

• Record ID: K070333
• Device Name: ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL
• Applicant: Acrymed, Inc.
• Product Code: FRO · SU
• Decision Date: Jul 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

AcryDerm Silver Antimicrobial OTC Wound Gel is intended for use on intact and broken skin and dermal injuries such as minor laceration, cuts, burns, scrapes and minor surgical procedures wounds.

Device Story

AcryDerm Silver Antimicrobial OTC Wound Gel is a moist amorphous gel wound filler containing ionic silver. Supplied in collapsible co-laminate tubes, it functions as an antimicrobial barrier. The gel is applied topically to intact or broken skin and dermal injuries to provide a protective barrier against bacteria and fungi. It is intended for over-the-counter use by patients for minor wounds. The antimicrobial properties are derived from ionic silver, which maintains barrier function for over 3 days, as demonstrated by in vitro serial transfer testing. The device aids in wound management by providing a moist environment and antimicrobial protection.

Clinical Evidence

No clinical trials were conducted for this submission. Evidence is based on bench testing, including Kirby-Bauer zone of inhibition assays demonstrating antimicrobial activity against a broad spectrum of bacteria and fungi, and USP Preservative Challenge Testing. Biocompatibility was assessed per ISO standards.

Technological Characteristics

Moist amorphous gel wound filler containing ionic silver. Repeat-use antimicrobial barrier. Supplied in collapsible heat-sealed co-laminate tubes with screw caps. Biocompatibility evaluated per ISO 10993 (Part 1).

Indications for Use

Indicated for use on intact and broken skin and dermal injuries, including minor lacerations, cuts, burns, scrapes, and minor surgical wounds.

Predicate Devices

• AcryDerm Silver Antimicrobial Wound Gel (K011994)
• SilverMed Antimicrobial Silver Hydrogel (Argentis Biomedical, Tx)
• Silver Shield Antimicrobial Skin and Wound Gel (Anacapa Tech., Inc., Ca)

Submission Summary (Full Text)

{0}------------------------------------------------

K070333
page 1 of 2

## 510(k) Summary

| Contact Person: | Bruce L. Gibbins, PhD | |
|----------------------------|---------------------------------------------|-------------|
| Date of preparation: | January 26, 2007 | JUL 10 2007 |
| Device Name (proprietary): | AcryDerm OTC Silver Antimicrobial Wound Gel | |
| Common Name: | Moist antimicrobial wound filler | |
| Classification Name: | Hydrophilic wound dressing | |
| Classification: | Unclassified | |

Legally marketed device(s) for substantial equivalence comparison:

AcryDerm Silver Antimicrobial Wound Gel (AcryMed, Inc., OR)

SilverMed Antimicrobial Silver Hydrogel (Argentis Biomedical, Tx)

Silver Shield Antimicrobial Skin and Wound Gel (Anacapa Tech., Inc., Ca)

Description of Device: AcryDerm Silver Antimicrobial OTC Wound Gel is a moist amorphous gel wound filler that contains antimicrobial silver. It is supplied in collapsible blind ended heat sealed co-laminate tubes fitted with screw caps.

Intended Use of the Device: AcryDerm Silver Antimicrobial OTC Wound Gel is intended for use on intact and broken skin and dermal injuries such as minor laceration, cuts, burns, scrap and minor surgical procedures.

Technological Characteristics: AcryDerm Silver Antimicrobial OTC Wound Gel is a repeatuse antimicrobial barrier amorphous gel wound cover that contains ionic silver. Antimicrobial barrier activity has been demonstrated by Kirby-Bauer zone of inhibition assays against a broad spectrum of bacteria and fungi including: Staphylococcus epidermitis, E. coli, Pseudomonas aeruginosa, Staphylococcus aureus (MRSA), Candida albicans, and Enterococcus faecium, Klebsiella pneumoniae (3 strains), Candida parapsilosis, Candida galbrata , Bacillus subtilis, Enterobacter cloacae (2 strains), Enterococcus faecalis (2 strains), Aspergillus niger, Serratia marcescens, Citrobacter diversus, Citrobacter kasseri, Staphylococcus saprophyticus, Epidermophyton sp., Microsporum sp., and Tricophyton sp. The silver antimicrobial wound gel has been shown by in vitro serial transfer testing to maintain a barrier function for more than 3 days.

Manufacturing: AcryDerm Silver Antimicrobial OTC Wound Gel will be manufactured according to the product specifications and under good manufacturing practices that ensure the device is safe, effective, and correctly labeled for its intended use.

Performance testing: The antimicrobial barrier activity of the new product has been established by the Kirby-Bauer zone of inhibition test. In addition, the new product conforms with the USP Preservative Challenge Test performed against the strains of organisms specified in the USP

Vlio

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image contains handwritten text. The top line reads "k 070333", with the 'k' being a lowercase letter. The second line reads "page 2 of 2", indicating it is the second page of a document. The handwriting is clear and legible.

Preservative Challenge Test protocol. Biocompatibility has been assessed according to Part-1 of the ISO standard (Biological Evaluation of Medical Devices).

## Purpose for this Submission

This application is being made in order to gain clearance to market a previously cleared product for Over The Counter (OTC) distribution. The product AcryDerm Silver Antimicrobial Wound Gel received clearance to market (K011994) and has been in continuous distribution since 2002 as a prescription only product. The complaint history, biocompatibility, safety, and performance in a wound healing study show that it would be safe for wider and more direct access of this product by patients. Clearance to OTC distribution is respectfully sought in this application.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right. To the left of the symbol is text arranged in a circular fashion, spelling out "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AcryMed, Inc. % Bruce Gibbons, PhD Chief Technology Officer 9560 SW Nimbus Avenue Beaverton, Oregon 97008

JUL 1 0 2007

Re: K070333

Trade/Device Name: AcryDerm Silver Antimicrobial OTC Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated: June 5, 2007 Received: June 20, 2007

Dear Dr. Gibbons:

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.

{3}------------------------------------------------

Page 2 - Bruce Gibbons, PhD

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,

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

Rum
Dip O.A
7/10/07

Enclosure

{4}------------------------------------------------

| 510(k) NUMBER (IF KNOWN): | K070333 |
|---------------------------|---------------------------------------------|
| DEVICE NAME: | AcryDerm Silver Antimicrobial OTC Wound Gel |

INDICATIONS FOR USE:

AcryDerm Silver Antimicrobial OTC Wound Gel is intended for use on intact and broken skin and dermal injuries such as minor laceration, cuts, burns, scrapes and minor surgical procedures wounds.

Prescription use (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1)

of

Page

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

pation (ODE) Office of Device Concurrence of CDRH,

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

510(k) Number_ LG T 6333