ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING

K091354 · Acrymed, Inc. · FRO · Oct 21, 2009 · SU

Device Facts

• Record ID: K091354
• Device Name: ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING
• Applicant: Acrymed, Inc.
• Product Code: FRO · SU
• Decision Date: Oct 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

AcryDerm Silver Antimicrobial Foam Wound Dressings are indicated for the management of 1st and 2nd degree burns, wounds such as venous and arterial ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.

Device Story

AcryDerm Silver Antimicrobial Foam Wound Dressing is a sterile, single-use hydrophilic polyurethane foam dressing. It incorporates silver saccharinate salt and metallic silver as stabilized reservoirs. Upon contact with aqueous moisture from exuding wounds, the dressing releases antimicrobial ionic silver. The hydrophilic foam matrix manages wound moisture levels. Used in clinical or home settings for various wound types; applied by healthcare providers or patients. The device provides a moist wound environment while delivering antimicrobial silver to the wound site, aiding in management of burns and various ulcer types.

Clinical Evidence

Bench testing only. Device meets or exceeds safety and biocompatibility assurance guidelines per ANSI/AAMI/ISO 10993-1:2003.

Technological Characteristics

Hydrophilic polyurethane foam matrix; silver saccharinate salt and metallic silver antimicrobial reservoirs. Ionic silver release mechanism triggered by aqueous moisture. Sterile, single-use.

Indications for Use

Indicated for management of 1st and 2nd degree burns, venous/arterial/pressure/diabetic ulcers, lacerations, abrasions, skin tears, surgical incisions, device insertion sites, graft sites, and donor sites.

Predicate Devices

• Optifoam® Ag Antimicrobial Foam Dressing (Medtrade Products Ltd.)
• Polymem® Silver (Ferris Mfg. Corp.)
• Silver Antimicrobial Wound Gauze (Medline Industries)

Submission Summary (Full Text)

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K091354
page 1 of

21 2009

## 510(k) Summary

| Sponsor: | AcryMed, Inc.<br>9560 SW Nimbus Avenue<br>Beaverton, OR 97008 | |
|--------------------------------|---------------------------------------------------------------|-----|
| Contact Person: | Charles K. Griffin; (503)-624-9830, ext. 280 | OCT |
| Device Name | AcryDerm® Silver Antimicrobial Foam<br>Wound Dressing | |
| Common Name: | Hydrophilic Wound Dressing | |
| Classification Product Code: | FRO | |
| Classification Advisory Panel: | General and Plastic Surgery | |

Legally marketed device(s) for substantial equivalence comparison:

Optifoam® Ag Antimicrobial Foam Dressing (Medtrade Products Ltd. Cheshire UK) Polymem® Silver (Ferris Mfg. Corp., Burr Ridge IL) Silver Antimicrobial Wound Gauze (Medline Industries, Mundelein IL)

Description of Device: AcryDerm Silver Antimicrobial Foam Wound Dressings are sterile, single use hydrophilic polyurethane foam dressings containing antimicrobial silver for use in the management of wounds.

Intended use of the Device: AcryDerm Silver Antimicrobial Foam Wound Dressings are indicated for the management of 1* and 2nd degree burns, wounds such as venous and arterial ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.

Technological Characteristics: The AcryDerm Silver Foam Antimicrobial Wound Dressings incorporate a combination of silver saccharinate salt and a metallic silver as stabilized reservoirs for generating antimicrobial ionic silver upon contact with aqueous moisture such as would be commonly encountered when used as a wound dressing on dermal surfaces and exuding wounds. The antimicrobial components are incorporated in the dressing matrix which is composed of a hydrophilic polyurethane foam which acts to help control the moisture level in the wound.

Testing: the new product meets or exceeds safety and biocompatibility assurance guidelines as provided in the guidance of Part-1 of the ANSI/AAMI/ISO standard (10993-1:2003 - Biological Evaluation of Medical Devices - Part I: Evaluation and Testing)

Manufacturing: The new silver antimicrobial foam dressing product will be manufactured according to the product specifications and in accordance with good manufacturing practices to ensure the device is safe and effective for the intended use.

Performance Standards: No performance standards are prescribed for the new product.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

AcryMed, Inc. % Mr. Charles K. Griffin 9560 SW Nimbus Avenue 82 Cambridge Street Beaverton, Oregon 97008

OCT 21 2009

Re: K091354

Trade/Device Name: AcryDerm Silver Antimicrobial Foam Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 8, 2009 Received: September 15, 2009

Dear Mr. Griffin;

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. Iisting 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

forth in the quality systems (OS) 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. Charles K. Griffin

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

4

510(k) Number (if known):

AcryDerm Silver Antimicrobial Foam Wound Dressing Device Name:

K09135

### Indications for Use:

AcryDerm Silver Antimicrobial Foam Wound Dressing is indicated for the management of 1st and 2" degree burns, wounds such as venous and arterial ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

| Concurrence of CDRH Office of Device Evaluation (ODE) | <i>Daniel Kure</i> <b>for</b> <i>MXM</i> |
|-------------------------------------------------------|------------------------------------------|
| (Division Sign-Off) | |
| Division of Surgical, Orthopedic, | |
| and Restorative Devices | |
| 510(k) Number | K091354 |

AcryDerm Silver Antimicrobial Foam Wound Dressing Pre-market Notification 510(k) Page No. 4