ALGICELL AG

K052536 · Derma Sciences Canada, Inc. · FRO · Sep 13, 2006 · SU

Device Facts

• Record ID: K052536
• Device Name: ALGICELL AG
• Applicant: Derma Sciences Canada, Inc.
• Product Code: FRO · SU
• Decision Date: Sep 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Under the supervision of a healthcare professional, Algicell® Ag dressing is an effective barner to bacterial penetration in moderate to heavily exuding wounds such as diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology), pressure ulcers/sores (partial and full thickness), donor sites, and traumatic and surgical wounds.

Device Story

Algicell® Ag is a wound dressing containing antimicrobial silver; functions as a physical barrier to bacterial penetration. Used in clinical settings under healthcare professional supervision for management of moderate to heavily exuding wounds. Dressing applied directly to wound site to absorb exudate and provide antimicrobial protection; aids in wound healing by maintaining moist environment and reducing bacterial load. No complex electronics or software involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Calcium alginate dressing impregnated with antimicrobial silver. Form factor is a wound dressing. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients with moderate to heavily exuding wounds, including diabetic foot ulcers, venous/arterial/mixed leg ulcers, partial and full-thickness pressure ulcers, donor sites, and traumatic or surgical wounds. Requires supervision by a healthcare professional.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 3 2006

Derma Sciences % Ms. Sharmini Atheray, M.Sc Corporate Director QA/RA 104 Shorting Road Toronto, Ontario M1S 3S4 Canada

Re: K052536

Trade/Device Name: Calcium Alginate Dressing with Antimicrobial Silver Regulatory Class: Unclassified Product Code: FRO Dated: August 23, 2006 Received: August 24, 2006

Dear Ms. Atheray:

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 - Ms. Sharmini Atheray, M.Sc

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

ely yours,
for

N. Mall

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

K052536 510(k) Number (if known):

Calcium Alginate Dressing with Antimicrobial Silver Device Name:

Indications For Use:

Under the supervision of a healthcare professional, Algicell® Ag dressing is an effective barner to bacterial penetration in moderate to heavily exuding wounds such as diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology), pressure ulcers/sores (partial and full thickness), donor sites, and traumatic and surgical wounds.

Prescription Use (Part 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)

of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Concurrence (Division Sign-C Page 1 of Division of General, Restorati and Neurological Devices