FERRIS POLYMEM SILVER WOUND DRESSING

K031307 · Ferris Mfg. Corp. · FRO · Oct 22, 2003 · SU

Device Facts

• Record ID: K031307
• Device Name: FERRIS POLYMEM SILVER WOUND DRESSING
• Applicant: Ferris Mfg. Corp.
• Product Code: FRO · SU
• Decision Date: Oct 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

For the management of: Pressure Ulcers (Stages I-IV) Venous stasis ulcers Acute wounds Leg ulcers Donor and graft sites Skin tears Diabetic ulcers Dermatologic disorders 1st and 2nd degree burns

Device Story

PolyMem Silver Wound Dressing is a topical wound care product. It functions as a dressing to manage wound exudate and provide a barrier. Used in clinical or home settings under prescription. The dressing is applied directly to the wound site by a clinician or patient. It aids in wound healing by maintaining a moist environment and managing moisture levels. The silver component provides antimicrobial properties to the dressing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Polymeric wound dressing containing silver. Form factor is a flexible pad/dressing. Non-active device; no software or electronic components.

Indications for Use

Indicated for management of pressure ulcers (stages I-IV), venous stasis ulcers, acute wounds, leg ulcers, donor/graft sites, skin tears, diabetic ulcers, dermatologic disorders, and 1st/2nd degree burns.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2003

Mr. Theodore Thorsen Director, Quality Assurance Ferris Manufacturing Corporation 16W300 83" Street Burr Ridge, Illinois 60527-5848

Re: K031307

Trade/Device Name: Polymem Silver Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 12, 2003 Received: August 12, 2003

Dear Mr. Thorsen:

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 (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. Theodore Thorsen

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,

Mark N Millman

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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510(k) NUMBER (IF KNOWN): K031307

DEVICE NAME: POLYMEM SILVER WOUND DRESSING

INDICATIONS FOR USE: For the management of:

| Pressure Ulcers (Stages I-IV) | Venous stasis ulcers | Acute wounds |
|-------------------------------|------------------------|--------------------------|
| Leg ulcers | Donor and graft sites | Skin tears |
| Diabetic ulcers | Dermatologic disorders | 1st and 2nd degree burns |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) X

OR

Over-the-Counter-Use (Optional Format 1-2-96)

Mark A. Milliman

vision Sign-Of Divisi in of General. Restorative and I curological Devices

510(k) Number K031307