FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING

K984539 · Ferris Mfg. Corp. · KMF · Mar 1, 1999 · General Hospital

Device Facts

• Record ID: K984539
• Device Name: FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING
• Applicant: Ferris Mfg. Corp.
• Product Code: KMF · General Hospital
• Decision Date: Mar 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

For the management of Leg ulcers Venous ulcers Diabetic ulcers Arterial ulcers Abrasions Second degree burns Full and partial thickness pressure ulcers Dehisced incisions

Device Story

Ferris PolyMem Calcium Alginate Dressing is a wound dressing used for the management of various ulcer types, abrasions, burns, and incisions. It is applied topically to the wound site by healthcare professionals or patients. The dressing functions as a physical barrier and absorbent material to manage wound exudate. It is not indicated for third-degree burns, nor is it labeled as a treatment, cure, artificial skin, or long-term dressing. It does not claim to accelerate wound healing or epithelization.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of intended use and device classification.

Technological Characteristics

Calcium alginate wound dressing; physical barrier and absorbent material; non-implantable; sterile.

Indications for Use

Indicated for management of leg, venous, diabetic, and arterial ulcers; abrasions; second-degree burns; full and partial thickness pressure ulcers; and dehisced incisions.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 1999

Mr. Theodore Thorsen Director of Quality Assurance Ferris Manufacturing Corporation 16W300 83rd Street Burr Ridge, Illinois 60521-5848

Re: K984539

> Trade Name: Ferris PolyMem Calcium Alginate Dressing Regulatory Class: Unclassifed Product Code: KMF Dated: December 16, 1998 Received: December 21, 1998

Dear Mr. Thorsen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- This device may not be labeled for use on third degree burns. 1.
- This device may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization.
- 3. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for any type of wound. 4.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).

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## Page 2 - Mr. Theodore Thorsen

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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R944539 Page 1 of 1

510(k) NUMBER (IF KNOWN):

DEVICE NAME: Ferris PolyMem Calcium Alginate Dressing

INDICATIONS FOR USE:

For the management of

Leg ulcers

・

Venous ulcers

Diabetic ulcers Arterial ulcers Abrasions

Second degree burns

Full and partial thickness pressure ulcers Dehisced incisions

(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

OR

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

Acosta
(Division Sign-Off)

Division of General Restorative Device 510(k) Number

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