FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER

K990906 · Ferris Mfg. Corp. · KMF · Apr 29, 1999 · General Hospital

Device Facts

• Record ID: K990906
• Device Name: FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER
• Applicant: Ferris Mfg. Corp.
• Product Code: KMF · General Hospital
• Decision Date: Apr 29, 1999
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Arterial Ulcers Pressure Ulcers (Stage III-IV) Venous Ulcers Diabetic Ulcers

Device Story

PolyMem PolyWic Sterile Cavity Wound Filler is a wound dressing designed for cavity wounds. It is applied by healthcare professionals to manage specific ulcer types. The device functions as a wound filler to assist in the management of the wound environment. It is not indicated for third-degree burns, as a long-term/permanent dressing, as artificial skin, or as a treatment/cure for wounds. It does not accelerate wound healing or epithelization.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile cavity wound filler. Form factor designed for cavity wound management. No specific materials or software characteristics described.

Indications for Use

Indicated for the management of arterial ulcers, pressure ulcers (Stage III-IV), venous ulcers, and diabetic ulcers.

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.

Predicate Devices

• K970706

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1999

Mr. Theodore R. Thorsen Director, Quality Assurance Ferris Manufacturing Corp. 16 West 300 83rd Street Burr Ridge, Illinois 60521

K990906 Re:

K970706
Trade Name: PolyMem PolyWic Sterile Cavity Wound Filler Regulatory Class: Unclassifed Product Codc: KMF Dated: March 17, 1999 Received: March 18, 1999

Dear Mr. Thorsen:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your becalled by equivalent (for the indications for the indications for above and we have decemined the devices marketed in interstate commerce prior to May 28, use stated in the enclosure) to devices markets in the endments or to devices that have been 1976, the enactified 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 (the Act). Tou may, therefore, maxicolo, maxicotic 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.
- This device may not be labeled as a long-term, permanent, or no-change dressing, or 3. 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 I he labeling claims fisted above would require a premarket notification submission (21 CFR 807.81).

The general controls provisions of the Act include requirements for annual registration, I he general controls provisions or ring practices, labeling, and prohibitions against misbranding and adulteration.

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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 to U.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

Enclosure

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K990906

Page | of |

510(k) Number (if known):_ K990906

Device Name: FERRIS ... LOLLEWIC CARLY WOUND FILLER

Indications For Use:

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Arcerial Ulcers Pressure Ulcers (Stage III-IV) Venous Ulcers

Diabetic Ulcers

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Division of General Restorative Devices | |
| 510(k) Number | K990906 |

Prescription Use X

(Per 21 CFR 801.109)

OR

Over-The-Counter Use

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(Optional Format 1-2-96)