ALLDRESS, ABSORBENT FILM DRESSING

K983554 · Molnlycke Health Care, Inc. · KMF · Nov 10, 1998 · General Hospital

Device Facts

• Record ID: K983554
• Device Name: ALLDRESS, ABSORBENT FILM DRESSING
• Applicant: Molnlycke Health Care, Inc.
• Product Code: KMF · General Hospital
• Decision Date: Nov 10, 1998
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Alldress is intended to absorb, protect, and maintain a moist environment in open and closed wounds such as; pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, surgical incisions, superficial burns, abrasions, lacerations, and skin tears.

Device Story

Alldress Absorbent Film Dressing is a sterile, moisture vapor permeable, self-adhesive absorbent dressing. It functions as a passive wound care product to absorb exudate, protect the wound site, and maintain a moist healing environment. Used in clinical or home settings for various wound types; applied by healthcare providers or patients. The device provides a physical barrier and fluid management without active electronic or mechanical components. It benefits patients by supporting wound management and protecting the site from external contaminants.

Clinical Evidence

Bench testing only. Device demonstrated non-toxicity and non-irritation via biological testing per ISO 10993 Part I with FDA modified matrix.

Technological Characteristics

Sterile, moisture vapor permeable, self-adhesive absorbent film dressing. Available in sizes 10x10cm, 15x15cm, and 15x20cm. Biocompatibility tested per ISO 10993 Part I.

Indications for Use

Indicated for patients with open and closed wounds, including pressure ulcers, venous/arterial leg ulcers, diabetic ulcers, surgical incisions, superficial burns, abrasions, lacerations, and skin tears. Not indicated for third-degree burns.

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

• Alldress® Multi-Layered Wound Dressing

Submission Summary (Full Text)

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NOV 10 1998

# 1983554

### 510(k) SUMMARY

| Applicant: | Mölnlycke Health Care<br>500 Baldwin Tower<br>Eddystone, PA 19022 |
|-------------------|------------------------------------------------------------------------------|
| Proprietary Name: | Alldress® Absorbent Film Dressing |
| Contact Person: | Miguel A. Negron, Manager, Regulatory Affairs & Quality<br>Tel. [phone] |
| Substantially | |

Equivalent Device:

Alldress® Multi-Layered Wound Dressing

The Alldress Absorbent Film Dressing is a sterile moisture vapor permeable selfadhesive absorbent dressing.

The Alldress dressing is individually sealed in medical grade paper pouches and packaged in cartons of ten (10) pouches each. The Alldress dressing is available in three sizes: 10x10cm (4" x 4"), 15x15cm (6" x 6") and 15x20cm (6" x 8").

Alldress is intended to absorb, protect, and maintain a moist environment in open and closed wounds such as; pressure ulcers, venous and arterial leg ulcers, surgical incisions, superficial burns, abrasions, lacerations, and skin tears.

Alldress sterile moisture vapor permeable selfadhesive absorbent dressing have been shown in laboratory tests to be nontoxic.

Alldress have been found to be non-toxic and non-irritating when tested by the above biological tests in accordance with the ISO 10993 Part I, "Biological Evaluation of Medical Devices" with FDA modified matrix (Guidance effective July 1, 1995).

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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the top half of the eagle.

NOV 10 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Miguel A. Negron Manager, Regulatory Affairs & Quality Molnlycke Health Care 500 Baldwin Tower Eddystone, Pennsylvania 19022

Re: K983554

> Trade Name: Alldress® Absorbent Film Dressing Regulatory Class: Unclassified Product Code: KMF Dated: October 08, 1998 Received: October 13, 1998

Dear Mr. Negron:

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:

- 1. This device may not be labeled for use on third degree burns.
- 2. This device may not be labeled as having any accelerating effect on the rate of 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.
- 4. This device may not be labeled as a treatment or a cure for any type of wound.

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).

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

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Page 2 - Mr. Miguel A. Negron

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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11-03-1998 12:55PM

FKUM M. INEGKUN DUSSAS I YZ

NOV 100 1998

#### Indications for Use Statement Section 8:

# PREMARKET NOTIFICATION

(983554

## INDICATIONS FOR USE STATEMENT

510(k) Number:

K983554

Mölnlycke Health Care

Device Name:

Alldress® Absorbent Film Dressing

Indications for Use:

Alldress is intended to absorb, protect, and maintain a moist environment in open and closed wounds such as; pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, surgical incisions, superficial burns, abrasions, lacerations, and skin tears.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Acce
ision Sign-Off

Division of General Restorative Devices
510(k) Number K9803554

Prescription Use (Per 21 CFR 801.109)

Or Over-The-Counter Use

Premarket Notification: Alldress®

Mölnlycke Health Care