MEPILEX

K983184 · Molnlycke Health Care, Inc. · MGP · Oct 28, 1998 · SU

Device Facts

• Record ID: K983184
• Device Name: MEPILEX
• Applicant: Molnlycke Health Care, Inc.
• Product Code: MGP · SU
• Decision Date: Oct 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Mepilex is designed for a wide range of shallow wounds, which have low to moderate levels of exudate, e.g., leg ulcers, pressure ulcers and skin lesions.

Device Story

Mepilex is a sterile, absorbent, silicone-coated foam dressing. It is applied topically to shallow wounds to manage low to moderate exudate. The device functions as a passive wound dressing; it does not accelerate healing, act as artificial skin, or serve as a permanent treatment. It is intended for use by healthcare professionals or patients in clinical or home settings. The dressing provides a protective barrier and absorbs wound fluid, aiding in the management of the wound environment.

Clinical Evidence

Bench testing only. Device found non-toxic and non-irritating per ISO 10993 Part I biological evaluation standards.

Technological Characteristics

Sterile, absorbent, silicone-coated foam dressing. Materials tested for biocompatibility per ISO 10993 Part I.

Indications for Use

Indicated for patients with shallow wounds, including leg ulcers, pressure ulcers, and skin lesions, exhibiting low to moderate exudate levels.

Predicate Devices

• Cutinova® Foam Dressing (Beiersdorf AG)

Submission Summary (Full Text)

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K983184

OCT 2 8 1998

## 510(k) SUMMARY

Applicant:

Mölnlycke Health Care, Inc. 500 Baldwin Tower Eddystone, PA 19022

Mepilex™

Proprietary Name:

Contact Person:

Miguel A. Negron, Manager, Regulatory Affairs & Quality 610-499-3383 Tel.

Substantially Equivalent Device:

Cutinova® Foam Dressing (Beiersdorf AG)

The Mepilex is a sterile, absorbent silicone-coated dressing designed for a wide range of shallow wounds, which have low to moderate levels of exudate, e.g., leg ulcers, pressure ulcers and skin lesions.

Mepilex is substantially equivalent in composition, function and intended use to the Beiersdorf AG Cutinova® Foam Dressing.

Mepilex 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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Public Health Service

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OCT 2 8 1998

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

Re: K983184 Trade Name: Mepilex™ Regulatory Class: Unclassified Product Code: MGP Dated: September 10, 1998 Received: September 11, 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:

- This device may not be labeled for use on third degree burns. 1.
- 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.
- 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).

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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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 vours.

pcoDlefe

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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## PREMARKET NOTIFICATION

## INDICATIONS FOR USE STATEMENT

K983184 Unassigned 510(k) Number:

Mölnlycke Health Care

Мерilex™ Device Name:

Indications for Use:

Mepilex is designed for a wide range of shallow wounds, which have low to moderate levels of exudate, e.g., leg ulcers, pressure ulcers and skin lesions.

(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

Besley

(Division Sign-Off) Division of General Restorative Devi 510(k) Number

Premarket Notification: Mepilex™

Mölnlycke Health Care