Mepitel is intended for the management of wounds in the granulation phase, especially painful wounds and wounds with newly formed delicate tissue such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, surgical incisions, second degree burns, skin abrasions, lacerations, partial and full thickness grafts, and skin tears.

Device Description

Mepitel is a sterile wound dressing which consists of three components: a medical grade silicone gel, a polyamide tricot net, and a low density polyethylene protective release liner. The dressing is delivered sterile in single packs and is available in the following sizes: 2" x 3" (5 cm x 7.5 cm); 3" x 4" (7.5 cm x 10 cm); 4" x 8" (10 cm x 18 cm); and 9" x 12" (20 cm x 30 cm).

AI/ML Overview

This document is a 510(k) summary for a medical device called Mepitel® Non Adherent Silicone Dressing. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device, which is the regulatory pathway for this type of device. Substantial equivalence means the new device is as safe and effective as a legally marketed device. This process typically involves comparisons of material composition, intended use, and technological characteristics, and often includes biocompatibility testing. It generally does not involve detailed performance studies with acceptance criteria in the way described in your request for AI/diagnostic devices.

Here's why the requested information cannot be found in the provided text:

Type of Device: This is a wound dressing, not an AI, diagnostic, or image-generating device. Its evaluation focuses on biocompatibility, physical properties, and a comparison to an existing similar product, rather than performance metrics like sensitivity, specificity, or reader improvement.
Regulatory Pathway: The 510(k) pathway for wound dressings relies heavily on demonstrating substantial equivalence to a predicate device. This means showing that the new device has the same intended use, similar technological characteristics, and is as safe and effective as one already on the market. It does not typically require performance studies with detailed acceptance criteria and ground truth establishment as would be required for a novel diagnostic or AI device.

Therefore, none of the specific points you asked for (acceptance criteria and reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set information) are present in this 510(k) summary. The study mentioned ("Mepitel have been found to be non-toxic and non-irritating when tested in accordance with the ISO 10993 Part I") is a biocompatibility test, not a performance study as requested.

Summary

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2-17-1999 9:31AM

K984371

510(k) SUMMARY

Applicant:

Mölnlycke Health Care 500 Baldwin Tower Eddystone, PA 19022

Proprietary Name:

Mepitel® Non Adherent Silicone Dressing

Contact Person:

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

Substantially Equivalent Device:

Mepitel® Non Adherent Silicone Dressing

Mepitel® Non Adherent Silicone Dressing is intended for the management of wounds in the granulation phase, especially painful wounds and wounds with newly formed delicate tissue such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, surgical incisions, second degree burns, skin abrasions, lacerations, partial and full thickness grafts, and skin tears.

Mepitel is a sterile wound dressing which consists of three components: a medical grade silicone gel, a polyamide tricot net, and a low density polyethylene protective release liner. Mepitel® Non Adherent Silicone Dressing is substantially equivalent in composition, function and intended use to the Moinlycke Health Care's own Mepitel® Non Adherent Silicone Dressing placed in commercial distribution pursuant to 510(k) notification number K914604.

The dressing is delivered sterile in single packs and is available in the following sizes: 2" x 3" (5 cm x 7.5 cm); 3" x 4" (7.5 cm x 10 cm); 4" x 8" (10 cm x 18 cm); and 9" x 12" (20 cm x 30 cm).

Mepitel have been found to be non-toxic and non-irritating when tested 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring a white bird-like shape superimposed over three human profiles, all rendered in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 3 1999

Mr. Miguel A. Negron Molnlycke Health Care 500 Baldwin Tower Eddystone, Pennsylvania 19022

Re: K984371

Trade Name: Mepitel Non-Adherent Silicone Dressing Regulatory Class: Unclassified Product Code: MGP Dated: December 4, 1998 Received: December 7, 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 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitations:

1. This device may not be labeled for use on third degree burns.
This device may not be labeled as having any accelerating effect on the rate of wound 2. healing or epithelization.
1. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
1. 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 practice, 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, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597,or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Neil R.P. Ogle, for

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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Section 9: Indications for Use Statement

PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

510(k) Number:

K984371

Mölnlycke Health Care

Device Name:

Mepitel® Non Adherent Silicone Dressing

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General Restorative Devices K984371
510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

N/A