(47 days)
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.
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.
This document is a 510(k) premarket notification for a medical device called Mepilex™, a sterile, absorbent silicone-coated wound dressing. The submission aims to demonstrate substantial equivalence to a predicate device, the Cutinova® Foam Dressing.
The document does not describe a study involving acceptance criteria and device performance in the context of an AI/ML algorithm or software. Instead, it focuses on the substantial equivalence of and biological safety of a wound dressing. Therefore, most of the requested information regarding AI/ML study details (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies) is not applicable.
Here's an analysis based on the provided text, focusing on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not contain a table of acceptance criteria in the sense of specific performance metrics for a device, nor does it report specific device performance data for Mepilex™ in a quantitative manner. The acceptance for this submission is based on substantial equivalence to an existing predicate device and biological safety testing.
| Acceptance Criteria Category | Description from Document | Performance/Outcome |
|---|---|---|
| Substantial Equivalence | "Mepilex is substantially equivalent in composition, function and intended use to the Beiersdorf AG Cutinova® Foam Dressing." | Met: The FDA reviewed the 510(k) and determined the device is substantially equivalent, allowing it to be marketed. |
| Biological Safety | "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)." | Met: Device demonstrated non-toxicity and non-irritation as per ISO 10993 Part I and FDA guidance. |
| 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." | Met: The indications for use were accepted by the FDA. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes a wound dressing and focuses on substantial equivalence and biocompatibility, not an AI/ML or software device requiring a test set of data. The biological tests performed for ISO 10993 Part I typically involve in vitro and in vivo (animal) studies, not a "test set" of clinical data in the context of AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable. Ground truth for a test set is relevant for AI/ML device validation, which is not the subject of this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as above.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is not applicable as this submission is for a physical wound dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable in the context of AI/ML ground truth. For biological safety testing, the "ground truth" would be the observed biological response to the material as interpreted by toxicologists or biocompatibility experts against established standards (ISO 10993). For substantial equivalence, the "ground truth" is the established characteristics and performance of the predicate device.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device.
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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
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The bird is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
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.
-
- 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 (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/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
N/A