(47 days)
Not Found
Not Found
No
The summary describes a wound dressing and contains no mention of AI, ML, or related concepts like image processing or performance metrics typically associated with AI/ML devices.
Yes
The device is intended for treating wounds, specifically leg ulcers, pressure ulcers, and skin lesions, which are therapeutic applications.
No
Explanation: The device, Mepilex, is described as a "sterile, absorbent silicone-coated dressing" intended for wound care, which functions as a treatment or management device rather than a device used to diagnose a condition.
No
The device description clearly states it is a "sterile, absorbent silicone-coated dressing," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for treating wounds (leg ulcers, pressure ulcers, skin lesions). This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a sterile, absorbent dressing. This is a physical barrier and absorbent material, not a device used to examine specimens from the human body.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. Mepilex is a wound dressing, which is a medical device used for wound management.
N/A
Intended Use / Indications for Use
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.
Product codes
MGP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Cutinova® Foam Dressing (Beiersdorf AG)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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).
1
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
2
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