(86 days)
Not Found
No
The device description and intended use clearly describe a sterile wound dressing with no mention of software, algorithms, or any technology that would suggest AI/ML capabilities. The performance studies focus on biocompatibility, not algorithmic performance.
No
The device is a wound dressing which is typically considered a device for wound management and protection, not a therapeutic device in the sense of actively treating or curing a disease or condition beyond providing a suitable environment for healing.
No
Explanation: The "Intended Use / Indications for Use" section states that Mepitel is "intended for the management of wounds," indicating a treatment or management function rather than a diagnostic one. Diagnostic devices are used to identify or characterize a disease or condition.
No
The device description clearly states it is a sterile wound dressing consisting of physical components (silicone gel, polyamide net, polyethylene liner), indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a wound dressing for managing various types of wounds. This is a topical application for direct treatment of a physical condition.
- Device Description: The description details the physical components of a wound dressing (silicone gel, net, liner).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVDs are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (on the body) for wound management.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MGP
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).
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)
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).
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
2-17-1999 9:31AM
GG
3
3
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).
1
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:
-
- 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.
-
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
-
- 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.
2
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
3
Image /page/3/Picture/2 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '9', '8', '4', '3', and '7'. The numbers are written in a clear, legible manner, with consistent spacing between them. The handwriting style appears to be casual and the ink is dark.
Section 9: Indications for Use Statement
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
510(k) Number:
Mölnlycke Health Care
Device Name:
Mepitel® Non Adherent Silicone Dressing
Indications for Use:
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, partial and full thickness grafts, and skin tears.
(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)
Or
Over-The-Counter Use