(59 days)
Not Found
No
The summary describes a wound dressing with antimicrobial properties and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The "Intended Use / Indications for Use" section states that the dressing is "indicated for the management of low to moderately exuding wounds such as leg and foot ulcers, pressure ulcers and partial thickness burns," which describes a therapeutic purpose.
No
The device is a wound dressing designed for management of wounds by reducing microbial colonization and absorbing exudate, not for diagnosing conditions.
No
The device description clearly describes a physical dressing with multiple material components (polyurethane foam, silver, activated charcoal, silicone, polyurethane film, polyethylene release film), indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of wounds (leg and foot ulcers, pressure ulcers, partial thickness burns). This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a wound dressing with absorbent and antimicrobial properties. It does not describe a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on the results.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information about a person's health. This device is a wound dressing applied directly to the body for healing and protection.
N/A
Intended Use / Indications for Use
Mepilex Ag Dressing is indicated for the management of low to moderately exuding wounds such as leg and foot ulcers, pressure ulcers and partial thickness burns. Silver sulphate present in the dressing helps reduce microbial colonization on the dressing.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Mepilex Ag is an anti-microbial, absorbent soft silicone dressing consisting of a flexible, absorbent polvurethane foam pad with added silver and activated charcoal, which is coated with a silicone wound contact layer and a wrinkled water vapor permeable polyurethane film backing. The silicone layer is covered with a polyethylene release film.
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)
Non-clinical Data The data provided in this submission substantiate a 24 month shelf life. No additional studies were performed. Clinical Data Not applicable
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
Page 1 of 1
JUL 1 3 2007
510(k) Summary Section 13:
510(k) SUMMARY
Applicant:
Mölnlycke Health Care 5550 Peachtree Parkway Suite 500 Norcross, GA 30092
Contact Person:
Steven Dowdley Director of Requlatory Affairs Tel.: 678-250-7930 Fax: 678-250-7981
Proprietary Name: Mepilex Ag Dressing Device Name: Silver Dressing Common/Usual Name: Device Classification: Unclassified Mepilex Ag Dressing Predicate Device
Description:
Mepilex Ag is an anti-microbial, absorbent soft silicone dressing consisting of a flexible, absorbent polvurethane foam pad with added silver and activated charcoal, which is coated with a silicone wound contact layer and a wrinkled water vapor permeable polyurethane film backing. The silicone layer is covered with a polyethylene release film.
Intended Use:
Mepilex Ag Dressing is indicated for the management of low to moderately exuding wounds such as leg and foot ulcers, pressure ulcers and partial thickness burns. Silver sulphate present in the dressing helps reduce microbial colonization on the dressing.
Substantial Equivalence
- Comparison of Technological Characteristics No changes have been made to the currently 를 marketed device or device indication for use.
- Non-clinical Data The data provided in this submission substantiate a 24 month shelf life. No 】 additional studies were performed.
- Clinical Data Not applicable
Conclusion:
The date provided in this 510(k) summary concludes that Mepilex Ag Absorbent Silicone-Coated Dressing is substantially equivalent to the currently marketed Mepilex Ag Absorbent Silicone-Coated Dressing marketed under K061554.
Special 510(k)
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background.
Public Health Service
JUL 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Molnlycke Heath Care Inc. % Mr. Steven Dowdley, RAC Director, Regulatory Affairs 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092
Re: K071354
Trade/Device Name: Mepilex Ag Dressing Regulatory Class: Unclassified Product Code: FRO Dated: May 10, 2007 Received: May 15, 2007
Dear Mr. Dowdley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Steven Dowdley, RAC
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson OM
Director
JIRSLR
7/12/07
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K071354
Device Name: Mepilex Ag Dressing
Indications For Use:
Mepilex Ag Dressing is indicated for the management of low to moderately exuding wounds such as leg and foot ulcers, pressure ulcers and partial thickness burns. Silver sulphate present in the dressing helps reduce microbial colonization on the dressing.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division -Off)
Division of General, Restorative,
and Neurological Devices Page 1 of 1
| Number | 1071354 |
|---|---|
| -------- | --------- |
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