(234 days)
Not Found
Not Found
No
The document describes a wound dressing with antimicrobial properties and does not mention any AI or ML components.
Yes
The device is a dressing used for wound management, which includes reducing microbial colonization and inactivating bacteria, directly contributing to the healing and management of medical conditions.
No
The device is described as an "anti-microbial, absorbent soft silicone dressing" used for managing wounds and reducing microbial colonization. Its intended use and description do not include any function related to diagnosing a condition or disease.
No
The device description clearly indicates it is a physical dressing made of polyurethane foam, silver, activated charcoal, and silicone, which are hardware components.
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 device is a dressing designed to absorb exudate and provide an anti-microbial barrier. It does not perform any tests on samples taken from the body to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status or to diagnose a disease.
- Performance Studies: The performance studies focus on biocompatibility and anti-microbial properties, which are relevant to a wound dressing, not a diagnostic device.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Mepelix 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 polyurethane 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)
Summary of Biocompatibility Testing:
Using the FDA-modified matrix, Mepilex Ag is a surface device which is used on breached or compromised surfaces and may be used for up to several days depending on the condition of the wound. Therefore, the Mepilex Ag was tested for cytotoxicity, sensitization and irritation and was found to be non-cytotoxic, non-irritating and non-sensitizing.
Summary of Testing for Anti-microbial Properties:
- The Mepilex Ag has been shown to provide a barrier against microbial contamination and inactivates a wide range of bacteria and fungi during a 24 hour period as shown in-vitro in the Corrected Zone of Inhibition (CZOI) test method.
- Mepilex Ag has also been shown to inactivate representative bacteria up to 7 days, as shown in vitro in CZOI.
- Mepilex Ag has also been shown to inactivate bacteria within 30 hours, as shown in vitro in Shake flask method ASTM E2141-01.
Based on the test results, Mepilex Ag has demonstrated effective anti-microbial properties by providing an anti-microbial barrier and an anti-microbial effect within and under the dressing. The Mepilex Ag has demonstrated a sustained release of silver lons for up to 7 days.
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.
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
510(k) SUMMARY
K061554
Page 1 of 2
| Applicant: | Mölnlycke Health Care
5550 Peachtree Parkway
Suite 500
Norcross, GA 30092 | |
|-----------------|---------------------------------------------------------------------------------------------|--------------------------------------------------|
| Contact Person: | Steven Dowdley
Director of Regulatory Affairs
Tel.: 678-250-7930
Fax: 678-250-7992 | |
| Device Name: | Proprietary Name: | Mepilex Ag Absorbent
Silicone-Coated Dressing |
| | Common/Usual Name:
Device Classification: | Silver Dressing
Unclassified |
Substantial Equivalence:
The Mepilex Ag is substantially equivalent in composition, function and "indications for use" to the Contreet Foam Dressings and the 3M Tegaderm Silver Nonwoven Dressing. In addition, Mepilex Ag is substantially equivalent in design to the currently marketed Mepilex Absorbent Silicone-Coated Dressing.
Intended Use:
Mepelix 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.
Description:
Mepilex Ag is an anti-microbial, absorbent soft silicone dressing consisting of a flexible, absorbent polyurethane 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.
Summary of Biocompatibility Testing:
Using the FDA-modified matrix, Mepilex Ag is a surface device which is used on breached or compromised surfaces and may be used for up to several days depending on the condition of the wound. Therefore, the Mepilex Ag was tested for cytotoxicity, sensitization and irritation and was found to be non-cytotoxic, non-irritating and non-sensitizing.
Summary of Testing for Anti-microbial Properties
- . The Mepilex Ag has been shown to provide a barrier against microbial contamination and inactivates a wide range of bacteria and fungi during a 24 hour period as shown in-vitro in the Corrected Zone of Inhibition (CZOI) test method.
- . Mepilex Ag has also been shown to inactivate representative bacteria up to 7 days, as shown in vitro in CZOI.
- . Mepilex Ag has also been shown to inactivate bacteria within 30 hours, as shown in vitro in Shake flask method ASTM E2141-01.
1
K 061554
page 2 of 2
Based on the test results, Mepilex Ag has demonstrated effective anti-microbial properties by providing an anti-microbial barrier and an anti-microbial effect within and under the dressing. The Mepilex Ag has demonstrated a sustained release of silver lons for up to 7 days.
Conclusion:
The date provided in this 510(k) summary concludes that Mepilex Ag Absorbent Silicone-Coated Dressing is substantially equivalent to Mepilex Absorbent Silicone-Coated Dressing, Contreet Foam Dressing and the 3M Tegaderm Silver Non-woven Dressing.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mölnlycke Health Care % Mr. Steven Dowdleyt 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092
JAN 2 5 2007
Re: K061554
Trade/Device Name: Mepilex® Ag Dressing Regulatory Class: Unclassified Product Code: FRO Dated: December 20, 2006 Received: December 21, 2006
Dear Mr. Dowdlevt:
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.
3
Page 2 - Mr. Steven Dowdleyt
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
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
PREMARKET NOTIFICATION
Indications for Use
510(k) Number (if known): K 06
Mepilex® Ag Dressing Device Name:
Indications for Use:
Mepelix 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page _ of _
Division G General, Restorative, and Neurological Devices
510(k) Number K061554