(108 days)
Not Found
No
The description focuses on the physical properties and antimicrobial action of a wound dressing, with no mention of AI or ML.
Yes
Explanation: The device is a wound dressing designed to manage exuding wounds and promote healing by maintaining a moist environment and providing antimicrobial properties, which are therapeutic actions.
No
The device description indicates it is a wound dressing designed for management and healing of wounds, not for diagnosing them. It absorbs exudate, maintains moisture, and has antimicrobial properties.
No
The device description clearly describes a physical wound dressing made of materials like silicone, polyurethane foam, and silver sulphate, which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "management of a wide range of exuding wounds". This is a direct application to the body for therapeutic purposes (wound healing).
- Device Description: The description details a wound dressing with absorbent and antimicrobial properties, designed to be applied to a wound.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve testing samples from the body.
- "In vitro" in the description: While the description mentions "in vitro" data regarding the antimicrobial effect, this refers to testing the device's properties in a lab setting (outside of a living organism), not using the device to diagnose a condition based on a sample from a patient.
Therefore, based on the provided information, Mepilex® Transfer Ag dressing is a therapeutic medical device for wound management, not an IVD.
N/A
Intended Use / Indications for Use
Mepilex® Transfer Ag dressing is indicated for the management of a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers, partial thickness burns, traumatic and surgical wounds. Mepilex® Transfer Ag can be used under compression bandaging.
Product codes
FRO
Device Description
Mepilex® Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound environment and has antimicrobial properties. A moist wound environment is shown to be beneficial for wound healing. Mepilex® Transfer Ag contains silver sulphate which acts as a preservative to reduce or minimize growth of microorganisms within the dressing. Mepilex® Transfer Ag has been shown to inactivate microorganisms for up to 14 days in vitro. Mepilex® Transfer Ag consists of: - a Safetac® adhesive layer . o which is a unique and a patented adhesive technology - a compressed polyurethane foam containing silver sulphate and activated carbon .
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)
The following performance testing was completed on the proposed device: - Antimicrobial effect against 16 stains . - Antimicrobial effect inside the dressing against P.a, S.a and C.a . All areas performed as expected to provide a level of efficacy deemed necessary for the intended use of this device. No clinical data was required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
APR 0 5 2013
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
| Date Prepared: | March 20, 2013 |
|---|---|
| Submitter: | Mölnlycke Health Care US, LLC |
| 5550 Peachtree Parkway, Suite 500 | |
| Norcross, GA 30092 | |
| Official Correspondent: | Angela L. Bunn, RAC |
| Director, Regulatory Affairs of the Americas | |
| Tel: 678-250-7930 | |
| Fax: 678-250-7981 | |
| e-mail: angela.bunn@molnlycke.com | |
| Trade/Proprietary Name: | Mepilex® Transfer Ag |
| Common Name: | Wound and Burn Dressing |
und and Burn Dressing Classification Name: Dressing, Wound, Drug Device Class: Unclassified Product Code: FRO Mepilex® Border Ag Predicate Device Name(s):
Description of Device:
Mepilex® Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound environment and has antimicrobial properties. A moist wound environment is shown to be beneficial for wound healing.
Mepilex® Transfer Ag contains silver sulphate which acts as a preservative to reduce or minimize growth of microorganisms within the dressing.
Mepilex® Transfer Ag has been shown to inactivate microorganisms for up to 14 days in vitro.
Mepilex® Transfer Ag consists of:
- a Safetac® adhesive layer . o which is a unique and a patented adhesive technology
- a compressed polyurethane foam containing silver sulphate and activated carbon .
1
Intended Use/Indication for Use:
Mepilex® Transfer Ag dressing is indicated for the management of a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers, partial thickness burns, traumatic and surgical wounds. Mepilex® Transfer Ag can be used under compression bandaging.
In vitro Data:
The following performance testing was completed on the proposed device:
- Antimicrobial effect against 16 stains .
- Antimicrobial effect inside the dressing against P.a, S.a and C.a .
All areas performed as expected to provide a level of efficacy deemed necessary for the intended use of this device.
Clinical Testing:
No clinical data was required.
Conclusion:
Based on the information presented in this submission, it can be concluded that the Mepilex Transfer Ag is equivalent to the Mepilex® Border Ag (K100029) predicate with respect to intended use, materials, design, and technological characteristics. The only difference in the two materials is the removal of the backing film from the predicate device to the proposed device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
MöInlycke Health Care US, LLC % Angela L. Bunn. RAC Director, Regulatory Affairs of the Americas 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092
Re: K123892
Trade/Device Name: Mepilex® Transfer Ag Regulatory Class: Unclassified Product Code: FRO Dated: February 20, 2013 Received: February 25, 2013
Dear Ms. Bunn:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the image.
Letter dated: April 5, 2013
3
Page 2 - Angela L. Bunn, RAC
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely yours,
Mark Nighterson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): _ _ _ _ _ _ K 123892
Device Name: Mepilex® Transfer Ag
Indications For Use:
Mepilex® Transfer Ag dressing is indicated for the management of a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers, partial thickness burns, traumatic and surgical wounds.
Mepilex® Transfer Ag can also be used under compression bandaging.
Prescription Use X X (Part 21 CFR 801 Subpart D)
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)
Jiyoung Dang -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123892