(401 days)
K984371, K 100430
Not Found
No
The summary describes a wound dressing with antimicrobial properties and a unique adhesive technology. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as "intended for the management of a wide range of exuding wounds" and includes an antimicrobial to "inhibit or reduce microbial growth on the dressing," which directly relates to treating or alleviating a condition.
No
Explanation: The device description clearly states that Mepitel Ag is a wound contact layer (a type of dressing) for managing exuding wounds and reducing microbial growth on the dressing itself. It does not mention any function related to diagnosing diseases or conditions.
No
The device description clearly describes a physical wound dressing made of materials like silicone, polyamide, and cellulose, containing silver sulphate. It is a tangible product, not software.
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 on the human body. This is a direct application to a patient for therapeutic purposes.
- Device Description: The description details a wound contact layer with antimicrobial properties applied directly to the wound.
- Lack of In Vitro Diagnostic Characteristics: An IVD is a medical device intended to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not involve the examination of specimens outside the body.
- Performance Studies: The performance studies mentioned are in vitro tests of the dressing's antimicrobial effect on the dressing itself, not diagnostic tests performed on patient samples.
Therefore, Mepitel Ag is a wound dressing, which is a type of medical device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Mepitel® Ag is intended for the management of a wide range of exuding wounds such as skin abrasions, sutured/surgical wounds, partial thickness burns, partial and full thickness grafts, lacerations, diabetic ulcers, and arterial ulcers. Silver Sulphate is added to the dressing as a preservative to inhibit or reduce microbial growth on the dressing.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Mepitel Ag is a soft silicone wound contact layer that allows exudate to pass vertically into a secondary dressing.
Mepitel Ag makes it possible to change only the secondary absorbent dressing. It maintains its structural integrity and can be left in place for up to eight (8) days depending on the wound condition and surrounding skin (or as indicated by accepted clinical practice).
In vitro testing demonstrates that Mepitel Ag gives a ≥4 log reduction, on the dressing, of the following Gram positive bacteria, Gram negative bacteria and yeast; Enterococcus feacalis (VRE), Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Acinetobacter baumanii, Enterobacter cloacae, Pseudomonas aeruginosa, Candida albicans, Candida guillermondi, Candida lusitiane. The dressing sustains antimicrobial activity for up to eight (8) days in in vitro studies. By reducing the number of micro-organisms, Mepitel Ag may also reduce odour.
Mepitel Ag has shown to have a 4 log microbial reduction up to eight (8) days when tested in vitro with a secondary dressing.
Mepitel Ag maintains a moist wound environment in combination with a secondary dressing.
Mepitel Ag can be used under compression bandaging.
Mepitel Ag consists of:
- a Safetac adhesive layer containing silver sulphate and cellulose compound. Safetac is a unique and a patented adhesive technology.
- a polyamide net
Contents of the dressing: Polydimethylsiloxane, Polyamide, Sodium carboxymethylcellulose.
The product and its packaging are not made with natural rubber latex.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (skin abrasions, sutured/surgical wounds, partial thickness burns, partial and full thickness grafts, lacerations, diabetic ulcers, and arterial ulcers, skin tears, venous ulcers)
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 in vitro performance testing was completed on the proposed device:
- Antimicrobial effect against 9 strains
- Antimicrobial effect on the dressing against P.a, S.a and C.a
All areas performed as expected to provide a level of effectiveness deemed necessary for the intended us of this device.
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.
Mepitel® (K984371), Urgotul® Ag (K 100430)
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
K130040
Page 1 of 2
510(k) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).
| Date Prepared: | November 19, 2013 | |
|---|---|---|
| Applicant: | Mölnlycke Health Care US, LLC | |
| 5550 Peachtree Parkway, Suite 500 | ||
| Norcross, GA 30092 | ||
| Registration number: | 3004763499 | |
| Owner/Operator Number: | 9067000 | |
| 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: | Mepitel® Ag | |
| Common Name: | Wound and Burn Dressing | |
| Classification Name: | Dressing, Wound, Drug | |
| Device Class: | Unclassified | |
| Product Code: | FRO | |
| Predicate Device Name(s): | Mepitel® and Urgotul® Ag |
Description of Device:
Mepitel Ag is a soft silicone wound contact layer that allows exudate to pass vertically into a secondary dressing.
Mepitel Ag makes it possible to change only the secondary absorbent dressing. It maintains its structural integrity and can be left in place for up to eight (8) days depending on the wound condition and surrounding skin (or as indicated by accepted clinical practice).
In vitro testing demonstrates that Mepitel Ag gives a ≥4 log reduction, on the dressing, of the following Gram positive bacteria, Gram negative bacteria and yeast; Enterococcus feacalis (VRE), Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Acinetobacter baumanii, Enterobacter cloacae, Pseudomonas aeruginosa, Candida albicans, Candida guillermondi, Candida lusitiane. The dressing sustains antimicrobial activity for up to eight (8) days in in vitro studies. By reducing the number of micro-organisms, Mepitel Ag may also reduce odour.
1
K130040
Page 2 of 2
Mepitel Ag has shown to have a 4 log microbial reduction up to eight (8) days when tested in vitro with a secondary dressing.
Mepitel Ag maintains a moist wound environment in combination with a secondary dressing.
Mepitel Ag can be used under compression bandaging.
Mepitel Ag consists of:
- a Safetac adhesive layer containing silver sulphate and cellulose compound. Safetac is a unique and a 1. patented adhesive technology.
-
- a polyamide net
Contents of the dressing: Polydimethylsiloxane, Polyamide, Sodium carboxymethylcellulose.
The product and its packaging are not made with natural rubber latex.
Intended Use/Indication for Use:
Mepite!® Ag is intended for the management of a wide range of exuding wounds such as skin abrasions, sutured/surgical wounds, partial thickness burns, partial and full thickness grafts, lacerations, diabetic ulcers, and arterial ulcers. Silver Sulphate is added to the dressing as a preservative to inhibit or reduce microbial growth on the dressing.
Performance Data:
The following in vitro performance testing was completed on the proposed device:
- Antimicrobial effect against 9 strains ●
- . Antimicrobial effect on the dressing against P.a, S.a and C.a
All areas performed as expected to provide a level of effectiveness deemed necessary for the intended us 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 Mepitel® Ag is equivalent to the Mepitel® (K984371) and the Urgoture Ag (K 100430) predicate devices with respect to intended use, materials, design, and technological characteristics.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized emblem with three curved lines, resembling a stylized caduceus or a symbol of health and medicine. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2014
Mölnlycke Health Care US, LLC Ms. Angela L. Bunn, RAC Director, Regulatory Affairs for the Americas 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092
Re: K130040
Trade/Device Name: Mepitel® Ag Regulatory Class: Unclassified Product Code: FRO Dated: January 10, 2014 Received: January 10, 2014
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 or any I outh 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
3
Page 2 - Ms. 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 conact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part the regulation untiled, "Missilling 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 I ou may obtain bate. generational 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/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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): ____________________________________________________________________________________________________________________________________________________
Mepitel® Ag Device Name:
Indications For Use:
Mepiter® Ag is intended for the management of a wide range of exuding wounds such as skin tears, skin abrasions, sutured/surgical wounds, partial thickness burns, partial and full thickness grafts, laccrations, disbectc ulcers, venous ulcers, and arterial ulcers. Silver Sulphate is added to the dressing as a preservative to inhibit or reduce microbial growth 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)
Image /page/4/Picture/10 description: The image shows the text "Jiyoung Dang -S" in a bold, sans-serif font. The words "Jiyoung" and "-S" are in plain black, while the word "Dang" is outlined with a decorative pattern. The overall impression is a stylized name or title.
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