(88 days)
Not Found
No
The description focuses on the material properties and antimicrobial function of a wound dressing, with no mention of AI/ML or related concepts.
Yes.
The device is indicated for the management of various wounds and dermal ulcers, providing an antimicrobial barrier and protective environment, aligning with the definition of a therapeutic device.
No
The device description indicates that it is a "wound care dressing" used for "management" of various skin conditions and to provide an "antimicrobial barrier." It does not mention any function for diagnosis, detection, or analysis of a medical condition.
No
The device description clearly identifies the product as "sterile, single-use wound care dressings," which are physical, tangible items, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the management of various types of wounds. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical properties of the dressing, its function as a wound covering, and its antimicrobial barrier properties. It does not mention any analysis of biological samples or diagnostic measurements.
- No mention of diagnostic activities: The text does not describe any process of analyzing samples (like blood, urine, tissue, etc.) to determine a medical condition or state.
The device is a wound care dressing, which falls under the category of medical devices used for treatment and management, not diagnosis.
N/A
Intended Use / Indications for Use
Low Adherent AFM Ag Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic). The Low Adherent AFM Ag Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.
Product codes
FRO
Device Description
The Low Adherent AFM Ag Dressings are sterile, single-use wound care dressings for use in moist wound management. The dressings are designed to contact the wound as a primary dressing and permit the passage of fluids. The dressings provide a protective environment for the wound and an effective protection against microbial contamination in the dressing. The devices are effective antimicrobial barrier dressings against both Gram-positive and Gram-negative bacteria, including the following organisms: methicillin-resistant Staphylococcus aureus (MRSA). methicillin- resistant Staphylococcus epidermidis (MRSE), vancomycin-resistant Enterococcus faecalis (VRE), Pseudomonas aeruginosa, and Acinetobacter baumannii.
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)
Validation activities to support the use of the Low Adherent AFM Ag Dressings consisted of three main elements:
- Biocompatibility Testing
- Validation of Antimicrobial Effectiveness
- Sterility Validation
Testing of the Low Adherent AFM Ag Dressings has demonstrated that the wound dressing fulfills prospectively defined performance criteria and that the modified system meets user needs.
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
510(k) Summary (per 21 CFR 807.92) Low Adherent AFM Ag Dressings
.
1. SPONSOR
も
て
JAN 21 2011
Milliken Healthcare Products, LLC 920 Milliken Road Spartanburg, SC 29303 Contact Person: Brian J. Lindsay Telephone: (864) 503-1323
Date Prepared: October 22, 2010
2. CONSULTANT/CONTACT
Medical Device Consultants, Inc. 11440 West Bernardo Drive, Suite 300 San Diego, CA 92127 Telephone: 858-753-1961 Facsimile: 858-753-1962
Primary Contact: Ron Warren
3. DEVICE NAME
| Proprietary Name: | Low Adherent AFM Ag Dressings |
|---|---|
| Common/Usual Name: | Wound Dressing |
| Classification Name: | Dressing, Wound, Drug (Product Code, FRO) |
4. DEVICE CLASSIFICATION
FDA has not finally classified silver-containing wound dressings. The Office of Device Evaluation has published the document, Draft Guidance for the Prèparation of a Premarket Notification for a Non-Interactive Wound and Burn Dressing, revision March 31, 1995, which includes Hydrophilic (procode KMF), Occlusive (procode MGP), Hydrogel (procode MGQ), and Porcine dressings (procode KGN). Other types of wound dressings are also non-interactive, and the guidance document is applicable to them as well, including Dressing (procode FRO) and Dressing, Wound, Hydrophilic (procode NAC). Most silver-containing wound dressing devices have been given the product code FRO but not classified, including the applicable predicate devices.
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5. PREDICATE DEVICES
i
- · Milliken Silver Wound Dressing (Milliken Healthcare Products, LLC) Cleared August 22, 2005 under K051445.
6. DEVICE DESCRIPTION
The Low Adherent AFM Ag Dressings are sterile, single-use wound care dressings for use in moist wound management. The dressings are designed to contact the wound as a primary dressing and permit the passage of fluids. The dressings provide a protective environment for the wound and an effective protection against microbial contamination in the dressing. The devices are effective antimicrobial barrier dressings against both Gram-positive and Gram-negative bacteria, including the following organisms: methicillin-resistant Staphylococcus aureus (MRSA). methicillin- resistant Staphylococcus epidermidis (MRSE), vancomycin-resistant Enterococcus faecalis (VRE), Pseudomonas aeruginosa, and Acinetobacter baumannii.
7. INTENDED USE
Low Adherent AFM Ag Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic). The Low Adherent AFM Ag Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.
8. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The subject of this Special 510(k) is a modification of the Milliken Silver Wound Dressing that was previously cleared on August 22, 2005 under Premarket Notification Number K051445. The subject of this Special 510(k) is the addition of a low adherent wound contact layer.
No modification is being made to any other components. The Low Adherent AFM Ag Dressings is identical to the original Milliken Silver Wound Dressings (K051445) except that it has been modified by the addition of a low adherent wound contact layer. The modification is minor and does not affect safety and effectiveness of the device.
9. PERFORMANCE TESTING
Validation activities to support the use of the Low Adherent AFM Ag Dressings consisted of three main elements:
2
- Biocompatibility Testing
- Validation of Antimicrobial Effectiveness
- Sterility Validation
i
Testing of the Low Adherent AFM Ag Dressings has demonstrated that the wound dressing fulfills prospectively defined performance criteria and that the modified system meets user needs.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Milliken Healthcare Products, LLC % Medical Device Consultants, Inc. Mr. Ronald S. Warren 11440 West Bernardo Court, Suite 300 San Diego, California 92127
JAN 21 2011
Re: K103141 '
Trade/Device Name: Low Adherent AFM Ag Dressings Regulatory Class: Unclassified Product Code: FRO Dated: December 10, 2010 Received: December 13, 2010
Dear Ms. Warren:
:
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
4
Page 2 – Mr. Ronald S. Warren
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.
1f 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
A.G. B. M. h.
Mark N. Melkerson Director Division of Surgical. Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
KIO3141 510(k) Number (if known):
Device Name: Low Adherent AFM Ag Dressings
Indications for Use:
Low Adherent AFM Ag Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic). The Low Adherent AFM Ag Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Daid Kume
(Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Levices
510(k) Number K103141