(127 days)
No
The description focuses on the physical composition and function of a wound dressing, with no mention of AI or ML technologies.
Yes
The device is indicated for the management of various wounds and dermal ulcers, which are conditions that require therapeutic intervention for healing and improved patient outcomes.
No
The device is a wound care dressing used for management of various wounds, not for diagnosing conditions.
No
The device description clearly describes a physical wound dressing with multiple layers and materials, not a software-only product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a wound care dressing applied externally to the body for managing various types of wounds. This is a therapeutic or wound management function, not a diagnostic one.
- Device Description: The description details the physical layers and materials of a wound dressing. It does not mention any components or processes related to analyzing samples from the body (like blood, urine, tissue, etc.) to diagnose a condition.
- Lack of Diagnostic Language: The text does not use any language typically associated with IVDs, such as "diagnosis," "detection," "measurement," "analysis of biological samples," or "in vitro."
- Performance Studies: The performance studies mentioned focus on biocompatibility and antimicrobial efficacy, which are relevant to a wound dressing, not an IVD.
IVDs are devices used to examine specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Silver Wound Pad is indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, lymphoedema, dermatological wounds, and Stage I-IV dermal ulcers (vascular, arterial, venous, pressure and diabetic).
Product codes
FRO
Device Description
The Silver Wound Pad is a sterile, single-use wound care dressing for use in moist wound management. The Silver Wound Pad is offered in several configurations including 24" x 36" and 36 " x 36" The dressings are comprised of 5 layers, each performing a specific function; an occlusive synthetic bottom layer (not in contact with patient), two absorbent layers, a layer of a knitted composite fabric (containing polyester on one side and nylon on the other side; coated with 15 ± 5% Antimicrobial AlphaSan® RC 2000 contained in a polyurethane binder) and a contact layer of apertured polyethylene film. These layers are then stitched or heat-sealed together along the edge.
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)
Biocompatibility testing was performed in accordance with the International Organization for Standardization recommendations. Results of the biocompatibility tests demonstrate that the device is suitable for its intended use. Antimicrobial testing was performed which showed that Silver Wound Pad provides efficacy against grampositive and gram-negative bacteria. Milliken believes that the data included in this submission including the technical characteristics and physical properties demonstrate that Silver Burn Pad is substantially equivalent in design, function and intended use to Exu-Dry®.
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 for Silver Wound Pad
APR 1 6 2009
1. SPONSOR
Milliken Chemical 920 Milliken Rd., M-333 Spartanburg, SC 29303 Contact Person: John D. Bruhnke, Ph.D.
Telephone:864-503-2844 Date Prepared: March 9, 2009
2. DEVICE NAME
Proprietary Name: Silver Wound Pad Wound Dressing Common/Usual Name: Classification Name: Dressing
3. PREDICATE DEVICES
- Smith & Nephew Exu-Dry® Non-Permeable Pad (K864011) .
4. DEVICE DESCRIPTION
The Silver Wound Pad is a sterile, single-use wound care dressing for use in moist wound management. The Silver Wound Pad is offered in several configurations including 24" x 36" and 36 " x 36" The dressings are comprised of 5 layers, each performing a specific function; an occlusive synthetic bottom layer (not in contact with patient), two absorbent layers, a layer of a knitted composite fabric (containing polyester on one side and nylon on the other side; coated with 15 ± 5% Antimicrobial AlphaSan® RC 2000 contained in a polyurethane binder) and a contact layer of apertured polyethylene film. These layers are then stitched or heat-sealed together along the edge.
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5. INTENDED USE
The Silver Wound Pad is indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, lymphoedema, dermatological wounds, and Stage I-IV dermal ulcers (vascular, arterial, venous, pressure and diabetic).
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Technological characteristics of the Silver Wound Pad and the predicate product are substantially equivalent in that they are both dressings suitable for use on partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, lymphoedema, dermatological wounds, and Stage I-IV dermal ulcers (vascular, arterial, venous, pressure and diabetic). The Silver Wound Pad substantially equivalent in design, function and intended use to the Smith & Nephew Exu-Dry® Non-Permeable Pad (K864011). The only significant difference between the Silver Wound Pad and the predicate device is that Silver Wound Pad contains a silver-based preservative in a polyurethane coating for control of microorganisms.
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7. PERFORMANCE TESTING
Biocompatibility testing was performed in accordance with the International Organization for Standardization recommendations. Results of the biocompatibility tests demonstrate that the device is suitable for its intended use. Antimicrobial testing was performed which showed that Silver Wound Pad provides efficacy against grampositive and gram-negative bacteria. Milliken believes that the data included in this submission including the technical characteristics and physical properties demonstrate that Silver Burn Pad is substantially equivalent in design, function and intended use to Exu-Dry®.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Milliken & Company % Medical Device Consultants, Inc. Ms. Mary McNamara-Cullinane, RAC Senior Regulatory Consultant 49 Plain Street North Attleboro, Massachusetts 02760
APR 1 6 2009
Re: K083659 ·
Trade/Device Name: Silver Wound Pad Regulation Name: Unclassified Product Code: FRO Dated: March 31, 2009 Received: April 1, 2009
Dear Ms. McNamara-Cullinane:
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 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 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to
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Page 2 - Ms. Mary McNamara-Cullinane, RAC
premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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, J
F.of P.ol.V
O.R
Mark N. Melkerson (A Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K083659 510(k) Number (if known):
Silver Wound Pad Device Name:
Indications for Use:
The Silver Wound Pad is indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, lymphoedema, dermatological wounds, and Stage I-IV dermal ulcers (vascular, arterial, venous, pressure and diabetic).
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)
Daniel D. Kime for MXM
(Division Sign-Off) (Division Sign Of General, Restorative, Division rological Devices
510(k) Number K083659