(88 days)
K#981299
Not Found
No
The device description and performance studies focus on the material properties and biological effects of the silver-plated fabric, with no mention of AI or ML technologies.
Yes
The device is described as a "Wound Contact Dressing" used for various types of wounds, including burns, lacerations, and ulcers, which clearly indicates its therapeutic purpose in managing and aiding the healing of these conditions.
No
The device is a wound contact dressing used for treatment and protection of wounds, not for diagnosis.
No
The device description clearly states it is a physical wound dressing made of silver-plated fabric, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a wound dressing for topical application to the skin to manage various types of wounds. This is a direct treatment or management of a physical condition on the body.
- Device Description: The description details the physical composition and function of a wound dressing, focusing on its material properties and how it interacts with the wound surface.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide information about a person's health status. This device is applied to the body for wound care.
N/A
Intended Use / Indications for Use
For over-the-counter use, Silverlon® Wound Contact Dressing may be used for: First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.
Under the supervision of a health care professional, Silverlon® Wound Contact Dressing may be used for the management of: Silverlon® Wound Contact Dressings provide an effective barrier to bacterial penetration and are intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).
Product codes
FRO
Device Description
Silverlon® Contact Wound Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in Silverlon® Wound Contact Dressings consists of a thin layer of metallic silver containing approximately one percent silver oxide that provides effective protection of the dressing against microbial contamination. Silverlon® Contact Wound Dressings are made of flexible, elastomeric, sterile, silver plated fabric consisting of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately one percent silver oxide. The coating of silver is circumferential between 0.8 and 1.0 um thick
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
For the over-the-counter market / Not Found
For the professional wound care market, a health care professional setting.
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)
Silverlon® Contact Wound Dressings were subjected to standard in vivo biocompatibility tests including cytotoxicity, sensitization, acute intracutaneous reactivity, acute systemic toxicity, and tissue compatibility (muscle implantation study). All tests were performed in accordance with Part-10993 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices) by North American Science Associates, Inc. (NAMSA), Northwood, Ohio. The studies indicated that Silverlon® Contact Wound Dressings are safe for their intended use.
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.
Silverlon Wound Contact Dressing (K#981299)
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
10. 510(k) Summary
Summary Information 10.1
10.1.1 Submitter's Name and Address
JAN 2 4 2003
Argentum Medical LLC #36 Lake Rabun Road Lakemont, Georgia 30552
Contact person and telephone number:
A. Bart Flick, M.D., Research Director Telephone: (706) 782-5064 (706) 782-3903 Telefax: abflick@alltel.net E-mail: Date summary was prepared: 15 November 2002
Device Name 10.1.2
Professional Trade Name:
Antimicrobial Barrier Wound Contact Dressing Antimicrobial Barrier Burn Wrap Dressing Antimicrobial Barrier Burn Contact Dressing Silverlon® Acute Burn Glove
10.1.3 Identification of predicate device substantial equivalence is being claimed
Silverlon® Antimicrobial Barrier Wound Contact Dressing and the Silverlon® Acute Burn Glove are substantially equivalent in function and intended use to the Silverlon Wound Contact Dressing (K#981299)
10.1.4 Device Description
Explanation of how the device functions: Silverlon® Contact Wound Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination.
Basic scientific concepts that form the basis for the device: The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in Silverlon® Wound Contact Dressings consists of a thin layer of metallic silver containing approximately one percent silver oxide that provides effective protection of the dressing against microbial contamination.
Significant physical and performance characteristics of the device such as device design, materials used, and physical properties: Silverlon® Contact Wound Dressings are made of flexible, elastomeric, sterile, silver plated fabric consisting of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately one percent silver oxide. The coating of silver is circumferential between 0.8 and 1.0 um thick
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10.1.5 Statement of the intended use of the device, including general description of the conditions the device will mitigate and the patient population for which the device is intended.
Silverlon® Contact Wound Dressings are external wound dressings that are designed as an interface between the wound and a conventional occlusive For the over-the-counter market, the Silverlon® Antimicrobial dressing. Wound Contact Dressings are sterile wound contact dressings are intended for local management of superficial wounds, minor burns, and abrasions and lacerations. For the professional wound care market, the family of Silverlon® Antimicrobial Wound Contact Dressings are indicated for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic). The Silverlon® Burn Wrap, Silverlon® Burn Glove, Silverlon® Burn Sock and Silverlon® Burn Contact Dressing are configured for the local management of partial thickness burns, skin grafts, and donor sites. The Silverlon® Wound Contact Dressing is configured for incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).
10.1.6 Statement of how the technological characteristics of the device compare to those of the predicate device
The technological characteristics of the silver content, flexibility, elasticity, primary wound contact, permeability to oxygen and fluids, and protection against microbial contamination of the dressing that are substantially equivalent to the predicate devices cited.
10.2 Assessment of Performance Data
Silverlon® Contact Wound Dressings were subjected to standard in vivo biocompatibility tests including cytotoxicity, sensitization, acute intracutaneous reactivity, acute systemic toxicity, and tissue compatibility (muscle implantation study). All tests were performed in accordance with Part-10993 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices) by North American Science Associates, Inc. (NAMSA), Northwood, Ohio. The studies indicated that Silverlon® Contact Wound Dressings are safe for their intended use.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized image of three human profiles facing right, layered on top of each other to create a sense of depth and connection. The profiles are abstract and minimalist, with clean lines and a focus on the shape of the head and face.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2003
A. Bart Flick, M.D. Research Director Argentum Research, Inc. P.O. Box 429 36 Lake Rabun Road Lakemont, Georgia 30552
Re: K023612
Trade/Device Name: Antimicrobial Barrier Wound Contact Dressing Antimicrobial Barrier Burn Wrap Dressing Antimicrobial Barrier Burn Contact Dressing Silverlon® Acute Burn Glove
Regulatory Class: Unclassified Product Code: FRO Dated: October 28, 2002 Received: October 28, 2002
Dear Dr. Flick:
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
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Page 2 - A. Bart Flick, M.D.
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.
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Cr Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2. INDICATIONS FOR USE
510(k) Number: # K023612
Device Name: Antimicrobial Barrier Wound Contact Dressing Antimicrobial Barrier Burn Wrap Dressing Antimicrobial Barrier Burn Contact Dressing Silverlon® Acute Burn Glove
For over-the-counter use, Silverlon® Wound Contact Dressing may be used for:
First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.
Under the supervision of a health care professional, Silverlon® Wound Contact Dressing may be used for the management of:
Silverlon® Wound Contact Dressings provide an effective barrier to bacterial penetration and are intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).
Miriam C. Provost
Division of General, Restorative and Neurological Devices
Number K023612
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) OR
Over-The-Counter Use