(169 days)
No
The description focuses on the material composition and physical properties of the wound dressing, with no mention of AI or ML capabilities.
Yes.
The device is intended for the local management of various types of wounds and includes descriptions of its materials and biological evaluation, fitting the definition of a therapeutic device designed for treatment and healing processes.
No
The device is a wound dressing designed for the local management of wounds, providing protection against microbial contamination and facilitating fluid and oxygen exchange. It does not perform any diagnostic function.
No
The device description clearly describes a physical wound dressing made of nylon fabric with a silver coating, which is a hardware component, 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 states that the Silverlon™ Contact Wound Dressings are for the "local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers". This describes a therapeutic or protective function applied directly to a wound on the body.
- Device Description: The description details a physical dressing made of nylon fiber with a silver surface. It describes how it interacts with the wound (contact, fluid passage, microbial protection of the dressing).
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the body (like blood, urine, tissue) to diagnose a condition, monitor a disease, or screen for health issues. IVDs are designed to provide information about a person's health status through testing of biological samples.
Therefore, the Silverlon™ Contact Wound Dressings are a medical device intended for wound care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Silverlon™ Contact Wound Dressings are sterile, non-adherent dressings intended 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).
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™ Contact Wound Dressings consists of a thin layer of metallic silver containing approximately 1% silver oxide that provides effective protection of the dressing against microbial contamination. Silverlon™ Contact Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of 1 or 4 layers of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1% silver oxide.
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)
Silverlon™ I-Layer and 4-Layer Contact Wound Dressings were subjected to standard in vitro and 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 (JSO) Standard (Biological Evaluation of Medical Devices) by North American Science Associates, Inc. (NAmSA), Northwood, Ohio. The studies indicated that Silverlon™ I-1.ayer and 4-Layer Contact Wound Dressings are safe for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Arglacs Filt11 Dressing (K970566), Acticoat Silver Coated Dressing (K955453), and Tegapore™ Wound Contact Material (K890354)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
SEP 25 1998
FAX NO.: 2028334157
09-23-98 03 : 4 4 P P.03
Argentum International LLC
510(k) Premarket Notification Silverlon™ Contact Wound Dressing K981299
September 23, 1998
10. 510(K) SUMMARY
Summary Information 10.1
: . . ...
10.1.1 Submitter's Name and Address
Argentum International LLC Post Office Box 429 Lakemont, GA 30552
Contact person and telephone number:
A. Bart Flick, M.D., Research Director Telephone: (706) 782-6700 Telefax: (706) 782-3903
Date summary was prepared:
September 23, 1998
10.1.2 Name of Device
Trade Name:
Common Name: Classification Name: Silverlon™ Contact Wound Dressing (1- and 4-Layer) Silver-nylon contact wound dressing Contact wound dressing
10.1.3 Identification of predicate device to which substantial equivalence is being claimed
Silverlon™ Contact Wound Dressings are substantially equivalent in function and intended use to the following cleared contact wound dressings: Arglacs Filt11 Dressing (K970566), Acticoat Silver Coated Dressing (K955453), and Tegapore™ Wound Contact Material (K890354).
1
Argentum International LLC
510(k) Premarket Notification Silverlon™ Contact Wound Dressing K981299
September 4, 1998
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™ Contact Wound Dressings consists of a thin layer of metallic silver containing approximately 1% 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, sterile, non-adherent fabric consisting of 1 or 4 layers of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1% silver oxide.
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 dressing. Silverlon™ Contact Wound Dressings are sterile, non-adherent dressings intended 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).
2
Argentum International LLC
510(k) Premarket Notification Silverlon™ Contact Wound Dressing K981299
September 4, 1998
10.1.6 Statement of how the technological characteristics of the device compare to those of the predicate device
The technological characteristics of the device such as flexible primary contact wound dressing, permeability to oxygen and fluids, and protection against microbial contamination of the dressing that are substantially equivalent to the predicate devices cited.
Assessment of Performance Data 10.2
Silverlon™ I-Layer and 4-Layer Contact Wound Dressings were subjected to standard in vitro and 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 (JSO) Standard (Biological Evaluation of Medical Devices) by North American Science Associates, Inc. (NAmSA), Northwood, Ohio. The studies indicated that Silverlon™ I-1.ayer and 4-Layer Contact Wound Dressings are safe for their intended use.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three heads, symbolizing the department's mission to protect and promote the health and well-being of all Americans. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
SEP 2 5 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
A. Bart Flick, M.D. Argentum International, LLC P.O. Box 429 Lakemont, Georgia 30552
K981299 Re:
Trade Name: Silverlon™ Contact Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: July 8, 1998 Received: July 8, 1998
Dear Dr. Flick:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
- This device may not be labeled for use on third degree burns. 1.
-
- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
-
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
-
- This device may not be labeled as a treatment or a cure for any type of wound.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
4
Page 2 - Dr. A. Bart Flick
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP
regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation ------------Center for Devices and Radiological Health
5
Argentum International LLC
510(k) Premarket Notification Silverlon™ Contact Wound Dressing K981299
August 10, 1998
2. INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
.
Silverlon™ Contact Wound Dressing
Indications for Use:
Silverlon™ Contact Wound Dressings are sterile, non-adherent dressings intended 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).
(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
(Division Sign-Off)
Division of General Restorative Devices
K90