(90 days)
No
The device description focuses on the physical layers and materials of the wound dressing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a wound dressing that protects the wound area and absorbs fluid, with an antimicrobial barrier. While it aids in wound healing, it does not actively deliver energy or substances to the body to treat a disease or condition, which is characteristic of a therapeutic device.
No
Explanation: The provided text describes the Silverlon™ Island Wound Dressing as a multi-layer, sterile, non-adherent, absorbent, composite, antimicrobial barrier wound dressing intended for wound management. Its primary functions are to protect the wound area, absorb drainage, and prevent microbial contamination. It does not perform any diagnostic function such as identifying, assessing, or monitoring a medical condition.
No
The device description clearly outlines a physical, multi-layer wound dressing composed of various materials, including fabric, film, and adhesive. There is no mention of software as a component or the primary function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Silverlon™ Island Wound Dressings are applied topically to wounds. They are physical dressings designed to protect the wound, absorb drainage, and provide an antimicrobial barrier.
- Intended Use: The intended use is for the local management of various types of wounds. This is a therapeutic or protective function, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
The device is a wound dressing, which falls under the category of medical devices used for wound care, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Silverlon™ Island Wound Dressings are multi-layer, sterile, non-adherent, absorbent, composite, antimicrobial barrier wound dressings indicated for local management of superficial wounds, minor burns, and abrasions and lacerations. A health care professional may be consulted prior to the first use of this product to determine whether these conditions exist. Silverlon™ Island Wound Dressings may also be used under the care of a health care professional for wounds such as vascular access or peripheral IV sites, orthopaedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers). Topical application of Silverlon™ Island Wound Dressings protects the wound area and the open weave of the silver-nylon fabric wound contact layer permits passage of wound fluid through the product to be absorbed by an overlying absorbent material. The silver provides effective protection of the dressing against microbial contamination.
The Over-The-Counter indications:
Local management of superficial wounds, minor burns, abrasions and lacerations.
The Prescription Professional indications:
Wounds such as vascular access or peripheral IV sites, orthopaedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to full thickness dermal ulcers (Stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).
Product codes
FRO
Device Description
Silverlon™ Island Wound Dressings are multi-layer, sterile, non-adherent, absorbent composite dressings with an attached adhesive tape or pad. The dressings are composed of five distinct layers:
- Layer 1 is a non-adherent wound contact layer that consists of 1 or 4 layers of knitted continuous nylon fiber substrate with a metallic silver surface (Silverlon™). The layers of Silverlon™ are sewn together with silver nylon thread that is plated in an identical fashion to the silver nylon utilized to make the Silverlon™ knitted fabric. The silver coating is a uniform 1-micron thick layer that completely covers the nylon.
- Layer 2 is Delnet P530N
- Layer 3 is a needle punched non-woven 8-ounce rayon web that absorbs drainage from the wound site.
- Layer 4 is polyurethane film that keeps external contaminants out and maintains a moist wound healing environment. (Note: Layers 2, 3, and 4 are manufactured as a laminate by AET).
- Layer 5 is a non-woven polyester fabric coated with a skin contact pressure sensitive acrylic adhesive backed with a one sided poly coated lay flat release liner. The pressure sensitive acrylic adhesive is H-566 a hypoallergenic adhesive that meets USP Class 6 standard and satisfies tripartite guidelines for skin contact devices. The Silverlon Island Pad does not have the tape layer.
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
A health care professional is mentioned for certain indications, suggesting use in a professional care setting, in addition to over-the-counter use for minor conditions.
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™ Island Wound Dressing was subjected to standard in vitro and in vivo biocompatibility tests including cytotoxicity, sensitization, and acute intracutaneous reactivity. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Qualtex Island Dressing (K910657), Silverlon™ Contact Wound Dressing (K981299)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows a handwritten date that appears to be "2/22/99". The numbers are written in a cursive style, and the slashes separate the month, day, and year. The handwriting is somewhat stylized, making the numbers slightly less clear, but the overall date is still legible.
510(k) SUMMARY 10.
Summary Information 10.1
10.1.1 Submitter's Name and Address
Argentum International LLC #36 Lake Rabun Road Lakemont, Georgia 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: 24 November 1998
10.1.2 Device Name
| Trade Name: | Silverlon™ Island Wound Dressing and
Silverlon™ Island Pad |
|--------------|---------------------------------------------------------------|
| Common Name: | Silver-nylon island wound dressing |
Classification Name: Wound and Burn Dressing
1
10.1.3 Identification of predicate device to which substantial equivalence is being claimed
Silverlon™ Island Wound Dressing is substantially equivalent with respect to function, intended use, and composition to:
10.1.4 Device Description
Explanation of how the device functions: Silverlon™ Island Wound Dressings are designed to intimately contact the wound as a primary dressing. They provide a protective, moist healing environment for the wound, permit the passage of wound fluids, are highly absorbent, and provide effective protection of the dressing against microbial contamination.
Basic scientific concepts that form the basis for the device: the nylon fabric that comprises the wound contact layer permits the passage of oxygen and fluids from the wound. The surface of the nylon fibers in Silverlon™ Island Wound Dressings consists of a thin layer of metallic silver containing approximately 1% silver oxide and 99% metallic silver 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™ Island
2
Wound Dressings are multi-layer, sterile, non-adherent, absorbent composite dressings with an attached adhesive tape or pad. The dressings are composed of five distinct lavers:
- Layer 1 is a non-adherent wound contact layer that consists of 1 or 4 ● layers of knitted continuous nylon fiber substrate with a metallic silver surface (Silverlon™). The layers of Silverlon™ are sewn together with silver nylon thread that is plated in an identical fashion to the silver nylon utilized to make the Silverlon™ knitted fabric. The silver coating is a uniform 1-micron thick layer that completely covers the nylon.
- . Layer 2 is Delnet P530N
- Layer 3 is a needle punched non-woven 8-ounce rayon web that absorbs . drainage from the wound site.
- . Layer 4 is polyurethane film that keeps external contaminants out and maintains a moist wound healing environment. (Note: Layers 2, 3, and 4 are manufactured as a laminate by AET).
- Layer 5 is a non-woven polvester fabric coated with a skin contact . pressure sensitive acrylic adhesive backed with a one sided poly coated lay flat release liner. The pressure sensitive acrylic adhesive is H-566 a hypoallergenic adhesive that meets USP Class 6 standard and satisfies tripartite guidelines for skin contact devices. The Silverlon Island Pad does not have the tape layer.
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
3
Silverlon™ Island Wound Dressings are multi-layer, sterile, non-adherent, absorbent, composite, antimicrobial barrier wound dressings indicated for local management of superficial wounds, minor burns, and abrasions and lacerations. A health care professional may be consulted prior to the first use of this product to determine whether these conditions exist. Silverlon™ Island Wound Dressings may also be used under the care of a health care professional for wounds such as vascular access or peripheral IV sites, orthopaedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers). Topical application of Silverlon™ Island Wound Dressings protects the wound area and the open weave of the silver-nylon fabric wound contact layer permits passage of wound fluid through the product to be absorbed by an overlying absorbent material. The silver provides effective protection of the dressing against microbial contamination.
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 are substantially equivalent to Qualtex Island Dressing (K910657) in relation to the absorbent pad, the polyurethane layer and the tape backing with release liners. The only physical difference between the Qualtex Island Dressing and the Silverlon™ Island Dressing is the wound contact layer. In the Qualtex Island Dressing this layer is reported to be a "non-adherent net" whereas in the Silverlon™ Island Wound Dressing this layer is composed of Silverlon™ (silver coated nylon). The primary difference between the Silverlon™ Island Wound Dressing and the Silverlon™ Contact Wound
27
4
Dressing (K981299) is that the Island wound dressing is a composite dressing that contains the Contact Wound Dressing as the layer that comes in contact with the wound.
10.2 Assessment of Performance Data
Silverlon™ Island Wound Dressing was subjected to standard in vitro and in vivo biocompatibility tests including cytotoxicity, sensitization, and acute intracutaneous reactivity. 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.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three curved lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2007
Mr. A. Bart Flick Research Director Argentum International LLC 36 Lake Rabun Road Lakemont, Georgia 30552
Re: K984208
Trade Name: Silverlon™ Island Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: November 24, 1998 Received: November 24, 1998
Dear Mr. Flick:
This letter corrects our substantially equivalent letter of February 22, 1999.
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 to legally marketed predicate devices marketed in interstate commerce rior to May 18, 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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act including requirements for annual registration, listoring of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration and the following limitations:
I . This device may not be labeled for use on third degree burns.
-
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.
6
Page 2 - Mr. A. Bart Flick
- 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).
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); 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.
This letter will allow you to continue 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.
7
Page 3 - Mr. A. Bart Flick
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. 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-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark Hi Milliken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
8
Argentum International, LLC
510(k) Premarket Notification Silverlon TMIsland Wound Dressing 24 November 1998
INDICATIONS FOR USE 2.
510(k) Number (if known):
Device Name:
Silverlon™ Island Wound Dressing
Silverlon™ Island Wound Dressings are multi-layer, sterile, non-adherent, antimicrobial barrier wound dressings.
The Over-The-Counter indications:
Local management of superficial wounds, minor burns, abrasions and lacerations.
The Prescription Professional indications:
Wounds such as vascular access or peripheral IV sites, orthopaedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to full thickness dermal ulcers (Stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).
NRO
(Division Sign-Off) Division of General Restorative Devices 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDTHER IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)