(3037 days)
Silverlon™ Direct Pressure (DP) Wound Closure Strips are absorbent antimicrobial barrier dressings.
The Over-The-Counter (OTC) indications:
Local management of superficial wounds and skin tears and minor lacerations.
The Prescription Professional indications:
Primary or secondary closure following surgery, supplementary-support to sutures, staples or sealants, wound support following suture removal, and wound sites where suturing would aggravate bleeding.
Silverlon™ DP Wound Closure Strips are designed to provide a balanced relief of tensions at the wound edges by exerting a compressive and downward force on the wound surface through the antimicrobial barrier multilaminate composite portion of the strip. Without impairment of microcirculation, the elastasticity of the non latex elastic component provides a stabilizing force to the wound edge reapproximation. The Silverlon™ component provides effective protection of the dressing against microbial contamination. The dressing maintains a moist wound environment which promotes wound healing. The design of the elastic component allows for the wound edges to be pulled together while minimizing the irritation, blistering and skin shearing associated with mechanical trauma. As the patient goes through the activities of daily living, the antimicrobial barrier composite laminate pad experiences minimal motion and therefore minimal disruption of the wound margins. The pattern of the elastic design of the DP portion of the closure strip provides the minimal motion and intimate contact between the antimicrobial barrier laminate and the wound margins as the edema subsides. The design of the relief holes in the elastic non latex elastic component allow: (1) minimum movement of the laminate and the wound edges as the surrounding skin moves; and (2) the physician to vary the compression on the wound surface after the dressing is applied by cutting bands.
Silverlon™ DP Wound Closure Strips are multi-layer, sterile, elastic, antimicrobial barrier absorbent composite wound closure strips. The dressings are composed of five distinct layers outlined in Figure 1 below:
Layer 1 is a non-adherent wound contact layer that consists of 1 or 4 layers of 0 continuous nylon fiber substrate with a metallic silver surface (Silverlon™). Layer 1, Layer 2, Layer 3, and Layer 4 are sewn together with silver nylon thread that is plated in an identical fashion to the silver nylon utilized to make the Silverlon™ 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 or 4-ounce rayon wed 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 composite laminate of non-woven polyester fabric (5.2, Figure 1) . coated with a skin contact pressure sensitive acrylic adhesive (5.4, Figure 1) backed with a one sided poly coated lay flat release liner and non latex elastic. The pressure sensitive acrylic adhesive H-566, is a hypoallergenic adhesive that meets USP Class 6 standard and satisfies tripartite guidelines for skin contact devices. The non-woven polyester tape is interrupted by a section of elastomeric non latex (5.1. Figure 1). Holes are punched out in the non latex elastic (5.3, Figure 1) to allow adjustability of the elastic component of the Silverlon™ DP Wound Closure Strip.
The provided text is a 510(k) Premarket Notification for the Silverlon™ Direct Pressure Wound Closure Strip. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a regulatory submission focused on demonstrating substantial equivalence, which primarily involves comparing the proposed device to already legally marketed predicate devices, rather than presenting new clinical study data with acceptance criteria.
Based on the provided text, I cannot complete the requested tables and information.
Missing Information:
- Acceptance Criteria and Reported Device Performance: This document does not establish specific performance acceptance criteria for the new device or present data demonstrating it meets such criteria.
- Sample Size for Test Set and Data Provenance: No clinical study data is included, therefore no test set sample size or provenance is available.
- Number and Qualifications of Experts for Ground Truth: No mention of experts establishing ground truth, as no new study data is presented.
- Adjudication Method: Not applicable as no new study data is presented.
- Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned as no new study data is presented.
- Standalone Performance Study: Not mentioned as no new study data is presented.
- Type of Ground Truth Used: Not applicable as no new study data is presented.
- Sample Size for Training Set: No mention of a training set, as this is a regulatory submission, not a study report for a machine learning model.
- How Ground Truth for Training Set was Established: Not applicable.
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K98 4204
rgentum International, LLC
510(k) Premarket Notification Silverlon ™ Direct Pressure Wound Closure Strip 24 November 1998
10.1 510(k)SUMMARY
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 Name of Device
Trade Name:
Common Name: ClassificationName: Silverlon™ DP Wound Closure Strips Tape Skin Closures Strip, adhesive, closure, skin
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10.1.3 Identification of predicate device to which substantial equivalence is being claimed.
Silverlon™ DP Wound Closure Strip is substantially equivalent with respect to function, intended use, and composition to:
- 3M Company, Steri-strip Antimicrobial barrier Skin (K813265); (1)
- (2) Genetic Laboratories, Suture Strip™ Wound Closure Strip (K842621):
- Silverlon™ Contact Wound Dressing (K981299) (3)
10.1.4 Device Description
Explanation of How the Device Functions: Silverlon™ DP Wound Closure Strips are designed to provide a balanced relief of tensions at the wound edges by exerting a compressive and downward force on the wound surface through the antimicrobial barrier multilaminate composite portion of the strip. Without impairment of microcirculation, the elastasticity of the non latex elastic component provides a stabilizing force to the wound edge reapproximation. The Silverlon™ component provides effective protection of the dressing against microbial contamination. The dressing maintains a moist wound environment which promotes wound healing. The design of the elastic component allows for the wound edges to be pulled together while minimizing the irritation, blistering and skin shearing associated with mechanical trauma. As the patient goes through the activities of daily living, the antimicrobial barrier composite laminate pad experiences minimal motion and therefore minimal disruption of the wound margins. The pattern of the elastic design of the DP portion of the closure
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strip provides the minimal motion and intimate contact between the antimicrobial barrier laminate and the wound margins as the edema subsides. The design of the relief holes in the elastic non latex elastic component allow: (1) minimum movement of the laminate and the wound edges as the surrounding skin moves; and (2) the physician to vary the compression on the wound surface after the dressing is applied by cutting bands.
Basic Scientific Concepts that Form the Basis for the Device: The basic scientific concepts of the Silverlon™ DP Wound Closure Strip are:
. Maintains Antimicrobial barrier Environment:
The surface of the multilaminate composite pad is silver-plated nylon fibers similar to the silver nylon in the Silverlon™ Contact Wound Dressing. The silver-plated nylon consists of a thin laver of autocatalytic plated metallic silver (1 micron) containing approximately 99% metallic silver and 1% silver oxide to provide an antimicrobial barrier against a broad range of microbial species. The silver provides effective protection of the dressing against microbial contamination.
. Maintains Moist Wound Environment:
Moist wound healing is provided by the 8 ounce and 4 ounce rayon pad laminate with polyurethane film. The polyurethane film provides a semipermeable membrane allowing the passage of oxygen but partially restricting the passage of fluids.
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- . Maintains Dynamic Lateral and Downward Compression of the Wound Margins:
The design of the elastic component allows for lateral and downward compression of the wound margins. The wound edges are pulled together while minimizing the irritation, blistering and skin shearing associated with mechanical trauma. The elastic design provides balanced relief of tensions at the wound edges by exerting a compressive and downward force on the wound surface. The direct pressure (DP) elastic design provides minimal motion and intimate contact between the antimicrobial barrier laminate and the wound margins. This is most noticeable as the edema surrounding the wound edges subsides. The design of the relief holes in the elastic non latex component allow: (1) minimum movement of the laminate and the wound edges as the surrounding skin moves; and (2) the physician to vary the compression on the wound surface after the dressing is applied by cutting bands.
Significant physical and performance characteristics of the device such as device design, materials used, and physical properties: Silverlon™ DP Wound Closure Strips are multi-layer, sterile, elastic, antimicrobial barrier absorbent composite wound closure strips. The dressings are composed of five distinct layers outlined in Figure 1 below:
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Argentum International, LLC
Image /page/4/Figure/2 description: This image shows a diagram labeled as "Figure 1" with a "Side View" of a layered structure. The diagram illustrates five layers, labeled as "Layer 1" through "Layer 5", with arrows pointing to each layer. The diagram also includes numerical labels such as 5.1, 5.2, 5.3, and 5.4, which appear to be associated with different components or sections of the layered structure.
Layer 1 is a non-adherent wound contact layer that consists of 1 or 4 layers of 0 continuous nylon fiber substrate with a metallic silver surface (Silverlon™). Layer 1, Layer 2, Layer 3, and Layer 4 are sewn together with silver nylon
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thread that is plated in an identical fashion to the silver nylon utilized to make the Silverlon™ 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 or 4-ounce rayon wed 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 composite laminate of non-woven polyester fabric (5.2, Figure 1) . coated with a skin contact pressure sensitive acrylic adhesive (5.4, Figure 1) backed with a one sided poly coated lay flat release liner and non latex elastic. The pressure sensitive acrylic adhesive H-566, is a hypoallergenic adhesive that meets USP Class 6 standard and satisfies tripartite guidelines for skin contact devices. The non-woven polyester tape is interrupted by a section of elastomeric non latex (5.1. Figure 1). Holes are punched out in the non latex elastic (5.3, Figure 1) to allow adjustability of the elastic component of the Silverlon™ DP Wound Closure Strip.
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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™ DP Wound Closure Strip are multi-layer, sterile, elastic, wound closure strips with a central antimicrobial barrier absorbent composite laminate, indicated for local management of superficial wounds and tears and minor lacerations. A health care professional may be consulted prior to the first use of this product to determine whether these conditions exist. Silverlon™ DP Wound Closure Strips may also be used under the care of a health care professional for primary or secondary closure following surgery, supplementary-support to sutures, staples or sealants, wound support following suture removal, and wound sites where suturing would aggravate bleeding.
10.1.6 Statement of how the technological characteristics of the device compare to those of the predicate device.
The 3M Company, Steri-strip Antimicrobial barrier Skin Closure (K 813265) and Genetic Laboratories, Suture Strip™ Wound Closure Strip (K842621) are composites of a non-woven fabric coated tape with a skin contact pressure sensitive adhesive coated on one side capable of intimately adhering the substrate to human skin. The Genetic Laboratories, Suture Strip™ Wound Closure Strip claim "Dynamic Adherence" with increased elongation at breakage. The dynamic adherence
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allows increased compliance, which allows for movement without stress and reduces irritation, blistering and skin shearing associated with mechanical trauma. The 3M Company, Steri-strip Antimicrobial Skin Closure 510(k) has deleted all references to the specifics of the antimicrobial agent utilized, only that the "antimicrobial has been evaluated for safety in vitro, on animals and on humans." The Silverlon™ Wound Contact Dressing (K981299), 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 and provides effective protection of the dressing against microbial contamination.
All three products are supplied sterile. The 3M Company, Steri-strip Antimicrobial b Skin and Genetic Laboratories, Suture Strip™ Wound Closure Strip are used as a primary non-suture skin closure, or as a adjunct to suture closure, or as a reinforcement for wounds after early suture or staple removal. The Silverlon™ Wound Contact Dressing is a nonadhering dressing providing effective protection of the dressing against microbialcontamination.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/8/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized eagle symbol, with three curved lines representing the eagle's wings.
MAR 1 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. A. Bart Flick Research Director Argentum International LLC 36 Lake Rabun Road Lakemont, Georgia 30552
K984204 Re:
K984204
Trade Name: Silverlon™ DP Wound Closure Strip 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 We have reviewed your Section 310(x) promised the is substantially equivalent to
device referenced above and have dest in interests comerce prior to May 28, device referenced above and have devices marketed in interstate commerce pror to May 28, 1976,
legally marketed predicated and all al Devices that have been legally marketed predical Device Amendments or to devices that have been
the enactment date of the Medical Device Amendments or to devices that have been the enactment date of the Medical Device Annellance of the Federal Food, Drug, and Cosmetic Act
reclassified in accordance with the provisions of the Federal Food, Drug, ther reclassified in accordance with the provisions of the Possible PVCA). You may, therefore,
(Act) that do not require approval of a prematice approval (PMA). You may, therefore (Act) that do not require approval on a provisions of the Act. The general
market the device, subject to the general controls of the Act. The general market the device, subject to the general controls for annual registration, listing of
controls provisions of the Act including requirements for annual registrating a controls provisions of the Agt including requirements for annual regions of the manufacturing and adulteration and the following limitations:
-
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.
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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.
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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-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mali M Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Argentum International, LLC
INDICATIONS FOR USE 2.
510(k) Number (if known): K984204
DeviceName:
Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2
Silverlon™ DP Wound Closure Strip
Silverlon™ Direct Pressure (DP) Wound Closure Strips are absorbent antimicrobial barrier dressings.
The Over-The-Counter (OTC) indications:
Local management of superficial wounds and skin tears and minor lacerations.
The Prescription Professional indications:
Primary or secondary closure following surgery, supplementary-support to sutures, staples or sealants, wound support following suture removal, and wound sites where suturing would aggravate bleeding.
n 1990
(Division Sign-Off) Division of General Restorative Devices 510(k) Number ..
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Over-The-Counter Use
N/A