(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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