(287 days)
Silverlon™ CA Advanced Antimicrobial Alginate Dressing is an effective barrier to microbial penetration for moderate to heavy exudating partial and fullthickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree burns. Silverlon™ CA Advanced Antimicrobial Dressing is indicated for external use only.
Silverlon™ CA Advanced Antimicrobial Alginate Dressing, is a sterile, non-woven pad composed of a calcium (and sodium) alginate and a silver nylon contact layer. The dressing is available in various sizes ( 2" x 2", 4.2", 4.25" x 4.25", 4" x 8", 8" x 12", and a %" x 12" rope) and packaged in Tyvek pouches. The release of silver ions provides an antimicrobial barrier, which protects the dressing from microbial colonization. The dressing absorbs exudates, maintains a moist wound environment and allows for intact removal.
The provided text describes a 510(k) summary for the Silverlon™ CA Calcium Alginate Dressing. However, it does not contain the acceptance criteria or the study details that you've requested.
The document focuses on:
- Device Identification: Name, submitter, contact information.
- Predicate Device: Claims equivalence to prior Silverlon products and other marketed alginate dressings.
- Device Description: Sterile, non-woven calcium alginate pad with a silver nylon contact layer for antimicrobial barrier and exudate absorption.
- Intended Use/Indications: For moderate to heavy exudating partial and full-thickness wounds (pressure ulcers, venous ulcers, diabetic ulcers, donor/graft sites, traumatic/surgical wounds, 1st and 2nd-degree burns). External use only.
- Technological Characteristics Comparison: States silver content and alginate amount per square inch are identical to the predicate device.
- Performance Data: Mentions non-clinical studies showing good balance of tolerability and safety. These studies are:
- Systemic Injection Test in Mice
- Cytotoxicity - Agar Diffusion
- Primary Dermal Irritation in Rabbits
- FDA Clearance Letter: Confirms substantial equivalence determination based on the 510(k) submission.
Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them because it is not present in the given text.
The document only details non-clinical safety and tolerability tests (Systemic Injection, Cytotoxicity, Dermal Irritation) which are part of demonstrating safety, but not specific performance acceptance criteria for its indicated uses (e.g., wound healing rates, infection reduction rates) or clinical study results to prove those.
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