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K Number
K984205
Device Name
SILVERLON ADHESIVE STRIP
Manufacturer
ARGENTUM INTERNATIONAL LLC.
Date Cleared
2007-03-19

(3037 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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. This device may not be labeled as a treatment or a cure for any type of wound.

Device Description

Not Found

AI/ML Overview

This document is a letter from the FDA regarding a 510(k) premarket notification for a medical device called Silverlon™ Adhesive Strip. It is a substantial equivalence letter.

As such, this document does not contain any information about:

  • Acceptance criteria or reported device performance for a study.
  • Sample sizes for test sets or their data provenance.
  • Number or qualifications of experts for ground truth establishment.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies or their effect sizes.
  • Standalone (algorithm only) performance studies.
  • Type of ground truth used (expert consensus, pathology, outcomes data).
  • Sample size for training sets.
  • How ground truth for training sets was established.

This letter primarily focuses on the regulatory aspects of the device, particularly its substantial equivalence to a predicate device and the limitations on its labeling and claims.

N/A