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K Number
K980451
Device Name
BIODERM CALCIUM ALGINATE DRESSING
Manufacturer
BIODERM, INC.
Date Cleared
1998-04-09

(63 days)

Product Code
KMF
Regulation Number
880.5090
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
    1. Venous Stasis Ulcers
    1. Pressure Ulcers
    1. Diabetic Ulcers
    1. Surgical Wounds
Device Description

Bioderm Calcium Alginate Wound Dressing

AI/ML Overview

This document is a marketing clearance letter for a medical device (Bioderm Calcium Alginate Dressing) and does not contain the specific information required to complete your request. The letter confirms that the device is substantially equivalent to existing devices based on its stated indications for use but does not provide details of acceptance criteria, study methodologies, or performance data.

Therefore, I cannot provide the requested information, including:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes for test sets or data provenance.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study details.
  6. Standalone performance details.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 880.5090 Liquid bandage.

(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.