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K Number
K991604
Device Name
EPI-FOAM SILICONE SHEETING
Manufacturer
BIODERMIS CORP.
Date Cleared
1999-06-09

(30 days)

Product Code
MDA
Regulation Number
878.4025
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Epi-Foam Sheeting is intended for the management of hypertrophic and keloid scars. Epi-Foam is not intended for use on open wounds.

Device Description

Not Found

AI/ML Overview

I'm sorry, but the provided text does not contain the information needed to describe acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) clearance letter for a device called "Epi-Foam Silicone Sheeting," indicating that it is substantially equivalent to a pre-existing device for the management of hypertrophic and keloid scars.

The letter does not include:

  • A table of acceptance criteria or reported device performance.
  • Details about a study, sample sizes, data provenance, ground truth establishment, or expert involvement.
  • Information on MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request based on the provided text.

§ 878.4025 Silicone sheeting.

(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.