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K Number
K100839
Device Name
BARIREP
Manufacturer
GORBEC PHARMACEUTICAL SERVICES, INC.
Date Cleared
2010-05-11

(48 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K083721
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

BariRep's intended use is to manage minor burns, minor abrasions, minor cuts and minor lacerations.

Device Description

BariRep is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for over-the-counter use. The product is formulated as an oil-inwater emulsion containing a cross-linked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of BariRep is composed of glyceride, squalane, lecithin, and fatty acids.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.

Instead, the document is a 510(k) summary for a medical device called BariRep. This summary is part of the process for seeking FDA clearance for a new medical device by demonstrating its "substantial equivalence" to a predicate device already on the market.

Here's what the document does say about the device and its assessment:

  • Device Name: BariRep
  • Common Name: Hydrogel wound dressing
  • Intended Use: To manage minor burns, minor abrasions, minor cuts and minor lacerations.
  • Predicate Device: Cleared under K083721, approved January 08, 2009.
  • Technological Comparison: The device is stated to be "identical in formulation, specifications and performance characteristics" to the predicate device. The only change mentioned is that it is being presented for over-the-counter use.
  • Non-Clinical Performance Data: "N/A" (Not Applicable)
  • Conclusion: "The product's ingredients and performance characteristics have remained unchanged and are therefore, identical to the predicate. Tests and performance data are not applicable as the product remains safe, effective and substantially equivalent to the predicate. Over the counter use will not result in any increased risk to the patient."

Critically, this document explicitly states that "Tests and performance data are not applicable." This means no study was conducted or presented to demonstrate the device's performance against specific acceptance criteria, as its clearance was based on its substantial equivalence to an already approved device.

Therefore, I cannot provide the requested information, such as:

  • A table of acceptance criteria and reported device performance (since none were established or tested).
  • Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details (since no non-clinical or clinical studies were performed for this submission).

N/A