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K Number
K993119
Device Name
STERILE HYDROGEL
Manufacturer
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
Date Cleared
1999-11-23

(64 days)

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

Hydrogel sterile dressing is for the wound management of partial and full thickness pressure ulcer, stasis ulcers, first & second degree burns, cuts, abrasions, irritations of the skin and skin condition associated with periostomal care.

Device Description

Sterile Hydrogel

AI/ML Overview

I am sorry, but based on the provided text, there is no information about the acceptance criteria for a device, a study that proves a device meets acceptance criteria, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance studies, types of ground truth, or training set details.

The text is a fragment of a 510(k) clearance letter from the FDA to Dumex Medical Surgical Products LTD regarding their "Sterile Hydrogel" device. It indicates that the FDA has found the device to be substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

It primarily discusses:

  • The FDA's review and determination of substantial equivalence.
  • Regulatory classifications and controls applicable to the device.
  • Contact information for further regulatory inquiries.
  • The intended use of the "Sterile Hydrogel" device.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details.

N/A