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K Number
K092878
Device Name
PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE
Manufacturer
PRUGEN IP HOLDINGS, INC
Date Cleared
2010-01-15

(119 days)

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

PruTect™ is a water-based emulated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, Ist and 2nd degree burns, including sunburns, and radiation dermatis. When applied properly to a wound, PruTect™ provides an optimum moist environment for the healing process and isolates the wound from harmful germs and other external contamination.

PruTectTM is indicated for use in:

  • · Full Thickness Wounds, Pressure Sores, Dermal Ulcers including Lower Leg Ulcers
  • · Superficial Wounds
  • · 1st and 2nd Degree Burns, including Sunburns
  • · Dermal Donor and Graft Site Management
  • · Radiation Dermatitis
  • · Minor Abrasio»
Device Description

PruTect™ Topical Emulsion is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requiring a physician diagnosis disease state) use in both 45 gm and 90 gm tube formats.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for PruTect™ Topical Emulsion, which describes its intended use and states that it is substantially equivalent to a predicate device (Biafine® Topical Emulsion).

The document mentions that "Functional and performance testing has been conducted to assess the safety and efficacy of PruTect™ Topical Emulsion and the results are satisfactory." However, it does not provide details about:

  • Specific acceptance criteria (e.g., performance metrics, thresholds for success).
  • The design, methodology, or results of any study that would demonstrate the device meets such criteria.
  • Sample sizes, data provenance, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study proving the device meets them based on the provided text.

N/A