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K Number
K973312
Device Name
TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING
Manufacturer
INNOVATIVE TECHNOLOGIES LTD.
Date Cleared
1997-10-22

(49 days)

Product Code
MGP
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K935796
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Innovative Technologies' Transparent Film and Intelligent Film Dressings are indicated for use on partial thickness wounds including:

  • Pressure sores
  • . Superficial burns
  • Abrasions
  • . Lacerations
  • . Post-operative surgical wounds
  • . Donor Sites
  • . Trauma Wounds
  • Dermal Lesions
  • IV Sites .
  • Fixation device ●
Device Description

Innovative Technologies' Transparent Film & Intelligent Film Dressings are conformable, sterile wound dressings intended to provide a moist healing environment for partial thickness wounds, eg. pressure sores, abrasions, lacerations, donor sites and superficial burns. The dressings may also be used for IV sites or as secondary fixation devices for products such as alginates, gels and foams used for venous stasis and diabetic ulcers. Dressings are supplied sterile in single use blister packs.

AI/ML Overview

This submission, K973312, is for Transparent Film and Intelligent Film Dressings. The submission does not contain information about acceptance criteria or a study to prove the device meets these criteria. Instead, it describes a substantial equivalence comparison to a predicate device (Hydroderm, K935796).

Here's a breakdown of the provided information, noting the absence of the requested points:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the submission. The document lists comparative features between the applicant's devices and the predicate device, but these are characteristics, not pre-defined acceptance criteria with performance targets.

CharacteristicsIT Transparent Film (Reported Performance)IT Intelligent Film (Reported Performance)Predicate: Hydroderm™ (Comparative Feature)Acceptance Criteria (Not Provided)
CompositionPolyurethane film and pressure sensitive acrylic adhesivePolyurethane film and pressure sensitive acrylic adhesivePolyurethane film and pressure sensitive acrylic adhesiveN/A
Adhesive Coverage100%Pattern coated 50 + 30%Pattern Coated 40%N/A
MVTR g/m²/24hrs

N/A