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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 ●

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.

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.

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