(128 days)
The following indications for use are for Over The Counter Use: Superficial Abrasions, Scrapes, Cuts, and Lacerations Minor Burns and scalds
Spyrogel Hydrogel Wound and Burn Dressings are sterile individually packaged hydrogel dressings.
The provided 510(k) summary for the Spyrogel® Hydrogel Wound and Burn Dressing does not contain information on acceptance criteria or a study proving that the device meets such criteria. This document is a premarket notification for a Class I device seeking substantial equivalence to existing products, rather than demonstrating performance against specific metrics through clinical trials.
The summary primarily focuses on:
- Description of the Device: Spyrogel® Hydrogel Wound and Burn Dressings are sterile, individually packaged hydrogel dressings.
- Intended Use: Over-the-counter use for superficial abrasions, scrapes, cuts, lacerations, minor burns, and scalds.
- Substantial Equivalence Claim: The device is claimed to be substantially equivalent to Spenco's 2nd Skin Moist Burn Pads and Johnson and Johnson's Nu-Gel, which are self-adhesive wound dressings for a wide variety of wounds.
- Safety Tests: Laboratory tests showed the device to be nontoxic, nonirritating, and nonsensitizing.
- FDA Response: The FDA letter confirms the substantial equivalence and outlines labeling limitations (e.g., not for third-degree burns, not to claim accelerated healing, not as a long-term dressing or artificial skin, not a treatment/cure).
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment as these details are not present in the provided text. The document indicates a regulatory pathway based on substantial equivalence, which often relies on demonstrating similarity to a predicate device rather than presenting detailed performance metrics from new clinical studies against predefined acceptance criteria.
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