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Advanced Medical Solutions Group plc Spyrogel Hydrogel Wound and Burn Dressing SA is intended for OTC use on: Superficial wounds such as, minor cuts, lacerations and minor burns and scalds

Advanced Medical Solutions Group plc Spyrogel® Hydrogel Wound and Rurn Dressing SA are supplied individually packaged in medical graum fuil pouches suitable for gamma irradiation. They are supplied to the market place as sterile dreasings. The intelligent film is as comercially distrubuted in the USA under 510(k) (K981753) June 30, 1998. The dressings are sterilized by gamma Irradiation. Isotron Laboratories provided Dose Mapping per ISO 11137, validation was undertaken in accordance with ISO 11137 Mothod 1. The verification dose required for a Sterllity Assurance Level (SAL) of 10-6 is 23.4 kGy. Starilization velidation data is on file at Isotron Laboratories. Biooompatability tosting has boon performed in accordance with ISO10983-1 Biological Evaluation of Medical Devices -- Part 1 Guidance on Selection of Tests First Edition. Data and Safety evaluation is as that submitted with aiready sporoved 510(k)'s K881753 and K982804. No components or raw materials have changed therefore no resubmission of loxicity data its required.

The provided document is a 510(k) premarket notification for a medical device called "Spyrogel® Hydrogel Wound and Burn Dressing SA." It describes the device, its intended use, and states that it has been determined substantially equivalent to legally marketed predicate devices.

However, this document does not contain the information requested regarding detailed acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI-powered device. The document is for a hydrogel wound dressing, not an AI/ML device.

Therefore, I cannot provide accurate answers to the questions based on the provided text. The questions are specifically tailored for an AI/ML device's validation process, which is not described in this regulatory filing for a wound dressing.

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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.

Ask a specific question about this device