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K Number
K991287
Device Name
SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA
Manufacturer
ADVANCED MEDICAL SOLUTIONS GROUP PLC
Date Cleared
1999-06-29

(76 days)

Product Code
FRO,MGP
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K982804,K981753
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

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.

AI/ML Overview

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.

N/A