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The SureSkin™ Hydrocolloid Wound Dressings manufactured by Euromed A/S are indicated for the management of dry and exudating pressure sores and leg ulcers.

The SureSkin™ Hydrocolloid Wound Dressings manufactured by Euromed A/S are indicated for the management of dry and exudating pressure sores and leg ulcers. The devices were originally cleared for marketing under K960393-SureSkin™ BORDER Dressing, K960394-SureSkin™ STANDARD Dressing, and K960404-SureSkin™ THIN Dressing. The only purpose of the current 510(k) premarket notification for these products is to update the device labeling to be consistent with equivalent products. The three dressings will be contraindicated for use on 3rd degree burns. No other changes have been made to the devices since the original marketing clearance was obtained and therefore, no other specific performance or biocompatibility testing was included in this submission.

This document is a 510(k) summary for a labeling revision of SureSkin™ Hydrocolloid Wound Dressings. It explicitly states that "No other changes have been made to the devices since the original marketing clearance was obtained and therefore, no other specific performance or biocompatibility testing was included in this submission."

Therefore, based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets those criteria for the current submission. The submission focuses solely on updating device labeling, specifically contraindicating the dressings for 3rd-degree burns.

Consequently, I cannot provide the requested information in the table or answer questions 2 through 9, as they pertain to performance studies that were not conducted or included in this specific 510(k) submission.

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The SureSkin® STANDARD Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of light to heavy exudating pressure sores and leg ulcers.

The SureSkin® STANDARD Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of light to heavy exudating pressure sores and leg ulcers. It is composed of a hydrocolloid material which is in contact with the wound, and an occlusive polyurethane backing.

The provided 510(k) summary for the SureSkin® STANDARD Hydrocolloid Wound Dressing does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth methodologies.

The document primarily focuses on:

• Administrative details: Date prepared, submitter, contact, device name, and classification.
• Device description: Stating its composition (hydrocolloid and polyurethane backing), intended use (management of light to heavy exudating pressure sores and leg ulcers), and comparison to a predicate device (DuoDerm Dressing).
• Substantial Equivalence claim: This equivalence is based on descriptive information (design, materials, intended use) and biocompatibility testing.

There is no mention of:

• Specific acceptance criteria for device performance.
• A study comparing the device's performance against defined criteria.
• Sample sizes for test or training sets.
• Data provenance (country, retrospective/prospective).
• Number or qualifications of experts.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or human-AI interaction.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size or ground truth establishment for a training set.

The statement "Results of all biocompatibility tests demonstrated that the device is suitable for its intended use" indicates that some testing was performed, but it only addresses biocompatibility, not the clinical efficacy or functional performance metrics that would typically be associated with acceptance criteria for device performance in managing wounds.

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