(32 days)
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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510(k) SUMMARY SureSkin® STANDARD Hydrocolloid Wound Dressing
DATE PREPARED 1.
January 25, 1996
SUBMITTER 2.
Euromed A/S Borgergade 6 DK-1300 Copenhagen Denmark
CONTACT 3.
Mr. Carsten Fredsbo General Manager Phone: 011-45-3316-3040
DEVICE NAME 4.
SureSkin® STANDARD Hydrocolloid Wound Dressing
DEVICE CLASSIFICATION 5.
Wound Dressings have not been finally classified by FDA. [Proposed Class I (21 CFR 878.4022)] Product Code: 79 MGP
DEVICE DESCRIPTION AND COMPARISON TO PREDICATE PRODUCTS 6.
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
Euromed SureSkin™ STANDARD 510(k)
1/25/96
Page D-1
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sores and leg ulcers. It is composed of a hydrocolloid material which is in contact with the wound, and an occlusive polyurethane backing. The dressing is similar in design, function, materials, and intended use to other hydrocolloid/occlusive dressings currently in commercial distribution, e.g., DuoDerm Dressing marketed by Convatec.
Determination of substantial equivalence for this product was based on descriptive information about the design, materials, and intended use of the device. Biocompatibility testing was performed on the device material in conformance with Tripartite and ISO 10993 recommendations. Results of all biocompatibility tests demonstrated that the device is suitable for its intended use.
N/A