(32 days)
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No
The description focuses on the material composition and intended use of a wound dressing, with no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The device is indicated for the management of various wounds, which implies a therapeutic purpose by aiding in the healing process.
No
The device is a wound dressing used for managing various types of wounds, not for diagnosing medical conditions.
No
The device description explicitly states it is a wound dressing composed of hydrocolloid material and a polyurethane film backing, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of wounds (dermal ulcers, post-operative wounds, superficial wounds and abrasions). This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a wound dressing made of hydrocolloid material and a polyurethane film backing. This is a physical barrier and absorbent material applied externally to a wound.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease. IVDs are designed to perform tests on biological samples to aid in diagnosis, monitoring, or screening.
The device is a wound care product, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The SureSkin® THIN Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of dry to lightly exudating dermal ulcers, post-operative wounds, and superficial wounds and abrasions.
Product codes (comma separated list FDA assigned to the subject device)
79 MGP
Device Description
The SureSkin® THIN Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of dry to lightly exudating dermal ulcers, post-operative wounds, and superficial wounds and abrasions. It is composed of a hydrocolloid material which is in contact with the wound, and an occlusive polyurethane film backing.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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N/A
0
510(k) SUMMARY
SureSkin® THIN Hydrocolloid Wound Dressing
DATE PREPARED 1.
January 25, 1996
2. SUBMITTER
Euromed A/S Borgergade 6 DK-1300 Copenhagen Denmark
CONTACT 3.
Mr. Carsten Fredsbo General Manager Phone: 011-45-3316-3040
4. DEVICE NAME
SureSkin® THIN Hydrocolloid Wound Dressing
5. DEVICE CLASSIFICATION
Wound Dressings have not been finally classified by FDA. [Proposed Class I (21 CFR 878.4022)] 79 MGP Product Code:
DEVICE DESCRIPTION AND COMPARISON TO PREDICATE PRODUCTS 6.
The SureSkin® THIN Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of dry to lightly exudating dermal ulcers, post-operative wounds, and superficial wounds and abrasions. It is composed of a hydrocolloid material which is in contact with the wound, and an occlusive polyurethane
1
film backing. The dressing is similar in design, function, materials, and intended use to other hydrocolloid/occlusive dressings currently in commercial distribution, e.g., DuoDERM Extra Thin Flexible Hydrocolloid Dressing.
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.
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