(32 days)
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Not Found
No
The description focuses on the material composition and function of a wound dressing, with no mention of AI or ML.
Yes
The device is indicated for the "management of lightly to heavily exudating pressure sores and leg ulcers," which is a therapeutic purpose.
No
Explanation: The device is described as a wound dressing for the management of exudating pressure sores and leg ulcers. Its function is to cover and protect the wound, not to diagnose a condition.
No
The device description clearly states it is a wound dressing composed of hydrocolloid material and a polyurethane backing, which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "management of lightly to heavily exudating pressure sores and leg ulcers." This describes a therapeutic or wound care application, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a "wound dressing composed of a hydrocolloid material... and an occlusive polyurethane backing." This is a physical dressing applied to a wound, not a device used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing information about a patient's health status based on in vitro analysis.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This wound dressing does not fit that description.
N/A
Intended Use / Indications for Use
The SureSkin® BORDER Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of lightly to heavily exudating pressure sores and leg ulcers.
Product codes
79 MGP
Device Description
The SureSkin® BORDER Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of lightly to heavily 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 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.
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
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
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Predicate Device(s)
DuoDerm Dressing
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(k) SUMMARY SureSkin® BORDER 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® BORDER 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® BORDER Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of lightly to heavily 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 dressing is similar in design,
1
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.
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