(32 days)
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.
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.
The provided text describes a 510(k) Summary for the SureSkin® BORDER Hydrocolloid Wound Dressing. It details the device's description, classification, and comparison to predicate devices, focusing on its design, materials, and intended use for wound management. The document also mentions biocompatibility testing.
However, the text does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria. It lacks the specific details requested in the prompt, such as performance metrics, sample sizes for test or training sets, expert involvement, or statistical analysis.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and a detailed study based solely on the provided input. The document focuses on regulatory submission information rather than a performance study report.
{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.
Page D-2
N/A