(32 days)
None
Not Found
No
The summary describes a standard wound dressing made of hydrocolloid and polyurethane, with no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The device is a wound dressing indicated for the management of pressure sores and leg ulcers, which are conditions that require therapeutic intervention for healing.
No
Explanation: The provided text describes the device as a wound dressing for managing pressure sores and leg ulcers. There is no mention of it being used to diagnose conditions or diseases. Its function is to manage wounds, not to identify them or provide diagnostic information.
No
The device description explicitly states it is a "wound dressing" composed of "hydrocolloid material" and a "polyurethane backing," which are physical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "management of light to heavy exudating pressure sores and leg ulcers." This describes a therapeutic device applied directly to a wound on the body.
- Device Description: The description details a "wound dressing" composed of hydrocolloid material and a polyurethane backing. This is a physical dressing applied externally.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
The device is clearly described as a wound dressing for topical application, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
79 MGP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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
Not Found
Predicate Device(s)
DuoDerm Dressing
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
" 第一辑
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
1
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.