(49 days)
No
The 510(k) summary explicitly states that no changes have been made to the devices since their original clearance, and the purpose of the submission is solely to update labeling. There is no mention of AI or ML in the device description or any of the other sections.
Yes
The device is a wound dressing indicated for the management of pressure sores and leg ulcers, which falls under therapeutic use.
No
The device is a wound dressing indicated for the management of pressure sores and leg ulcers, which is a treatment, not a diagnosis.
No
The device description explicitly states it is a wound dressing, which is a physical product, not software. The 510(k) is for updating labeling of existing physical devices.
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 dry and 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 "Hydrocolloid Wound Dressing." This is a physical dressing applied to a wound, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting biomarkers, or providing diagnostic information.
Therefore, the SureSkin™ Hydrocolloid Wound Dressings are wound care devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The SureSkin™ Hydrocolloid Wound Dressings manufactured by Euromed A/S are indicated for the management of dry and exudating pressure sores and leg ulcers.
Product codes
79 MGP
Device Description
The SureSkin™ Hydrocolloid Wound Dressings manufactured by Euromed A/S are indicated for the management of dry and exudating pressure sores and leg ulcers. The devices were originally cleared for marketing under K960393-SureSkin™ BORDER Dressing, K960394-SureSkin™ STANDARD Dressing, and K960404-SureSkin™ THIN Dressing. The only purpose of the current 510(k) premarket notification for these products is to update the device labeling to be consistent with equivalent products. The three dressings will be contraindicated for use on 3rd degree burns. No other changes have been made to the devices since the original marketing clearance was obtained and therefore, no other specific performance or biocompatibility testing was included in this submission.
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
No other specific performance or biocompatibility testing was included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
SEP 23 1996
3 9
510(k) SUMMARY SureSkin™ Hydrocolloid Wound Dressings Labeling Revision
1. DATE PREPARED
August 2, 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 SureSkin™ BORDER Hydrocolloid Wound Dressing SureSkin™ THIN Hydrocolloid Wound Dressing
DEVICE CLASSIFICATION 5.
Wound Dressings have not been finally classified by FDA. [Proposed Class I (21 CFR 878.4022)] 79 MGP Product Code:
..
1
DEVICE DESCRIPTION AND COMPARISON TO PREDICATE 6. PRODUCTS
The SureSkin™ Hydrocolloid Wound Dressings manufactured by Euromed A/S are indicated for the management of dry and exudating pressure sores and leg ulcers. The devices were originally cleared for marketing under K960393-SureSkin™ BORDER Dressing, K960394-SureSkin™ STANDARD Dressing, and K960404-SureSkin™ THIN Dressing. The only purpose of the current 510(k) premarket notification for these products is to update the device labeling to be consistent with equivalent products. The three dressings will be contraindicated for use on 3rd degree burns. No other changes have been made to the devices since the original marketing clearance was obtained and therefore, no other specific performance or biocompatibility testing was included in this submission.