(495 days)
Not Found
No
The device description and intended use focus on the material composition and physical properties of a wound dressing. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is a wound dressing designed to manage various types of wounds, including ulcers, burns, and abrasions, by providing an antimicrobial barrier and absorbing exudate, which are therapeutic functions.
No
Explanation: The SureSkin III with Silver Wound Dressings are indicated for the management and treatment of wounds, providing an antimicrobial barrier and occlusive covering. They do not diagnose conditions but rather treat them.
No
The device description clearly indicates it is a physical wound dressing made of hydrocolloid material with a polyurethane film backing, 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 to manage and protect wounds by providing an antimicrobial barrier and absorbing exudate. This is a therapeutic and protective function applied directly to the body.
- Device Description: The device is a wound dressing made of hydrocolloid material and a polyurethane film backing. These are materials designed for direct application to a wound.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition, monitor a disease, or screen for a disease.
- Performance Studies: The performance studies focus on antimicrobial effectiveness, microbial barrier properties, and biocompatibility – all related to the device's function as a wound dressing applied to the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This wound dressing does not fit that description.
N/A
Intended Use / Indications for Use
The SureSkin III with Silver Wound Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.
The SureSkin III with Silver Wound Dressings are sterile hydrocolloid wound dressings indicated for the management of lightly to heavily exudating wounds such as pressure sores and leg ulcers, and for the management of dry to lightly exudating wounds such as dermal ulcers, post-operative wounds, superficial wounds, and abrasions. The SureSkin III with Silver Wound Dressings are also suitable for use on second degree burns and donor sites.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The SureSkin III with Silver Wound Dressings are identical to the SureSkin II products with the exception that the formulation has been slightly modified to include silver. The SureSkin III formulation includes the same well-known materials that are used in other hydrocolloid wound dressings. Polyurethane film (Border/Thin) backings provide an occlusive covering of the wound. The polyurethane backing (film) is impermeable to water and bacteria. The dressing maintains a constant thickness of hydrocolloid material to the edge of the dressing. The thickness of the hydrocolloid material is decreased at the edges (beveled edges) of the Border Dressing to improve adherence and reduce the risk of the dressing rolling up. The border itself is a continuation of the hydrocolloid adhesive material. The dressings can be left in place up to seven days if exudate is minimal.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Antimicrobial effectiveness and Microbial Barrier testing was performed according to the USP methods and showed that the SureSkin III with Silver Wound Dressings provide an effective microbial barrier in the wound pad. Biocompatibility testing was performed in accordance with the International Organization for Standardization recommendations. Results of the biocompatibility tests demonstrate that the device is suitable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
N/A
0
510(k) Summary
for
Euromed SureSkin III with Silver Wound Dressings
-
- SPONSOR
MAY 17 2003
- SPONSOR
KO50032
1 3
Euromed, Inc. 411 Clinton Ave Northvale, NJ 07647
Contact Person: Mr. Jarl Jensen 201-750-1840 Telephone:
January 6, 2005 Date Prepared:
DEVICE NAME 2.
| Proprietary Name: | SureSkin™ III with Silver Border Wound Dressing
SureSkin™ III with Silver Thin Wound Dressing |
|----------------------|--------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Wound Dressing |
| Classification Name: | Occlusive Wound and Burn Dressing |
PREDICATE DEVICES 3.
| • Contreet Antimicrobial Wound Dressing | K013525 |
|---|---|
| • Xylos Corporation Cell Antimicrobial Wound Dressing | K024054 |
| • SureSkin II Wound Dressings | K992363 |
DEVICE DESCRIPTION 4.
The SureSkin III with Silver Wound Dressings are identical to the SureSkin II products with the exception that the formulation has been slightly modified to include silver. The SureSkin III formulation includes the same well-known materials that are used in other hydrocolloid wound dressings. Polyurethane film (Border/Thin) backings provide an occlusive covering of the wound. The polyurethane backing (film) is impermeable to water and bacteria. The dressing maintains a constant thickness of hydrocolloid material to the edge of the dressing. The thickness of the hydrocolloid material is decreased at the edges (beveled edges) of the Border
510(k) Summary · Page 1
1
page 2 of 3
Dressing to improve adherence and reduce the risk of the dressing rolling up. The border itself is a continuation of the hydrocolloid adhesive material. The dressings can be left in place up to seven days if exudate is minimal.
ട്. INTENDED USE
The SureSkin III with Silver Wound Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.
The SureSkin III with Silver Wound Dressings are sterile hydrocolloid wound dressings indicated for the management of lightly to heavily exudating wounds such as pressure sores and leg ulcers, and for the management of dry to lightly exudating wounds such as dermal ulcers, post-operative wounds, superficial wounds, and abrasions. The SureSkin III with Silver Wound Dressings are also suitable for use on second degree burns and donor sites.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The SureSkin III with Silver Wound Dressings manufactured by Euromed, Inc. are composed of a hydrocolloid material and silver, which are in contact with the wound, and an occlusive polyurethane backing. The dressings are identical in design, function and intended use to the commercially available predicate SureSkin II wound dressings. The only difference is the slight change in formulation of the materials.
The technological characteristics of the SureSkin III with Silver Wound Dressings and the predicate products are identical in that they are all dressings that contain a silver component suitable for use on pressure sores, leg ulcers, post-operative wounds, superficial wounds and abrasions. The only differences between the new SureSkin III with Silver products and the predicate devices are slightly different formulations, which are minor and do not affect safety and effectiveness of the device.
7. PERFORMANCE TESTING
Antimicrobial effectiveness and Microbial Barrier testing was performed according to the USP methods and showed that the SureSkin III with Silver Wound Dressings provide an effective microbial barrier in the wound pad. Biocompatibility testing was performed in accordance with the International Organization for Standardization
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Page 3 of 3
recommendations. Results of the biocompatibility tests demonstrate that the device is suitable for its intended use.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three abstract shapes forming the head, body, and legs.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 17 2006
Euromed Inc. % Medical Device Consultants, Inc. Ms. Mary McNamara-Cullinane, RAC Staff Consultant 49 Plain Street North Attleboro, Massachusetts 02760
Re: K050032
Trade/Device Name: Euromed SureSkin III with Silver Wound Dressings Regulatory Class: Unclassified Product Code: FRO Dated: March 29, 2006 Received: March 30, 2006
Dear Ms. McNamara-Cullinane:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Ms. Mary McNamara-Cullinane, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Herbert Remmering
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
Indications for Use
510(k) Number (if known): Ko 500 32
Euromed SureSkin III with Silver Wound Dressings_ Device Name: ____
Indications for Use:
The SureSkin III with Silver Wound Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.
The SureSkin III with Silver BORDER wound dressings are indicated for the management of lightly to heavily exudating wounds, such as pressure sores and leg ulcers.
The SureSkin™ III with Silver THIN wound dressings are indicated for the management of dry or lightly exudating wounds, such as dermal ulcers, post-operative wounds, superficial wounds and abrasions.
The SureSkin™ III with Silver wound dressings are also indicated for use on second degree burns and donor sites.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Richard Lesner us
Division of General, Restorative. and Neurological Devices
510(k) Number K050032
Euromed, Inc. 510(k) SureSkin III with Silver Wound Dressings
January 6, 2005
CONFIDENTIAL Page vi