(28 days)
Not Found
No
The device description focuses on the physical properties and materials of a hydrocolloid wound dressing, with no mention of software, algorithms, or any technology that would suggest AI/ML.
Yes
The device is a wound dressing indicated for the management of various types of wounds, which is a therapeutic function.
No
The device is a wound dressing, indicated for the management of wounds and burns, not for diagnosing medical conditions.
No
The device description clearly outlines a physical wound dressing made of hydrocolloid material, polyurethane foam, and polyurethane film, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the dressings are for the "management of lightly to heavily exudating wounds, such as pressure sores and leg ulcers," "dermal ulcers, post-operative wounds, superficial wounds and abrasions," "second degree burns and donor sites." These are all applications directly on the body for wound care.
- Device Description: The description details a hydrocolloid wound dressing that is applied to the wound bed. It describes its physical properties and how it functions as a wound covering.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (on the body) for wound management.
N/A
Intended Use / Indications for Use
The SureSkin II STANDARD and SureSkin II BORDER hydrocolloid wound dressings are indicated for the management of lightly to heavily exudating wounds, such as pressure sores and leg ulcers.
The SureSkin™ II THIN hydrocolloid wound dressing is indicated for the management of dry or lightly exudating wounds, such as dermal ulcers, post-operative wounds, superficial wounds and abrasions.
The SureSkin™ II dressings are also indicated for use on second degree burns and donor sites.
Product codes
MGP
Device Description
The SureSkin II wound dressings are identical to the SureSkin Plus products with the exception that the formulation has been slightly modified. The SureSkin II hydrocolloid wound dressing formulation includes the same well known materials w that are used in other hydrocolloid wound dressings.
The adhesive hydrocolloid surface of these wound dressings is in contact with the wound bed. Polyurethane foam (Standard) and polyurethane film (Border/Thin) backings provide an occlusive covering of the wound. The polyurethane backing (foam or film) is impermeable to water and bacteria. The dressing maintains a constant thickness of hydrocolloid material to the edge of the dressing (Standard and Thin). 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
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
Not Found
Predicate Device(s)
K983249, K960393, K960394, K960404, K863390
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
AUG 12 2000
510(k) Summary for SureSkin™ II Hydrocolloid Wound Dressings
1. SPONSOR
Euromed, Inc. 411 Clinton Ave Northvale, NJ 07647
Contact Person: Mr. Carsten Fredsbo Telephone: 201-750-1840
Date Prepared:
2. DEVICE NAME
| Proprietary Name: | SureSkin™ II |
|---|---|
| Common/Usual Name: | Hydrocolloid Wound Dressing |
| Classification Name: | Occlusive Wound and Burn Dressing |
July 14, 1999
PREDICATE DEVICES 3.
| SureSkin™ Plus Dressing | K983249 |
|---|---|
| SureSkin™ BORDER Dressing | K960393 |
| SureSkin™ STANDARD Dressing | K960394 |
| SureSkin™ THIN Dressing | K960404 |
| DuoDerm Dressings by Convatec | K863390 |
4. DEVICE DESCRIPTION
The SureSkin II wound dressings are identical to the SureSkin Plus products with the exception that the formulation has been slightly modified. The SureSkin II hydrocolloid wound dressing formulation includes the same well known materials w that are used in other hydrocolloid wound dressings.
1
The adhesive hydrocolloid surface of these wound dressings is in contact with the wound bed. Polyurethane foam (Standard) and polyurethane film (Border/Thin) backings provide an occlusive covering of the wound. The polyurethane backing (foam or film) is impermeable to water and bacteria. The dressing maintains a constant thickness of hydrocolloid material to the edge of the dressing (Standard and Thin). 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.
INTENDED USE ડ.
The intended use of the SureSkin II wound dressings are the same as for the original SureSkin™ and SureSkin Plus™ products already cleared by FDA.
The SureSkin II 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. All of the SureSkin™ dressings are suitable for use on second degree burns and donor sites.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE ર્ભ.
The SureSkin™ II Hydrocolloid Wound Dressings manufactured by Euromed, Inc. are wound dressings composed of a hydrocolloid material, which is in contact with the wound, and an occlusive polyurethane backing. The dressing is identical in design, function and intended use to the commercially available predicate SureSkin™ Plus wound dressings. The only difference is the slight change in formulation of the materials.
7. PERFORMANCE TESTING
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with three wing-like shapes extending from its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1:2 1999
Euromed, Inc. c/o Marv McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
K992363 Re:
Trade Name; SureSkin II Hydrocolloid Weund Dressing Regulatory Class: Unclassified Product Code: MGP Dated: July 14, 1999 Received: July 15, 1999
Dear Ms. McNamara-Cullinane:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Mary McNamara-Cullinane
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colin M. Wittmer, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: SureSkin II Hydrocolloid Wound Dressings
Indications for Use:
The SureSkin II STANDARD and SureSkin II BORDER hydrocolloid wound dressings are indicated for the management of lightly to heavily exudating wounds, such as pressure sores and leg ulcers.
The SureSkin™ II THIN hydrocolloid wound dressing is indicated for the management of dry or lightly exudating wounds, such as dermal ulcers, post-operative wounds, superficial wounds and abrasions.
The SureSkin™ II dressings are also indicated for use on second degree burns and donor sites.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arcadele
(Division (Division of General Restorative Devices / 992313 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)