(70 days)
Not Found
No
The document describes a hydrocolloid wound dressing with a slight material change and does not mention any computational or analytical capabilities.
No.
The device is a wound dressing designed for the management of exudating wounds and superficial injuries, which is explicitly stated in the "Intended Use / Indications for Use" section. It functions as a hydrocolloid dressing to protect and manage wounds, not to provide therapeutic treatment in the sense of curing or actively intervening in disease processes beyond wound management.
No
Explanation: The device is described as a hydrocolloid wound dressing used for the management of various types of wounds. Its function is to cover and protect wounds, not to diagnose medical conditions.
No
The device description clearly states it is a wound dressing composed of physical materials (hydrocolloid and polyurethane backing), indicating it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a wound dressing for managing various types of wounds. This is a topical application for wound care, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details the composition and function of a wound dressing. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
Therefore, the SureSkin™ Plus hydrocolloid wound dressings are classified as medical devices for wound management, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
SureSkin™ Plus STANDARD and Plus BORDER Dressings are sterile hydrocolloid wound dressings indicated for the management of lightly to heavily exudating pressure sores and leg ulcers. The SureSkin™ THIN Plus Dressing is a sterile hydrocolloid wound dressing indicated for the management of dry to lightly exudating dermal ulcers, post-operative wounds, superficial wounds and abrasions. All three of the dressings are suitable for use on post-operative wounds, superficial wounds and abrasions.
The SureSkin™ Plus STANDARD and SureSkin™ Plus BORDER hydrocolloid wound dressings are indicated for the management of lightly to heavily exudating wounds, such as pressure sores and leg ulcers.
The SureSkin™ Plus THIN hydrocolloid wound dressing is indicated for the management of dry to lightly exudating wounds, such as pressure sores and leg ulcers.
The SureSkin™ Plus dressings are also indicated for use on superficial wounds and abrasions. second degree burns, and donor sites.
Product codes
MGP
Device Description
The new SureSkin™ Plus Standard, SureSkin™ Plus Border, and SureSkin™ Plus Thin hydrocolloid wound dressings are identical to the predicate SureSkin™ products except for a slight change in the hydrocolloid materials. The materials are the same except that mineral oil has been added and gelatin has been omitted from the hydrocolloid.
The SureSkin® Plus 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.
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)
K960393, K960394, K960404, K863390, K853844
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(k) Summary for SureSkin™ Plus Hydrocolloid Wound Dressings
-
- SPONSOR
2 5 1998
- SPONSOR
NOV
Euromed. Inc. 411 Clinton Ave Northvale, NJ 07647
Mr. Carsten Fredsbo Contact Person: 210-750-1840 Telephone:
September 15, 1998 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | SureSkin™ Plus Standard |
|---|---|
| SureSkin™ Plus Border | |
| SureSkin™ Plus Thin | |
| Common/Usual Name: | Hydrocolloid Wound Dressing |
| Classification Name: | Occlusive Wound and Burn Dressing |
3. PREDICATE DEVICES
| SureSkin™ BORDER Dressing | K960393 |
|---|---|
| SureSkin™ STANDARD Dressing | K960394 |
| SureSkin™ THIN Dressing | K960404 |
| DuoDerm Dressings by Convatec | K863390 |
| DuoDerm Hydroactive Dressing with Border | K853844 |
4. DEVICE DESCRIPTION
The new SureSkin™ Plus Standard, SureSkin™ Plus Border, and SureSkin™ Plus Thin hydrocolloid wound dressings are identical to the predicate SureSkin™ products except for a slight change in the hydrocolloid materials. The materials are the same except that mineral oil has been added and gelatin has been omitted from the hydrocolloid.
1
INTENDED USE ક.
SureSkin™ Plus STANDARD and Plus BORDER Dressings are sterile hydrocolloid wound dressings indicated for the management of lightly to heavily exudating pressure sores and leg ulcers. The SureSkin™ THIN Plus Dressing is a sterile hydrocolloid wound dressing indicated for the management of dry to lightly exudating dermal ulcers, post-operative wounds, superficial wounds and abrasions. All three of the dressings are suitable for use on post-operative wounds, superficial wounds and abrasions.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The SureSkin® Plus 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™ 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
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is that of an official or institutional heading.
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
NOV 25 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Euromed, Inc. c/o Ms. Mary McNamara-Cullinane, RAC Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Re: K983249
Trade Name: SureSkin™ Plus Standard, Border and Thin Hydrocolloid Wound Dressings Regulatory Class: Unclassified Product Code: MGP Dated: September 15, 1998 Received: September 16, 1998
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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
- This device may not be labeled for use on third degree burns. 1.
- This device may not be labeled as having any accelerating effect on the rate 2. of wound healing or epithelization.
- This device may not be labeled as a long-term, permanent, or no-change 3. dressing, or as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for any type of 4. wound.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
3
Page 2 - Ms. Mary McNamara-Cullinane
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 (CFR), Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP 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.
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 your 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,
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K983249 510(k) Number (if known):
Device Name: SureSkin™ Plus Hydrocolloid Wound Dressings
Indications For Use:
The SureSkin™ Plus STANDARD and SureSkin™ Plus BORDER hydrocolloid wound dressings are indicated for the management of lightly to heavily exudating wounds, such as pressure sores and leg ulcers.
The SureSkin™ Plus THIN hydrocolloid wound dressing is indicated for the management of dry to lightly exudating wounds, such as pressure sores and leg ulcers.
The SureSkin™ Plus dressings are also indicated for use on superficial wounds and abrasions. 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)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983249
(Optional Format 1-2-96)