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.

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. 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.

AI/ML Overview

The provided 510(k) summary for SureSkin™ Plus Hydrocolloid Wound Dressings does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics in the way a diagnostic or AI-driven device would.

This submission is for a medical device (wound dressing) where the primary focus is demonstrating substantial equivalence to existing predicate devices, rather than meeting specific performance thresholds through a clinical study with detailed statistical endpoints.

Here's a breakdown of why the requested information is absent and what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable in this context. For devices like wound dressings, acceptance criteria typically relate to material properties, strength, sterility, biocompatibility, and intended use equivalence, rather than specific numerical diagnostic performance metrics (e.g., sensitivity, specificity).
The document states: "Results of the biocompatibility tests demonstrate that the device is suitable for its intended use." This is a general statement of compliance, not a report of specific numerical performance against acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable. There is no "test set" in the context of diagnostic performance as described in the prompt. The "testing" referred to is biocompatibility testing of the materials themselves, governed by ISO recommendations. The document does not specify sample sizes for these tests, nor data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not Applicable. "Ground truth" as defined in the prompt (expert consensus, pathology, outcomes data) is relevant for diagnostic performance studies. For this wound dressing, the "truth" is established through
- Material composition: The key change is the addition of mineral oil and omission of gelatin, which constitutes the primary difference from predicate devices.
- Biocompatibility testing: This confirms the new material is safe for contact with human tissue.
- Comparison to predicate devices: The "truth" of its efficacy and safety stems from the established history of the predicate devices.

4. Adjudication Method:

Not Applicable. No ground truth establishment or diagnostic performance evaluation requiring adjudication occurred.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study (comparing human readers with and without AI assistance) is specifically for evaluating diagnostic AI systems, which this device is not.

6. Standalone Performance Study (Algorithm Only):

No. This is also relevant for AI/diagnostic algorithms, not for a wound dressing.

7. Type of Ground Truth Used:

Not Applicable for diagnostic performance. The "ground truth" for this device revolves around its material science properties and biocompatibility as per ISO standards, and its functional equivalence to predicate devices (K960393, K960394, K960404, K863390, K853844).

8. Sample Size for the Training Set:

Not Applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable.

Summary of available information from the document related to "acceptance" and "proof":

Acceptance Criteria (Implied): The device must be "substantially equivalent" to predicate devices, meaning it has the same intended use, technological characteristics, and safety and effectiveness.
- Key implied criteria:
  - Biocompatibility: Meet ISO recommendations.
  - Material change: The new formulation (addition of mineral oil, omission of gelatin) must not negatively impact safety or effectiveness compared to the previous formulation.
  - Intended Use: Match the predicate devices.
  - Design & Function: Identical to predicate devices.
Study Proving Acceptance (Method):
- "Performance Testing" refers to Biocompatibility testing. The document states: "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."
- Comparison to Predicate Devices: The core of the 510(k) submission is to demonstrate that despite the material change, the device remains "identical in design, function and intended use to the commercially available predicate SureSkin™ wound dressings." This comparison itself is the "proof" of meeting the acceptance criteria of substantial equivalence.

In essence, this 510(k) relies on the established safety and efficacy of predicate devices and confirms that minor material changes do not alter that status, backed by general biocompatibility testing. It is not a performance study in the way one would evaluate a new diagnostic tool.

Summary

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K983249

510(k) Summary for SureSkin™ Plus Hydrocolloid Wound Dressings

1. SPONSOR
  2 5 1998

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

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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.

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.

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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.

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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

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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)

Regulation Number and Section

N/A