Algoplaque Film Extra Thin Hydrocolloid Dressing is a topical wound dressing that is intended for the local management of superficial, dry to lightly-exudating wounds, including pressure sores, dermal ulcers, post-operative wounds or suture sites, and abrasions and lacerations.

Algoplaque Film Extra Thin Hydrocolloid Dressings are also suitable for use as protective skin coverings.

Algoplaque Film Extra Thin Hydrocolloid Dressings are not intended for use on third degree burns.

Device Description

ALGOPLAQUE FILM is a flexible, semiocclusive, topical wound dressing that consists of a polyurethane backing sheet and a hydrocolloid layer. The hydrocolloid layer interacts with wound exudate - liquifying into a soft gel. This gel enables the dressing to be removed with minimal trauma to the underlying tissues.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called "ALGOPLAQUE FILM Extra Thin Hydrocolloid Dressing." This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The 510(k) summary does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way one might expect for a novel AI/software medical device. Instead, it focuses on demonstrating safety, effectiveness, and substantial equivalence to existing hydrocolloid dressings already on the market.

Therefore, many of the requested sections about specific types of studies (MRMC, standalone algorithm performance, training/test set details, expert ground truth) are not applicable to this type of traditional medical device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide specific quantitative acceptance criteria or detailed performance metrics as you would see for a diagnostic device. Instead, the "acceptance criteria" are implied by compliance with safety tests and equivalence to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Safety:
- Meet USP Cytotoxicity (Agar Diffusion) requirements	Met the requirements of the USP
- Meet USP Cytotoxicity (Elution Method) requirements	Met the requirements of the USP
- Non-hemolytic	Determined to be nonhemolytic
- Pass Systemic Injection test in mice	Passed the systemic injection test in mice
- Not a primary irritant or corrosive (Skin Irritation in Rabbits)	Not classified as a primary irritant or as a corrosive
- Not a sensitizer (Delayed Contact Hypersensitivity in Guinea Pigs)	Not a sensitizer
Sterility:
- Sterility Assurance Level (SAL) of 1 x 10^-6	Achieved 1 x 10^-6 SAL via beta-irradiation, validated according to AAMI protocol
Intended Use:
- Suitable for local management of superficial, dry to lightly-exudating wounds (pressure sores, dermal ulcers, post-operative wounds, suture sites, abrasions, lacerations)	Stated as intended use, aligned with predicate devices
- Suitable as protective skin coverings	Stated as intended use
- Not for third-degree burns	Stated as a limitation of use
Substantial Equivalence:
- Technologically similar to predicate devices (e.g., composition, mechanism of action, intended use)	Confirmed through comparison to ALGOPLAQUE Hydrocolloid Dressing (K970518), DuoDERM Extra Thin CGF Dressing (K925990), and Comfeel Ulcer Dressing (K840438)

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

Sample Size: Not explicitly stated for specific in-vivo animal tests (e.g., number of mice, rabbits, guinea pigs).
Data Provenance: The studies are described as "in vitro tests and animal safety studies." Given the submitter (Laboratoires URGO) is in France, it's reasonable to infer these studies were conducted by or for them, likely in Europe, though specific country details are not provided. The studies are retrospective in the sense that they were completed before submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. For these types of safety tests (cytotoxicity, hemolysis, irritation, sensitization), the "ground truth" is established by standard biological assays and the observed physiological responses in animal models, not by human expert consensus or interpretation of complex medical images.

4. Adjudication Method for the Test Set:

Not applicable. The safety tests described involve objective measurements and observations in laboratory and animal settings, not a review of cases by multiple human readers requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This device is a wound dressing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone algorithm performance study was not done. This device is a physical wound dressing and does not involve AI algorithms.

7. The Type of Ground Truth Used:

For the safety studies, the ground truth was based on:
- Biological assay results: Compliance with USP standards for cytotoxicity, non-hemolytic status.
- In-vivo physiological responses: Observation of lack of primary irritation, corrosivity, systemic toxicity, and sensitization in animal models (mice, rabbits, guinea pigs).

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of this device. It is not an AI/ML algorithm that learns from data. Its performance is based on its physical and chemical properties and biological interactions, as demonstrated by the safety tests.

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

Not applicable. As there is no training set for an AI/ML algorithm, no ground truth needed to be established in this manner.

Summary

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FEB 1 3 1998

510(k) SUMMARY Algoplaque Film Extra Thin Hydrocolloid Dressing K974348

page 1 of 4

510(k) SUMMARY

ALGOPLAQUE FILM Extra Thin Hydrocolloid Dressing (79 MGP)

SUBMITTER'S NAME 1.
CONTACT PERSON AT LABORATOIRES URGO 2.
U.S. REGULATORY AGENT FOR LABORATOIRES URGO 3.
DATE THAT 510(k) SUMMARY WAS PREPARED 4.
NAME OF THE MEDICAL DEVICE (Classification / Common / Proprietary) ട.
LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS રે. CLAIMED
DESCRIPTION OF THE DEVICE 7.
INTENDED USE OF THE DEVICE 8.
TECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE g. DEVICES
SUMMARY OF SAFETY STUDIES AND CONCLUSIONS FROM SAFETY STUDIES 10.
STERILIZATION / STERILITY ASSURANCE LEVEL 11.

1. SUBMITTER'S NAME
Laboratoires URGO42, rue de Longvic21300 ChenoveFRANCETelephone: 011-33-3-80 44 79 67Fax: 011-33-3-80 44 71 12

2. CONTACT PERSON AT LABORATOIRES URGO
Sophie Lambert-Fortin
Manager, Regulatory Affairs
Telephone:	011-33-3-80 44 79 67
Fax:	011-33-3-80 44 71 12

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U.S. REGULATORY AGENT FOR LABORATOIRES URGO
Evan Dick, Ph.D.EGDA
7527 Westmoreland AvenueSt. Louis, MO 63105
Telephone:	(314) 721-0112
Fax:	(314) 721-7591

4. DATE THAT 510(k) SUMMARY WAS PREPARED

November 19, 1997

5. NAME OF THE MEDICAL DEVICE
Classification name	Dressing, wound and burn, occlusive(Surgery 79 MGP)
Common / usual name	Hydrocolloid dressing
Proprietary name	ALGOPLAQUE® FILMExtra Thin Hydrocolloid Dressing

ALGOPLAQUE® FILM Extra Thin Hydrocolloid Dressing will also be distributed under the additional proprietary name SORBEX Thin.

LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE I CLAIMED CLAIMED · ALGOPLAQUE Hydrocolloid Dressing (K970518, URGO) · DuoDERM Extra Thin CGF Dressing (K925990, ConvaTec) · Comfeel Ulcer Dressing (K840438, Coloplast)

P.15

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page 3 of 4

7. SUDESCRIPTION OF THE DEVICE IS CONTRACT

8. INTENDED USE OF THE DEVICE OF THE DEVICE OF THE BE

Algoplaque Film Extra Thin Hydrocolloid Dressings are also suitable for use as protective skin coverings.

Algoplaque Film Extra Thin Hydrocolloid Dressings are not intended for use on third degree burns.

TECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE DEVICES DEVICES

Algoplaque Film Extra Thin Hydrocolloid Dressings, Algoplaque Hydrocolloid Dressings (K970518), DuoDERM Extra Thin CGF Dressings (K925990), and Comfeel Ulcer Dressings (K840438) are all flexible, hydrocolloid wound dressings that consist of a polyurethane backing sheet and a hydrocolloid layer. For all of these devices, the hydrocolloid layer is composed of:

· natural polymers primarily for absorption
· synthetic polymers plasticizers, elastomers, tackifiers
· stabilizers to help maintain the integrity of the final product

Algoplaque Film Extra Thing Hydrocolloid Dressing and the predicate devices are all composed, in similar proportions, of closely related natural polymers, synthetic polymers, and stabilizers.

Algoplaque Film Extra Thin Hydrocolloid Dressings are thinner than, for example, Algoplaque Hydrocolloid Dressings (K970518, URGO) and Comfeel Ulcer Dressings (K840438). Thinner dressings are more flexible and therefore easier to place upon dressing sites that require contouring (e.g., elbows). DuoDERM Extra Thin CGF Dressings (K925990) are also specially thin hydrocolloid dressings.

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page 4 of 4

SUMMARY OF SAFETY STUDIES AND CONCLUSIONS FROM SAFETY STUDIES ALGOPLAQUE FILM Extra Thin Hydrolloid Dressing (Algoplaque Film Dressing) has been evaluated through in vitro tests and animal safety studies. All data is consistent in indicating that this product is safe for use as a topical wound dressing. The categories of safety tests and the safety test conclusions are as follows: · Cytotoxicity - USP Agar Diffusion · Algoplaque Film Dressing met the requirements of the USP · Cytotoxicity - USP Elution Method · Algoplaque Film Dressing met the requirements of the USP · Hemolysis Study - In Vitro Procedure · Algoplaque Film Dressing was determined to be nonhemolytic · Systemic Injection In Mice · Algoplaque Film Dressing passed the systemic injection test in mice. • Primary Skin Irritation In Rabbits > Algoplaque Film Dressing is not classified as a primary irritant or as a corrosive · Delayed Contact Hypersensitivity in Guinea Pigs

· Algoplaque Film Dressing is not a sensitizer

STERILIZATION /STERILITY ASSURANCE LEVEL ( FERIE MARK 1

Algoplaque Film Extra Thin Hydrocolloid Dressing is sterilized using beta-irradiation. The sterility assurance level (S.A.L.) for Algoplaque Film Extra Thin Hydrocolloid Dressing is 1 X 10 as validated according to AAMI protocol / validation criteria.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 1998

Evan G. Dick, Ph.D. E.G. Dick & Associates Representing Laboratoires Urgo S.A. 7527 Westmoreland Avenue St. Louis, Missouri 63105

Re: K974348

ALGOPLAOUE® FILM Extra Thin Hydrocolloid Dressing Regulatory Class: Unclassified Product Code: MGP Dated: November 7, 1997 Received: November 19, 1997

Dear Dr. Dick:

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:

1. 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 of wound healing or epithelization.
1. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
1. This device may not be labeled as a treatment or a cure for any type of 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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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,

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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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K974348

ALGOPLAQUE FILM Extra Thin Hydrocolloid Dressing Device Name:

Indications For Use:

Algoplaque Film Extra Thin Hydrocolloid Dressings are intended for the local management of superficial, dry to lightly-exudating wounds, including superficial burns, pressure sores, dermal ulcers, post-operative wounds or suture sites, abrasions and lacerations.

Algoplaque Film Extra Thin Hydrocolloid Dressings are also suitable for use as protective skin coverings.

Algoplaque Film Extra Thin Hydrocolloid Dressings are not intended for use on third degree burns.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number 974348

Prescription Use
(per 21 CFR 01.109)

OR Over-The-Counter Use

Regulation Number and Section

N/A