The Biatain Foam Adhesive Dressing is indicated for use in the management of low to highly exudating leg ulcers, skin tears, and pressure sores. The dressing can also be used for 2nd degree burns, 2nd degree partial thickness burns, donor sites, post operative wounds and skin abrasions.

Device Description

The Biatain Foam Adhesive Dressing is a highly absorbent 3-D polymer dressing consisting of a Polyurethane foam with a Polyurethane film printed with inks and a hydrocolloid containing adhesive. The dressing is supplied in two size:120x120 cm (3420) and 180x180cm (3423). The dressings are packaged in individual peel pouches and sterilized by ß-irradiation.

AI/ML Overview

Here's an analysis of the provided text regarding the Biatain Foam Adhesive Dressing, focusing on acceptance criteria and supporting studies:

This document primarily serves as a 510(k) summary for a medical device (Biatain Foam Adhesive Dressing), demonstrating its substantial equivalence to a predicate device. It is not a detailed clinical study report designed to present efficacy data with acceptance criteria for a specific device performance metric.

Therefore, many of the requested categories for a study proving device performance (like sample sizes for test/training sets, expert qualifications, MRMC studies, etc.) are not applicable to this type of regulatory submission. The studies referenced are primarily for safety and biocompatibility, not efficacy against specific performance targets.

However, I can extract the relevant information from the document regarding acceptance criteria and the studies that support them, even if they aren't about clinical efficacy.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Biocompatibility (Foam)	Non-cytotoxic (cytotoxicity grade ≤2)	In the USP Elution Test, diluted and undiluted solutions of the Biatain Foam Dressing were shown to be non-cytotoxic (cytotoxicity grad ≤2).
Biocompatibility (Foam)	Primary irritation index = 0.0 (intracutaneous test)	In the intracutanous test in the rabbit of the Biatain Foam Adhesive Dressing, the primary irritation index was 0.0.
Biocompatibility (Foam)	No evidence of delayed contact hypersensitivity	In the test for delayed contact hypersensitivity test using the guinea pig maximization test, the Biatain Foam Adhesive Dressing showed no evidence of delayed contact hypersensitivity.
Biocompatibility (Adhesive)	Composed of same components as K942283 (Comfeel Plus Transparent Dressing), which is already approved as safe.	The adhesive consists of the same components as Comfeel Plus Transparent Dressing K942283, and no further toxicological studies have been performed. (This implies that the established safety of the predicate adhesive serves as the acceptance criterion for the new device's adhesive component).

Study Details (as per available information in the 510(k) summary):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- USP Elution Test: Not specified. Standardized in the US Pharmacopeia.
- Intracutaneous Test: Not specified. Performed in rabbits.
- Delayed Contact Hypersensitivity Test: Not specified. Performed in guinea pigs.
- Data Provenance: Not explicitly stated for the tests, but studies are typically conducted by the manufacturer or contracted labs.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. These are laboratory and animal studies, not human clinical trials requiring expert consensus on ground truth. The "ground truth" is determined by standardized test protocols and readings.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are typically for subjective assessments in clinical trials. These are objective lab/animal tests.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. This device is a wound dressing, not an AI-powered diagnostic tool. MRMC studies are irrelevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is a physical wound dressing, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Biocompatibility Studies: Ground truth is established by the standardized test methodologies themselves (e.g., cell viability observation for cytotoxicity, skin reaction scoring for irritation, immune response assessment for hypersensitivity). For the adhesive, the "ground truth" of its safety is deferred to the prior approval of the predicate device (K942283).
The sample size for the training set
- N/A. There is no "training set" in the context of these biocompatibility studies for a physical device.
How the ground truth for the training set was established
- N/A. Not applicable for this type of device and study.

Summary

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DFC 6 1009

510(k) SUMMARY Biatain Foam Adhesive Dressing Page 1 of 3

Coloplast Corporation Submitter: 1. 1955 West Oak Circle Marietta, Georgia 30062-2249

Contact Person: Ms. Syd Lilly

Date of Preparation: July 30, 1998

1. DEVICE NAME:
  Proprietary Name: Biatain Foam Adhesive Dressing Topical Wound Dressing Common name: Classification Name: Wound Dressing

DEVICE CLASSIFICATION: 3. Unclassified

PRODUCT CLASSIFICATION NUMBER: 79FRO 4.

5. PREDICATE DEVICE:

Tielle Hydropolymer Dressing (J&J Ltd. UK); 946245.

DEVICE DESCRIPTION: 6.

The Biatain Foam Adhesive Dressing is a highly absorbent 3-D polymer dressing consisting of a Polyurethane foam with a Polyurethane film printed with inks and a hydrocolloid containing adhesive.

The dressing is supplied in two size:120x120 cm (3420) and 180x180cm (3423). The dressings are packaged in individual peel pouches and sterilized by ß-irradiation.

The topical safety of Biatain Foam Adhesive Dressing has been established in the following studies:

The foam formulation:

In the USP Elution Test, diluted and undiluted solutions of the Biatain Foam Dressing were shown to be non-cytotoxic (cytotoxicity grad ≤2).

In the intracutanous test in the rabbit of the Biatain Foam Adhesive Dressing the primary irritation index was 0.0.

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K983173

510(k) SUMMARY Biatain Foam Adhesive Dressing Page 2 of 3

In the test for delayed contact hypersensitivity test using the guinea pig maxi mation test, the Biatain Foam Adhesive Dressing showed no evidence of delayed contact hypersensitivity.

The Adhesive

The adhesive consists of the same components as Comfeel Plus Transparent Dressing K942283, and no further toxicological studies have been performed.

7. INTENDED USE:

For use in the management of low to medium exudating leg ulcers, and pressure sores. The dressing can also be used for 2nd degree burns, 2nd degree partial thickness burns, donor sites, post operative wounds and skin abrasions.

COMPARISON TO PREDICATE DEVICE 8.

Biatain Foam Adhesive Dressing is similar in composition, function, and inten ded use to other foam wound dressings, such as Tielle Hydropolymer Dressing (J&J Ltd. UK); K946245. A comparison is presented in the following Table.

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|6983173

510(k) SUMMARY Biatain Foam Adhesive Dressing

	Biatain Foam AdhesiveDressing	Tielle Hydropolymer Dressing
DeviceDescription	Biatain Foam AdhesiveDressing provides an exudatehandling system for low tomedium exudating wounds. Itis a highly absorbent 3-Dpolymer dressing. It has ahydrocolloidadhesive and a central 3-Dpolymer absorbent pad with awaterproof semi-permeablefilm backing	Tielle Hydropolymer Dressingprovides an exudate handlingsystem for low to moderateexudating wounds. It is a highlyabsorbent dressing. Theabsorbent material is a syntheticpolymer. The island dressngprovides a moist woundenvironment that aids in thewound healing process. Duringuse the absorbent island gentlyexpands as it takes up exudate.
Sizes	120x120 cm, 180x180 cm	7x9 cm, 11x11 cm, 15x15 cm,15x20 cm, 18x18 cm, 18x18 cmsacrum
Use (single,reusabledisposable)	Single	Single
Intended use	For use in the management oflow to medium exudating legulcers, and pressure sores.Can also be used formanagement of 2nd degreeburns, 2nd degree partialthickness burns, donor sites,post operative wounds andskin abraisons.It can be used for diabetic orinfected wounds under the	For use in the management ofboth chronic and superficial, lowto moderate exudating wounds,including the following: Pressuresores (all stages) and venousulcers.It is suitable for use undercompression bandaging
	supervision of a health careprofessional.Is suitable for use under
	compression bandaging
Sterility	Sterile	Sterile

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC I 6 1998

Ms. M. Sydney Lilly Quality Assurance and Regulatory Affairs Manager Coloplast Corporation 1955 West Oak Circle Marietta, Georgia 30062-2249

Re: K983173

Trade Name: Biatain Foam Adhesive Dressing Regulatory Class: Unclassified Product Code: MGP Dated: November 4, 1998 Received: November 17, 1998

Dear Ms. Lilly:

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 of 2. wound healing or epithelization.
This device may not be labeled as a long-term, permanent, or no-change dressing, or 3. as an artificial (synthetic) skin.
This device may not be labeled as a treatment or a cure for any type of wound. 4.

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. M. Sydney Lilly

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 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,

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: Biatain Foam Adhesive Dressing

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

Restorative Devices

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

N/A