Alldress is intended to absorb, protect, and maintain a moist environment in open and closed wounds such as; pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, surgical incisions, superficial burns, abrasions, lacerations, and skin tears.

Device Description

The Alldress Absorbent Film Dressing is a sterile moisture vapor permeable selfadhesive absorbent dressing. The Alldress dressing is individually sealed in medical grade paper pouches and packaged in cartons of ten (10) pouches each. The Alldress dressing is available in three sizes: 10x10cm (4" x 4"), 15x15cm (6" x 6") and 15x20cm (6" x 8").

AI/ML Overview

This document is a 510(k) summary for the Alldress® Absorbent Film Dressing. As such, it is focused on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria in the manner of a clinical trial for a new drug or a novel AI diagnostic device.

Therefore, many of the requested categories related to device performance studies, such as sample sizes for test and training sets, expert qualifications, and adjudication methods, are not applicable or not provided in this type of regulatory submission. The "acceptance criteria" here refer more to the biocompatibility and functional characteristics typically tested in laboratory settings for wound dressings, rather than diagnostic accuracy metrics.

Here's a breakdown of the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance
Biocompatibility	Non-toxicity	Shown to be nontoxic through laboratory tests.
	Non-irritation	Found to be non-toxic and non-irritating when tested in accordance with ISO 10993 Part I, "Biological Evaluation of Medical Devices" with FDA modified matrix (Guidance effective July 1, 1995).
Functional Characteristics	Moisture Vapor Permeability	Described as a "sterile moisture vapor permeable selfadhesive absorbent dressing." (Implicitly meets functional requirements for this type of dressing).
	Absorbency	"Intended to absorb..." (Implicitly meets functional requirements for absorbency).
	Adhesion	"Selfadhesive" (Implicitly meets functional requirements for adhesion).
Material/Sterility	Sterile	"Individually sealed in medical grade paper pouches" and described as "sterile." (Meets sterility requirements).

Note: The document does not provide specific quantitative thresholds for "nontoxic" or "non-irritating," but rather refers to compliance with a recognized standard (ISO 10993 Part I).

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. This submission describes laboratory tests for biocompatibility and functional performance of a wound dressing, not a diagnostic algorithm. There isn't a "test set" of patient data in the context of an AI device. The tests mentioned (e.g., ISO 10993) involve material testing, not data analysis.

3. 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)

Not applicable/Not provided. As above, this pertains to material testing based on established standards, not interpretation of patient data by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Not provided.

5. 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

Not applicable/Not provided. This device is a wound dressing, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not provided. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For biocompatibility, the "ground truth" is defined by the established criteria and methodology outlined in ISO 10993 Part I, "Biological Evaluation of Medical Devices" with FDA modified matrix. These standards define what constitutes "nontoxic" and "non-irritating" through specific biological test procedures.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided. This is not an AI device that requires a training set.

Summary

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NOV 10 1998

1983554

510(k) SUMMARY

Applicant:	Mölnlycke Health Care500 Baldwin TowerEddystone, PA 19022
Proprietary Name:	Alldress® Absorbent Film Dressing
Contact Person:	Miguel A. Negron, Manager, Regulatory Affairs & QualityTel. 610-499-3383
Substantially

Equivalent Device:

Alldress® Multi-Layered Wound Dressing

The Alldress Absorbent Film Dressing is a sterile moisture vapor permeable selfadhesive absorbent dressing.

The Alldress dressing is individually sealed in medical grade paper pouches and packaged in cartons of ten (10) pouches each. The Alldress dressing is available in three sizes: 10x10cm (4" x 4"), 15x15cm (6" x 6") and 15x20cm (6" x 8").

Alldress is intended to absorb, protect, and maintain a moist environment in open and closed wounds such as; pressure ulcers, venous and arterial leg ulcers, surgical incisions, superficial burns, abrasions, lacerations, and skin tears.

Alldress sterile moisture vapor permeable selfadhesive absorbent dressing have been shown in laboratory tests to be nontoxic.

Alldress have been found to be non-toxic and non-irritating when tested by the above biological tests in accordance with the ISO 10993 Part I, "Biological Evaluation of Medical Devices" with FDA modified matrix (Guidance effective July 1, 1995).

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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the top half of the eagle.

NOV 10 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Miguel A. Negron Manager, Regulatory Affairs & Quality Molnlycke Health Care 500 Baldwin Tower Eddystone, Pennsylvania 19022

Re: K983554

Trade Name: Alldress® Absorbent Film Dressing Regulatory Class: Unclassified Product Code: KMF Dated: October 08, 1998 Received: October 13, 1998

Dear Mr. Negron:

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.
This device may not be labeled as a long-term, permanent, or no-change dressing, or 3. 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

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Page 2 - Mr. Miguel A. Negron

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 (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

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11-03-1998 12:55PM

FKUM M. INEGKUN DUSSAS I YZ

NOV 100 1998

Indications for Use Statement Section 8:

PREMARKET NOTIFICATION

(983554

INDICATIONS FOR USE STATEMENT

510(k) Number:

K983554

Mölnlycke Health Care

Device Name:

Alldress® Absorbent Film 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)

Acce
ision Sign-Off

Division of General Restorative Devices
510(k) Number K9803554

Prescription Use (Per 21 CFR 801.109)

Or Over-The-Counter Use

Premarket Notification: Alldress®

Mölnlycke Health Care

Regulation Number and Section

§ 880.5090 Liquid bandage.

(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.