DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC) by DUMEX MEDICAL SURGICAL PRODUCTS, LTD.

Non-Woven dressing impregnated with Sodium Chloride is intended for use on moderately to heavily exudating wounds. The dressing will absorb exudate and maintain a moist hypertonic environment when applied to the wound. A moist wound environment will support autolytic debridement of the wound. The dressing is appropriate for the following indications:minor cuts, minor burns and minor lacerations. Under the guidance of a heatth care professional, "AbsorbaSalt" Cotton Gauze Packing is also indicated for surgical incisions and excisions, venous stasis ulcers, pressure ulcers and decubitus ulcers.

Device Description

Dumex Pak-its Non-Woven Dressing Impregnated with Sodium Chloride

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Dumex Pak-its Non-Woven Dressing:

Based on the provided document, which is a 510(k) premarket notification letter from the FDA, the information requested about acceptance criteria and a study proving device performance is not explicitly available in this format.

The document primarily focuses on:

Confirming "substantial equivalence" of the device to existing predicate devices. This means the FDA has determined the new device is as safe and effective as a legally marketed device that was on the market before May 28, 1976, or has been reclassified.
Stating specific limitations on labeling claims for the device (e.g., no claims of accelerating wound healing, no claims for third-degree burns).
Outlining general regulatory requirements for the device.
Listing the "Indications for Use."

A 510(k) submission typically includes data to support substantial equivalence, which might involve performance data. However, the FDA letter itself is a summary of the regulatory decision, not the full performance study report. Therefore, I cannot extract the detailed study information you requested directly from these pages.

However, I can infer some aspects and highlight what information is missing based on your request categories:

Here's an attempt to fill out the table, acknowledging that most of the requested detail is not present in the provided FDA letter:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred/Not Explicit)	Reported Device Performance (Inferred/Not Explicit)
Safety	Non-toxic, non-irritating, biocompatible.	Assumed to meet safety profile similar to predicate; no adverse events reported in summary.
Effectiveness (Indications)	Ability to absorb exudate, maintain moist hypertonic environment, support autolytic debridement.	Assumed to exhibit these properties for minor cuts, minor burns, minor lacerations, surgical incisions/excisions, venous stasis ulcers, pressure ulcers, and decubitus ulcers. Performance is "substantially equivalent" to predicate.
Material Properties	Absorbency, tensile strength (for dressing).	Not specified, but implied to be comparable to predicate.
Sterility	Must be sterile (for wound care).	Not explicitly stated, but implied for medical dressing.
Labeling Compliance	Adherence to specific FDA labeling restrictions.	Explicitly outlined as restrictions in the letter (e.g., no 3rd-degree burn claims, no accelerated healing claims).
Substantial Equivalence	Device is as safe and effective as a legally marketed predicate device.	FDA determined the device is substantially equivalent to existing predicate(s).

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

Sample Size: Not specified in the provided document.
Data Provenance: Not specified. It's likely from a combination of bench testing, possibly some preclinical data, and comparison to existing predicate devices. Whether it's retrospective or prospective is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. For substantial equivalence, the "experts" are often the manufacturers providing data, and FDA reviewers.

4. Adjudication method for the test set

Not specified.

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

MRMC Study: Unlikely to be applicable. This device is a wound dressing, not an imaging AI diagnostic tool. Therefore, MRMC studies and "human readers improve with AI" metrics are not relevant in this context.

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

Not applicable as this is a physical medical device (wound dressing), not an algorithm or AI system.

7. The type of ground truth used

For a physical device like a wound dressing, "ground truth" would typically refer to objective measures of performance (e.g., absorbency tests, biocompatibility tests, clinical outcomes in trials if clinical data was part of the submission), and comparison to the performance of predicate devices. The letter indicates that the device's performance is assumed to be equivalent to the predicate.

8. The sample size for the training set

Not applicable to this type of device and submission (no "training set" in the AI/ML sense).

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

Not applicable to this type of device and submission.

Summary of missing information:

The provided document is an FDA clearance letter for a 510(k) submission. It confirms regulatory clearance based on "substantial equivalence" to a predicate device and outlines labeling restrictions. It does not contain the detailed study design, specific performance metrics, sample sizes, or expert review processes that would be submitted by the manufacturer to the FDA as part of the 510(k) application itself. To get that level of detail, one would need access to the full 510(k) submission report, which is usually hundreds or thousands of pages long.

Summary

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Image /page/0/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 a stylized symbol resembling an abstract caduceus or a bird-like figure with three curved lines representing wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Sharmini Atheray, M.Sc Dumex Medical Surgical Products Limited 104 Shorting Road Scarborough, Ontario MIS3S4, Canada

MAY 1 1 1998

K980863 Trade Name: Dumex Pak-its Non-Woven Dressing Impregnated with Sodium Chloride Regulatory Class: Unclassified Product Code: KMF Dated: March 4, 1998 Received: March 5, 1998

Dear Mr. Atheray:

Re:

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.
This device may not be labeled as having any accelerating effect on the rate of 2. 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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Page 2 - Mr. Atheray

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 vour 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,

2 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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Form B

Indications for Use Form

ORD GIDE

510(k) Number (if known): ¿ 98086 3

IMPREGNATED Device Name: Dumax PAK-ITS NON HOVEN ORESSING HITH SODIVM CHLORIDE ( HYPERTONIC) Indications for Use:

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use $\checkmark$

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Page

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.