Like the predicate device, the Kendall Hydrophilic Powder Wound Dressing is indicated for the management of exudating wounds such as dermal ulcers (e.g., venous stasis, pressure, arterial, diabetic), surgical incisions, traumatic wounds (e.g., lacerations, abrasions).

Device Description

The proposed Kendall Hydrophilic Powder Wound Dressing is a sterile composition of maltodextrin, sodium alginate and chitosan chloride. As the powder absorbs wound exudate It converts to a gel. This gel forms a moist environment at the wound interface conducive to healing The product is available in 6 gram, 12 gram and 25 gram packets.

AI/ML Overview

The provided text is a 510(k) summary for the Kendall Hydrophilic Powder Wound Dressing and subsequent FDA correspondence. It focuses on establishing substantial equivalence to a predicate device, rather than presenting a study demonstrating the device meets specific performance acceptance criteria.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria. The provided text primarily addresses:

Device identification and contact information.
Classification and legal marketing identification of a predicate device.
Device description and intended use.
Product comparison to the predicate device (similar materials, function, indications).
Nonclinical testing for biocompatibility.
FDA's substantial equivalence determination letter with labeling limitations.

Specifically, regarding the requested information:

A table of acceptance criteria and the reported device performance: Not present. The submission focuses on equivalence, not performance against specific criteria.
Sample size used for the test set and the data provenance: Not applicable, as no performance study is described. Biocompatibility testing is mentioned, but details on sample size or provenance are not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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. This device is a wound dressing, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The "Nonclinical Testing" section mentions "Biocompatibility testing... based upon guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1." While this indicates testing was performed according to established standards, it does not specify performance acceptance criteria (e.g., cytotoxicity levels, irritation scores) or the specific results of these tests. It only states that the testing "demonstrated that it contains no bioactive components."

Summary

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Ka70266

EXHIBIT #4

APR 23 1997

510(k) Summary

Kendall Hydrophilic Powder Wound Dressing

In accordance with section 513(I) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by

Kendall Healthcare Products Company 15 Hampshire Street Mansfield, MA 02048 Date Prepared: April 21, 1997

1.5.19.12.2014 1

ﻟﺴﻴﺴ Contact Person

11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 17

David A. Olson Manager Regulatory Affairs (508) 261-8530

2 Name of Medical Device
Classification Name. Unclassified Hydrophilic Powder Wound Dressing Common or Usual Name:

ﺯﻣﺎ Identification of Legally Marketed Device

The proposed Kendall Hydrophilic Powder Wound Dressing is substantially equivalent in intended use and composition to the commercially available DeRoyal Multidex® Hydrophilic Powder Wound Dressing, 510(k) No K945000.

4 Device Description

5 Device Intended Use

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Product Comparison 6

The Kendall Hydrophilic Powder Wound Dressing is equivalent to the referenced predicate device in that they are fabricated from similar materials, have a similar function and equivalent indications for use

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1 . UU4

14970264

7 Nonclinical Testing

Biocompatibility testing of the Kendall Hydrophilic Powder Wound Dressing has demonstrated that it contains no bioactive components. Testing performed on the product was based upon guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.

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Image /page/2/Picture/1 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 heads, each head in profile. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 200/

Mr. David A. Olson Manager, Regulatory Affairs Kendall Healthcare Products Company 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K970266 Kendall Hydrophilic Powder Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: January 22, 1997 Received: January 23, 1997

Dear Mr. Williams:

This letter corrects our substantially equivalent letter of April 23, 1997.

We have reviewed your Section 510(k) premarket notification of intent to market the wc nave reviewed your bootion be (--)----------------------------------------------------------------------------------------------------------------------------------------ucvice referenced about and it closure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device m interstate commerce proble to maj 20, 2017 reclassified in accordance with the provisions of Amendinents of to area, and Cosmetic Act (Act) that do not require approval of a the Federal Pood, Drug, and Costient Hev (100), market the device, subject to the general promatics approvisions of the Act. The general controls provisions of the Act include controls providents of an annual registration, listing of devices, good manufacturing practice, requirements for anifall registrations and adulteration and the following limitations:

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 wound healing or epithelization.
This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.

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Page 2 – Mr. David A. Olson

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).

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your (1 vice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not I carrier agencies: "Four and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section Fins letter will and in your of substantial equivalence of your device 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.

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Page 3 - Mr. David A. Olson

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. N son Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Regulation Number and Section

N/A