Theae dressings are intended for use as a primary dressing in the management of medium to heavy draining wounds such as minor burne, abrasions and lacerations. These dressings may also be used under the care of a health tare professional for wounds such as surgical incisions, skin grafts, and dermal ulcers.

Device Description

The proposed Kendall Curity Non-Adhering Dressing is a sterile, single-use, dressing consisting of cellulose acetate fabric impregnated with a specially formulated petrolatum emulsion. It is packaged in clear polyester pouches and is available in 3" x 3", 3" x 8", 3" x 16" and 14" x 4 yds sizes.

AI/ML Overview

Here's an analysis of the provided text regarding the Kendall Curity Non-Adhering Dressing, focusing on the absence of acceptance criteria and a study proving their fulfillment:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no table of acceptance criteria or reported device performance in the provided document. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative performance metrics against pre-defined acceptance criteria.

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

No information regarding a "test set" in the context of evaluating performance against acceptance criteria is provided. The document refers to "Biocompatibility testing," but doesn't specify sample sizes, data provenance (e.g., country of origin), or whether it was retrospective or prospective.

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

This information is not applicable or available in the provided document. The submission type (510(k) for a non-adhering wound dressing) does not typically involve the establishment of ground truth by clinical experts in the way AI or diagnostic device studies would. The assessment revolves around material composition and intended use equivalence.

4. Adjudication Method for the Test Set:

This information is not applicable or available as there is no described test set or clinical performance evaluation involving adjudication.

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

No MRMC comparative effectiveness study was done or reported. The 510(k) submission for this type of device does not typically require an MRMC study. The focus is on product comparison to a predicate device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This information is not applicable as the device is not an algorithm or AI-driven system. It is a physical wound dressing.

7. The Type of Ground Truth Used:

Ground truth in the typical sense (expert consensus, pathology, outcomes data) is not applicable for this device submission. The primary "truth" being established is the safety and effectiveness through substantial equivalence to a legally marketed predicate device, based on material composition and intended use. The biocompatibility testing implies adherence to established safety standards, which can be seen as a form of "ground truth" derived from scientific principles, but not clinical outcomes in the same way.

8. The Sample Size for the Training Set:

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reason as above.

Summary of Device Submission Type and Relevance:

The provided document is a 510(k) Pre-Market Notification for a wound dressing. This regulatory pathway primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves:

Comparison of Technical Characteristics: Showing similar materials, design, energy (if applicable), and intended use.
Performance Data (often non-clinical): Such as biocompatibility, sterility, and physical properties, to ensure the new device performs as safely and effectively as the predicate.
Clinical Data (rarely required for 510(k)s for simple devices like dressings): Unless the device has novel technology, a new intended use, or raises new safety/effectiveness questions not addressed by a predicate.

In this specific case, the submission relies on:

Substantial Equivalence: To the Johnson & Johnson Medical, Inc., Adaptic® Non-Adhering Dressing based on similar materials and intended use.
Biocompatibility Testing: Based on ISO 10993 standards and FDA guidelines (memorandum G95-1). This testing aims to ensure the materials used are not toxic or irritating to the human body, which is a key safety aspect.

The absence of detailed quantitative acceptance criteria and a "study that proves the device meets the acceptance criteria" in the way one might expect for an AI or diagnostic device is consistent with the nature of a 510(k) submission for a non-adhering wound dressing in 1997. The "proof" lies in the demonstration of substantial equivalence and adherence to general safety standards (like biocompatibility).

Summary

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K973619

DEC I O 1997

EXHIBIT #6

510(k) Summary

Kendall Curity Non-Adhering 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 September 17, 1997 Date Prepared:

Contact Person 1.
David A. Olson Manager Regulatory Affairs (508) 261-8530
Name of Medical Device 2.
Classification Name: Unclassified Common or Usual Name: Non-Adhering Dressing
Identification of Legally Marketed Device ਤੇ.
The proposed Kendall Curity Non-Adhering Dressing is substantially equivalent in intended use and composition to the Johnson & Johnson Medical, Inc., Adaptic® Non-Adhering Dressing which was in commercial distribution before May 28, 1976.

Device Description 4.

Device Intended Use 5.
The Kendall Curity Non-Adhering Dressings are intended for use as a primary dressing in the management of medium to heavy draining wounds such as minor burns, abrasions and lacerations. These dressings may also be used under the supervision of a health care professional for wounds such as surgical incisions, skin grafts, and dermal ulcers.

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6. Product Comparison

The Kendall Curity Non-Adhering 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.

7. Nonclinical Testing

Biocompatibility testing of the Kendall Curity Non-Adhering 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 eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 1997

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

Re: K973619 Kendall Curity Non-Adhering Dressing Regulatory Class: Unclassified Product Code: KMF Dated: September 18, 1997 Received: September 23, 1997

Dear Mr. Olson:

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

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Page 2 - Mr. David A. Olson

registration, listing of devices, good manufacturing practices, labeling, and prohibitions against 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

Enclosure

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510(k) Number (if known): K973619

Device Name: Kendall Curity Non-Adhering 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)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K973619

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use
		(Optional Format 1-2-96)

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.