The Kendall Xeroform Petrolatum Wound Dressing is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate where mild medication and deodorization are desired.

Device Description

The proposed Kendall Xeroform Petrolatum Wound Dressing is a sterile, singleuse, non-adherent dressing consisting of absorbent gauze impregnated with Xeroform in a petrolatum blend. It is packaged in metalized chevron pouches and is available in 4" x 3yd roll, 1" x 8", 5" x 9", 2" x 2" and 4" x 4" sizes.

AI/ML Overview

The provided document is a 510(k) summary for the Kendall Xeroform Petrolatum Wound Dressing. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing specific device performance against acceptance criteria from a clinical study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be fully extracted as it pertains to a traditional clinical performance study for an AI/CADe device. The provided text describes the device's characteristics and its equivalence to a predicate device based on material, function, and indication for use, alongside biocompatibility testing. It is not a document describing the results of a controlled clinical trial with performance metrics.

I can, however, extract the relevant information that is present regarding non-clinical testing and the comparison method:

1. Table of acceptance criteria and the reported device performance:

Criteria Type	Acceptance Criteria	Reported Device Performance
Biocompatibility	Based on guidelines in 10993 ISO Standard, Part 1, with FDA modified matrix G95-1.	Demonstrated that the device "contains no bioactive components."
Material Equivalence	Similar materials to predicate device (Sherwood Medical Xeroform Petrolatum Dressing).	Device is "fabricated from similar materials" to the predicate.
Functional Equivalence	Similar function to predicate device.	Device has a "similar function" to the predicate.
Intended Use Equivalence	Equivalent indications for use as predicate device.	Device has "equivalent indications for use" as the predicate.

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

Sample Size for Test Set: Not applicable. The document discusses device characteristics and performance in terms of biocompatibility and equivalence, not a test set of data points for an algorithm.
Data Provenance: Not applicable.

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

Not applicable. This is not a study involving expert-established ground truth for a test set.

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

Not applicable.

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:

No MRMC comparative effectiveness study was done. This document does not describe an AI/CADe device.

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

No standalone algorithm performance study was done. This is not an algorithmic device.

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

Not applicable in the context of an algorithm's ground truth. However, the ground for the device's safety and effectiveness relies on biocompatibility testing standards and demonstration of substantial equivalence to a previously marketed device (Sherwood Medical Xeroform Petrolatum Dressing) which was already deemed safe and effective.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

Summary

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171350 /

EXHIBIT #7

DEC 1 5 1997

510(k) Summary

Kendall Xeroform Petrolatum 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 September 3, 1997 Date Prepared:

1. Contact Person

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

2. Name of Medical Device

Classification Name: Common or Usual Name: Unclassified Xeroform Petrolatum Wound Dressing

Identification of Legally Marketed Device ന്

The proposed Kendal! Xeroform Petrolatum Wound Dressing is substantially equivalent in intended use and composition to the Sherwood Medical Xeroform Petrolatum Dressing which was in commercial distribution before May 28, 1976.

ধ: Device Description

ട. Device Intended Use

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6. Product Comparison

The Kendall Xeroform Petrolatum 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.

7. Nonclinical Testing

Biocompatibility testing of the Kendall Xeroform Petrolatum 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 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 image of a human figure with outstretched arms, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 1997

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

Re: K973507 Kendall Xeroform Petrolatum Dressing Regulatory Class: Unclassified Product Code: FRO Dated: September 15, 1997 Received: September 16, 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 acceleratimg 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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K973507

510(k) Number (if known):

Device Name: Kendall Xeroform Petrolatum Dressing

Indications For Use:

It is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate where mild medication and deodorization are desired.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K973507

Prescription Use	X
(Per 21 CFR 801.109)

Over-The-Counter Use	_________________
(Optional Format 1-2-96)

(Optional Format 1-2-96)

Regulation Number and Section

N/A