The Dynarex Iodoform Packing Strip is a device used as an antibacterial barrier and for general use in wound packing and management. This Iodoform Packing Strip is indicated for external use only.

Device Description

The Dynarex lodoform Packing Strip is substantially equivalent in function and intended use to these examples of products presently on the market. Specifically, the Dynarex lodoform Packing Strip is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices. The packaging methods and packaging materials are exactly the same, respectively. The Dynarex lodoform Packing Strip is a device for general use in wound packing and management and is not different than the predicate device example, therefore the safety, effectiveness and overall function of this device is assured.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Dynarex Iodoform Packing Strip. This document asserts substantial equivalence to a predicate device rather than presenting a study demonstrating the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be found in this type of submission.

Here's a breakdown of the available information based on the provided text, and where information is missing for your specific requests:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria/Performance: Not applicable. The document does not define specific performance acceptance criteria or report performance data for this device. The basis for clearance is "substantial equivalence" to a predicate device, meaning it is considered equally safe and effective.

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

Sample Size/Data Provenance: Not applicable. No test set or study data is presented in this 510(k) submission.

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

Experts/Qualifications: Not applicable. No ground truth was established for a test set as no study was performed.

4. Adjudication method for the test set

Adjudication Method: Not applicable. No test set or adjudication was performed.

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: No. This device is a physical product (Iodoform Packing Strip), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant.

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

Standalone Performance: Not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used

Type of Ground Truth: Not applicable. No ground truth was established as no study was performed.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This is not an AI/algorithm-based device; therefore, no training set was used.

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

Training Set Ground Truth: Not applicable. No training set was used for this device.

Summary of Device and 510(k) Basis:

Device Name: Dynarex Iodoform Packing Strip
Intended Use: Device for general use in wound packing and management, as an antibacterial barrier. Indicated for external use only.
Basis for Clearance: Substantial equivalence to already marketed predicate devices. The submission states: "The Dynarex Iodoform Packing Strip is substantially equivalent in function and intended use to these examples of products presently on the market. Specifically, the Dynarex Iodoform Packing Strip is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices. The packaging methods and packaging materials are exactly the same, respectively. The Dynarex Iodoform Packing Strip is a device for general use in wound packing and management and is not different than the predicate device example, therefore the safety, effectiveness and overall function of this device is assured."

This type of 510(k) submission does not typically involve detailed performance studies against specific acceptance criteria, but rather a robust comparison to an existing, legally marketed device to demonstrate equivalence.

Summary

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OCT 1 7 2002

Dynarex Corporation (Pre-market Notification)

Page 14

Re: K012816

Appendix A (Summary of Safety And Effectiveness)

Submitter:

John Gagliardi, President (contact person) MidWest Process Innovation, LLC 7736 Woodside Court Maineville, OH 45039 513-573-0085 (Telephone and fax) or 513-573-0519 (Telephone and fax) JGAGL777@One.Net

Trade Name: Dynarex Iodoform Packing Strip

Common Name: Iodoform Packing Strip

Classification Name: Unclassified

Iodoform: 5%

Summary of Safety and Effectiveness:

The Dynarex lodoform Packing Strip is substantially equivalent in function and intended use to these examples of products presently on the market.

Specifically, the Dynarex lodoform Packing Strip is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices.

The packaging methods and packaging materials are exactly the same, respectively.

The Dynarex lodoform Packing Strip is a device for general use in wound packing and management and is not different than the predicate device example, therefore the safety, effectiveness and overall function of this device is assured.

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Image /page/1/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 three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble a ribbon or banner. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 7 2002

Mr. John Gagliardi President MidWest Process Innovation, LLC 7736 Woodside Court Maineville, Ohio 45039

Re: K012816 Trade/Device Name: Dynarex Iodoform Packing Strip Regulatory Class: Unclassified Product Code: FRO Dated: August 19, 2002 Received: August 22, 2002

Dear Mr. Gagliardi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device 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 limited to: registration 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.

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Page 2 - Mr. John Gagliardi

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours, elia M. Witten, Ph.D., M.D

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

Enclosure

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012816

Revised: 5/26/02

Dynarex Corporation Pre-market Notification

Page 5

Device Name: Dynarex Iodoform Packing Strip

Indications for Use: The Dynarex Iodoform Packing Strip is a device used as an antibacterial barrier and for general use in wound packing and management. This Iodoform Packing Strip is indicated for external use only. Federal (USA) law restricts this Iodorm
sale by or on the order of a physician sale by or on the order of a physician.

Styfe Ruvets

(Division Sign-Off) (Division Sigir On) Restorative Division of ogical Devices

510(k) Number K012816

Regulation Number and Section

N/A