The Dynarex Towel Drape is a device consisting of natural or synthetic materials intended to be used as a patient covering during General Surgical Procedures.

Device Description

The Dynarex Towel Drape is composed of nonwoven fabric or polyethylene film and are of various configurations appropriate for General Surgical procedures. These devices use nonwoven and film materials as a protective patient covering during surgical procedures. These barrier materials are essentially impervious to fluids and microorganisms, thus function to isolate the operative site from the surrounding area. Dynarex Towel Drapes may feature tape adhesive to temporarily bind the drape to the periphery of the operative site. Fluid collection pouches are attached to the drape for collection of operative wound solid and liquid effluents. The Dynarex Towel Drape will be subjected to a sterilizing dose of gamma irradiation to achieve a Sterility Assurance Level (SAL) of 10-6. This towel drape is a single use, disposable provided in a sterile package.

AI/ML Overview

The provided text is a pre-market notification for a medical device called the "Dynarex Towel Drape." This document is a 510(k) submission to the FDA, which aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device.

Based on the information provided, this submission is not for an AI/ML-driven device that would have the typical acceptance criteria and study designs you've listed. Instead, it's for a physical medical product (a surgical towel drape). Therefore, many of the requested fields are not applicable in this context.

Here's an analysis of the available information in relation to your questions:

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

Acceptance Criteria	Reported Device Performance
Functional Equivalence: The Dynarex Towel Drape is substantially equivalent in function, intended use, and functional design to predicate devices.	The Dynarex Towel Drape is "exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices" (referring to DEKA Medical Surgical Drape - K90210 and Invotec International Drape K911039).
Material Composition: Composed of nonwoven fabric or polyethylene film.	Composed of nonwoven fabric or polyethylene film.
Protective Barrier: Essentially impervious to microorganisms to isolate the operative site.	"These barrier materials are essentially impervious to microorganisms thus function to isolate the operative site from the surrounding area."
Sterility Assurance Level (SAL): Sterile product with an SAL of 10^-6.	The device "will be subjected to a sterilizing dose of gamma irradiation to achieve a Sterility Assurance Level (SAL) of 10^-6." Compliance with ANSI/AAMI ST39-1991 for validation and routine monitoring of sterilization.
Packaging: Packaging methods and materials are the same as predicate devices.	"The packaging methods and packaging materials are exactly the same, respectively."
Intended Use: Patient covering during General Surgical Procedures.	Intended for "General Surgical Procedures."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission relies on demonstrating similarity to predicate devices rather than clinical trial data for performance. For a physical product like a drape, testing would typically involve material integrity, barrier effectiveness, and sterility validation, which usually don't involve "test sets" in the AI/ML sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the submission is not for an AI/ML device that requires expert-established ground truth for a diagnostic task.

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

This is not applicable for the same reasons as above.

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

This is not applicable as the device is not an AI-driven diagnostic or assistive tool.

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

This is not applicable as the device is not an algorithm.

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

For this type of device, the "ground truth" would relate to its physical properties and performance characteristics, such as:
* Material specifications: Conformance to intended material (nonwoven fabric or polyethylene film).
* Sterility: Conformance to SAL 10^-6, verified by microbiological testing and sterilization validation.
* Imperviousness: Performance as a barrier to microorganisms, likely tested according to established standards for barrier materials.
* Functional design: Direct comparison and manufacturing to mimic the design of predicate devices.

The document states compliance with ANSI/AAMI ST39-1991 for sterilization validation, which would constitute a form of "ground truth" based on recognized standards.

8. The sample size for the training set

This is not applicable as there is no "training set" for a physical product like this.

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

This is not applicable as there is no "training set." The "ground truth" for demonstrating substantial equivalence for this device is primarily established by adherence to existing material standards, sterilization protocols, and direct comparison to legally marketed predicate devices.

Summary

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Dynarex Corporation (Pre-market Notification)

Page 14

KO12957

Appendix A (Summary of Safety And Effectiveness)

6 2002 MAR

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: Towel Drape

Common Name: Towel Drape

Classification Name: Surgical Towel Drape

Summary of Safety and Effectiveness:

The Dynarex Towel Drape is substantially equivalent in function The Dynarex Towel Drape Is substantially equivals in Invelec International Drape K911039
and intended use to the DEKA Medical Surgical Drape -- K90210, Invotes International and intended use to the DERA Medical Surgical Drape - RoobErry In Solor
and the 18" x 26" Towel Drape, manufactured for Dynarex Corporation (see example of labeling in Appendix D). These products are presently on the market.

Specifically:

Specifically.
the Dynarex Towel Drape is exactly similar in functional design, performs the the Dynarex Tower Drape is exactly of hiller in rainer presently distributed devices.
same functions and has the same intended use as these presently distributively same functions and has the same intended abo as those problems.
The packaging methods and packaging materials are exactly the same, respectively.

The Dynarex Towel Drape is composed of nonwoven fabric or polyethylene film and are of The Dynarex Towel Drape is composed of nomfordinations or procedures. These devices use nonvarious collingurations approphate for General Suring surgical procedures.
woven and film materials as a protective patient covering during surgest them, thus f woven and film materials as a procective pacific surgitive argust them, thus function These barrier materials are essentially impervious to anarex Towel Drapes may feature
to isolate the operative site from the surrounding area. Dynarefiya site Fluid to isolate the operative site from the surrounding around of the operative site. Fluid
tape adhesive to temporarily bind the drape to the peripher wound solid, and tape admesive to temporarily bind the drape for collection of operative wound solid and collection pouches are attached to the drupe for collected to a sterilizing dose of gamma
liquid effluents. The Dynarex Towel Drape will be subjected to a sterilizing dose of ilquid ematines. The Dynarex a Sterility Assurance Level (SAL) of 10-6.

This towel drape is a single use, disposable provided in a sterile prockage. The This tower drape is a shigic use, disposuble pro validate the sterilization process are in
method of sterilization and the method used to validate the study of the clubs method of Stemization and the method used to validation of Health Care Products-----------------------------------------------------------------------------------------------Compliance with ANSI/Arily 1991 1139 17 000. Requirements for Validation and Routho Corner Towel Drape is 10th This is assured through assurance level (SAL) intenthot is achieved with each lot of sterilized product.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three diagonal lines representing the wings of a bird or the staff of Hermes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 6 2002

Dynarex Corporation C/O John Gagliardi Midwest Process Innovation 7736 Woodside Court Mainsville, Ohio 45039

Re: K012957

Trade/Device Name: Dynarex Towel Drape Regulation Number: 878.4370 Regulation Name: Towel Drape Regulatory Class: II Product Code: KKX Dated: January 28, 2002 Received: January 31, 2002

Dear Mr. Gagliardi:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your secures some 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 interstate conmisered prior to may 20, 20, 20, 20, 20, 2011, 2017 10, 2019 10, 2019 10, 2019 Amendinone, or to avriles and Cosmetic Act (Act) that do not require approval of a premarket the Four I vou, Drag, and Sounday, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provise 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 (I MIT), it may be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be round the 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.

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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.

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) 594-4618. 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

Tim Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Dynarex Corporation_Pre-market Notification

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Device Name: Dynarex Towel Drape KO12957

Indications for Use: The Dynarex Towel Drape is a device consisting of natural or synthetic materials intended to be used as a patient covering during General Surgical Procedures.

Clins S. Lin

("Tivision Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 8 100k) Number _

Regulation Number and Section

§ 878.4370 Surgical drape and drape accessories.

(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.