Tidi brand Sterilization/CSR Wrap is suitable for both medical and dental facilities as a wrapping material for sterilizing instruments and equipment.

Available in numerous sizes, CSR wrap is a single-use product intended for use in steam and ethylene oxide sterilization applications. The wraps maintain their wrapped integrity after sterilization to maintain contents' sterility before use.

CSR Wraps can also be used for many needs that do not require sterilization, such as draping a tray and acting as a protective sheet between a surface and instruments.

Device Description

The Banta Healthcare Group Tidi Brand Sterilization/CSR Wrap is suitable for both medical and dental facilities as a wrapping material for sterilizing instruments and equipment. The Sterilization/CSR Wrap is made from a blue, wet formed nonwoven fabric comprised of natural wood pulp fibers bonded with a synthetic resin binder and is available in numerous sheet sizes. Sterilization/CSR Wrap is a single-use product intended for use in steam and ethylene oxide sterilization applications.

AI/ML Overview

This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets them. Instead, it focuses on demonstrating substantial equivalence to a predicate device. Therefore, I cannot generate the requested table and study details.

Here's why and what information is available:

1. Acceptance Criteria and Device Performance:

Not provided. The document does not define specific acceptance criteria for the Tidi Brand Sterilization/CSR Wrap's performance (e.g., burst strength, microbial barrier effectiveness after sterilization).
Instead, it states: "The differences between the Banta Healthcare Group Tidi Brand Sterilization/CSR Wrap specifications and the predicate device specifications do not result in different performance or raise new questions regarding safety and effectiveness." This implies that the 'acceptance criterion' is essentially meeting the performance level of the predicate device, but no quantitative metrics are given.

2. Sample Size and Data Provenance:

Not applicable / Not provided. Since no new performance studies are detailed, there's no mention of sample sizes, test sets, or data provenance. The submission relies on the established safety and effectiveness of the predicate device.

3. Number of Experts and Qualifications:

Not applicable / Not provided. Ground truth establishment by experts is relevant for studies involving subjective assessment (e.g., image interpretation). This submission is for a physical device, and its safety and effectiveness are being assessed through comparison to an existing device, not through expert review of data.

4. Adjudication Method:

Not applicable / Not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable / Not provided. MRMC studies are typically used for diagnostic or interpretive devices where human performance with and without AI assistance is being evaluated. This is a sterilization wrap, not a diagnostic tool.

6. Standalone (Algorithm Only) Performance:

Not applicable / Not provided. This concept applies to AI algorithms. The Tidi Brand Sterilization/CSR Wrap is a physical product.

7. Type of Ground Truth Used:

Not applicable / Not provided (in the context of new studies). The "ground truth" for this submission is effectively the established performance and safety profile of the predicate device, Ahlstrom Dexter - Dextex II Sterilization Wrap (K800123). The argument is that the new device is functionally identical, and therefore, its "ground truth" performance should align with the predicate.

8. Sample Size for Training Set:

Not applicable / Not provided. Training sets are used for machine learning.

9. How Ground Truth for Training Set Was Established:

Not applicable / Not provided.

In summary: The provided text is a 510(k) summary that emphasizes substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria for a new, independent evaluation. This means it leverages the regulatory clearance of an existing device by demonstrating that the new device is essentially the same in terms of intended use and technological characteristics, or that any differences do not raise new questions of safety or effectiveness.

Summary

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NOV 1 7 2004

510(k) SUMMARY

Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The string appears to be "K042580". The characters are written in a dark ink on a white background. The handwriting is somewhat messy, but the characters are still legible.

Submission Correspondent:Address:	Emergo Group, Inc.2454 McMullen Booth RoadSuite 427Clearwater, FL 33759
Phone:	(727) 797-4727
Fax:	(727) 797-4757
Contact:	Mr. Ian Gordon
Submission Sponsor:	Banta Healthcare Group570 Enterprise DriveNeenah, WI 54957
Date Prepared:	September 7, 2003
Trade Name:	Tidi Brand Sterilization/CSR Wrap
Common Name:	Sterilization Wrap
Classification:	FRG, Wrap, SterilizationClass II, Regulation No. 880.6850

Description:

Intended Use:

Tidi brand Sterilization/CSR Wrap is suitable for both medical and dental facilities as a wrapping material for sterilizing instruments and equipment.

CSR Wraps can also be used for many needs that do not require sterilization, such as draping a tray and acting as a protective sheet between a surface and instruments.

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Predicate Devices: The predicate device referenced in this submission is:

Ahlstrom Dexter - Dextex II Sterilization Wrap, 510(k) # K800123

Safety and Effectiveness:

The differences between the Banta Healthcare Group Tidi Brand Sterilization/CSR Wrap specifications and the predicate device specifications do not result in different performance or raise new questions regarding safety and effectiveness.

Summary and Conclusion Regarding Substantial Equivalence:

By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.

The differences between the Banta Healthcare Group Tidi Brand Sterilization/CSR Wrap and the predicate device cited do not raise any different questions regarding safety and effectiveness. There are no differences in the technological characteristics and the associated procedures are nearly identical. The intended use is identical to the intended use of the previously cleared predicate device, and the indications are equivalent.

The device, as designed, is as safe and effective as the predicate device, and the device is determined to be substantially equivalent to the referenced predicate device.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

NOV 1 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Banta Healthcare Group, Limited C/O Mr. Tamas Borsai Responsible Third Party Official T ÜV Rheinland of North America 12 Commerce Road Newton, Connecticut 06470

Re: K042580

Trade/Device Name: Tidi Brand Sterilization/CSR Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: November 3, 2004 Received: November 4, 2004

Dear Mr. Borsai

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 appear 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 (1 Mr.), it a 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 Eederal Register.

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Page 2 - Mr. Borsai

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. or me For of any 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), nlease 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Clares

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

KO42580 310(k) Number (if known): _

Tidi Brand Sterilization/CSR Wrap Device Name:

Indications for Use:

Tidi brand Sterilization/CSR Wrap is suitable for both medical and dental facilities as a wrapping material for sterilizing instruments and equipment.

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

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use . (Per 21 CFR 801.109) OR

Over the Counter Use_ x

Ques

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital.
Division Control Dental Devices Division of Anesthouldress Infection Control. Dental Devices

510(k) Number: K042580

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).