(56 days)
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.
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.
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.
§ 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).