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510(k) Data Aggregation
(84 days)
The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose:
- medical devices in a single or double pouch configuration
- trays containing medical devices in a single or double pouch configuration
- small items requiring surface sterilization in a single pouch configuration within a tray
NOTE: Trays must be legally marketed for use in the V-PRO Low Temperature or STERRAD Sterilization Systems and contain a vent surface area to tray volume ratio ≥ 0.135 in-1 with the maximum number of instrument organizers installed.
and to be sterilized in the:
- Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO® Low Temperature Sterilization Systems
- Default Cycle of the STERRAD 100S Sterilizer
- Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers
- Express, Standard, Flex Scope, and DUO Cycles of the STERRAD 100NX with ALLClear Technology Sterilizers
The pouches maintain the sterility of the enclosed devices until used.
When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch.
The proposed Vis-U-All Low Temperature Sterilization Pouches/Tubing is identical to the predicate and is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in V-PRO Low Temperature Sterilization Systems. As is the predicate device, the proposed device is available as a self seal pouch, a heat seal pouch, or heat seal tubing.
The provided text describes the acceptance criteria and the results of non-clinical testing for the Vis-U-All Low Temperature Sterilization Pouches/Tubing. However, it does not contain information about a study involving AI, human readers, or ground truth established by experts/pathology/outcomes data, nor does it specify sample sizes for test or training sets in the context of an AI/algorithm device.
This document is a 510(k) summary for a medical device (sterilization pouches) and the testing described is related to the physical and microbial barrier properties, as well as the effectiveness of sterilization and residual levels of sterilant, for the pouch itself. It is not an AI/algorithm-based device and therefore does not have the types of criteria or studies you've requested.
Based on the provided text, here is the information that is available concerning the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| Effective Sterilant Penetration into Pouches (including pouched trays and, if applicable, pouches placed within a tray) | Worst case test articles shall be reproducibly sterilized under worst case ½ cycle conditions for the: | |
| • STERRAD 100S Default Cycle | ||
| • STERRAD NX Standard Cycle | ||
| • STERRAD NX Advanced Cycle | ||
| • STERRAD 100NX Standard Cycle | ||
| • STERRAD 100NX Flex Scope Cycle | ||
| • STERRAD 100NX Express Cycle | ||
| • STERRAD 100NX Duo Cycle | PASS | |
| Pouch Integrity: Physical and Microbial Barrier Properties (Tensile Strength) | Pouch material tensile strength will show no statistical difference between processed and unprocessed samples. | PASS |
| Pouch Integrity: Physical and Microbial Barrier Properties (Whole Package Integrity - Burst) | Pouch burst strength will show no statistical difference between processed and unprocessed pouches. | PASS |
| Pouch Integrity: Physical and Microbial Barrier Properties (Seal Strength) | Pouch seal strength will show no statistical difference between processed and unprocessed pouches. | PASS |
| Pouch Integrity: Physical and Microbial Barrier Properties (Microbial Retention) | Tyvek microbial retention will show no statistical difference between processed and unprocessed pouches. | PASS |
| Maintenance of Package Integrity | Packaged instruments shall remain sterile through event-related and real-time studies. | PASS |
| Aeration: Hydrogen Peroxide Residuals | Hydrogen peroxide residuals on the pouch will be reduced to acceptable levels. | PASS |
Information Not Applicable/Not Provided in the Document:
The product mentioned in the document (Vis-U-All Low Temperature Sterilization Pouches/Tubing) is a physical medical device (sterilization pouches/tubing), not an AI/algorithm or diagnostic imaging device. Therefore, the following requested information points are not applicable to the context of this document:
- Sample sizes used for the test set and the data provenance: Not applicable. This refers to test sets for algorithmic performance, not physical product testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/algorithm.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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