(145 days)
The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose medical devices to be sterilized in Lumen and Non Lumen Cycles in the V-PRO 60 Low Temperature Sterilization System. The pouches are intend to maintain the sterility of the enclosed devices until used.
Pouches are intended to contain devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. Devices with stainless steel lumens and the following minimum internal diameter (ID) and maximum length can be processed in Vis-U-All Low Temperature Sterilization Pouch/Tubing using the Lumen Cycle.
- o single or dual lumen devices
- 0.77 mm ID and 410 mm in length I
- o triple lumen devices
- 1.2 mm ID and 275 mm in length D
- . 1.8 mm ID and 310 mm in length
or
- 트 2.8 mm ID and 317 mm in length
The proposed Vis-U-All Low Temperature Sterilization Pouch/Tubing is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in the V-PRO 60 Low Temperature Sterilization System. The proposed device is available as a self seal pouch, a heat seal pouch, or heat seal tubing.
The STERIS® Vis-U-All Low Temperature Sterilization Pouch/Tubing underwent several tests to demonstrate its safety and substantial equivalence to a predicate device. The information provided outlines the acceptance criteria and a summary of the test results for each.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Effective Sterilant Penetration | Worst case test article shall be reproducibly sterilized under worst case ½ cycle conditions. | PASS |
| Tensile Strength | Pouch material tensile strength will show no statistical difference between processed and unprocessed samples. | PASS |
| Whole Package Integrity (Burst) | Pouch burst strength will show no statistical difference between processed and unprocessed pouches. | PASS |
| Seal Strength | Pouch seal strength will show no statistical difference between processed and unprocessed pouches. | PASS |
| 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 for dermal contact. | PASS |
| Cytotoxicity | Pouch materials shall be non-cytotoxic following worst case exposure in a V-PRO 60 Sterilizer. | PASS |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for each specific test or the data provenance (e.g., country of origin, retrospective or prospective) for the test set. It broadly mentions "Testing of the Vis-U-All Low Temperature Sterilization Pouch/Tubing" and provides summarized conclusions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests appear to be laboratory-based performance evaluations with objective, measurable criteria, rather than those requiring expert human interpretation for ground truth establishment.
4. Adjudication method for the test set:
This information is not provided in the document. Given the nature of the tests (physical and microbial barrier properties, chemical residuals), it's unlikely that an adjudication method typically used for subjective assessments (like 2+1 or 3+1 for expert consensus) would be relevant.
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:
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI-assisted diagnostic tools with human readers, which is not applicable to a sterilization pouch.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device is a physical sterilization pouch, not an algorithm. Therefore, "standalone" algorithm performance is not applicable. The tests performed are inherent to the physical and chemical properties of the pouch itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for these tests is based on objective, quantifiable measurements and established scientific/engineering principles for material performance, microbial viability, and chemical safety. For example:
- Effective Sterilant Penetration: Ground truth is achieving sterilization, likely verified by biological indicators or sterility testing methods.
- Tensile Strength, Burst Strength, Seal Strength, Microbial Retention: Ground truth is determined by comparing measured values against statistical equivalence to unprocessed samples or defined material specifications.
- Maintenance of Package Integrity: Ground truth is confirmed by maintaining sterility through various stress tests and real-time aging, likely using microbial challenge tests.
- Hydrogen Peroxide Residuals: Ground truth is the reduction of residuals to acceptable, predefined safety levels.
- Cytotoxicity: Ground truth is the absence of cytotoxic effects, determined by established biological evaluation methods (e.g., ISO 10993).
8. The sample size for the training set:
A "training set" is not applicable as this is a physical medical device (sterilization pouch) undergoing performance validation, not a machine learning algorithm.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for a machine learning algorithm in this context.
§ 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).