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510(k) Data Aggregation
(107 days)
TSO3 Inc., Now a part of Stryker
The STERIZONE® VP4 Test Pack is intended to be used for routine monitoring of the STERIZONE® VP4 Sterilizer cycle (Cycle 1) and for the performance validation of the STERIZONE® VP4 Sterilizer system.
The STERIZONE® VP4 Test Pack is a Process Challenge Device (PCD) designed to have greater resistance than the worst-case sterilization load of the STERIZONE® VP4 Sterilizer. The STERIZONE® VP4 Test Pack is intended to simulate products to be sterilized and to constitute a defined challenge to the sterilization process and used to assess the effective performance of the process.
The STERIZONE® VP4 Test Pack (subject device) is composed of a Self-contained Biological Indicator (the Terragene's Bionova® BT96), a 10 mL syringe and its plunger, and a diffusion restrictor. A STERIZONE® CI+ Chemical Indicator is also added, external to the syringe, to allow differentiating processed from unprocessed test packs. All components of the Test Pack are single-use, disposable items.
The provided text describes the performance testing of the STERIZONE® VP4 Test Pack (subject device) which uses the Terragene Bionova® BT96 biological indicator, compared to a predicate device that used a different biological indicator. The goal was to demonstrate substantial equivalence.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Test Purpose | Test Acceptance Criteria | Subject Device Test Result |
|---|---|---|---|
| Half-cycle Survivability | Determine if the SCBI, when used within the Test Pack, can provide a resistance to the sterilization process that is equal to or greater than the most difficult item routinely processed in the sterilizer, per ISO 14937, ISO 11138-7 and the Guidance for Industry and Staff – Biological-Indicator (BI) Premarket Notification [510(k)] Submission. | The SCBI in the Test Pack must show growth at half-cycle in all the limit parameter loads tested. | The SCBI in the Test Pack showed growth at half-cycle in all the limit parameter loads tested. |
| Full cycle inactivation | Determine if the SCBI used within the Test Pack can repeatedly and consistently show an inactivation point in the second half of the sterilization cycle. | The SCBI in the Test Packs must demonstrate a survival ratio of 0% at least at the full cycle using the worst-case challenge load. | The SCBI in the Test Pack shows survival ratio of 0% in the second half of the sterilizer cycle, thus shows total inactivation by the end of a full cycle. |
| Increased resistance | Determine if the use of the Test Pack provides a greater challenge to the process than the BI itself, per Guidance for Industry and Staff - Biological-Indicator (BI) Premarket Notification [510(k)] Submission. | The SCBI in the VP4 Test Pack must show a higher survival ratio than its naked counterpart. | When exposed to the same partial cycles, the SCBI in the Test Pack showed growth while the naked SCBI was fully inactivated. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the numerical sample size for the test set (e.g., number of test packs, number of sterilization cycles). It mentions "all the limit parameter loads tested" for half-cycle survivability and "partial cycles" for increased resistance, implying multiple runs, but no specific number.
The data provenance is from bench testing ("Performance Testing - Bench") conducted by TSO3 Inc. (now part of Stryker) for this 510(k) submission. The location of the testing is not specified, but the submitter is TSO3 Inc. in Québec, Canada and Stryker in Portage, Michigan, USA. The nature of the study is prospective, as it's performance testing for a new device qualification.
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. For biological indicators, the ground truth is typically established by the growth or non-growth of spores, which is a direct biological outcome, not subject to expert interpretation in the same way as, for example, a medical imaging diagnosis.
4. Adjudication method for the test set:
This information is not applicable and therefore not provided. The results of biological indicator testing (growth or no growth) are objective and do not require adjudication by multiple experts.
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 information is not applicable as the device is a sterilization process indicator, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is not an algorithm, but a physical biological indicator used in a sterilization process. Its performance is inherent to its design and biological response, not an algorithm's output.
7. The type of ground truth used:
The ground truth used is biological growth/non-growth of Geobacillus stearothermophilus spores. This is a direct measure of the effectiveness of the sterilization process in inactivating microorganisms.
8. The sample size for the training set:
This information is not applicable. The STERIZONE® VP4 Test Pack is a physical device, not a machine learning model, so there is no training set in the context of AI/ML. The device's resistance characteristics are determined through experimental validation, not by "training" an algorithm.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set. The performance is assessed against established standards for biological indicators.
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