(102 days)
The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and nonmetal reusable medical devices in health care facilities.
The single pre-set cycle of the STERIZONE® VP4 Sterilizer uses hydrogen peroxide and ozone. The injection of vaporized hydrogen peroxide is followed by the injection of ozone, with residual hydrogen peroxide to form hydroxyl radicals.
Sterilization efficacy was demonstrated using a representative sample of one or more device types and packaging, in nine separate validation loads, as described in Table 1. The load to be processed should be maintained between 20℃ to 26℃ (68°F to 78°F). Total load weight shall not exceed 75 lb, inclusive of the containers/packaging weight but excluding the 25 1b loading rack.
The STERIZONE® VP4 Sterilizer is a versatile low temperature sterilizer using two sterilants (vaporized hydrogen peroxide [H₂O₂] and ozone [O₃]) in a multi-phase process to sterilize reusable medical instruments up to a maximum load of 75 lb. In contrast to the sterilization processes using H2O2 only and having multiple cycles, the STERIZONE® VP4 Sterilizer enables the sterilization of a wider range of instruments and load configuration with only one preset cycle. The dynamic system to distribute the sterilant ensures an adequate supply of the sterilant through multiple successive pulsed injections that adapt to the different load conditions (size, weight and temperature). The STERIZONE® VP4 Sterilizer offers a unique preset sterilization cycle (Cycle 1) to sterilize a wide range of loads consisting of general instruments, flexible endoscopes with one channel, double channels and multi-channels, and devices with rigid and semi-rigid channels, including rigid endoscopes with single or double channels.
This document is a 510(k) premarket notification for the STERIZONE® VP4 Sterilizer, specifically addressing an air vent option (K173694) in comparison to a previously cleared version (K153689). The primary focus of the document is to demonstrate substantial equivalence, rather than providing a detailed report of the original validation study for the sterilizer's efficacy.
Therefore, many of the requested details about a study proving the device meets acceptance criteria, such as specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment, are not explicitly provided for the overall sterilizer efficacy. The document focuses on showing that the change (air vent option) does not negatively impact performance or safety.
However, based on the provided text, here is an attempt to address your questions where information is available:
1. A table of acceptance criteria and the reported device performance
The document primarily discusses sterilization efficacy as the overarching performance goal. The "acceptance criteria" for sterilization efficacy is implicitly achieving sterilization, meaning a biological indicator showing no growth. The reported "device performance" is that sterilization efficacy was demonstrated.
| Acceptance Criteria (Implicit for Sterilization Efficacy) | Reported Device Performance |
|---|---|
| Sterilization of medical devices (no microbial growth) | Sterilization efficacy was demonstrated |
| Residual sterilants within acceptable limits | Residual sterilants within clearance criteria (for the air vent change) |
The document outlines the types of devices and loads used in validation studies but doesn't provide specific numerical outcomes for sterilization efficacy (e.g., Sterility Assurance Level, or SAL, achieved). It states that the device is "intended for use in terminal sterilization of cleaned, rinsed, and nonmetal reusable medical devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The sterilization efficacy was demonstrated using a "representative sample of one or more device types and packaging, in nine separate validation loads" (as described in Table 1). The specific number of individual devices or biological indicators within each load is not detailed in this summary.
- Data Provenance: Not explicitly stated as retrospective or prospective, but validation studies for medical devices are typically prospective. The company (TSO3 Inc.) is based in Quebec, Canada, suggesting the studies could have been performed there or internationally.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For sterilization efficacy, the "ground truth" is typically established by the growth or non-growth of biological indicators (e.g., spore strips) after exposure to the sterilization process, followed by incubation. This is a scientific and microbiological assessment, not usually based on expert consensus in the way image interpretation might be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable in the context of sterilization efficacy studies as described. The outcome (sterile or not sterile) is determined by objective microbiological testing methods using biological indicators, not human adjudication.
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
Not applicable. The STERIZONE® VP4 Sterilizer is a medical device for sterilization, not an AI-assisted diagnostic tool or an imaging device. Therefore, MRMC studies are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to a physical sterilizer device. Its performance is inherent to its mechanical and chemical processes, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For sterilization efficacy, the ground truth is established by biological indicator (BI) testing. This involves placing a known quantity of highly resistant microorganisms (e.g., Geobacillus stearothermophilus spores) in challenge devices within the sterilization load. After the sterilization cycle, these BIs are retrieved and incubated. No growth of the test organism indicates successful sterilization (a negative BI result).
Additionally, physicochemical monitoring, such as chemical indicators (CIs) or physical parameters measured by the device itself, would also be used as part of the total validation of the sterilization process.
8. The sample size for the training set
Not applicable. This document describes the validation of a physical sterilizer, not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable. This document describes the validation of a physical sterilizer, not a machine learning algorithm.
Additional Information from the Document Regarding the Validation Study:
- Validation Loads: Nine distinct validation loads were used, described in Table 1 (pages 3, 4, 7). These loads varied in terms of medical instrument geometries (e.g., clamp, serrated surface, hinged, lumens, scopes), packaging types (wrapped plastic tray, aluminum tray, pouch, rigid containers), and total weight. They included both general medical instruments and flexible and rigid endoscopes with varying channel diameters and lengths.
- Load Conditions: The load to be processed must be maintained between 20℃ to 26℃ (68°F to 78°F). Total load weight shall not exceed 75 lb, inclusive of containers/packaging, but excluding the 25 lb loading rack.
- Sterilization Method: Uses hydrogen peroxide and ozone, forming hydroxyl radicals.
- Cycle: A single pre-set cycle ("Cycle 1").
- The overall conclusion is that the updated device (with the air vent option) is "substantially equivalent" to the predicate device, implying that the established sterilization efficacy of the predicate is maintained.
- Biocompatibility testing was also performed, verifying that residual sterilants were within acceptable criteria, demonstrating biological safety.
§ 880.6860 Ethylene oxide gas sterilizer.
(a)
Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.(b)
Classification. Class II (performance standards).