(293 days)
The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.
The STERIZONE® VP4 Sterilizer (VP4) is a self-contained stand-alone device, using vaporized hydrogen peroxide and ozone in a multiphase process. The VP4 offers a single sterilization cycle intended for general instruments, flexible endoscopes (including single, dual, and multi-channel devices), and rigid-channel devices (including single-channel and doublechannel rigid endoscopes).
Lumen claims for the VP4 have been expanded to include double and multiple-channel devices with no more than four channels.
Here's a breakdown of the acceptance criteria and the study details for the STERIZONE® VP4 Sterilizer, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the device's performance in terms of its ability to achieve sterility under various load conditions and its compliance with safety standards. The core acceptance criterion for effectiveness is demonstrating a Sterility Assurance Level (SAL) of 10⁻⁶.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Details/Evidence |
|---|---|---|---|
| Effectiveness (Sterilization) | Achievement of a Sterility Assurance Level (SAL) of 10⁻⁶ for packaged reusable medical devices. | Demonstrated achievement of SAL of 10⁻⁶ using the "overkill" approach. | Performance validation testing on directly inoculated medical devices employing half-cycle. |
| Efficacy for various device geometries and types (clamps, serrated, box-lock, hinges, scopes, cannulas, lumens, flexible endoscopes, multi-channel endoscopes). | Sterilization efficacy demonstrated across nine validation loads covering a wide range of instrument geometries and types. | Nine separate validation loads (Table 1) | |
| Efficacy for various packaging types (wrapped plastic trays, pouches, rigid aluminum containers). | Demonstrated efficacy with various packaging types. | Mentioned within the description of validation loads (Table 1) | |
| Operation within specified load temperature range for processed items. | Load to be maintained between 20°C to 26°C (68°F to 78°F). | Stated in "Indications for Use" and device description. | |
| Operation within specified total load weight. | Total load weight not to exceed 75 lbs (excluding 25 lbs loading rack). | Stated in "Indications for Use" and device description. | |
| Safety | Compliance with North American safety codes and standards. | Designed, constructed, and tested to meet safety and performance requirements of CSA Standard C22.2 No 61010-1, UL 61010-1, FCC Part 18 / EN 55011, IEC 61326-1, IEC 61010-1, IEC 61010-2-040. | Performance Data - Safety section. |
| Implementation of safety features and control redundancies. | Fault Tree Analysis and Mitigation (FTA-MIT) and Failure Mode Effects and Criticality Analysis (FMECA) conducted. | Performance Data - Safety section. | |
| Software controls verification and validation. | Software controls underwent V&V testing in accordance with FDA guidance for "moderate risk" software; no unresolved anomalies. | Performance Data - Safety section. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The test set for effectiveness involved nine separate validation loads. The specific number of individual medical devices or biological indicators within each load is implied to be sufficient to demonstrate SAL 10⁻⁶ for the represented device types and geometries, but a precise count of individual items is not given.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. However, given that it's a 510(k) submission to the U.S. Food & Drug Administration (FDA) by a company (TSO3 Inc.) located in Quebec, Canada, it's reasonable to infer that the studies were conducted by or on behalf of TSO3 Inc., likely in Canada or a facility compliant with regulatory standards for such testing. The validation studies appear to be prospective, designed specifically to demonstrate the effectiveness of the sterilizer for the expanded claims.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not explicitly provided in the document. The determination of sterility (ground truth for effectiveness) in such studies is typically established through the "overkill" approach using biological indicators (BIs) with a known high resistance to the sterilization process. The expertise involved would be in microbiology and sterilization sciences, ensuring proper BI preparation, inoculation, exposure, and recovery methods that align with standards like ANSI/AAMI/ISO 14937. However, no specific number of experts or their qualifications are mentioned.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided. Sterilization validation studies using biological indicators do not involve human "adjudication" in the sense of multiple experts reviewing results like in diagnostic imaging studies. The outcome (sterility or growth) of biological indicators is a direct, objective measure interpreted by microbiological methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, sometimes with AI assistance. The STERIZONE® VP4 Sterilizer is a medical device for sterilization, which has objective performance metrics (sterility, safety) and does not involve human readers interpreting device output in a comparative effectiveness setting as described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the effectiveness study of the STERIZONE® VP4 Sterilizer is inherently a standalone performance evaluation. The device's primary function is to perform sterilization independently. The "performance validation testing" described directly assesses the sterilizer's ability to achieve a Sterility Assurance Level (SAL) of 10⁻⁶ without human intervention or interpretation during the sterilization process itself. The study confirms that the sterilizer, as a standalone automated system, effectively sterilizes the specified medical devices.
7. The Type of Ground Truth Used:
The ground truth used for effectiveness was based on microbiological challenge testing, specifically:
- Biological Indicators (BIs): The "overkill" approach typically involves using biological indicators with a high concentration of resistant microorganisms (e.g., bacterial spores like Geobacillus stearothermophilus) placed in the most challenging locations within the test load.
- Achievement of SAL 10⁻⁶: The ground truth is confirmed by showing the complete inactivation of these highly resistant microorganisms, demonstrating a sterility assurance level of 1 viable microorganism in a million.
8. The Sample Size for the Training Set:
This information is not applicable and therefore not provided. The STERIZONE® VP4 Sterilizer is a physical device that performs a sterilization process, not an AI/machine learning algorithm that requires a "training set" of data in the computational sense. Its performance is validated through defined physical and microbiological challenges.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated in point 8. The device's operational parameters and design are based on established scientific principles of sterilization, engineering, and validated through performance testing rather than training on a data set.
§ 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).