(226 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 Sterilization chamber has a capacity of 4.4 cu. ft. (125 liters). It requires oxygen (94% pure and greater), electricity and the 125-280 Solution™ containing 50% hydrogen peroxide by weight. Both hydrogen peroxide and ozone are used in a multiphase process.
The STERIZONE® VP4 Sterilizer is equipped with a factory-programmed control system offering a unique sterilization cycle.
Processed medical instruments are ready to use immediately after the cycle ends; no aeration is required.
Polypropylene non-woven wrapping material, non-woven polyethylene (Tyvek™) with polyester/LDPE transparent film pouches, and vaporized hydrogen peroxide compatible aluminium containers using disposable polypropylene filters, are used as packaging for medical devices to be sterilized. Plastic and metal trays are also suitable packaging means when combined with polypropylene wraps.
A self-contained biological indicator containing spores of G. stearothermophilus, incorporated into a test pack, is recommended to monitor cycle performance.
The STERIZONE® VP4 Sterilizer could be installed as a free standing unit or recessed behind the wall.
No exhaust gas ventilation duct is required as long as the room is adequately ventilated.
The document is a 510(k) premarket notification for the STERIZONE® VP4 Sterilizer, which is intended for terminal sterilization of reusable medical devices in healthcare facilities. It provides information regarding the device's indications for use, its sterilization process, safety and effectiveness testing, and a comparison to predicate devices to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents "Performance Requirements for Effectiveness" and "Performance Requirements for Safety" for the STERIZONE® VP4 Sterilizer, along with the results.
| Performance Requirements for Effectiveness | Results |
|---|---|
| 1. Effective to sterilize medical devices inoculated with 10^6 microorganism at the half-cycle conditions (Half-cycle validation testing) | Met requirements |
| 2. Effective to sterilize medical devices inoculated with 10^6 microorganism in the presence of organic and inorganic matter at the complete cycle (Simulated-use testing) | Met requirements |
| 3. Sterilize medical devices in real life conditions (In-use testing) | Met requirements |
| 4. Pass the AOAC Sporicidal Screening Test | Met requirements |
| 5. Sterilize effectively on non-woven polyethylene sterilization pouches, rigid aluminum containers and wrapped trays | Met requirements |
| 6. Sterilization efficacy is repeatable | Met requirements |
| Performance Requirements for Safety | Results |
| 1. Sterilant is not toxic for users and patients | Met requirements |
| 2. Most of the materials used in the manufacturing of medical devices are compatible with the hydrogen peroxide-ozone sterilization process | Met requirements |
| 3. Sterilizer complies with electrical safety standards UL 61010-1, CAN/CSA 61010-1, EN/IEC 61010-1 and 61010-2-040 | Met requirements |
| 4. Sterilizer complies with EMI/EMC requirements of FCC 47CFR, part 18, subpart B, and IEC 613261 | Met requirements |
| 5. A Fault Tree Analysis and Mitigation (FTA-MIT) analysis have been preformed on the sterilizer and potential hazards were identified and mitigations were implemented among the control software safeties and design features | Met requirements |
| 6. A Failure Mode Effects and Criticality Analysis (FMECA) was done for each component of the sterilizer and safeties were included in the design of the device according to the findings of this study (built-in safeties) | Met requirements |
| 7. The amount of hydrogen peroxide and ozone remaining on containers and pouches immediately after cycle is not significant | Met requirements |
| 8. There are no toxic residue or by-products residues remaining in/on medical product after the sterilization cycle is completed. After the cycle is completed, medical devices are cool to touch and ready to use immediately (no aeration is required) | Met requirements |
| 9. The sterilization process is safe from an occupational safety point of view | Met requirements |
2. Sample Size Used for the Test Set and Data Provenance:
The "Effectiveness" validation was demonstrated using a "representative sample of one or more device types and packaging, in seven separate validation loads" (Table 1 and 2, pages 2-3 and 7-8). Each load contained various medical instruments representing different geometries and packaging types. The specific number of individual devices or biological indicators within each load is not explicitly stated as a "sample size" in the way it might be for a clinical trial. Instead, the "overkill" approach mentions inoculating medical devices with 10^6 microorganisms, implying a high concentration of test organisms rather than a large count of unique physical samples being tested. This type of testing is generally prospective, designed specifically for validation. The country of origin of the data is not explicitly stated, but the applicant's address is in Quebec, Canada, suggesting Canadian provenance for at least some of the underlying work.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of sterilization efficacy testing does not typically rely on human expert consensus for "ground truth" in the same way as, for example, image interpretation. The ground truth for sterilization is established through microbiological testing (e.g., demonstrating the eradication of 10^6 microorganisms, achieving a sterility assurance level (SAL) of 10^-6), and chemical analysis for residue. The document does not specify the number or qualifications of experts involved in analyzing these microbiological and chemical results, as these are standardized laboratory procedures.
4. Adjudication Method for the Test Set:
Not applicable in the context of sterilization device validation. Adjudication methods like "2+1" are used in studies involving subjective human interpretation, such as clinical image reading. Sterilization efficacy is determined by objective microbiological and chemical tests.
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 outputs, often looking at how AI assistance changes their performance. For a sterilizer, the focus is on the device's inherent ability to achieve sterility, not on human interpretation of data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the effectiveness testing describes the standalone performance of the STERIZONE® VP4 Sterilizer. The entire study focuses on the device's ability to sterilize medical devices on its own, independent of human intervention during the sterilization cycle once initiated. The "half-cycle validation testing," "simulated-use testing," and "in-use testing" all evaluate the device's performance directly.
7. The Type of Ground Truth Used:
The primary ground truth used for effectiveness testing is microbiological efficacy, specifically demonstrating a sterility assurance level (SAL) of 10^-6, which means a probability of one non-sterile item in a million. This is achieved through controlled inoculation of medical devices with a known quantity (10^6) of highly resistant microorganisms (e.g., Geobacillus stearothermophilus spores) and verifying their eradication after sterilization. Secondary ground truths include chemical analysis to ensure the absence of toxic residues and by-products.
8. The Sample Size for the Training Set:
This document does not describe a "training set" in the context of machine learning. The STERIZONE® VP4 Sterilizer is not an AI/ML device in the sense of requiring a training set of data for an algorithm to learn from. The "training" for a sterilization device would be the engineering design, development, and iterative testing that precedes the final validation studies.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as the device is not an AI/ML device that requires a training set and corresponding ground truth. The "ground truth" during the development and design phases would be based on established principles of microbiology, chemistry, and engineering for effective and safe sterilization.
§ 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).