(141 days)
The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and are thus suitable for processing medical devices sensitive to heat and moisture.
The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle can sterilize:(a)
- Lumened and non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations: (a)
- o single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
- o dual channeled devices with stainless steel lumens that are > 0.77 mm ID and 2.8 mm ID and 1 mm ID and 1 mm ID and
The V-PRO 1 Plus and V-PRO maX Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Devices that meet the criteria described within the indications for use and composed of compatible materials are placed within the sterilization chamber and the appropriate cycle selected through the graphic user interface. The preprogrammed cycles all utilize a conditioning phase which prepares the chamber, a sterilize phase in which loaded devices are exposed to the sterilizing agent, VHP, at low pressure and an aeration phase to remove residual hydrogen peroxide. The packaged sterilized devices are ready for use at the completion of the cycle, no cool down or aeration period is required following completion of the cycle.
The V-PRO 1 Plus Low Temperature Sterilization System provides two cycle options, Lumen and Non Lumen. The sterilizer contains a 136 L welded aluminum chamber with two shelves for device loading, an onboard printer to provide cycle printouts, a cup interface where the VAPROX HC cups are loaded, a display for the graphic user interface and the components necessary to achieve the desired cvcle parameters (injection cylinder, vaporizer, vacuum pump and catalytic converter). The side panels of the sterilizer are composed of stainless steel.
The V-PRO maX Low Temperature Sterilization System provides three cycle options, Lumen, Non Lumen and Flexible. The sterilizer contains a 136 L welded aluminum chamber with two shelves for device loading, an onboard printer to provide cycle printouts, a cup interface where the VAPROX HC cups are loaded, a display for the graphic user interface and the components necessary to achieve the desired cycle parameters (injection cylinder, vacuum pump and catalytic converter). The side panels of the sterilizer are composed of plastic.
The purpose of this pre-market notification is to modify the maximum load weight for the Non Lumen Cycle from 19.65 to 50 lbs, to add titanium diffusion-restricted areas to the indications for use of the Non Lumen Cycle, and to remove the term "reusable" from indications for use statement.
The FDA 510(k) summary for the V-PRO® 1 Plus and V-PRO® maX Low Temperature Sterilization Systems describes performance testing to support the substantial equivalence claim. Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the "PASS" result in the context of sterilization, meaning the device successfully sterilized the test articles under specified conditions. The document acts as a summary, so detailed quantitative acceptance criteria (e.g., specific log reduction of microorganisms) are not explicitly stated in this high-level summary but are inherent to sterilization validation.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| ½ Cycle Modified Total Kill Endpoint Verification | All sterile results within validation load at standard and at least one lower sterilant injection weight. Partial positives/all survive at lower injection weights. | PASS |
| ½ Cycle Sterilization Verification of Cycle Claims | Reproducibly sterilizes non-lumened devices, mated surfaces, and device tray accessories contact sites under worst-case conditions in ½ Cycle. | PASS |
| Simulated Use Test | Verified ability of Non Lumen Cycle to sterilize medical devices under worst-case processing conditions. | PASS |
| Final Process Qualification | All cycle specifications met through manual inspection of process parameter data. | PASS |
| Sterilizer Accessories Performance | Reproducibly sterilizes SCBIs under worst-case ½ cycle conditions; PIs exhibit passing color change; SCBIs negative for growth under full cycle conditions; Chemical indicators show complete color change; Test articles effectively sterilized when packaged as specified. | PASS |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state a numerical sample size for the test set in terms of the number of items sterilized in total. However, it provides details on the load configurations used in the validation studies:
- Lumen Cycle: Maximum of twenty (20) lumens per load, using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.
- Non Lumen Cycle: Validation load consisting of two instrument trays for a total weight of 50 lbs. (This is a modification from the previous 19.65 lbs of two instrument trays and two pouches).
- Flexible Cycle (Config 1): Two flexible endoscopes (with light cord/mat) with no additional load.
- Flexible Cycle (Config 2): One flexible endoscope (with light cord/mat) and additional non-lumened instruments (instrument tray and one pouch) for a total load weight of 24.0 lbs.
The data provenance is not explicitly stated as retrospective or prospective, nor is a country of origin identified for the data. Given it's a pre-market notification for a medical device by the STERIS Corporation (Mentor, OH, USA), it is highly likely the studies were prospective, conducted by the manufacturer, and likely performed in the USA or under relevant international standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of human experts to establish ground truth for the test set. Sterilization validation typically relies on objective measures, primarily biological indicators (BIs) containing highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) and chemical indicators (CIs). The "ground truth" for sterilization is the complete inactivation of these spores, indicated by no growth.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the ground truth for sterilization is objective (growth/no growth of biological indicators), not based on human interpretation or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a sterilization system, not an AI-assisted diagnostic or interpretive device that would involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is a standalone system. The "algorithm" here is the pre-programmed sterilization cycle, and its performance is assessed directly against the ability to sterilize. There is no human intervention in the sterilization process itself; the human selects the cycle and loads the sterilizer. The performance data presented (e.g., ½ Cycle Modified Total Kill Endpoint Verification, Simulated Use Test) are indeed standalone performance of the device without human interpretation of the sterilization outcome itself.
7. Type of Ground Truth Used
The primary ground truth for sterilization efficacy is the inactivation of biological indicators (BIs). The document explicitly mentions:
- "reproducibly sterilized under worst case ½ cycle conditions" for STERIS VERIFY® V24 Self-Contained Biological Indicator (SCBI).
- "all SCBIs were negative for growth under worst case full cycle conditions."
Additionally, chemical indicators (CIs) are used to confirm exposure to the sterilant, showing "complete color change."
8. Sample Size for the Training Set
Not applicable. This device is a physical sterilizer and its associated pre-programmed cycles, not a machine learning model that requires a "training set" in the conventional AI sense. The "training" of the cycles would refer to the developmental and engineering process of determining optimal parameters, which involves a different type of experimental design and validation than data-driven machine learning model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reasons as point 8. The "ground truth" for developing the sterilizer's parameters (e.g., sterilant injection, exposure time, pressure, temperature) would have been established through extensive empirical experimentation and adherence to sterilization standards (e.g., AAMI, ISO) to achieve a validated Sterility Assurance Level (SAL) of 10^-6 or better. This involves progressively testing parameters with biological indicators to determine the minimum conditions required for sterility.
§ 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).