(214 days)
The V-PRO 1, 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 and semi-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 ≤ 527 mm in length
- o triple channeled devices with stainless steel lumens that are
- ≥ 1.2 mm ID and ≤ 275 mm in length
- ≥ 1.8 mm ID and ≤ 310 mm in length
- or
-
2.8 mm ID and 1 mm ID and 1 mm ID and 1 mm ID and 1 mm (~3/64") ID and
The V-PRO 1, V-PRO 1 Plus, V-PRO maX and V-PRO 60 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 Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). 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, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems are programmed to enact one (the Lumen Cycle), two (the Lumen Cycle and the Non Lumen Cycle) or three (the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycle) cycles, respectively.
The V-PRO 60 Low Temperature Sterilization System, with VAPROX® HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The three pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.
The STERIS V-PRO Low Temperature Sterilization Systems were studied to verify two modifications: the removal of eye-contacting limitations and the addition of polyurethane as a compatible material for the Lumen Cycle.
Here's a breakdown of the acceptance criteria and study details:
1. Acceptance Criteria and Reported Device Performance
| Device Modification | Verification / Validation Activity | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Removal of Eye-Contacting Limitations | |||
| Compare the residual hydrogen peroxide level for materials after processing under worst-case conditions in the V-PRO Sterilizers and the STERRAD 100NX Sterilizer. | Residual hydrogen peroxide levels in V-PRO processed samples should be statistically less than or equal to materials similarly processed in the predicate device (STERRAD 100NX Sterilizer). | Pass: "V-PRO 60 Sterilizer (worst-case) processed samples hydrogen peroxide residues were statistically less than or equal to materials similarly processed in the STERRAD 100NX Sterilizer." | |
| Compare the dilution required to achieve non-cytotoxic results for materials after processing under worst-case conditions in the V-PRO Sterilizers and the STERRAD 100NX Sterilizer. | The cytotoxic response for materials processed in the V-PRO Sterilizer cycles (worst-case) should be equivalent to or less than the cytotoxic response for the same materials processed in the predicate device (STERRAD 100NX Sterilizer Cycles). | Pass: "The cytotoxic response for all materials processed in the V-PRO 60 Sterilizer cycles (worst-case) was equivalent to or less than the cytotoxic response for the same materials processed in STERRAD 100NX Sterilizer Cycles." | |
| Confirm that the cytotoxic component present in each extract (if the neat sample is cytotoxic) is hydrogen peroxide (H2O2) by the addition of catalase to the extracts. | The cytotoxic component should be identified as hydrogen peroxide (H2O2). | "The cytotoxic component for all V-PRO 60 Sterilizer (worst-case) processed materials was identified as hydrogen peroxide (H2O2)." (This is an observation supporting the mechanism, not a pass/fail criteria itself, but confirms understanding of the cytotoxic agent). | |
| Determine the cytotoxicity for medical devices after processing in three (3) back-to-back V-PRO 60 Sterilizer (worst-case) Lumen Cycles. | Following exposure to three (3) back-to-back cycles, devices should be non-cytotoxic at the neat dilution. | Pass: "Following exposure to three (3) back-to-back cycles, devices are non-cytotoxic at the neat dilution." | |
| Compare the residual hydrogen peroxide level for medical devices after processing in three (3) back-to-back V-PRO 60 Sterilizer (worst-case) Lumen Cycles to hydrogen peroxide levels known to cause eye biocompatibility concerns. | Following exposure to three (3) back-to-back cycles, device hydrogen peroxide residues should be below levels known to cause biocompatibility concerns (specifically eye biocompatibility concerns). | Pass: "Following exposure to three (3) back-to-back cycles, device hydrogen peroxide residues are below levels known to cause biocompatibility concerns." | |
| Evaluate V-PRO Sterilizer materials processed for 3 consecutive cycles for ocular irritation per ISO 10993-10. | Materials coupons processed for 3 consecutive cycles in the V-PRO maX Lumen (worst-case) Cycle should be non-irritants per ISO 10993-10 evaluation. | Pass: "Materials coupons processed for 3 consecutive cycles in the V-PRO maX Lumen (worst-case) Cycle are non-irritants per ISO 10993-10 evaluation." | |
| Addition of Polyurethane as a compatible material for V-PRO Sterilizers' Lumen Cycle | |||
| Evaluate polyurethane material compatibility after processing the worst-case V-PRO Sterilizer Cycle. | No material degradation or cosmetic changes should be observed for the polyurethane-containing device. | Pass: "No material degradation or cosmetic changes were observed for the polyurethane-containing device." | |
| Sterilization efficacy for polyurethane in Lumen Cycle is demonstrated by previously completed testing in the V-PRO maX and V-PRO 60 Sterilizers’ (worst-case) Non Lumen Cycle. | Sterilization efficacy for polyurethane should be demonstrated to meet the required sterility assurance level (SAL). (Implied from the "Pass" result, as specific SAL is not stated here but is a standard requirement for sterilization validation.) | Pass: (Specific sterility efficacy data is not provided in this table, but the "Pass" indicates that prior testing supports this. This would typically involve bacterial spore inactivation.) |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the exact "sample size for the test set" in terms of number of unique devices or materials for each specific test. However, it indicates:
- For residual hydrogen peroxide and cytotoxicity comparison: "materials" were processed.
- For in-device cytotoxicity and tissue residue: "medical devices" were processed.
- For ocular irritation: "Materials coupons" were processed.
- For polyurethane compatibility: "polyurethane-containing device" and "polyurethane material" were evaluated.
Data Provenance: The studies were conducted by STERIS Corporation for a 510(k) premarket notification. This implies the data is prospective for the purpose of demonstrating the safety and effectiveness of the proposed changes. The country of origin of the data is not specified but is presumably the USA, where STERIS Corporation is based.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The tests described are primarily laboratory-based evaluations of chemical residues, cytotoxicity, material compatibility, and biological irritation, rather than assessments requiring interpretation by clinical experts. For biocompatibility tests like ocular irritation per ISO 10993-10, trained toxicologists or evaluators would interpret the results.
4. Adjudication Method for the Test Set
This information is not applicable as the studies described are laboratory-based experimental validations, not clinical studies requiring independent interpretation or adjudication of outcomes by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is typically performed to evaluate the diagnostic accuracy of imaging or other interpretive devices, often with and without AI assistance to human readers. The STERIS V-PRO System is a sterilizer, and its performance is evaluated through physical, chemical, and biological efficacy studies, not reader interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone study was not done because the device itself is a sterilizer, not an algorithm. Its performance is inherent in its operation (sterilization efficacy, material compatibility, residue levels), not in an algorithmic output.
7. Type of Ground Truth Used
The ground truth used in these studies is based on:
- Quantitative measurements: Residual hydrogen peroxide levels (chemical analysis).
- Biological assays: Cytotoxicity tests (e.g., using live cells to detect toxic effects), ocular irritation tests (per ISO 10993-10 guidelines, likely involving animal models or in vitro alternatives).
- Visual assessment: Material degradation or cosmetic changes.
- Sterilization efficacy: Implied to be based on inactivation of biological indicators with a known sterility assurance level (SAL).
8. Sample Size for the Training Set
This information is not applicable as the V-PRO Sterilization System is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device type.
§ 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).