(147 days)
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 reusable 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 low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.
The V-PRO 60 Sterilizer's Lumen Cycle can sterilize:
- Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
- Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations:
- single or dual lumen devices with stainless steel lumens that are ≥ 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (16-9/64") in length
- triple lumen devices with stainless steel lumens that are
- ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-55/64") in length
- ≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length
- or ≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length
The V-PRO 60 Sterilizer's Non Lumen Cycle can sterilize
- Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors.
The V-PRO 60 Sterilizer's Flexible Cycle can sterilize:
- One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a:
- single or dual lumen device with lumens that are ≥ 1 mm (~3/64") ID and ≤ 990 mm (38-63/64") in length
The V-PRO 60 Low Temperature Sterilization System is a new vaporized hydrogen peroxide sterilizer model to be added to the STERIS V-PRO family of sterilizers. The V-PRO product line currently consists of the Amsco V-PRO 1, Amsco V-PRO 1 Plus and Amsco V-PRO maX Sterilizers. As with the predicate device (K102330), the V-PRO 60 Sterilizer has three preprogrammed cycles: the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycle. The V-PRO 60 Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities. The V-PRO 60 Sterilizer uses VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Its three preprogrammed cycles all utilize a conditioning phase, a sterilize phase and an aeration phase. 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.
This document describes the V-PRO® 60 Low Temperature Sterilization System, a vaporized hydrogen peroxide sterilizer. The acceptance criteria are based on achieving sterility and maintaining material compatibility.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | ||
| AOAC Sporicidal Test | All carriers processed should be sterile. | All 720 carriers processed using 3 lots of EOSL sterilant were sterile. |
| Determination of D-value and Total Kill Endpoint | Greater than a 12 log reduction of the most resistant organism. | Greater than a 12 log reduction of the most resistant organism is achieved within all cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) of the V-PRO 60 Sterilizer. |
| ½ Cycle Modified Total Kill Endpoint Verification | All sterile results within the validation load. | Modified total kill end point analysis was demonstrated for all three V-PRO 60 Sterilizer cycles. The standard injection weight of 1.1 g and at least one lower injection weight resulted in all sterile results within the validation load used to qualify each sterilizer cycle. Partial positives or all survive results were seen at lower injection weights. |
| ½ Cycle Sterilization Verification of Cycle Claims | Reproducible sterilization of specified devices/lumens. | • The Lumen Cycle reproducibly sterilizes single, dual and triple lumen devices under worst case conditions in ½ Cycle. |
| • The Flexible Cycle reproducibly sterilizes 1 x 990 mm flexible endoscope lumens under worst case conditions in ½ Cycle. | ||
| • The Non Lumen Cycle reproducibly sterilizes non-lumened devices under worst case conditions in ½ Cycle. | ||
| ½ Cycle Verification of Mated Surfaces | Sterile efficacy for mated surfaces under worst case conditions. | Sterile efficacy was demonstrated for mated surfaces under worst case conditions. |
| Simulated Use Test | Sterilization of medical devices under worst case conditions. | Simulated use testing verified the ability of the V-PRO 60 Sterilizer cycles to sterilize medical devices under worst case processing conditions. |
| In Use Test | Sterilization of patient-soiled, clinically-cleaned instruments. | The in use investigation demonstrated the ability of the V-PRO 60 Sterilizer cycles to sterilize patient-soiled, clinically-cleaned, medical instruments. |
| Device Compatibility & Integrity | ||
| Biocompatibility | Biocompatibility after processing. | Cytotoxicity and residue analysis of 23 materials have demonstrated biocompatibility after processing in the V-PRO 60 Sterilizer. |
| Medical Device Material Compatibility | Compatibility with materials of construction after multiple cycles. | Evaluation of medical devices after multiple cycles in the V-PRO 60 Sterilizer has demonstrated compatibility with 23 materials of construction. |
| Process Control & Verification | ||
| Final Process Qualification | Successful qualification for all cycles. | The V-PRO 60 Sterilizer final process qualification was successful for all three (3) sterilizer cycles. All three lots of CI exhibited complete color change. All three SCBI PIs exhibited a passing color change and all SCBIs were negative for growth. Manual inspection of the process parameter data confirmed that all cycle specifications were met. |
| Conformity to Standards (Safety and EMC) | Compliance with EN 61010-1:2001 and EN61326-1:2006. | The V-PRO 60 Low Temperature Sterilization System has been tested for conformity and is certified to EN 61010-1:2001 and EN61326-1:2006. |
Study Proving Device Meets Acceptance Criteria:
The document summarizes the "Summary of Nonclinical Tests" performed on the V-PRO 60 Low Temperature Sterilization System to demonstrate its substantial equivalence to the predicate device, the V-PRO maX Low Temperature Sterilization System. The studies aim to prove the device's ability to sterilize various medical devices effectively and safely.
2. Sample Size Used for the Test Set and Data Provenance:
The document provides specific sample sizes for particular tests:
- AOAC Sporicidal Test: "All 720 carriers processed using 3 lots of EOSL sterilant."
- Validation Loads:
- Lumen Cycle: "a maximum of twelve (12) lumens per load... consisting of one instrument tray with instrument organizers and mat and two pouches for a total weight of 11 lbs (5.0 kg)."
- Non Lumen Cycle: "a validation load consisting of one instrument tray with instrument organizers and mat and one pouch for a total weight of 12 lbs (5.4 kg)."
- Flexible Cycle: "one flexible endoscope, packaged into a tray with silicone mat, instrument organizers and light cord (if not integral to scope) and no additional load."
- Biocompatibility and Material Compatibility: "23 materials" were analyzed.
Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. However, based on the nature of medical device clearance submissions to the FDA (United States Food and Drug Administration), these are typically prospective laboratory and simulated-use studies conducted by the manufacturer or authorized testing facilities, aiming to meet regulatory requirements prior to market entry.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the "number of experts" or their "qualifications" used to establish ground truth. The studies involve standardized microbiological and engineering tests rather than expert interpretation of results in a clinical setting. For sterilization studies, the ground truth is typically established by laboratory methods such as growth/no growth of biological indicators (e.g., Geobacillus stearothermophilus) following exposure to the sterilization process.
4. Adjudication Method for the Test Set:
Not applicable. The tests described are objective performance evaluations (e.g., sterility, log reduction, material compatibility) rather than interpretation-based assessments that would require an adjudication method like 2+1 or 3+1.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The device is a sterilizer, and its performance is evaluated through objective physical and biological tests, not through human reader interpretation of cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies described are standalone performance evaluations of the sterilization device. There is no "human-in-the-loop" interaction in the output or interpretation of the sterilization cycle results beyond operating the device and reading standard indicators. The device itself is the "algorithm only" in the context of its function.
7. The Type of Ground Truth Used:
The primary type of ground truth used would be:
- Microbiological Negativity/Positivity: For sterilization efficacy tests (AOAC Sporicidal, D-value/Total Kill, ½ Cycle Modified Total Kill Endpoint, ½ Cycle Sterilization Verification, Simulated Use, In Use), the ground truth is established by culturing biological indicators or test organisms and observing the presence or absence of growth. "Sterile" or "no growth" is the ground truth for effective sterilization.
- Physical/Chemical Analysis: For biocompatibility and material compatibility, the ground truth is established through laboratory analyses (e.g., cytotoxicity assays, residue analysis, visual inspection for degradation) and quantitative measurements.
- Process Parameter Verification: For Final Process Qualification, the ground truth is established by objective measurements of process parameters (time, temperature, pressure, sterilant injection weight) and the observed color change of chemical indicators.
8. The Sample Size for the Training Set:
Not applicable. This is a physical device (sterilizer) and not an AI/machine learning model that would require a 'training set' of data in the conventional sense. The development of the sterilizer's cycles and parameters is based on engineering principles and iterative testing, not on data training in the way an algorithm learns from a dataset.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this device. The physical and biological principles governing sterilization, along with extensive engineering development and testing, define the performance of the sterilizer.
§ 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).