(107 days)
The V-PRO® s2 Low Temperature Sterilization System using VAPROX® HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues.
Each Cycle can sterilize non-luments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
The V-PRO s2 Sterilizer Non Lumen Cycle can sterilize: † Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.
The V-PRO s2 Sterilizer Fast Cycle can sterilize: * Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:
- Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm (~1/32”) internal diameter (ID) and ≤ 410 mm (~16-9/64”) in length
- Triple channeled devices with stainless steel lumens that are either: ≥ 1.2 mm (~3/64”) ID and ≤ 275 mm (~10-53/64”) 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
Non-lumened instruments including non-lumened general medical instruments. non-lumened rigid, semi-rigid and flexible endoscopes.
The V-PRO s2 Sterilizer Flexible Cycle can sterilize: @ One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and 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.
- Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions ≥ 2 mm (~5/64”) ID and ≤ 400 mm (~15 3/4”) in length ≥ 0.76 mm (~1/32”) ID and ≤ 233 mm (~9 11/64”) in length ≥ 1.0 mm (~3/64”) ID and ≤ 254 mm (~10”) in length
The V-PRO s2 Sterilizer Lumen Cycle can sterilize: ^ Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:
- Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm (~1/32”) internal diameter (ID) and ≤ 410 mm (16-9/64”) in length
- Triple channeled devices with stainless steel lumens that are either: ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") 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® s 60 Low Temperature Sterilization System using VAPROX® HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues.
Each Cycle can sterilize non-luments and instruments with diffusionrestricted spaces such as the hinged portion of forceps and scissors.
The V-PRO 60 Sterilizer Non Lumen Cycle can sterilize: t Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.
The V-PRO 60 Sterilizer Flexible Cycle can sterilize: @ One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and 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.
- Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions ≥ 2 mm (~5/64”) ID and ≤ 400 mm (~15 3/4”) in length ≥ 0.76 mm (~1/32”) ID and ≤ 233 mm (~9 11/64”) in length ≥ 1.0 mm (~3/64”) ID and ≤ 254 mm (~10”) in length
The V-PRO 60 Sterilizer Lumen Cycle can sterilize: ^ Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:
- Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm (~1/32”) internal diameter (ID) and ≤ 410 mm (16-9/64”) in length
- Triple channeled devices with stainless steel lumens that are either: ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") 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 s2 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 V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO maX 2 and V-PRO 60 Sterilizers.
The V-PRO s2 Sterilizer contains the same three sterilization cycles as the predicate device (K172319), the Lumen, Non Lumen and Flexible Cycles, with a new cycle, the Fast Cycle. In addition, compared to the claimed predicate device, the proposed device contains a cabinetry modification, adds additional claims for devices that may be processed in the Flexible Cycle, and increases the maximum claimed load weight for the Non Lumen Cycle.
The V-PRO 60 Low Temperature Sterilization System is a vaporized hydrogen peroxide sterilizer model that currently exists in the STERIS V-PRO family of sterilizers. The current proposed device claims are intended to modify the indications for use statement.
As with the predicate device (K172319), the V-PRO 60 Sterilizer has three preprogrammed cycles: the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycle, none of which are being altered. The V-PRO 60 Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged surgical instruments used in healthcare facilities.
The V-PRO s2 and V-PRO 60 Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried and packaged surgical instruments used in healthcare facilities and utilizes VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The pre-programmed 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.
The provided text is a 510(k) Premarket Notification from the FDA, detailing the substantial equivalence of the STERIS V-PRO s2 Low Temperature Sterilization System and modifications to the V-PRO 60 Low Temperature Sterilization System to a legally marketed predicate device. This document describes the acceptance criteria and the study that proves a medical device (sterilizer) meets these criteria, rather than an AI/ML powered device.
Therefore, the requested information points related to AI/ML device studies (sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, etc.) do not apply to this document as it pertains to a physical sterilization device and not a diagnostic AI/ML system.
However, I can extract the acceptance criteria for the sterilization device and the reported performance based on the provided text.
Acceptance Criteria and Reported Device Performance (for a Sterilization Device)
The "acceptance criteria" for a sterilizer device are typically demonstrated through various validation studies to ensure the device effectively sterilizes medical instruments. The "reported device performance" is the conclusion that these studies meet the established criteria.
Here's a table based on the "Summary of Nonclinical Tests" section (Page 17-18) which outlines the tests conducted (functioning as acceptance criteria) and their successful results (reported performance):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Name) | Reported Device Performance (Result and Conclusion) |
|---|---|
| Determination of D-value and Total Kill Endpoint | Result: Greater than a 12 log reduction of the most resistant organism is achieved within Fast, Non Lumen and Flexible Cycles of the V-PRO s2 Sterilizer. |
| Conclusion: PASS | |
| ½ Cycle Modified Total Kill Endpoint Verification | Result: Modified total kill end point analysis was demonstrated for Non Lumen and Flexible V-PRO s2 and V-PRO 60 Sterilizer cycles and for the Fast V-PRO s2 Sterilizer cycle. The standard injection weight of 1.1 g and at least one lower injection weight resulted in all sterile results for all cycles. |
| Conclusion: PASS | |
| ½ Cycle Sterilization Verification of Surfaces | Result: Verified surface sterilization efficacy for the most resistant material for VHP within a worst-case validation load in the V-PRO s2 Sterilizer Fast ½ Cycle and the V-PRO 60 Non Lumen Cycle. |
| Conclusion: PASS | |
| ½ Cycle Verification of Mated Surfaces | Result: Sterile efficacy was demonstrated for mated surfaces under worst case conditions in the Fast and Non Lumen V-PRO s2 Sterilizer cycles. |
| Conclusion: PASS | |
| Simulated Use Test | Result: Simulated use testing verified the ability of the Sterilizer cycles to sterilize medical devices under worst case processing conditions in the V-PRO s2 and V-PRO 60 Non Lumen and Flexible Cycles and in the V-PRO s2 Fast Cycle. |
| Conclusion: PASS | |
| In Use Test | Result: The in use investigation demonstrated the ability of the V-PRO s2 and V-PRO 60 Sterilizer Flexible Cycle and the V-PRO s2 Fast Cycle to sterilize patient-soiled, clinically-cleaned, medical instruments. |
| Conclusion: PASS | |
| Biocompatibility | Result: Cytotoxicity and residue analysis of worst case materials have demonstrated biocompatibility after processing in the V-PRO s2 Sterilizer's Fast Cycle. |
| Conclusion: PASS | |
| Final Process Qualification | Result: The V-PRO s2 Sterilizer final process qualification was successful for the Fast Cycle. |
| Conclusion: PASS | |
| Compliance with Safety Standards (IEC 61010-1:2010) | Conclusion: Certified |
| Compliance with Safety Standards (IEC 61010-2-040: 2015) | Conclusion: Certified |
| Compliance with Safety Standards (IEC 61326-1:2006/2012 (EMC)) | Conclusion: Certified |
Regarding the AI/ML-specific questions, as stated previously, this document does not contain information on an AI/ML powered device. Therefore, the following points are not applicable:
- Sample size used for the test set and the data provenance: Not applicable. The document discusses "validation studies" and "validation loads" for a sterilizer, which are physical materials and instruments, not data samples for an AI test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a sterilizer is established through scientific validation (e.g., microbial kill, chemical indicators), not human expert review.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For a sterilizer, the ground truth is the demonstrable absence of viable microorganisms ("sterility") and material compatibility, established through laboratory methods (e.g., biological indicators, chemical indicators, and material analysis) under worst-case conditions, as opposed to expert consensus, pathology, or outcomes data in the context of diagnostic AI.
- The sample size for the training set: Not applicable. This refers to a physical device, not an AI model.
- How the ground truth for the training set was established: Not applicable.
§ 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).