(73 days)
The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems using VAPROX HC Sterilant are 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 temperature, suitable for processing medical devices without leaving toxic residues. Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle.
The V-PRO 1 Plus and V-PRO maX Sterilizers' Non Lumen Cycle can sterilize:
Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid and flexible endoscopes.
The V-PRO maX Sterilizer's Flexible Cycle can sterilize:
Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations:
- Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. The flexible endoscopes may contain either:
A single lumen that is ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length
Or two lumens with:
One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length - One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. The flexible endoscope may contain either:
A single lumen that is > 1 mm ID and ≤ 1050 mm in length
Or two lumens with:
One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length.
The V-PRO 1, V-PRO 1 Plus and V-PRO maX Sterilizers' Lumen Cycle can sterilize:
Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:
Single channeled devices with a stainless lumen that is ≥ 0.77 mm ID and ≤ 500 mm in length
Single channeled devices with a stainless lumen that is ≥ 1.8 mm ID and ≤ 542 mm in length
Dual channeled devices with stainless lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length
Triple channeled devices with stainless lumens that are either
≥ 1.2 mm ID and ≤ 275 mm in length
≥ 1.8 mm ID and ≤ 310 mm in length or
≥ 2.8 mm ID and ≤ 317 mm in length
The V-PRO maX 2 Low Temperature Sterilization Systems using VAPROX HC Sterilant are 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 temperature, suitable for processing medical devices without leaving toxic residues.
Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle and Fast Non Lumen Cycle.
The Non Lumen Cycle can sterilize:
Non-lumened instruments including non- lumened general medical instruments, non- lumened rigid, semi-rigid and flexible endoscopes.
The Fast Non Lumen Cycle can sterilize:
Non-lumened instruments including non- lumened general medical instruments, non- lumened rigid, semi-rigid and flexible endoscopes.
The Flexible Cycle can sterilize:
Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations:
- Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. The flexible endoscopes may contain either:
A single lumen that is ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length
Or two lumens with:
One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length - One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. The flexible endoscope may contain either:
A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length
Or two lumens with:
One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length.
The Lumen Cycle can sterilize:
Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:
Single channeled devices with a stainless lumen that is ≥ 0.77 mm ID and ≤ 500 mm in length
Single channeled devices with a stainless lumen that is ≥ 1.8 mm ID and ≤ 542 mm in length
Dual channeled devices with stainless lumens that are > 0.77 mm ID and
The V-PRO Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers. The sterilizers have one or more of the following pre-programmed cycles (the Lumen Cycle, the Non Lumen Cycle, the Flexible Cycle and the Fast Non Lumen Cycle). The V-PRO Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities. The V-PRO Sterilizers uses VAPROX HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The four 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 Low Temperature Sterilization Systems, specifically the V-PRO 1, V-PRO 1 Plus, V-PRO maX, and V-PRO maX 2 models. The information provided focuses on their indications for use and the validation studies conducted to prove their effectiveness.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes two main tests to demonstrate the device meets acceptance criteria for sterilization efficacy. The acceptance criteria for biological indicators (BIs) are generally defined by a "total kill endpoint," meaning no microbial growth after sterilization, which is achieved at a specific sterilant injection weight. The "simulated use test" acceptance criteria are that the sterilizer cycles successfully sterilize medical devices under worst-case conditions.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 1/2 Cycle Modified Total Kill Endpoint Verification: | Modified total kill endpoint analysis was demonstrated for the sterilizer cycles. The standard injection weight of 2.1 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. (Implies the device successfully sterilizes at specified sterilant levels and has a clear kill endpoint.) |
| Simulated Use Test: | Simulated use testing verified the ability of the sterilizer cycles to sterilize medical devices under worst-case processing conditions. (Implies the device meets its sterilization claims under challenging real-world scenarios). |
2. Sample Size for the Test Set and Data Provenance:
The document doesn't explicitly state a "test set" in the context of a typical AI/ML study (e.g., number of images, cases). Instead, it refers to "validation loads" and "lumen sizes" for sterilization efficacy testing.
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Validation Loads: Various validation loads are described depending on the specific cycle (Non Lumen, Flexible, Lumen) and device model.
- V-PRO 1 Plus and V-PRO maX (Non Lumen Cycle): Two instrument trays for a total weight of 50 lbs (22.7 kg).
- V-PRO maX (Flexible Cycle, Configuration 1): Two flexible endoscopes, each packaged into a tray with a silicone mat and light cord.
- V-PRO maX (Flexible Cycle, Configuration 2): One flexible endoscope in a tray with a silicone mat and light cord, plus an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg).
- V-PRO 1, V-PRO 1 Plus, V-PRO maX (Lumen Cycle): A maximum of 20 lumens per load. The validation studies used a load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg).
- V-PRO maX 2 (Non Lumen Cycle): Two instrument trays for a total weight of 50 lbs (22.7 kg).
- V-PRO maX 2 (Fast Non Lumen Cycle): One pouched instrument tray for a total weight of 11 lbs (5 kg).
- V-PRO maX 2 (Flexible Cycle, Configuration 1): Two flexible endoscopes, each packaged into a tray with a silicone mat and light cord.
- V-PRO maX 2 (Flexible Cycle, Configuration 2): One flexible endoscope in a tray with a silicone mat and light cord, plus an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg).
- V-PRO maX 2 (Lumen Cycle): A maximum of 20 lumens per load. The validation studies used a load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg).
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Data Provenance: The document does not specify the country of origin of the data. The studies are described as "validation studies" and "non-clinical performance tests," implying they were conducted prospectively to validate the sterilization claims of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided. In the context of sterilization validation, "ground truth" is typically established through microbiological methods (e.g., culturing biological indicators to confirm sterility or lack thereof) rather than expert interpretation of medical images or case data. Therefore, the concept of "experts" in the traditional sense of clinical opinion is not directly applicable to this type of device validation. The "experts" would likely be microbiologists or validation engineers.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the "ground truth" for sterilization efficacy is typically determined by objective microbiological culture results (growth/no growth of biological indicators), not by subjective expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. These devices are sterilizers, and their performance is evaluated based on direct microbiological efficacy, not on the improvement of human reader performance using AI assistance. The document explicitly states the studies are "non-clinical performance tests."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable in the context of this device. The V-PRO systems are sterilization machines, not AI algorithms designed to assist human interpretation. Their "standalone" performance is the validation of their sterilization efficacy without human intervention in the sterilization process itself. The software controls the sterilization cycle, and its performance is part of the overall device validation.
7. The Type of Ground Truth Used:
The ground truth for these validation studies is primarily:
- Microbiological Sterility (Biological Indicators): The "total kill endpoint verification" test indicates the use of biological indicators (BIs) which contain a known number of resistant microorganisms (e.g., Geobacillus stearothermophilus spores). Sterility is achieved when no growth of these microorganisms is detected after processing.
- Physical and Chemical Parameters: The document mentions "critical process parameters" such as "Time, Chamber Temperature, Vaporizer Temperature, Chamber Pressure Prior to Injection, Sterilant Injection Weight." These parameters are controlled and monitored to ensure the cycle performs optimally, contributing to the "ground truth" that appropriate conditions for sterilization were met.
8. The Sample Size for the Training Set:
This information is not provided, and the concept of a "training set" in the context of machine learning is not directly applicable to these physical sterilization devices. The physical properties and mechanisms of sterilization are based on established scientific principlesvalidated through controlled experiments, not through training an algorithm on a dataset. The formulation of the VAPROX HC Sterilant and the design of the sterilization cycles are based on research and development, not on a machine learning training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no mention of a "training set" for an AI/ML algorithm within the provided text for these sterilization devices. The "ground truth" for the development and validation of these sterilizers is based on established methods in microbiology and validated sterilization principles (e.g., D-value determination, overkill methods) which define what constitutes a sterile condition and how to achieve it.
§ 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).