(262 days)
The V-PRO maX 2 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 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.
The Non Lumen Cycle can sterilize: †
Non-lumened instruments including non-luments, non-luments, non-lumened rigid, sem-rigid and flexible endoscopes.
- The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).
The Fast Non Lumen Cycle can sterilize: *
Non-lumened instruments including non-luments. non-luments. non-lumened rigid, semi-rigid and flexible endoscopes.
- The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).
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:
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Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain single or dual channel lumens that are ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length. * The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).
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One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. ** The flexible endoscope may contain single or dual channel lumens that are > 1 mm ID and ≤ 1050 mm in length
Additional instruments may include non-lumened or lumened medical devices with the following configurations: Single, dual or triple channel stainless steel lumen that is ≥ 0.48 mm ID and ≤ 100 mm in length
++ The validation studies were conducted with a flexible endoscope in a tray with endoscope accessories, silicone mat, light cord (if not integral to endoscope) and 5 stainless steel lumens. Also included in the load was a tray with additional instruments, and silicone mat for a total weight of 24 lbs (11 kg).
The Lumen Cycle can sterilize: †
Medical devices with the following configurations:
· Single, dual or triple channeled stainless steel lumen that are:
-
0.77 mm ID and
The V-PRO Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers.
The V-PRO maX 2 sterilizer has the following pre-programmed cycles: the Lumen Cycle, the Non Lumen Cycle, the Flexible Cycle, the Fast Non Lumen Cycle, and the Specialty Cycle. The V-PRO Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried, and packaged surgical instruments used in healthcare facilities.
The V-PRO Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The five preprogrammed cycles all use 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 describes a 510(k) premarket notification for the STERIS V-PRO maX 2 Low Temperature Sterilization System. It focuses on the substantial equivalence of the proposed device to a predicate device, specifically regarding the addition of a "Specialty Cycle."
Based on the provided information, the device is a sterilizer, and the "acceptance criteria" and "study proving the device meets the acceptance criteria" refer to the sterilization efficacy and the validation studies conducted to demonstrate that the new Specialty Cycle effectively sterilizes the specified materials/devices.
Here's the breakdown of the information requested, based on the provided document:
Acceptance Criteria and Reported Device Performance
The core acceptance criterion for a sterilizer is to demonstrate the elimination of viable microorganisms. This is typically shown through achieving sterility with a certain Sterility Assurance Level (SAL), often by processing inoculated Biological Indicators (BIs). The effectiveness is demonstrated through "½ Cycle (Sterilization) Efficacy" and "Final Process Qualification."
Table of Acceptance Criteria and Reported Device Performance (Inferred from the document's validation summary):
| Acceptance Criterion (Implicit) | Reported Device Performance (Result) |
|---|---|
| Sterilization Efficacy (½ Cycle): Achieve sterilization (kill all inoculated Biological Indicators) under challenging conditions. | The standard injection weight of 2.1 g resulted in all sterile results within the validation load used to qualify each sterilizer cycle. (PASS) |
| Material Compatibility: Demonstrate that the sterilization process does not adversely affect the materials intended for processing. | Material evaluations verified the compatibility of tested materials in the V-PRO maX 2 Sterilizer's Specialty Cycle. (PASS) |
| Biocompatibility: Ensure that processed devices remain biocompatible (absence of toxic residues or material degradation leading to toxicity). | Testing in accordance with ISO 10993-1 have demonstrated biocompatibility of identified materials after processing in three (3) consecutive cycles of the V-PRO maX 2 Sterilizer's Specialty Cycle. (PASS) |
| Final Process Qualification: Overall validation of the new sterilization cycle to ensure it meets performance requirements. | The V-PRO maX 2 Sterilizer final process qualification was successful for the Specialty Cycle. (PASS) |
Additional Requested Information:
1. Sample sizes used for the test set and the data provenance:
- Test Set Sample Sizes:
- Non Lumen Cycle: Validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).
- Fast Non Lumen Cycle: Validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).
- Flexible Cycle (Config 1): Two flexible endoscopes with a light cord and mat (no additional load).
- Flexible Cycle (Config 2): One flexible endoscope with a light cord and mat, plus a tray with additional instruments and silicone mat for a total weight of 24 lbs (11 kg). This configuration also included 5 stainless steel lumens.
- Lumen Cycle: Validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg), with a maximum of 20 lumens per load.
- Specialty Cycle (Non-lumened instruments): Validation load consisting of one pouched instrument tray or one pouch with guide(s)/model(s) (with or without tray) for a total weight of 11 lbs (5 kg).
- Specialty Cycle (3D Printed Materials): Validation load consisting of pouched guide(s)/model(s) (with or without tray) for a total weight of 5 lbs (2.3 kg) 3D printed material.
- Data Provenance: The document implies these are prospective validation studies conducted by STERIS Corporation for regulatory submission. The country of origin is not explicitly stated but can be inferred as the United States given the FDA submission.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This is a sterilization device, not an AI diagnostic tool. Ground truth for sterilizers is established through microbiological assays (e.g., biological indicators) and physical/chemical measurements (temperature, pressure, time, hydrogen peroxide concentration, etc.), not expert reader consensus like in imaging. Therefore, the concept of "experts establishing ground truth for the test set" in the context of human readers does not apply here. The expertise lies in microbiology, engineering, and quality assurance to design and execute the validation studies.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for a sterilization device validation study. Sterility is typically determined by the absence of growth in biological indicators, which is an objective measurement rather than a subjective human interpretation requiring adjudication.
4. 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. This device is a sterilizer, not an AI or diagnostic imaging system. There are no "human readers" involved in performing or interpreting the sterilization process in a way that would warrant an MRMC study.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, a sterilizer, not an algorithm. The "performance" is the physical process of sterilization.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for sterilization efficacy is established through microbiological assays, specifically the 6-log reduction or complete kill of highly resistant bacterial spores (Geobacillus stearothermophilus) contained within biological indicators (BIs). This is an objective, quantitative measure of sterilization. Additional ground truth includes adherence to engineering specifications for process parameters and chemical validation.
7. The sample size for the training set:
- Not applicable. This is a medical device (sterilizer) and its validation, not an AI/machine learning model that requires a "training set." The performance data comes from experimental validations and engineering studies.
8. How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of an AI model. The validation studies demonstrate the device's capability to sterilize.
§ 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).