(170 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: t
Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid, semi-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 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
- 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).
- 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 validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg).
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
- 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 1 mm (~3/64") ID and 1.8 mm (~5/64") ID and
The V-PRO 1, V-PRO 1 Plus, V-PRO maX and V-PRO 60 Low Temperature Sterilization Systems, using 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 the V-PRO maX and V-PRO 60 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 Cycles, respectively.
The provided text describes the acceptance criteria and supporting studies for the STERIS Amsco V-PRO Low Temperature Sterilization Systems.
Here's the breakdown:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Results |
|---|---|---|
| Determination of Worst Case (Most Resistant) Material for VHP | Test: The most resistant material (MRM) is the material that is most difficult to sterilize (the material with the largest number of non-sterile results) | |
| Controls: Controls shall perform as intended. | Pass: As identified within previous V-PRO Sterilizer submissions, the most resistant material (MRM) for surface sterilization is Kraton. | |
| Medical Device Material Compatibility | The devices shall be processed for 50 V-PRO 60 Sterilizer Lumen Cycles (worst case). The devices shall show no structural defects (crazing, cracks or chipping). The devices shall function following processing. | Pass: This testing verified compatibility of the tested 20 materials with the V-PRO Sterilizers. |
| Cytotoxicity Evaluation of Medical Devices | All Worst Case Cycles shall proceed to completion. The cytotoxic endpoint for each medical device shall be determined. Cytotoxicity Assay Controls shall perfrom as intended. | Pass: Testing demonstrates that various medical devices containing [unspecified, but likely referring to the materials tested in compatibility study] were determined to be non-cytotoxic following processing in three (3) V-PRO 60 Sterilizer Lumen Cycles. |
| Hydrogen Peroxide Residual Analysis of Processed Medical Devices | The residual hydrogen peroxide level for each medical device shall be determined and compared to the allowable hydrogen peroxide limits for mucosal and internal tissue contact. Each device shall demonstrate exhaustive extraction by showing less than a 10% increase for two (2) consecutive sample time points. Hydrogen Peroxide Residual Analysis Controls shall perform as intended. | Pass: Testing demonstrates that the hydrogen peroxide residuals from the medical devices composed of the 19 proposed compatible materials are from 2660-fold lower to greater than 13,000-fold lower than the tolerable exposure limits for mucosal and internal tissue contact when processed in three (3), worst case, back-to-back Lumen Cycles in the V-PRO 60 Sterilizer. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document primarily describes validation studies for the V-PRO sterilization systems, which are typically performed in a prospective manner.
- Determination of Worst Case Material for VHP: This refers to previous submissions, but the current document specifically highlights Kraton as the "most resistant material." No specific sample size is given for how many materials were evaluated to determine Kraton as the worst case in previous studies.
- Medical Device Material Compatibility: "20 materials" were tested.
- Cytotoxicity Evaluation of Medical Devices: "various medical devices containing [unspecified material components]" were tested.
- Hydrogen Peroxide Residual Analysis of Processed Medical Devices: "19 proposed compatible materials" were tested across "three (3), worst case, back-to-back Lumen Cycles" in the V-PRO 60 Sterilizer.
The provenance of the data (country of origin) is not explicitly stated, but as this is an FDA submission for a U.S. company (STERIS Corporation, Mentor, OH), it's highly probable the studies were conducted in the U.S. or at facilities compliant with U.S. regulatory standards.
3. 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 type of information is not applicable to the studies described. The studies are engineering and chemical validation tests for a sterilization system, not diagnostic device studies that would require expert human review or interpretation of medical images or patient data to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as the studies are not diagnostic assessments requiring adjudication of human reader interpretations. The acceptance criteria are based on measurable physical and chemical properties and biological effects (sterilization efficacy, material integrity, cytotoxicity, residuals).
5. 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
This is not applicable. The device is a sterilization system, not an AI-powered diagnostic tool used by human readers. Therefore, no MRMC study or AI assistance improvement metrics are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a sterilization system and there is no algorithm or AI component involved in its operation or performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in these validation studies is established by objective scientific and engineering measurements and standards:
- Sterilization effectiveness: Implicit in the "Worst Case Material" determination, where the goal is sterilization. Sterilization is typically confirmed by biological indicators demonstrating the inactivation of a specific resistant microorganism (e.g., Geobacillus stearothermophilus) to a defined sterility assurance level (SAL). While not explicitly detailed here, this is a standard method for sterilization validation.
- Material compatibility: Visual inspection for defects (crazing, cracks, chipping) and functional testing of devices after processing.
- Cytotoxicity: In vitro assays to assess cellular toxicity, with controls to ensure assay validity.
- Hydrogen peroxide residual analysis: Chemical analytical methods to quantify residual hydrogen peroxide, compared against established biological tolerance limits for mucosal and internal tissue contact.
8. The sample size for the training set
This is not applicable. The device is a sterilization system, not a machine learning model. There is no concept of a "training set."
9. How the ground truth for the training set was established
This is not applicable as there is no training set.
§ 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).