(150 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. 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-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes.
t: 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:
- 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 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
The V-PRO maX 2 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, V-PRO maX and V-PRO 60 Sterilizers.
As with the predicate device (K162413), the V-PRO maX 2 Sterilizer has three preprogrammed cycles (the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycle) with a fourth added (the Fast Non Lumen Cycle). The V-PRO maX 2 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 maX 2 Sterilizer uses VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Its 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.
The provided text describes the V-PRO® maX 2 Low Temperature Sterilization System, a medical device for sterilizing instruments. It is a 510(k) premarket notification, indicating it is intended to be substantially equivalent to a predicate device, not a new type of device requiring extensive clinical trials for efficacy. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to performance tests demonstrating substantial equivalence to the predicate device and the general efficacy of the sterilization process.
Here's an breakdown based on your request, interpreting "acceptance criteria" as the required successful outcomes of the performance tests for substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| AOAC Sporicidal Test | All carriers must be sterile, demonstrating killing of spores. | All 720 carriers processed using 3 lots of EOSL sterilant were sterile. |
| Determination of D-value and Total Kill Endpoint | Achieve greater than a 12 log reduction of the most resistant organism within all cycles. | Greater than a 12 log reduction of the most resistant organism is achieved within all cycles (Lumen Cycle, Non Lumen Cycle, Flexible Cycle and Fast Non Lumen) of the V-PRO maX 2 Sterilizer. |
| 1/2 Cycle Modified Total Kill Endpoint Verification | All sterile results within the validation load for standard and at least one lower injection weight. Partial positives or all survive results seen at even lower injection weights. | Modified total kill end point analysis was demonstrated for all four V-PRO maX 2 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. |
| 1/2 Cycle Sterilization Verification of Cycle Claims | Each cycle must reproducibly sterilize specified load configurations under worst-case conditions in 1/2 cycle. | - The Lumen Cycle reproducibly sterilizes single, dual and triple lumen devices under worst case conditions in 1/2 Cycle.- The Flexible Cycle reproducibly sterilizes 1 x 990 mm flexible endoscope lumens under worst case conditions in 1/2 Cycle.- The Non Lumen Cycle reproducibly sterilizes non-lumened devices under worst case conditions in 1/2 Cycle.- The Fast Non Lumen Cycle reproducibly sterilizes non-lumened devices under worst case conditions in 1/2 Cycle. |
| ½ Cycle Verification of Mated Surfaces | Demonstrate sterile efficacy for mated surfaces under worst-case conditions. | Sterile efficacy was demonstrated for mated surfaces under worst case conditions. |
| Simulated Use Test | Verify the ability of the sterilizer cycles to sterilize medical devices under worst-case processing conditions. | Simulated use testing verified the ability of the V-PRO maX 2 Sterilizer cycles to sterilize medical devices under worst case processing conditions. |
| In Use Test | Demonstrate the ability of the sterilizer cycles to sterilize patient-soiled, clinically-cleaned, medical instruments. | The in use investigation demonstrated the ability of the V-PRO maX 2 Sterilizer cycles to sterilize patient-soiled, clinically-cleaned, medical instruments. |
| Biocompatibility | Demonstrate biocompatibility of materials after processing. | Cytotoxicity and residue analysis of 23 materials have demonstrated biocompatibility after processing in the V-PRO 60 Sterilizer (implicitly considered relevant for V-PRO maX 2). |
| Medical Device Material Compatibility | Demonstrate compatibility of medical devices with the sterilization process after multiple cycles. | Evaluation of medical devices after multiple cycles in the V-PRO maX 2 Sterilizer has demonstrated compatibility with 23 materials of construction. |
| Final Process Qualification | Successful qualification for all sterilizer cycles. | The V-PRO maX 2 Sterilizer final process qualification was successful for all four (4) sterilizer cycles. |
2. Sample Size Used for the Test Set and Data Provenance:
The document primarily discusses device performance and sterilization efficacy, not diagnostic accuracy where "test sets" of patient data are typically used. Instead, the "test set" here refers to the biological indicators (BIs) and test loads used in the sterilization efficacy studies.
- AOAC Sporicidal Test: "All 720 carriers processed using 3 lots of EOSL sterilant were sterile." This implies a total of 720 biological indicators (carriers).
- Other Efficacy Tests (D-value, Total Kill, 1/2 Cycle Verification, Simulated Use, In Use): These tests involve specific "validation loads" and "worst-case conditions."
- Non Lumen Cycle: Validation load of two instrument trays for a total weight of 50 lbs (22.7 kg).
- Fast Non Lumen Cycle: Validation load of one pouched instrument tray for a total weight of 11 lbs (5 kg).
- Flexible Cycle (Load Config 1): Two flexible endoscopes, each packaged into a tray with silicone mat and light cord.
- Flexible Cycle (Load Config 2): One flexible endoscope in a tray with silicone mat and light cord, plus an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg).
- Lumen Cycle: A maximum of 20 lumens per load, using a validation load of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg).
- "Patient-soiled, clinically-cleaned, medical instruments" were used for the in-use test.
Data Provenance: The studies were conducted by the device manufacturer (STERIS Corporation) internally as part of their premarket notification for the Food and Drug Administration (FDA) in the USA. These are laboratory and simulated/actual use tests, not human data. The context implies these are prospective tests designed to prove the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not applicable in the context of device sterilization validation. "Ground truth" for sterilization is established by scientific principles of microbial inactivation (e.g., whether biological indicators containing a known number of resistant spores are killed), rather than expert consensus on interpretive tasks. The methodology for assessing sterility (e.g., incubation of biological indicators) relies on established microbiological techniques.
4. Adjudication Method for the Test Set:
Not applicable. Sterility tests involve objective outcomes (growth or no growth of microorganisms). There is no "adjudication" in the sense of resolving disagreements between human readers, as for an AI diagnostic tool.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and AI might assist in that interpretation. This document is about a sterilization device, which does not involve human interpretation of output in that manner.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device itself is a "standalone" sterilizer. Its performance is evaluated purely on its ability to sterilize medical instruments, without human intervention in the sterilization process once initiated. The tests performed (e.g., AOAC Sporicidal Test, D-value determination) are indeed standalone assessments of the device's efficacy. There is no "human-in-the-loop" concept for the primary function of sterilization.
7. The Type of Ground Truth Used:
The ground truth used for these performance tests is microbiological eradication/inactivation.
- For the AOAC Sporicidal Test, D-value, and Total Kill Endpoint, the ground truth is the absence of viable microorganisms (specifically, highly resistant bacterial spores like Geobacillus stearothermophilus). This is determined by standard microbiological culture techniques (e.g., incubating biological indicators and observing for growth).
- For the "In Use Test," the ground truth for successful sterilization of patient-soiled instruments would similarly be the absence of microbial growth from processed items.
- For biocompatibility and material compatibility, the ground truth is established through standardized cytotoxicity assays and visual / functional assessment of materials following repeated processing.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical sterilizer and not an AI/machine learning model that undergoes "training." Its operational parameters are designed and validated based on scientific principles of sterilization, not statistical inference from a training dataset derived from "training examples."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no "training set" in the context of this traditional device validation.
§ 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).