(360 days)
The Amsco V-PROTM MAX Low Temperature Sterilization System, with VAPROX™ HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The three pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.
The Amsco V-PRO MAX Low Temperature Sterilization System's Lumen Cycle, cleared under K062297, can sterilize:
- Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- Medical devices, including rigid endoscopes, with a single stainless steel lumen with:
- an inside diameter of 1 mm or larger and a length of 125 mm or shorter
- an insider diameter of 2 mm or larger and a length of 250 mm or shorter
- an inside diameter of 3 mm or larger and a length of 400 mm or shorter
a The validation testing for all lumen sizes was conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 Ibs.
The Amsco V-PRO MAX Low Temperature Sterilization System's Non Lumen Cycle, cleared under K083097, can sterilize:
Non-lumened instruments including non-lumened rigid endoscopes and non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.
b The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.
The Amsco V-PRO MAX Low Temperature Sterilization System's Flexible Cycle, the subject of this submission, can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of two load 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 with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter
- or two lumens with:
- one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter
- and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter
C 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 including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors.
The flexible endoscope can contain either:
- a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter
- or two lumens with:
- one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter
- and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter
d 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 load weight of 24.0 lbs.
The Amsco V-PRO MAX Low Temperature Sterilization System is a new sterilizer model to be added to the Amsco V-PRO family of sterilizers. The V-PRO product line currently consists of the Amsco V-PRO 1 and Amsco V-PRO 1 Plus Sterilizers.
The V-PRO MAX Sterilizer has three pre-programmed cycles: the Lumen Cycle (K062297), the Non Lumen Cycle (K083097) and the Flexible Cycle (subject of this submission). The V-PRO MAX 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 Sterilizer uses VAPROX HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Its three preprogrammed cycles all utilize a conditioning phase, a sterilization 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.
The Flexible Cycle has been designed to sterilize surgical flexible endoscopes (such as those used in ENT, Urology and Surgical care) and bronchoscopes. The flexible endoscopes can be single or dual channeled and they may be processed in a flexible endoscope-only load or in combination with non-lumened medical instruments. The cycle is approximately 35 minutes long.
The Verify V24 SCBI (K073244 and K09051), Verify VH2O2 Process Indicator (K091174), V-PRO Sterilization Trays (K070769), and Vis-U-All Tyvek pouches (K070765, K071087, and K090371) have been validated for use in the V-PRO MAX Sterilizer.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Amsco V-PRO MAX Low Temperature Sterilization System:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the "PASS" conclusion for each test, indicating that the device met the pre-defined success metrics for that particular test. The document provides a summary of test results and conclusions.
| Test | Acceptance Criteria (Implied) | Reported Device Performance | Conclusion |
|---|---|---|---|
| AOAC Sporicidal Test | All carriers processed with sterilant must be sterile. | All 720 carriers processed using 3 lots of EOSL sterilant were sterile. | PASS |
| Determination of D-value and Total Kill Endpoint | Greater than a 12 log reduction of the most resistant organism must be achieved within the Flexible Cycle sterilant exposure time. | Greater than a 12 log reduction of the most resistant organism is achieved within the Flexible Cycle sterilant exposure time. | PASS |
| 1/2 Cycle Modified Total Kill Endpoint Verification | Modified total kill end point analysis must be demonstrated, showing sterile results for validation loads at standard and lower injection weights, and survival at the lowest weight, with partial positives at intermediate weights. | Modified total kill end point analysis was demonstrated. The standard injection weight of 2.1 g and a lower injection weight of 1.457 g resulted in all sterile results for both validation loads. All survival results were shown at the lowest weight evaluated, 0.121 g. Partial positives results were seen at the intermediate injection weights. | PASS |
| 1/2 Cycle Sterilization Verification of Lumen Claims | The V-PRO Flexible Cycle must reproducibly sterilize 1 x 1050 mm lumens under worst-case conditions in a V-PRO Flexible ½ Cycle. | The V-PRO Flexible Cycle reproducibly sterilizes 1 x 1050 mm lumens under worst case conditions in a V-PRO Flexible ½ Cycle. | PASS |
| 1/2 Cycle Verification of Mated Surfaces | Sterile efficacy must be demonstrated for mated surfaces packaged in a double-wrapped tray or in a double-pouch configuration under worst-case conditions in a V-PRO Flexible ½ Cycle. | Sterile efficacy was demonstrated for mated surfaces packaged in a double-wrapped tray or in a double-pouch configuration under worst case conditions in a V-PRO Flexible ½ Cycle. | PASS |
| ½ Cycle Verification of Non Mated Surfaces | Sterile efficacy must be demonstrated for non-mated surfaces packaged in a double-wrapped tray under worst-case conditions in a V-PRO Flexible ½ Cycle. | Sterile efficacy was demonstrated for non mated surfaces packaged in a double-wrapped tray under worst case conditions in a V-PRO Flexible ½ Cycle. | PASS |
| Simulated Use Test | The V-PRO Flexible Cycle must verify its ability to sterilize flexible endoscopes and non-lumened medical devices under worst-case processing conditions. | Simulated use testing verified the ability of the V-PRO Flexible Cycle to sterilize flexible endoscopes and non lumened medical devices under worst case processing conditions. | PASS |
| In Use Test | The in-use investigation must demonstrate the ability of the V-PRO Flexible Cycle to sterilize clinically-cleaned, patient-soiled medical instruments. | The in use investigation demonstrated the ability of the V-PRO Flexible Cycle to sterilize clinically-cleaned, patient-soiled medical instruments. | PASS |
| Biocompatibility | Cytotoxicity and residue analysis of materials must demonstrate biocompatibility after processing in the V-PRO MAX Sterilizer. | Cytotoxicity and residue analysis of 23 materials have demonstrated biocompatibility after processing in the V-PRO MAX Sterilizer. | PASS |
| Medical Device Material Compatibility | Evaluation of medical devices after multiple cycles in the V-PRO MAX Sterilizer must demonstrate compatibility with the specified materials of construction. | Evaluation of medical devices after multiple cycles in the V-PRO MAX Sterilizer has demonstrated compatibility with 23 materials of construction. | PASS |
| Flexible Cycle Final Process Qualification | All three lots of Chemical Indicators (CI) must exhibit complete color change. All three Sterilization Chemical/Biological Indicators (SCBI) Process Indicators (PI) must exhibit a passing color change, and all SCBIs must be negative for growth. Manual inspection of process parameter data must confirm all cycle specifications were met. | The V-PRO Flexible Cycle final process qualification was successful. All three lots of CI exhibited complete color change. All three SCBI PIs exhibited a passing color change and all SCBIs were negative for growth. Manual inspection of the process parameter data confirmed that all cycle specifications were met. | PASS |
| Validation of Accessories (Verify V24 SCBIs) | Three lots of Verify V24 SCBIs must be sterile (no growth) after processing in the V-PRO Flexible ½ Cycle. | Three lots of Verify V24 SCBIs were sterile (no growth) after processing in the V-PRO Flexible ½ Cycle. | PASS |
| Validation of Accessories (Verify Vaporized VH2O2 Process Indicators) | Three lots of Verify Vaporized VH2O2 Process Indicators must exhibit a complete color change under worst-case simulated use. | Three lots of Verify Vaporized VH2O2 Process Indicator exhibited a complete color change under worst case simulated use. | PASS |
| Validation of Accessories (V-PRO Sterilization Trays) | 1 x 1050 mm lumens must be successfully sterilized in the V-PRO Sterilization Trays under ½ cycle worst-case conditions. | 1 x 1050 mm lumens were successfully sterilized in the V-PRO Sterilization Trays under ½ cycle worst case conditions. | PASS |
| Validation of Accessories (Vis-U-All Tyvek Pouches) | Mated and non-mated surfaces must be successfully sterilized in the Vis-U-All Tyvek Pouches under ½ cycle worst-case conditions. | Mated and non mated surfaces were successfully sterilized in the Vis-U-All Tyvek Pouches under ½ cycle worst case conditions. | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a consolidated "test set" sample size in terms of the number of medical devices. However, it provides details for specific tests:
- AOAC Sporicidal Test: "All 720 carriers processed" - this implies a sample size of 720 biological indicator carriers for this specific test.
- Lumen Cycle Validation: "maximum of twenty (20) lumens per load."
- Non Lumen Cycle Validation: Validation load consisting of "two instrument trays and two pouches."
- Flexible Cycle Validation:
- Load 1: "Two flexible endoscopes with a light cord"
- Load 2: "One flexible endoscope with a light cord... and additional non-lumened instruments."
- Biocompatibility / Material Compatibility: "23 materials" were evaluated.
- Accessory Validation (SCBIs, Process Indicators): "Three lots" were tested for each accessory.
The data provenance is implicitly prospective testing conducted by STERIS Corporation. There is no mention of country of origin for the data, but it is a submission to the US FDA, so the studies would ideally follow relevant US or international standards for medical device testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not provided in the document. Sterilization validation studies typically rely on established microbiological methods (e.g., spore log reduction, sterility testing of biological indicators) rather than human expert consensus for "ground truth" in the same way clinical diagnostic studies might. The "ground truth" here is the biological inactivation (sterility).
4. Adjudication Method for the Test Set
This information is not applicable for these types of technical performance studies. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where human readers interpret images or make diagnoses, and a consensus is needed for the "ground truth." Here, the outcomes are objective (e.g., presence/absence of microbial growth, color change, successful sterilization).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is used for diagnostic devices involving human interpretation (e.g., radiologists reading images and the AI assisting them). The Amsco V-PRO MAX is a sterilization system, and its effectiveness is determined by objective measures of microbial inactivation, not human diagnostic performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable in the traditional sense for a sterilization device. The device itself (the Amsco V-PRO MAX Sterilization System) operates in a "standalone" fashion to sterilize instruments. Its performance is evaluated intrinsically through various tests described, without a human "algorithm interpreter" in the loop for its primary function. The "algorithm" here is the sterilization cycle itself.
7. Type of Ground Truth Used
The ground truth used in these studies is primarily microbiological sterility, based on the inactivation of highly resistant bacterial spores (Biological Indicators, e.g., using Geobacillus stearothermophilus spores which are highly resistant to hydrogen peroxide). Other ground truths include:
- Physical/Chemical Indicators: Color changes in chemical indicators (CIs) and process indicators (PIs) demonstrating exposure to sterilant.
- Material Compatibility: Physical integrity and biocompatibility verified through lab tests.
- Lumen Sterilization: Direct testing of the sterilization efficacy within lumens of various sizes.
8. Sample Size for the Training Set
Not applicable/Not provided. This is a physical device (sterilizer) and not a software algorithm that undergoes machine learning training. Therefore, there is no "training set" in the context of AI/ML. The device's parameters and cycles are designed and validated through engineering and scientific principles, not by learning from a data set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, there is no training set for this type of device. The "ground truth" in its development would have been established through extensive research, development, and iterative testing, guided by microbiology, engineering, and material science principles to define optimal sterilization parameters.
§ 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).