(360 days)
The Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems, with VAPROX HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.
The V-PRO 1 Cycle, which is identical to the V-PRO 1 Plus Lumen Cycle, was cleared under K062297 and can sterilize: *
- Instruments with diffusion-restricted spaces such as the hinged portion of . forceps and scissors
- Medical devices with a single stainless steel lumen with: .
- an inside diameter of 1 mm or larger and a length of a 125 mm or shorter o
- an insider diameter of 2 mm or larger and a length of 250 mm or shorter o
- an inside diameter of 3 mm or larger and a length of 400 mm or shorter o
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- 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 lbs.
The Amsco V-PRO 1 Plus Low Temperature Sterilization System's Non Lumen Cycle was cleared under K.083097 and can sterilize: **
Non-lumened instruments including non-luments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.
- ** 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 1 and V-PRO 1 Plus Low Temperature Sterilizers are selfcontained stand-alone devices using vaporized hydrogen peroxide. These devices are intended for use in terminal sterilization of cleaned, rinsed and dried, reusable medical devices used in healthcare facilities. The sterilizers operate at low pressure and low temperature and are therefore suitable for processing medical devices sensitive to heat and moisture.
The provided text describes the acceptance criteria and the study conducted for the STERIS Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems. The changes to the device described in this submission are an update to the device Operator Manual to include polyether ether ketone (PEEK) as a compatible material for the V-PRO 1 Cycle and V-PRO 1 Plus Lumen and Non Lumen Cycles; and polyurethane as a compatible material for the V-PRO 1 Plus Non Lumen Cycle.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity and residue analysis have demonstrated biocompatibility after processing in the V-PRO sterilizer | Pass |
| Material Compatibility | Device maintains functionality following sterilization | Pass |
| ½ Cycle Sterilization Efficacy | No survivors at ½ cycle condition with End Of Shelf Life (EOSL) Sterilant | Pass |
| Simulated Use Evaluation | No survivors on device surface after processing with the V-PRO Non Lumen Cycle using EOSL sterilant | Pass |
| In Use Evaluation | Sterile results on all polyurethane and PEEK containing devices | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a separate "test set" sample size in the context of typical AI/ML studies (i.e., a dataset used for final model evaluation). Instead, the listed "tests" appear to be validation activities for the material compatibility claims.
- Sample Size: The document mentions that the Biocompatibility, Material Compatibility, ½ Cycle Sterilization Efficacy, Simulated Use Evaluation, and In Use Evaluation tests were completed for both polyurethane and PEEK.
- For the V-PRO 1 Cycle / V-PRO 1 Plus Lumen Cycle, validation testing for lumen sizes used a maximum of twenty (20) lumens per load. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs. This was for the original K062297 clearance.
- For the V-PRO 1 Plus Non Lumen Cycle, validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs. This was for the original K083097 clearance.
- The current submission adds PEEK and polyurethane, and these materials were subjected to the tests mentioned in the table. The exact number of PEEK/polyurethane items tested for each specific test is not detailed beyond "all polyurethane and PEEK containing devices" for the In Use evaluation.
- Data Provenance: The document does not specify the country of origin. Given it's a STERIS Corporation submission (located in Mentor, OH, USA) to the FDA, it is highly likely the studies were conducted in the USA or under US regulatory guidelines. The studies appear to be prospective validation studies rather than retrospective data analysis, as they involve performing specific tests to demonstrate safety and effectiveness for the new material claims.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not directly applicable in the context of this device and study. The "ground truth" for a sterilizer device typically involves established scientific and regulatory standards for sterility (e.g., no microbial survivors). The validation studies involve laboratory testing and biological indicator challenges, not expert interpretation of outputs in the same way an AI diagnostic imaging system would. Therefore, there's no mention of "experts" establishing ground truth in terms of clinical image interpretation or similar tasks.
4. Adjudication Method for the Test Set
Not applicable. The study is based on laboratory and performance testing of a physical device and its sterilization efficacy, not on human interpretation or adjudication of data.
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
Not applicable. This is not an AI-assisted diagnostic device, but a sterilization system. Therefore, no MRMC study or AI-related comparative effectiveness was conducted or reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used in these studies is based on established sterilization principles and methods, primarily:
- Absence of Microbial Survivors: Demonstrated through biological indicators (e.g., spore strips) or direct microbial culture methods, particularly for "½ Cycle sterilization efficacy" and "Simulated Use evaluation."
- Biocompatibility Standards: Referring to established methods (e.g., ISO standards for cytotoxicity and residue analysis).
- Material Functionality: Assessed through engineering and functional tests to ensure the device maintains its intended performance after sterilization.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML system, so there is no "training set." The studies are validation efforts for material compatibility of a physical sterilization system.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML model.
§ 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).