(67 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 Amsco 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: .
- o 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
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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 K083097 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the STERIS® Amsco® V-PRO™ 1 and V-PRO™ 1 Plus Low Temperature Sterilization Systems:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Modification | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Odor Filter | Oil smell shall not be present in devices using the proposed filter before that observed for devices using the current filter. | PASS |
| Vacuum pump oil | For devices using the proposed oil, oil smell shall not be detected before or at higher levels than that observed for devices using the current oil. No alarms or failures shall be observed during testing. | PASS |
| ARS Filter | The proposed ARS filters perform equally to or better than the current ARS filters. | PASS |
| Gas Ballast Filter | The proposed filters perform equally to or better than the current filters. | PASS |
| Software Modifications | Software shall be appropriately verified and validated. | PASS |
2. Sample Size Used for the Test Set and Data Provenance
- Odor Filter: Implied sample size based on "running continuous Non-Lumen cycles." No specific number of cycles or devices is given.
- Vacuum pump oil: Testing was performed "concurrently with the ARS Filter testing." No specific number of devices or cycles is given.
- ARS Filter: "Nine filters of each variety were run either until an oil smell was detected or 750 cycles were reached."
- Gas Ballast Filter: "The proposed filters (a total of 5) was tested by running until a failure was detected."
- Software Modifications: No specific sample size mentioned, just "Software Validation."
Data Provenance: The document does not specify the country of origin for the data. The studies appear to be prospective, as they involve testing proposed modifications against existing versions to determine equivalency or improvement.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for this set of performance tests. The acceptance criteria are objective and measurable (e.g., presence of oil smell, performance comparison, software validation).
4. Adjudication Method for the Test Set
No adjudication method is described, as the testing involves objective measurement against pre-defined criteria rather than expert interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
No, an MRMC comparative effectiveness study was not done. These tests are focused on the hardware and software performance of a sterilization system, not on human interpretation or diagnostic efficacy.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
This concept is not applicable here. The device is a sterilization system, not an algorithm, and its performance is inherently standalone in its function (sterilizing medical devices). The tests described evaluate the device's components and software in isolation from human intervention in the sterilization process itself.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on objective performance metrics and pre-defined standards comparing the modified components/software against the existing, predicate device components/software. For example:
- Absence/presence of oil smell
- Equal or better performance of filters
- Appropriate verification and validation of software
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to the performance testing of a physical sterilization device and its components/software. These tests are evaluations, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
As there is no training set in the context of this device's performance evaluation, this question is not applicable.
§ 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).