(65 days)
The Amsco® V-PRO™ 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
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 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.
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
- 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
- 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 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilizers are self-contained 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 document is a 510(k) premarket notification for the Amsco V-PRO Low Temperature Sterilization Systems, specifically concerning modifications to the VAPROX® HC Sterilant cartridge. The study described focuses on demonstrating substantial equivalence of the modified product to previously cleared predicate devices.
Here's the breakdown of the acceptance criteria and the study, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Modification | Testing | Acceptance Criteria | Results |
|---|---|---|---|
| Sterilant cartridge materials change | Testing at time 0 and 3 months to demonstrate no difference between resins used in construction of the cartridge or current or the current and proposed cartridge design. | No difference in the following characteristics at the 0 time point and following 3 months of storage: | |
| • Package Appearance | |||
| • Sterilant Color | |||
| • Clarity | |||
| • Hydrogen Peroxide Concentration | |||
| • Sterilant pH | PASS |
Testing demonstrates that cups meet 0 time point and stability specifications at 3 months. |
| Sterilant cartridge design change | (No specific testing or acceptance criteria for design change are detailed in the provided table, but the document implies that the "Sterilant cartridge materials change" testing addresses both aspects.) | (Not explicitly stated for design change alone in the table.) | (Not explicitly stated for design change alone in the table.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample size for the test set in terms of the number of cartridges tested. It mentions "Testing at time 0 and 3 months," suggesting a stability study over time.
- Data Provenance: The document does not specify the country of origin of the data. The study is prospective in nature, as it involves testing the modified product at specific time points (0 and 3 months) to evaluate its characteristics.
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 applicable to this study. The study focuses on the physical and chemical characteristics of a sterilant cartridge, not on diagnostic accuracy requiring expert interpretation (e.g., radiologists interpreting images). The "ground truth" here is the chemical and physical properties of the sterilant itself.
4. Adjudication Method for the Test Set
This information is not applicable to this study. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments where consensus is needed to establish ground truth, which is not the case here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical devices that involve human readers (e.g., CAD systems for image analysis), which is not the function of a sterilant cartridge.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study in the context of an algorithm or AI system was not done. This study concerns the physical and chemical characteristics of a sterilant cartridge and its substantial equivalence to predicate devices, not an independent algorithm's performance.
7. The Type of Ground Truth Used
The ground truth used in this study relates to the chemical and physical specifications of the sterilant. Specifically, the acceptance criteria for "Package Appearance," "Sterilant Color," "Clarity," "Hydrogen Peroxide Concentration," and "Sterilant pH" serve as the ground truth against which the modified sterilant cartridge is evaluated at different time points. These are objective measurements against established specifications.
8. The Sample Size for the Training Set
This study does not involve a "training set" in the context of machine learning or AI. The study is a direct performance and stability test of a medical device component.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in this context, this question is not applicable. The "ground truth" for the performance evaluation (chemical and physical specifications) would have been established through a combination of engineering design specifications, industry standards, and regulatory requirements for sterilants.
§ 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).