(290 days)
The Amsco V-PRO 1 Plus 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 two pre-programmed sterilization cycles; the Lumen and the Non Lumen 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 Plus Low Temperature Sterilizer System's (Lumen Cycle) was cleared under (K062297) 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
- 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
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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 Ibs.
The Amsco V-PRO 1 Plus Low Temperature Sterilization System's (Non Lumen Cycle) the subject of this (K083097) 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 Plus Low Temperature Sterilizer is a self-contained standalone device using vaporized hydrogen peroxide. This device is intended for use in terminal sterilization of cleaned, rinsed and dried, reusable medical devices used in healthcare facilities. The sterilizer operates at low pressure and low temperature and is therefore suitable for processing medical devices sensitive to heat and moisture.
The provided document is a 510(k) Summary for the Amsco V-PRO 1 Plus Low Temperature Sterilization System, focusing on the addition of a Non Lumen Cycle. It describes the device's validation against established criteria for sterilization effectiveness and safety.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Effectiveness (Sterilization) | Complete kill of biological indicators. | Demonstrated by complete kill of biological indicators. |
| Sterility Assurance Level (SAL) | At least 10⁻⁶ probability of survival. | Verified an appropriate safety factor or sterility assurance level (SAL) of at least 10⁻⁶ probability of survival. |
| Validation Standards | Meet requirements of FDA Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities, 1993, and Addendum to the Sterilizer guidance document, 1995. | The Amsco V-PRO 1 Plus Low Temperature Sterilization System has been validated to meet these requirements. |
| Safety (Electrical) | Compliance with Underwriters Laboratory (UL) Electrical Safety Code 61010-1. | Certified by Intertek Testing Services (ITS). |
| Safety (Canadian Electrical) | Compliance with Canadian Standards Association (CSA) Standard C22.2 No. 1010-1. | Certified by Intertek Testing Services. |
| Safety (Pressure Vessels) | Compliance with American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired pressure vessels. | Complies with this requirement. |
| Intended Use - Non Lumen Cycle | Sterilize non-lumened instruments, including non-lumens with stainless steel diffusion-restricted areas (e.g., hinged portion of forceps or scissors). | "The Amsco V-PRO 1 Plus Low Temperature Sterilization System's Non Lumen Cycle can sterilize**: Non-lumened instruments including non-luments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors." |
| Validation Load Capacity - Non Lumen Cycle | Not explicitly stated as a criterion, but a validation load was specified for the studies. | 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. |
Study Information:
The document describes "Performance Testing - Bench" and "Effectiveness" studies.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state a numerical sample size for the test set in terms of number of instruments or specific configurations beyond the validation load. For the Non Lumen Cycle, it states: "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." This load represents the challenge in the sterility effectiveness tests. The number of biological indicators (BIs) used is not specified.
- Data Provenance: The studies are described as "Performance Testing - Bench" and "verification studies." There is no mention of country of origin of the data or whether the studies were retrospective or prospective, but given the nature of a 510(k) submission for a sterilizer, these would typically be prospective, controlled bench studies and laboratory tests conducted by the manufacturer (STERIS Corporation, USA).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- The document does not specify the number of experts used or their qualifications for establishing ground truth. For sterilization efficacy, ground truth is typically established by laboratory methods demonstrating the complete kill of highly resistant biological indicators, rather than human expert interpretation of device performance.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., medical imaging diagnostics) where there might be disagreement among readers. For sterilization efficacy, the outcome (kill/no kill of BIs) is objectively measured in a laboratory setting, not subject to human adjudication in the same way.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study is not relevant for a sterilizer's performance evaluation. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) is affected by AI assistance, which is not applicable here as the device is a sterilization system, not a diagnostic tool that involves human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Yes, effectively. The performance testing described (complete kill of biological indicators, verifying SAL, meeting FDA guidance) evaluates the sterilizer system's ability to achieve sterility on its own without human intervention influencing the sterilization outcome. While human operators load the device and select cycles, the performance of the sterilization process itself is measured as a standalone function of the device.
7. The Type of Ground Truth Used
- The primary ground truth for sterilization effectiveness is the complete kill of biological indicators (BIs) which are highly resistant microorganisms (spores) placed in challenging locations. This is an objective, laboratory-based physical/biological measure, designed to demonstrate a high Sterility Assurance Level (SAL) (at least 10⁻⁶). This is a direct measure of microbial inactivation.
8. The Sample Size for the Training Set
- Not applicable. The Amsco V-PRO 1 Plus Low Temperature Sterilization System is a physical sterilization device, not an AI software/algorithm that requires a "training set" in the machine learning sense. Its design and operation are based on validated physical and chemical principles, not learned patterns from data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As explained above, there is no "training set" for this type of medical device. The device's performance is established through rigorous validation studies based on scientific and regulatory standards.
§ 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).