(101 days)
The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:
- Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. .
- Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP. Prevacuum, Gravity, Liguid, Leak Test and DART (Bowie-. Dick) cycles.
The Amsco Evolution Medium Steam Sterilizer models HC-600 and HC-1500 are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:
- Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and ● DART (Bowie-Dick) cycles.
- Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, Prevacuum, ● Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The chamber sizes of the proposed Amsco Evolution Medium Steam Sterilizer Models are as follows: - 26" x 26" x 39" (660 mm x 660 mm x 991 mm) Model HC-600 .
- Model HC-1500 26" x 37½" x 60" (660mm x 950mm x 1524mm) .
This document is a 510(k) premarket notification for the Amsco Evolution Medium Steam Sterilizer. It focuses on demonstrating substantial equivalence to a predicate device after certain modifications. Therefore, the "study" referred to is the verification and validation activities conducted to ensure the modifications do not affect the safety or effectiveness of the device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Modification | Verification / Validation Activity | Acceptance Criteria | Results of Verification / Validation |
|---|---|---|---|
| Control replacement | Performance testing | Per ST8 | Pass |
| Electrical safety | Per IEC 61010-1 | Pass | |
| Software modifications | Software validation | Software shall be appropriately verified and validated | Pass |
| Vacuum pump replacement | Performance testing | Per ST8 | Pass |
| Printer replacement | Software validation | Software shall be appropriately verified and validated | Pass |
| Valve modifications | Performance testing | Per ST8 | Pass |
| Switch modification | Actuation | Proper actuation, no alarms | Pass |
| Door mounting bracket modification | Door operation check | Proper function after multiple cycles | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (e.g., number of sterilizers tested, number of cycles run). The "test set" in this context refers to the modified sterilizer models (HC-600 and HC-1500) on which the verification and validation activities were performed. The data provenance is not specified beyond "STERIS Corporation" where the studies were conducted. The studies appear to be prospective, as they are verification and validation activities performed on the modified devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications
This information is not provided. The acceptance criteria reference industry standards (ST8, IEC 61010-1) and internal functional requirements ("Proper actuation, no alarms," "Proper function after multiple cycles"). It's implied that engineering and regulatory experts at STERIS established these criteria, but their specific number or qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of performance testing for a sterilizer, "adjudication" in the sense of expert review for ambiguous results is unlikely to be a primary method. The results ("Pass") indicate direct verification against objective criteria.
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
This is not applicable. The device is a steam sterilizer, not an AI-powered diagnostic tool requiring human readability of results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a steam sterilizer, not an algorithm. The software modifications were validated to ensure the sterilizer's proper functioning, not as a standalone diagnostic.
7. The Type of Ground Truth Used
The ground truth for these verification activities is a combination of:
- Industry Standards: AAMI ST8 (often referred to as ST8) for steam sterilization performance and IEC 61010-1 for electrical safety. These are recognized international/national standards for medical device safety and performance.
- Engineering Specifications/Functional Requirements: "Software shall be appropriately verified and validated", "Proper actuation, no alarms", "Proper function after multiple cycles". These are internal specifications derived from the device's design and intended function.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical sterilizer and not an AI/machine learning model that undergoes a "training set" phase.
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no "training set" for this type of device.
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).