(116 days)
The Amsco Evolution Medium Steam Sterilizer Models HC-900 and HC-1200 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 Amsco Evolution Medium Steam Sterilizer models HC-900 and HC-1200 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 371/2' x 42" (Model HC 900)
- 26'' x 37½' x 54'' (Model HC 1200)
The provided text describes a 510(k) premarket notification for a steam sterilizer device, not an AI/ML-based medical device. Therefore, much of the requested information regarding AI/ML device testing (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable or present in this document.
However, I can extract the acceptance criteria and performance data for this traditional medical device:
Acceptance Criteria and Device Performance for Amsco® Evolution Medium Steam Sterilizer
The STERIS Corporation performed verification activities to ensure that modifications to their Amsco® Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200) did not affect its safety or effectiveness. The study demonstrates that the device passed all established acceptance criteria.
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 |
Note: "Per ST8" refers to AAMI ST8, a recognized standard for hospital steam sterilizers. "Per IEC 61010-1" refers to an international standard for electrical equipment for measurement, control, and laboratory use, which includes safety requirements.
Information Not Applicable or Available in the Provided Document (Pertaining to AI/ML Devices)
This document describes a traditional medical device (steam sterilizer), not an AI/ML device. Therefore, the following information, typically required for AI/ML device studies, is not applicable or found in this submission:
- Sample sizes used for the test set and the data provenance: Not applicable. Performance testing for sterilizers involves functional checks and adherence to standards rather than data sets like those used for AI/ML.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a sterilizer's performance is objective (e.g., passing a specific test cycle, electrical safety standards met), not based on expert consensus of complex data.
- Adjudication method for the test set: Not applicable. Performance is binary (pass/fail) against objective criteria.
- 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 imaging or diagnostic device involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device's performance is inherently "standalone" in its function as a sterilizer.
- The type of ground truth used: For this device, ground truth is based on established engineering and safety standards (ST8, IEC 61010-1), and functional performance checks (e.g., proper actuation, no alarms, proper door function after multiple cycles). It is not expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.
- The sample size for the training set: Not applicable, as this is not an AI/ML device trained on data.
- How the ground truth for the training set was established: Not applicable.
§ 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).