(130 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, t Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
The Amsco Evolution Medium Steam Sterilizer is designed for sterilization of heat and moisture-stabile 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 is offered in the following chamber sizes: - 26" x 26" x 39" (660 mm x 660 mm x 991 mm) HC-600
- HC-1500 . 26" x 37½" x 60" (660mm x 950mm x 1524mm)
The STERIS Amsco Evolution Medium Steam Sterilizer is a medical device designed for sterilization of heat and moisture-stabile materials in healthcare facilities. The information provided outlines the device's technical specifications and the validation studies conducted to demonstrate its effectiveness and safety.
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria for the Amsco Evolution Steam Sterilizer are based on the requirements of ANSI/AAMI ST8, Fourth Edition, November 2001, and are primarily focused on achieving a sterility assurance level (SAL) of at least 10⁻⁶ probability of survival and satisfying specific physical parameters for each cycle type.
| Acceptance Criterion (from ANSI/AAMI ST8) | Reported Device Performance (Amsco Evolution Steam Sterilizer) |
|---|---|
| Empty Chamber Testing: | Performed as described in Section 5.4.2.5 of ANSI/AAMI-ST8 for Prevac, Gravity, Liquid, and SFPP cycles. Demonstrated capability of providing steady-state thermal conditions consistent with predicted SAL in the load. Meets requirements of Sections 4.4.2.2 and 4.4.2.5 of ANSI/AAMI-ST8. |
| SFPP Cycles (Fabric Test Pack, Section 5.5.2.1): | Qualified according to Section 5.5.2 ANSI/AAMI-ST8. Demonstrated a sterility assurance level of at least 10⁻⁶ through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots. |
| SFPP Cycles (Full Load Instrument Trays, Section 5.5.4.1): | Qualified according to Section 5.5.4 ANSI/AAMI-ST8. Demonstrated a sterility assurance level of at least 10⁻⁶ using half-cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper. |
| GRAVITY Cycles (Fabric Test Pack, Section 5.5.2.1): | Qualified according to Section 5.5.2 ANSI/AAMI-ST8. Demonstrated a sterility assurance level of at least 10⁻⁶ through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and no evidence of wet spots. |
| GRAVITY Cycles (Full Load Instrument Trays, Section 5.5.4.1): | Qualified according to Section 5.5.4 ANSI/AAMI-ST8. Demonstrated a sterility assurance level of at least 10⁻⁶ using half-cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper. |
| PREVAC Cycles (Fabric Test Pack, Section 5.5.2.1): | Qualified according to Section 5.5.2 ANSI/AAMI-ST8. Demonstrated a sterility assurance level of at least 10⁻⁶ through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, moisture retention of less than 3% increase in presterilization test pack weight, and exhibited no wet spots. |
| PREVAC Cycles (Full Load Instrument Trays, Section 5.5.4.1): | Qualified according to Section 5.5.4 ANSI/AAMI-ST8. Demonstrated a sterility assurance level of at least 10⁻⁶ using half-cycle analysis, moisture retention of less than 20% increase in presterilization weight of the towel, and no evidence of wet spots on the outer wrapper. |
| LIQUID Cycles (Three 1,000 ml flasks, Section 5.5.3.1): | Qualified according to Section 5.5.3 of ANSI/AAMI-ST8. Demonstrated a sterility assurance level of at least 10⁻⁶ through achievement of a time-at-temperature sufficient to produce an Fo value of at least 12, water loss not exceeding 50 ml, and automatic sealing of the flask closure. |
| DART Cycle (Bowie-Dick Test Pack, Section 5.6.1.1): | Qualified according to Section 5.6.1 of the ANSI/AAMI-ST8, and demonstrated a uniform color change throughout the test sheet. |
| Software Validation (Moderate Level of Concern, FDA Guidance 05/11/05): | Performed according to FDA's moderate level of concern recommendations provided in the document "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (05/11/05)." (Specific performance details of software validation are not provided in the excerpt, only that it was performed to the standard). |
| Electrical Safety Code Compliance: | Underwriters Laboratory (UL) Electrical Safety Code 61010-1 certified by Intertek Testing Services (ITS), Canadian Standards Association (CSA) Standard C22.2 No. 1010-1 as certified by Intertek Testing Services. (Compliance is stated; specific performance metrics are not detailed). |
| Pressure Vessel Standards Compliance: | American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired pressure vessels. (Compliance is stated; specific performance metrics are not detailed). |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes validation studies that demonstrate the effectiveness of the sterilizer, but does not specify numerical sample sizes for biological indicator (BI) tests or specific material loads beyond "full load instrument trays," "fabric test pack," or "three 1,000 ml flasks." It implies that these tests were conducted as per ANSI/AAMI ST8, which would dictate appropriate sample sizes for validation.
The data provenance is prospective, as STERIS "validates its sterilization cycles using recommended practices, standards and guidelines developed by independent organizations." This indicates that tests were conducted specifically for the purpose of validating the Amsco Evolution Steam Sterilizer. The country of origin of the data is not explicitly stated, but given STERIS Corporation is based in Mentor, Ohio, USA, and the validation references ANSI/AAMI standards, it is reasonable to infer the data is primarily from the USA or follows international standards adopted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number or qualifications of experts used to establish ground truth for the validation studies. The ground truth (sterility assurance) is established through the complete kill of biological indicators and verification of an appropriate SAL, which are objective measurements performed in accordance with established standards (ANSI/AAMI ST8) by those conducting the validation.
4. Adjudication Method for the Test Set:
Not applicable. The validation studies involve objective measurements of physical parameters and biological indicator kill rates, not subjective assessments requiring adjudication by experts.
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:
Not applicable. This device is a steam sterilizer, a physical apparatus. It does not involve "human readers" or "AI assistance" in its operation or performance assessment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable for the primary function of sterilization. While the device does include software for cycle operation, and software validation was performed, it is a physical sterilizer and not an "algorithm only" device in the context of medical imaging or diagnostic AI. The software validation ensures the algorithm controlling the sterilizer operates correctly.
7. The Type of Ground Truth Used:
The ground truth for the effectiveness of the sterilizer function is established through:
- Biological Indicator (BI) Kill: Complete kill of biological indicators.
- Sterility Assurance Level (SAL): Verification of an appropriate SAL of at least 10⁻⁶ probability of microbial survival.
- Physical Parameters: Achievement of specific time-at-temperature (Fo value of at least 12), moisture retention limits, and absence of wet spots.
- Bowie-Dick Test Pack Results: Uniform color change for the DART cycle.
These are objective, quantitative biological and physical measurements, rather than expert consensus, pathology, or outcomes data in the typical sense of medical device validation for diagnostic or therapeutic devices.
8. The Sample Size for the Training Set:
Not applicable. This device does not use an "AI" or "machine learning" algorithm in the sense of requiring a training set of data. The "software validation" mentioned refers to traditional software engineering verification and validation, ensuring the control logic functions as designed, not a learning algorithm trained on data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As noted in point 8, there is no "training set" or "ground truth for a training set" in the context of machine learning for this type of device. The software validation would typically involve comparing software behavior to predefined functional specifications and requirements.
§ 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).