(451 days)
The Steelco VS Series Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with twelve factory-programmed cycles, provided on the following page. At no time will there be patient contact with the subject device.
The Steelco VS Series Steam Sterilizers use saturated steam, generated from a house steam utility (e.g. boiler system) or from a steam generator, to sterilize heat-stable health care products. The sterilizer accomplishes this by removing the air in the chamber, exposing the load to saturated steam for a defined combination of time and temperature, and drying the load. Removal of air from the chamber occurs using either of two methods, gravity displacement or mechanical vacuum. Once the air removal phase is completed, the sterilizer progresses to the steam exposure phase. During the steam exposure phase, every surface of the load is exposed to saturated steam for a defined combination of time and temperature. Once the steam exposure phase is completed, steam is removed from the chamber and the load is dried using the latent heat in the load and the vacuum pump.
The provided text describes the non-clinical testing performed for the Steelco VS Series Steam Sterilizers (K213545) to demonstrate its safety and effectiveness.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Purpose | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|
| Performance | Ensure performance, labeling, and safety per AAMI ST8:2013 | Labeling complies with section 4.1 of ST8. | Compliance is documented in the labeling, user manual, service manual, and inventory of user interface screens and the ST8 Compliance Test Protocols for the individual models. | Pass |
| Sterilizer design, construction, components, and accessories comply with section 4.2 of ST8. | Compliance is documented in the Machine Hardware Design Specification, risk analysis, FMEA section 3, mechanical aspects, ETL construction data file, ETL report IEC 61010-1 and 61010-2-040 compliance data report, ETL corrigendum, and the ST8 Compliance Test Protocols for the individual models. | Pass | ||
| Sterilizer safety complies with section 4.3 of ST8. | Compliance is documented in the Machine Hardware Design Specification, risk analysis, FMEA section 3, mechanical aspects, ETL construction data file, ETL report IEC 61010-1 and 61010-2-040 compliance data report, and ETL corrigendum, and the ST8 Compliance Test Protocols for the individual models. | Pass | ||
| Process monitoring and control devices comply with section 4.4 of ST8. | Compliance is documented in the Design Specification Control and User Interface Hardware, ETL construction data file, ETL report IEC 61010-1 and 61010-2-040 compliance data report, ETL corrigendum, and the ST8 Compliance Test Protocols for the individual models. | Pass | ||
| Biological performance of sterilizers complies with section 4.5 of ST8. | Compliance is documented in the ST8 Compliance Test Protocols for the individual machines. | Pass | ||
| Mechanical air removal complies with section 4.6 of ST8. | Compliance is documented in the ST8 Compliance Test Protocols for the individual machines. | Pass | ||
| Moisture retention complies with section 4.7 of ST8. | Compliance is documented in the ST8 Compliance Test Protocols for the individual machines. | Pass | ||
| General Electrical Safety | Ensure electrical safety in construction and design | Compliance with appropriate provisions of IEC/UL 61010-1 and 61010-2-040. | Compliance is documented in the ETL construction data file, ETL report IEC 61010-1 and 61010-2-040 compliance data report, and ETL corrigendum. | Pass |
| Sterilizer Electrical Safety | Ensure electrical safety in construction and design | Compliance with appropriate provisions of IEC/UL 61010-1 and 61010-2-040. | Compliance is documented in the ETL construction data file, ETL report IEC 61010-1 and 61010-2-040 compliance data report, and ETL corrigendum. | Pass |
| EMC testing | Ensure no interference with nearby machinery and no interference from external EMC issues | Compliance with appropriate provisions of EN IEC 61326 part 1. | Compliance is documented in the EN IEC 61326 pt. 1 compliance report. | Pass |
| Software validation | Ensure software executes designed functions and takes machine to safe state if it fails | Compliance with software validation provisions of ISO 62304. | Compliance is documented in the Software Requirements Specification Functional Specification Control and User Interface System, Risk Analysis, FMEA section 5 for control systems, and software validation. | Pass |
| Pressure Vessel Safety | Ensure pressure vessels are designed and built safely | Compliance with safety requirements of ASME Boiler and Pressure Vessel Code, Section VIII (Division 1) for chamber and jacket, and Section 1 for boiler (if furnished). | Meets requirements of ASME Boiler and Pressure Vessel Code, Section VIII (Division 1) for the chamber and jacket and Section 1 for the boiler (if furnished). See rating plate, section 6.2 of the ST8 Compliance Test Protocols for the individual machines. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the "sample size used for the test set" in terms of number of sterilization cycles or units tested. However, it mentions "ST8 Compliance Test Protocols for the individual machines" being documented for various performance criteria. This suggests that testing was conducted for the specific models of sterile, but the exact number of tests or cycles performed is not provided.
Regarding data provenance, the testing was non-clinical (laboratory/engineering testing) and focused on compliance with established standards (e.g., AAMI ST8, IEC/UL 61010, EN IEC 61326, ASME Boiler and Pressure Vessel Code). The document does not specify the country of origin of the testing data, but the manufacturer (Steelco S.P.A.) is based in Italy. The testing described is prospective in nature, as it was conducted to demonstrate compliance of the device before market introduction.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the described study is a non-clinical performance and safety validation study for a steam sterilizer, not an AI or diagnostic imaging device needing expert ground truth for interpretation. The "ground truth" here is defined by established engineering and medical device standards (AAMI ST8, IEC/UL 61010, etc.) and the physical performance of the machine.
4. Adjudication Method for the Test Set
This section is not applicable for a non-clinical performance and safety validation study of a steam sterilizer. The "adjudication" is met by demonstrating compliance with the specified technical standards and their criteria, not through consensus of human evaluators on specific cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted medical devices where human interpretation plays a role. The Steelco VS Series Steam Sterilizers are physical machines for sterilization, and their effectiveness is evaluated through engineering and microbiological performance testing against standards, not through human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable in the context of this device. The device is a steam sterilizer, a physical machine designed to operate independently to achieve sterilization. It does not involve "algorithms" in the sense of AI-driven interpretation or diagnostic assistance where "human-in-the-loop" performance would be relevant. The software validation mentioned ensures the machine's control software functions correctly and safely.
7. The Type of Ground Truth Used
The "ground truth" for the performance criteria of the Steelco VS Series Steam Sterilizers is based on established industry standards and regulatory requirements. Specifically, this includes:
- ANSI/AAMI ST8:2013: For general performance, biological performance, mechanical air removal, and moisture retention.
- IEC/UL 61010-1 and 61010-2-040: For electrical safety.
- EN IEC 61326 part 1: For electromagnetic compatibility (EMC).
- ISO 62304: For software validation.
- ASME Boiler and Pressure Vessel Code, Section VIII (Division 1) and Section 1: For pressure vessel safety.
Compliance with these standards, as evidenced by testing and documentation, serves as the ground truth for the device's acceptable performance, safety, and effectiveness.
8. The Sample Size for the Training Set
This section is not applicable. The Steelco VS Series Steam Sterilizers are physical machines, not an AI model or a system that requires a "training set" in the machine learning sense. The software validation refers to functional testing and adherence to software development lifecycle standards, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as #8. 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).