(267 days)
The Getinge 800HC-E Series Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.
The Getinge 800HC-E Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. The only model designation provided in the 800HC-E Series Steam Sterilizer is 833HC-E. The model 833HC-E is available in 2 chamber sizes; 42 inches long (39.6 cu ft) and 76 inches long (72.0 cu ft).
The Getinge 800HC-E Series Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 17 cycles can be easily accessed and custom cycle names can be designated by the user (duplicate cycles are provided to allow for user designated names). All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.
The Getinge 800HC-E Series Steam Sterilizer is a device designed for the sterilization of heat and moisture-stable materials in healthcare facilities. The pivotal study for this device is the "Summary of Performance Testing" which demonstrates its ability to reliably sterilize under various cycle types and load configurations.
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria for the Getinge 800HC-E Series Steam Sterilizer are aligned with the requirements of ANSI/AAMI ST8:2008 Hospital Steam Sterilizers. The device performance is deemed successful if these criteria are met.
| Acceptance Criteria (ANSI/AAMI ST8:2008) | Reported Device Performance |
|---|---|
| Empty Chamber Testing (Section 5.4.2.5): | Met: The results demonstrated that the sterilizer is capable of providing steady-state thermal conditions within the chamber that are consistent with the predicated sterility assurance level (SAL) in the load. |
| PREVAC and GRAVITY Cycles (Fabric Process Challenge Packs - Section 5.5.2): - Sterility Assurance Level (SAL) of at least 10^-6 - F₀ value of at least 12 - Complete Biological Indicator (BI) kill - Moisture retention of less than 3% increase in pre-sterilization test pack weight - No visible wet spots | Met: The results from this testing demonstrated a sterility assurance level of at least 10^-6 through achievement of time at temperature sufficient to produce an F₀ value of at least 12, complete BI kill, and moisture retention of less than 3% increase in pre-sterilization test pack weight, including no visible wet spots. |
| PREVAC and GRAVITY Cycles (Wrapped Instrument Process Challenge Devices - Section 5.5.4): - Sterility Assurance Level (SAL) of at least 10^-6 - F₀ value of at least 12 - Complete Biological Indicator (BI) kill - Moisture retention of less than 20% increase in pre-sterilization weight of the towel - No visible wet spots on the outer wrapper | Met: The results from this testing demonstrated a sterility assurance level of at least 10^-6 through achievement of time at temperature sufficient to produce an F₀ value of at least 12, complete BI kill, and moisture retention of less than 20% increase in pre-sterilization weight of the towel, including no visible wet spots on the outer wrapper. |
| Liquid Loads Cycles (Using 3 one-liter flasks - Section 5.5.3): - Sterility Assurance Level (SAL) of at least 10^-6 - F₀ value of at least 12 - Complete Biological Indicator (BI) kill - Water loss not exceeding 50ml | Met: The results from this testing demonstrated a sterility assurance level of at least 10^-6 through achievement of time at temperature sufficient to produce an F₀ value of at least 12, complete BI kill, and water loss not exceeding 50ml. (Note: Liquid Cycles are not intended for the sterilization of liquids used for direct patient contact.) |
| Bowie Dick Cycle (Section 5.6.1.1): - Successful completion according to the Bowie-Dick test pack | Met: Bowie Dick cycle was validated using the Bowie-Dick test pack as described in ANSI/AAMI ST8:2008 section 5.6.1.1. (Implies successful completion, as failure would have been noted). |
| Software Validation: - Compliance with FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (5/11/2005)" | Met: The software validation for the cycle operation was performed according to FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (5/11/2005)". |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state a numerical sample size in terms of the number of sterilization cycles or tests performed. However, it indicates that "Factory recommended cycles were tested," and for specific validation types (e.g., liquid loads), it mentions "3 one liter flasks." The implied sample size for each specific test type (empty chamber, fabric packs, instrument packs, liquid loads, Bowie-Dick) would be the minimum required by ANSI/AAMI ST8:2008 to demonstrate a statistically significant number of successful sterilizations to achieve the required Sterility Assurance Level (SAL). Given the nature of sterilization validation, this typically involves multiple successful runs to establish consistency and reliability.
- Data Provenance: The testing was conducted by Getinge Sourcing LLC, the manufacturer, at their facilities. This is considered prospective validation testing performed during the development and verification phase of the device. The country of origin for the data is implicitly the United States, as Getinge Sourcing LLC is located in Rochester, NY, and the submission is to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not specify the "number of experts" or their specific qualifications for establishing the ground truth during the performance testing. However, the ground truth itself is established by adherence to recognized industry standards: ANSI/AAMI ST8:2008 Hospital Steam Sterilizers. This standard defines the methodologies for testing, including the use of Biological Indicators (BIs), F₀ value calculations, and other physical and chemical indicators. Therefore, the "experts" are the developers of the AAMI standard and the trained personnel (e.g., sterilization validation engineers, microbiologists, quality assurance personnel) who conducted the tests according to these established protocols. Their qualification is their adherence to these standards.
4. Adjudication Method for the Test Set:
There is no mention of an "adjudication method" in the context of expert consensus, such as 2+1 or 3+1. For a steam sterilizer, validation is typically based on objective, measurable criteria defined by the AAMI standard. The success or failure of a sterilization cycle is determined by the physical parameters (temperature, pressure, time), the F₀ value, the kill of Biological Indicators (a direct measure of sterility), and physical assessments like moisture retention and wet spots. These are not subject to expert interpretation in the same way clinical image analysis might be.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices where human readers interpret outputs, and the AI's impact on their performance is being evaluated. The Getinge 800HC-E Series Steam Sterilizer is an automated sterilization device, not an AI-powered diagnostic tool, so such studies are not applicable.
6. Standalone (Algorithm Only Without Human-in-the Loop) Performance:
Yes, a standalone performance evaluation was conducted. The "Summary of Performance Testing" implicitly describes the standalone performance of the sterilizer. The device's ability to achieve sterilization (complete BI kill, F₀ value, etc.) is assessed based on its own operational cycles and parameters, without human intervention during the sterilization process itself. The "software validation" also attests to the standalone performance of the control algorithms.
7. Type of Ground Truth Used:
The primary ground truth used for the performance testing is a combination of:
- Biological Kill (Microbiological Data): Complete kill of Biological Indicators (BIs) is the ultimate confirmation of sterility, directly demonstrating the achievement of a sterility assurance level (SAL).
- Physical Parameters and F₀ Value (Engineering/Process Data): Achievement of specified temperature, pressure, and time parameters, and calculation of the Fo value, which quantifies the lethality of the steam sterilization process.
- Physical Assessment: Evaluation of moisture retention, presence of wet spots, and water loss, as defined by the AAMI standard.
- Standard Adherence: Compliance with the methodologies and acceptance criteria outlined in ANSI/AAMI ST8:2008 Hospital Steam Sterilizers.
8. Sample Size for the Training Set:
This information is not applicable (N/A). The Getinge 800HC-E Series Steam Sterilizer is a physical electromechanical device for sterilization, which does not employ machine learning or AI models that require "training sets" in the conventional sense of data-driven algorithm development. Its "training" involves engineering design, calibration, and iterative physical testing to optimize its performance before formal validation.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable (N/A) for the same reasons as above. The "ground truth" for the device's development relates to fundamental scientific principles of steam sterilization (e.g., thermal death kinetics of microorganisms, heat transfer, pressure dynamics) and engineering design specifications, rather than a labeled dataset for an AI model.
§ 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).