(196 days)
The Getinge GSS67N Series Steam Sterilizer is intended for use by health care facilities 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 GSS67N Series Steam Sterilizer is available in 3 models differentiated by chamber length; GSS67N Model 6710 (39 inch chamber), GSS67N Model 6713 (51 inch chamber) and GSS67N Model 6717 (67 inch chamber).
The Getinge GSS67N Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. There are three model designations to identify three different chamber lengths. The model 6710 is 1000 mm (39") long, model 6713 is 1300 mm (51") long and model 6717 is 1700 mm (67") lona.
The Getinge GSS67N Series Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 11 standard cycles can be easily accessed and custom cycle names can be designated by the user. All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.
This document pertains to the Maquet GmbH Getinge GSS67N Series Steam Sterilizer (K172159).
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria for the GSS67N Series Steam Sterilizer are derived from the ANSI/AAMI ST8:2013 Hospital Steam Sterilizers standard. The reported device performance indicates that the sterilizer meets these requirements.
| Performance Metric | Acceptance Criteria (ANSI/AAMI ST8:2013) | Reported Device Performance (Summary of Performance Testing Section) |
|---|---|---|
| Sterility Assurance Level (SAL) | At least 10^-6 (complete BI kill and sufficient Fo value) | Achieved SAL of at least 10^-6 through complete BI kill and Fo value of at least 12 for all PREVAC, GRAVITY, and IUSS cycles. |
| Moisture Retention (Fabric Packs) | Less than 3% increase in pre-sterilization test pack weight, no visible wet spots. | Demonstrated less than 3% increase in pre-sterilization test pack weight, including no visible wet spots for PREVAC (excluding PREVAC 2 and PREVAC 5) and GRAVITY cycles. |
| Moisture Retention (Wrapped Instrument Trays) | Less than 20% increase in pre-sterilization weight of towel, no visible wet spots on outer wrapper. | Demonstrated less than 20% increase in pre-sterilization weight of the towel, including no visible wet spots on the outer wrapper for PREVAC and GRAVITY cycles using wrapped instruments. |
| Empty Chamber Thermal Conditions | Capable of providing steady-state thermal conditions consistent with predicated SAL. | Demonstrated capability to provide steady-state thermal conditions within the chamber consistent with the predicated SAL. |
| Bowie-Dick Test | Satisfactory performance as described in ANSI/AAMI ST8:2013 section 5.6.1.1. | Bowie-Dick cycle validated using the Bowie-Dick test pack as described in ANSI/AAMI ST8:2013 section 5.6.1.1. (Implicitly passed, as performance testing summary states validation). |
| Liquid Load Cycles (Water Loss) | Water loss not exceeding 50 mL for 1-liter flasks. | Demonstrated water loss not exceeding 50 mL for 1-liter flasks. |
| Software Validation | Per FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | Software validation for cycle operation performed according to the specified FDA guidance document. |
| Electrical Safety & EMC | Compliance with IEC 61010-1, IEC 6101-2-040, and IEC 61326:2013. | Electrical safety and EMC testing completed per IEC 61010-1, IEC 6101-2-040, and IEC 61326:2013. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a specific "sample size" in terms of number of sterilizers or distinct test runs for the validation of each cycle. However, the performance testing was conducted according to ANSI/AAMI ST8:2013 Hospital Steam Sterilizers, which outlines rigorous testing protocols. For each cycle type (PREVAC, GRAVITY, IUSS, Liquids, Bowie-Dick), validation was performed using specific process challenge devices and configurations as detailed in the standard.
- Data Provenance: The testing was carried out by Maquet GmbH, the manufacturer, to demonstrate compliance with the ANSI/AAMI ST8:2013 standard. The data is prospective as it involves validation testing specifically for this device series, rather than retrospective analysis of existing data. The country of origin of the data is implicitly Germany (manufacturer location).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This document does not provide information on the "number of experts" or their specific "qualifications" for establishing ground truth for the test set. For steam sterilizers, the "ground truth" is typically established by physical and biological indicators showing successful sterilization, rather than expert judgment in interpreting images or clinical outcomes. The adherence to the ANSI/AAMI ST8:2013 standard itself implies that the methodologies for determining effective sterilization are standardized and technically validated.
4. Adjudication Method for the Test Set:
Not applicable in the context of sterilizer performance validation. The outcomes of sterilization cycles are determined by objective measurements (temperature, time, pressure) and biological indicator analysis. There is no subjective interpretation or "adjudication" in the sense of expert review of discrepancies.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No. This is not a diagnostic device that involves human readers interpreting data.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done:
Yes, in essence. The device (steam sterilizer) operates autonomously based on its programmed cycles. The performance validation assessed the sterilizer's ability to achieve sterilization without human intervention in the sterilization process itself. Human involvement is in operating the device and loading/unloading items, but the sterilization process is automated ("algorithm only" in the context of its defined cycles).
7. The Type of Ground Truth Used:
The ground truth used for performance validation is based on:
- Biological Indicators (BI kill): Complete kill of biological indicators is a primary ground truth for sterility.
- Physical/Chemical Indicators: Achievement of sufficient Fo value (a measure of sterilization lethality related to time and temperature).
- Physical Measurements: Temperature, pressure, and time parameters are monitored.
- Moisture Retention: Quantitative measurement of weight increase and qualitative assessment of wet spots.
- Bowie-Dick Test Pack: Changes indicating proper air removal and steam penetration.
- Water Loss: Quantitative measurement for liquid cycles.
These are objective, outcome-based measurements directly demonstrating the physical and biological effectiveness of the sterilization process according to established industry standards.
8. The Sample Size for the Training Set:
Not applicable. This device is a hardware sterilizer, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for the device would be its engineering design and validation processes against established standards.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set in the context of AI/ML. The device's "ground truth" for its operation is established by adherence to the physical and biological principles of steam sterilization, codified in standards like ANSI/AAMI ST8:2013, and confirmed through extensive engineering design and testing.
§ 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).