(110 days)
The Getinge 400HC/500HC 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 Models 422HC, 433HC, 522HC and 533HC steam sterilizers are the same model designations as the predicate device (K012573). Modifications to the device have been made to include control software updates, vessel material change and the options for a vacuum pump system (in place of water ejector) and stainless steel piping and components (in place of brass piping and components). The modifications made to the 400HC/500HC series Steam Sterilizer do not affect the intended use of the device and do not alter the fundamental science technology of the device. The modifications were made under the procedures and processes of the documented design control process. Performance testing of the modified device models was to ANSI/AAMI ST8:2008.
The Getinge Model 400HC/500HC Series Steam Sterilizer (K103504) is a Class II medical device intended for sterilizing heat and moisture-stable items in healthcare facilities via pressurized steam. The submission describes modifications to a previously cleared device (K012573), including control software updates, a vessel material change, and options for a vacuum pump system and stainless steel piping.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Acceptance Criteria and Reported Device Performance:
The device's performance aligns with the requirements of ANSI/AAMI ST8:2008. While explicit "acceptance criteria" tables with numerical targets are not directly provided, the overall implication is that the sterilizer cycles performed as specified in the "Steam Sterilizer Cycles and Load Chart" and effectively sterilized the described loads within the given parameters (exposure temperature, exposure time, dry time).
The tables in the submission (K103504, pages {1} and {2}) detail the various sterilization cycles, their factory settings (temperature, time, dry time), and the maximum load configurations applicable to each sterilizer model (433HC, 533HC, 422HC, 522HC).
For example, a "PREVAC 1 (vac)" cycle for the 433HC/533HC models has reported performance parameters of:
- Exposure Temp: 275°F (135°C)
- Exposure Time: 3 min
- Dry Time: 16 min
- Load Configuration: Double-wrapped instrument trays (up to 25 lb per tray), Fabric packs
- Maximum Items: 2 (433HC)/3 (533HC) instrument trays, or 4 (433HC)/12 (533HC) fabric packs.
The statement in the conclusion ({3}) indicates: "This steam sterilizer meets the applicable requirements of AAMI ST8:2008 performance standards." This implies that the device successfully met the sterilization efficacy, safety, and performance criteria outlined in the ANSI/AAMI ST8:2008 standard.
Table of Acceptance Criteria (Implied) and Reported Device Performance:
| Acceptance Criterion (Implied by ANSI/AAMI ST8:2008) | Reported Device Performance (Examples from provided charts) |
|---|---|
| Sterilization Efficacy for "PREVAC 1 (vac)" | Achieved with 275°F (135°C) for 3 min, 16 min dry time |
| - Double-wrapped instrument trays | - Maximum 2 trays (433HC), 3 trays (533HC) |
| - Fabric packs | - Maximum 4 packs (433HC), 12 packs (533HC) |
| Sterilization Efficacy for "GRAVITY 1 (grv)" | Achieved with 250°F (121°C) for 30 min, 45 min dry time |
| - Double-wrapped instrument trays | - Maximum 2 trays (422HC), 3 trays (522HC) |
| - Fabric packs | - Maximum 4 packs (422HC), 12 packs (522HC) |
| Sterilization Efficacy for "Flash 3+" | Achieved with 275°F (135°C) for 3 min, 30 sec dry time |
| - Unwrapped non-porous single instrument | - Maximum 1 instrument |
| - Unwrapped non-porous instrument trays | - Maximum 2 trays |
| Liquid Cycle Performance (Liquids 1 & 2) | Achieved with 250°F (121°C) for 30/45 min, 0.75 psi/min cooldown (for containers ≤ 1000 mL) |
| Compliance with ANSI/AAMI ST8:2008 | "This steam sterilizer meets the applicable requirements of AAMI ST8:2008 performance standards." ({3}) |
| Predicate Device Equivalence | No substantial changes in technology or intended use compared to K012573. ({3}) |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "Performance testing of the modified device models was to ANSI/AAMI ST8:2008" ({0}) and "Load configurations during testing validations follow AAMI Standard ST8 Hospital Steam Sterilizers where applicable." ({2}). It also mentions "All Fabric Packs and instrument trays formulated as described in AAMI Standard ST8 Hospital Steam Sterilizers." ({2}).
The specific numerical sample size for the test set (number of sterilization cycles, number of test devices, etc.) is not explicitly stated. However, it would have followed the recommendations and requirements for validation testing as outlined in ANSI/AAMI ST8:2008 for each specified cycle and load configuration.
The provenance of the data is that it was generated through prospective performance testing and validation conducted by Getinge Sourcing LLC according to an industry standard (ANSI/AAMI ST8:2008). The country of origin of the data is not explicitly mentioned but is presumably the United States, given the company's address and submission to the FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the submission. For a steam sterilizer, the "ground truth" for sterilization efficacy is typically established through the use of biological indicators (BIs) and physical/chemical indicators, which are standardized and provide an objective measure of microbial kill. Expert human review might be involved in interpreting these results, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set:
This information is not provided. Given that the "ground truth" for sterilization is established through standardized indicators and physical measurements, a traditional medical image "adjudication" process (like 2+1 or 3+1) is not applicable or described for this type of device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study comparing human readers with and without AI assistance is relevant for diagnostic imaging devices, not for a steam sterilizer.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, in essence, the performance testing described is "standalone" for the device's function. The sterilizer operates automatically based on its programmed cycles. The performance validation (to ANSI/AAMI ST8:2008) assesses the device's ability to achieve and maintain the necessary sterilization parameters and efficacy independently. There is no "human-in-the-loop performance" in the context of the sterilization process itself; humans load and unload the device and initiate cycles.
7. The Type of Ground Truth Used:
The ground truth used for verifying the steam sterilizer's performance is based on sterilization efficacy confirmation using standardized biological indicators (BIs) and physical/chemical indicators as per the requirements of ANSI/AAMI ST8:2008. This standard outlines methods for validating that sterilization parameters (temperature, time, pressure, steam quality) are met and that a sufficient level of microbial inactivation (typically a sterility assurance level, SAL, of 10^-6) is achieved.
8. The Sample Size for the Training Set:
This information is not applicable or not provided in the context of this submission. The device is a physical steam sterilizer, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for the device refers to its design, engineering, and manufacturing to meet specified performance standards and safety requirements.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable or not provided since there isn't a "training set" in the AI/ML context. The device's design and operating parameters are established through engineering principles, adherence to recognized standards (like ANSI/AAMI ST8:2008), and potentially iterative testing and refinement during development.
§ 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).