(27 days)
Castle® 400HC/500HC Series Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids (liquids to be used to tienties mappes contact) by means of pressurized steam.
The 400HC/500HC Series Steam Sterilizer is intended for use in hospital and health care facilities. The product incorporates an update to the control system that provides additional functionality and ease of use to the end user. It includes a larger color display that will allow the user to choose from the entire list of available cycles. Similar features to those on the Series 100HC include renaming and re-sequencing of sterilization cycles. The full lists of available cycles are provided in Table 1 for vacuum sterilizers (Models 433HC and 533HC) and Table 2 for gravity sterilizers (Models 422HC and 522HC).
Here's an analysis of the provided text regarding the Castle® 400HC/500HC Series Steam Sterilizer, focusing on acceptance criteria and the study proving its performance.
Please note: This document is a 510(k) summary for a medical device (steam sterilizer), not a study report for a human-AI effectiveness study. Therefore, many of the requested fields related to AI, human readers, and ground truth in a clinical context are not applicable. The information provided heavily focuses on the device's functional specifications and equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly defined by its functional specifications, regulatory standards, and claimed equivalence to a predicate device. The performance is reported in terms of its ability to achieve sterilization under specific cycle parameters and load configurations.
| Acceptance Criteria Category | Specific Acceptance Criteria (from text) | Reported Device Performance (from Tables 1 & 2) |
|---|---|---|
| Intended Use | Sterilize wrapped and unwrapped surgical instruments, linens, and liquids (liquids not for direct patient contact) by means of pressurized steam. | The device provides specific cycles and load configurations for these items (e.g., "Double-wrapped Instrument trays," "Fabric packs," "Unwrapped non-porous single instrument," "Up to 250 mL containers," "Up to 1000 mL containers") across various temperatures and times, indicating its capability to perform the intended function for these items. |
| Sterilization Efficacy (Cycle Parameters) | Achieve sterilization at specified temperatures and times for various load types. | The tables provide detailed "Exp. Temp." (Exposure Temperature) and "Exp. Time" (Exposure Time) for each cycle type (e.g., GRAVITY 1: 250°F/121°C for 30 min; PREVAC 1: 275°F/135°C for 3 min). These are the operational parameters designed to achieve sterilization. |
| Drying Efficacy | Ensure items are dry after sterilization, with provisions for extended drying. | "Dry Time" is specified for each cycle type (e.g., GRAVITY 1: 30 min; Flash cycles: 10 sec, with a note that items may not be dry). The notes indicate that "Factory set drying time is the recommended minimum drying time. Extended drying time may be required depending on local conditions." and "Gravity cycle drying time may be reduced by selecting vacuum drying phase." |
| Load Capacity | Handle specific maximum quantities and types of items per chamber size. | "Maximum Items per Chamber Size" is specified for both 433HC/422HC and 533HC/522HC models across all cycle types (e.g., GRAVITY 1 (433HC): 2 double-wrapped trays, 4 fabric packs; LIQUIDS 2 (533HC): 32 x 1000 mL containers). |
| Compliance with Standards | Adherence to applicable requirements of AAMI ST8, AAMI ST46, AAMI ST37, CSA-Z314.7, GGS-1340A, and GGS-1343A Standards. | The document explicitly states: "Load configurations follow AAMI Standards ST8 Hospital Steam Sterilizers where applicable." and "Refer to AAMI Standards ST46 Good Hospital Practice: Steam Sterility Assurance and ST37 Good Hospital Practice: Flash Sterilization - Steam Sterilization of Patient Care Items for Immediate Use." The conclusion also states the device "meets the applicable requirements of AAMI ST8, CSA-Z314.7, GGS-1340A and GGS-1343A Standards." This implies that the device's performance aligns with these established sterilization standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" in the context of clinical data for AI systems. For a physical device like a sterilizer, testing would involve multiple runs under various conditions. The exact number of test runs or items processed during validation is not provided in this 510(k) summary.
- Data Provenance: Not applicable in the context of clinical data. The validation of a sterilizer typically involves engineering and microbiological challenge tests performed in a laboratory or factory setting. The specific country of origin for these tests is not mentioned, but the submitting company is "Getinge/Castle Inc." located in Rochester, NY, USA. The testing would be considered prospective as it validates the device's performance against its specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. For a sterilizer, the "ground truth" for sterilization efficacy is typically established through standardized microbiological challenge tests (e.g., using biological indicators or thermocouples to verify physical parameters) rather than expert consensus on images or clinical outcomes.
- Qualifications of Experts: If experts (e.g., microbiologists, sterilization specialists) were involved in validating the test methodologies or interpreting results for sterilization, their qualifications are not provided in this summary.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are used in clinical studies, often for image interpretation tasks, to resolve discrepancies between readers. For a sterilizer, validation relies on objective physical and biological measurements.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or interpretive tools, not for a physical device like a steam sterilizer.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The "device" is a physical sterilizer, not an algorithm. Its performance is inherent to its design and function. While it has an updated control system and software, these are integral to the sterilizer's operation, not a separate standalone AI algorithm.
7. The Type of Ground Truth Used
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Type of Ground Truth: For a steam sterilizer, the ground truth for sterilization efficacy is established through:
- Microbiological challenge tests: Using biological indicators (BIs) containing highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) to demonstrate a sterility assurance level (SAL).
- Physical parameter monitoring: Measuring and confirming that critical parameters (temperature, pressure, time, steam penetration) are met throughout the sterilization cycle using calibrated sensors (e.g., thermocouples).
- Chemical indicators: Used as process indicators but not primary ground truth for sterility.
- Industry Standards: Compliance with recognized national and international sterilization standards (e.g., AAMI, ISO).
The document explicitly mentions adherence to AAMI standards (ST8, ST46, ST37) and CSA-Z314.7, GGS-1340A, and GGS-1343A Standards, implying these are the basis for validating "ground truth" performance.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This summary is for a physical steam sterilizer, not an AI or machine learning model that requires a training set of data. The device's "training" refers to its design, engineering, and manufacturing process.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As mentioned, this is not an AI/ML device. For a physical device, its "ground truth" (i.e., its intended design specifications and performance parameters) is established through design controls, engineering principles, and adherence to relevant industry standards and regulatory requirements. These designs are then validated through 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).