(56 days)
Castle® Series 100HC Steam Sterilizers are intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids (liquids not intended for direct patient contact) by means of pressurized steam.
The 100HC Steam Sterilizers represent a series of sterilizers intended for use in hospital and health care facilities. The product provides an update to the control system that provides additional functionality and ease of use to the end user that includes the added flexibility to adjust cycle parameters (as on previous sterilizer models), rename, and reassign (re-sequence) the designated sterilization cycles.
Here's an analysis of the provided text regarding the Castle® Series 100HC Steam Sterilizers, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the way one might expect for software or diagnostic devices (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria for this medical device (steam sterilizer) are tied to its ability to meet established industry standards for sterilization and its substantial equivalence to a predicate device.
The reported device performance is described by its various sterilization cycles, which are designed to achieve specific sterilization parameters for different load configurations. The implicit acceptance criteria are that these cycles, when executed by the device, achieve the necessary conditions for sterility.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Compliance with AAMI ST8, ST37 & ST46 Standards and Guidelines | The sterilizers meet the applicable requirements of AAMI ST8, CSA-Z314.7, and GGS-1340A standards. The "Load configurations are based on AAMI ST8, ST37 & ST46 Standards and Guidelines." Various cycles (Gravity, Liquids, Flash, Prevacuum, Bowie-Dick Test, Leak Test) are detailed with specific temperatures, times, and load capacities designed for effective sterilization according to these standards. |
| Substantial Equivalence to Predicate Device (Castle® Series 100 Steam Sterilizers [K970907]) | "Castle® Series 100HC Steam Sterilizers provide substantially equivalent product as those of our predicate device. There have been no substantial changes in technology, intended use, or labeling of this device." The modifications are described as improvements to the control system and user flexibility, not fundamental changes to the sterilization efficacy. |
| Effective Sterilization for Intended Use | Intended for "use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids (liquids not intended for direct patient contact) by means of pressurized steam." The detailed cycle table specifies parameters for these uses. |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe a "test set" in the context of data for an algorithm or diagnostic. The device in question is a steam sterilizer, a piece of hardware designed to perform a physical process.
- Sample Size: Not applicable in the context of data for an algorithm. The testing would involve physical load configurations and sterility assurance levels, typically standardized by regulatory bodies and industry rather than a statistical "test set" of data.
- Data Provenance: Not applicable. The document refers to compliance with standards (e.g., AAMI, CSA) which represent established scientific and industry best practices for sterilization, not data collected from a specific patient population or geographical region.
- Retrospective/Prospective: Not applicable. Testing for a sterilizer's efficacy is typically conducted through controlled laboratory and real-world simulations to ensure it meets performance standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of device submission. For a steam sterilizer, "ground truth" is established by scientific principles of microbiology and engineering, and validated through standardized testing protocols (e.g., using biological indicators, thermocouples) that demonstrate the destruction of microorganisms. The document refers to compliance with standards established by organizations like AAMI, which involve experts in sterilization, microbiology, and healthcare, but does not detail the specific experts or their qualifications for this particular submission's ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. There is no human adjudication process described for the performance of a steam sterilizer. The performance is assessed against physical and biological parameters defined by recognized standards.
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
Not applicable. This is not an AI-assisted diagnostic or imaging device. It is a steam sterilizer.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device does not involve an algorithm for diagnostic or interpretative purposes. The "algorithms" in this context refer to the programming of the sterilization cycles, which operate autonomously once initiated according to pre-validated parameters.
7. The Type of Ground Truth Used
The ground truth for the efficacy of the sterilizer is based on:
- Scientific Principles of Sterilization: The complete destruction of all viable microorganisms, typically confirmed through biological indicators (spores) and physical monitoring (temperature, pressure, time).
- Industry Standards: Compliance with established sterilization standards and guidelines such as AAMI ST8, ST37, ST46, CSA-Z314.7, and GGS-1340A. These standards define the parameters (temperature, pressure, time exposures for specific loads) required to achieve sterilization.
- Engineering Validation: Verification that the device can consistently deliver the specified physical conditions (temperature, pressure, vacuum) within the sterilization chamber.
8. The Sample Size for the Training Set
Not applicable. This device does not use an "AI" training set. Its operational parameters (cycles) are designed based on scientific principles and extensive validation testing of sterilization processes, not machine learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the AI sense. The "ground truth" for developing the sterilizer's parameters (temperature, time, pressure for various loads) would be established through a combination of:
- Microbiological Studies: Determining the D-value (decimal reduction time) of highly resistant microorganisms (e.g., Geobacillus stearothermophilus) at specific temperatures and humidities.
- Engineering and Thermal Mapping Studies: Extensive testing with thermocouples and biological indicators within simulated load configurations to ensure that every point within the load reaches and maintains the required sterilizing conditions for the specified duration.
- Compliance with Recognized Sterilization Standards: These standards (e.g., AAMI, ISO) provide scientifically validated guidelines for effective sterilization cycles.
In summary, this document describes a traditional medical device (a steam sterilizer) where performance is evaluated against established physical and biological standards for sterilization, rather than through empirical data analysis of an algorithm's output or human reader performance.
§ 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).