Search Results

Model 222: The Castle Model 222 Gravity Steam Sterilizer is intended for steam sterilization of hospital supplies. Typical clinical (Hospital) applications include wrapped hard goods and linens. Wrapped-goods cycles are provided for processing wrapped linen packs, as well as wrapped hard goods such as instruments and utensils. Unwrapped goods cycles (flash) are used to process unwrapped hard goods such as instruments and utensils. Steam stenlization by the unwrapped (flash) method is employed when time does not permit the use of the preferable, wrapped sterilization procedure. Implantables should never be sterilized by the unwrapped (flash) method. All cycles employ gravity or downward displacement with positive pulsing conditioning for dynamic air removal. Processing temperatures range from 250°F to 275°F (121°C to 135°C)

Model 233: The Castle Model 233 Vacuum Steam Sterilizer is intended for steam sterilization of hospital supplies. Typical clinical (Hospital) applications include wrapped hard goods and linens. Wrapped-goods (Hi Vac) cycles are provided for processing wrapped linen packs, as well as wrapped hard goods such as instruments and utensils. A gravity cycle is provided for processing wrapped dry goods and/or hard goods. Additionally, a Vacuum Leak Test cycle, not intended for sterilization, and an Air-Removal-Test-Pack (Bowie-Dick) cycle, not intended for sterilization is provided. The wrapped-goods (Hi Vac) cycles employ vacuum-and-positive pulsing to condition a load before processing at the selected exposure temperature. The gravity cycle employs the gravity, or downward displacement method of air removal. Processing temperatures for wrapped goods cycles range from 250°F (121°C to 135°C).

Model 223: The Castle Model 223 Gravity Steam Sterilizer is intended for steam sterilization of hospital supplies. Typical clinical (Hospital) applications include wrapped and unwrapped hard goods and linens. Wrapped-goods cycles are provided for processing wrapped linen packs, as well as wrapped hard goods such as instruments and utensils. The cycles employ gravity or downward displacement with positive pulsing conditioning for dynamic air removal. Processing temperatures for wrapped goods cycles range from 250°F to 275°F (121°C to 135°C).

All Models: Castle Series 200 Steam Sterilizers are programmed with factory recommended sterilization parameters (cycle settings) which have been verified and validated for efficacy. By using a supervisory password, the controls allow for flexibility in selecting exposure temperature, exposure time, and drying time. It is possible, with that password, to select cycle settings that will not necessarily achieve the desired sterlity assurance level. Users with password access are responsible for the efficacy of any cycle settings other than the factory recommended settings.

The Castle Series 200 Sterilizers (Powerclave) is a control system upgrade of an existing microcomputer control system intended to be used with hospital steam sterilizers. Specifically, PACS 2000 controls applied to the Series 200 (Powerclave) Steam Sterilizer are to be used with "Castle" brand sterilizers manufactured by Getinge/Castle, Inc for use in health care facility environments. These sterilizers are intended to be used to sterilize wrapped and unwrapped surgical instruments, hard goods, and linens. The difference between the predicate sterilizer controls and the PACS 2000 controls is that the PACS 2000 controls are provided with a more modern microprocessor, software, and an interactive operator interface. The piping remains relatively unchanged, with the addition of a chamber drain float switch to signal possible water-in-chamber conditions and a thermostatic drain discharge temperature control. A minor change on each chamber vessel size has changed the interior chamber width from 24 inches to 26 inches; the length on the mid-sized vessel has changed from 49 inches to 50 inches.

Here's a breakdown of the acceptance criteria and the study information for the Castle Series 200 Steam Sterilizers (Powerclave) based on the provided text, structured to answer your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for the sterilizer's performance are the established sterilization cycles and their effectiveness in achieving a specified sterility assurance level (SAL). The reported device performance is that these cycles were validated to meet a SAL of at least $10^{-6}$.

*Exposure times listed are actual times of the cycles to be cleared and are not half times.

Beyond sterilization efficacy, the device also meets the following requirements:

• Safety Standards: UL544 and CSA C22.2 Nº 151 product safety standards for medical devices.
• Pressure Vessel Code: Section VIII of the ASME pressure vessel code.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: The document mentions "Evaluation studies consisting of fabric and instrument loads (wrapped and unwrapped)". However, it does not specify the exact number or sample size of these loads used for the validation testing.
• Data Provenance: The studies were conducted internally by Getinge/Castle, Inc. and are retrospective in nature (testing of the developed device). The country of origin of the data is implicitly the USA, where Getinge/Castle, Inc. is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• The document does not mention the use of experts to establish the ground truth for the sterilization testing. Sterilization efficacy is typically validated through microbiological challenge tests and physical measurements, rather than expert consensus on images or diagnoses.

4. Adjudication Method for the Test Set:

• Given that the validation relied on established industrial standards and the measurement of sterility assurance levels through "half cycle analysis," no human adjudication method (like 2+1, 3+1) was used or is relevant for this type of device testing.

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 is relevant for diagnostic devices where human readers interpret medical images or data, often with and without AI assistance. This document pertains to a steam sterilizer, which is a therapeutic/device processing tool, not a diagnostic one.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• This question is not applicable to a steam sterilizer. The "device" in question is the sterilizer itself, which operates autonomously to sterilize items based on pre-programmed cycles. Its performance is inherent to the machine, not an algorithm that assists human interpretation.

7. The Type of Ground Truth Used:

• The ground truth for the sterilization efficacy was established through microbiological challenge tests resulting in a sterility assurance level (SAL) of at least $10^{-6}$. This is inferred from the statement "Validation testing was performed using accepted half cycle analysis and results consistent with a sterility assurance level of at least $10^{-6}$ were obtained." This type of ground truth is based on a quantifiable reduction of microbial life, a standard method for sterilizer validation.

8. The Sample Size for the Training Set:

• This question is not applicable to this device. A steam sterilizer does not involve a "training set" in the context of machine learning or AI algorithms. The sterilizer operates based on engineered physics, control systems, and pre-defined parameters, not learned data sets.

9. How the Ground Truth for the Training Set Was Established:

• This question is not applicable for the same reasons as #8. There is no training set or corresponding ground truth in the context of this traditional medical device. The "ground truth" for its operation is the established science of sterilization (heat, pressure, time) and the engineering principles applied in its design.

Ask a specific question about this device