(162 days)
The 2545D tabletop Steam Sterilizer is designed for the sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities. (e.g., hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical & dental offices).
The 2545D was validated for use in:
Unwrapped instruments, wrapped instruments, sterilizing dental handpieces and textiles/porous loads.
The subject device (model: 2545D) is a table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. The 2545D uses steam as a sterilizing agent, produced by warming up a controlled amount of demineralized water which then flows into the chamber as steam. A heating element wrapped around the chamber maintains the required temperatures and steam. All processes are controlled by the device's computerized control system.
To use, the operator fills the water reservoir with water (distilled or purified), loads the trays with cleaned instruments, and manually closes the chamber door. The operator then selects the appropriate sterilization cycle on the user interface. Once "Start" is pressed, the sterilizer automatically performs all necessary operations, including Filling, Heating, Sterilization, Venting, and Drying. Sterilization parameters and process status are displayed on the screen.
The 2545D is designed with the following external ports and printing functions:
- One built-in USB port to enable the operation of an external USB device to record sterilization cycles.
- Built-in report printer to print sterilization records.
- Built-in memory to record up to 16000 sterilization cycles, which can be exported to a USB device.
- Built-in label printer to print labels with a unique cycle ID barcode, Program name, and expiry dates (optional additions).
The chamber and door are made of corrosion-resistant 304L stainless steel. It features an LCD Display and touch pad user interface, High Temperature Silicon Rubber door gaskets, a manual door lock, and a door safety interlock. It also has an ASME pressure relief valve and an Overheat Protection (Thermostat@250°C). The device is powered by AC 120V 60 Hz 1750VA. The operation principle is sterilization by heating a controlled amount of demineralized water to generate steam and maintaining its temperature with a heating element. It includes a vacuum mechanism for air removal and drying.
The provided FDA 510(k) clearance letter is for a Steam Sterilizer (2545D), which is a Class II device. This type of device does not involve Artificial Intelligence (AI) and therefore the questions related to AI-specific performance, human reader studies, and effect sizes of AI assistance are not applicable.
The acceptance criteria and study information provided in the document are focused on the safety and performance of the steam sterilizer in meeting sterilization standards.
Here's the breakdown of the information as requested:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| Safety | Passed; the results of the evaluation demonstrate compliance of the device to the standards (ANSI/UL 61010-1, IEC 61010-2-040, ANSI/AAMI ST55:2016). |
| EMC | Passed; the results of the evaluation demonstrate compliance of the device to the standards (IEC 60601-1-2 Edition 4.1 2020-09). |
| Software | Meeting standard specification (IEC 62304-2006+A1:2015). |
| Performance - Bowie & Dick | Passed, the Bowie-Dick test indicator sheet showed a uniform color change (verifying air removal performance according to ANSI/AAMI ST55:2016). |
| Performance - Air leaks | Passed, the average leak rate is 0.0133kPa/min (verifying air removal performance according to ANSI/AAMI ST55:2016). |
| Performance - Temperature control | Passed. The chamber temperature during the exposure time remains within +3℃ and -0℃ of selected sterilization exposure temperature for cycles Quick 273, Universal 273, and Universal 250 (verifying steady-state thermal conditions consistent with desired sterility assurance level, according to ANSI/AAMI ST55:2016). |
| Performance - Biological performance | Passed. The results showed that the tested cycle has a 10^-6^ SAL (Sterility Assurance Level) or an SAL providing a greater assurance of sterility. There shall be no growth observed in the vials containing turbines or in the extraction of any of the turbines (verifying biological performance with textile PCD, wrapped instrument PCD, and dental handpieces, according to ANSI/AAMI ST55:2016). |
| Performance - Moisture retention | Passed. The results showed that the gain in weight less than 2% and 0.5% for Textile PCD and wrapped instruments respectively, no water droplets for paper-plastic pouch (verifying drying performance for cycles Quick 273, Universal 273, and Universal 250 with Textile PCD, wrapped instruments, and paper-plastic pouch, according to ANSI/AAMI ST55:2016). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for tests such as Bowie & Dick, air leaks, temperature control, biological performance, or moisture retention. The performance is assessed against the requirements of the standards (e.g., ANSI/AAMI ST55:2016), which typically define the number of test cycles or items required for validation.
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied that the tests were conducted as part of the device's validation process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This product is a steam sterilizer, not a diagnostic device that relies on expert interpretation for ground truth. The "ground truth" for its performance is established by objective measurements and biological indicators adhering to recognized standards for sterilization effectiveness (e.g., absence of microbial growth, specific temperature ranges, acceptable moisture levels). Therefore, experts in the sense of medical diagnosticians are not applicable here. The experts involved would be those qualified to conduct and interpret the results of physical and biological sterilization tests according to the cited standards. Their number and specific qualifications are not detailed in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers to resolve discrepancies in diagnoses or interpretations of medical images or data. This is not applicable to the performance testing of a steam sterilizer, which relies on objective physical and microbiological endpoints.
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. The device is a steam sterilizer, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a steam sterilizer. Its performance is inherent to its design and operation and is a "standalone" mechanical/software system, but not in the context of an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the sterilizer's performance is based on well-established scientific principles and objective measurements defined by industry standards for sterilization. This includes:
- Physical Measurements: Temperature (within specified range), pressure, leak rates (within limits).
- Chemical Indicators: Bowie-Dick test color change indicating proper air removal.
- Biological Indicators: Absence of microbial growth to confirm sterility (e.g., 10^-6^ SAL) for biological performance tests.
- Weight Measurements: To assess moisture retention performance.
This is a form of "outcomes data" in the sense of directly observing and measuring the physical and biological outcomes of the sterilization process.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device that requires a training set.
§ 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).