(179 days)
The TEEClean® automated cleaner disinfector is intended to replace manual cleaning of Transesophageal (TEE) ultrasound probes and automate high-level disinfection of TEE probes. The system uses TEEZyme® enzymatic cleaner to clean TEE probes as well as TD-5 or TD-8 disinfectant to high level disinfect TEE probes. TEE probes must undergo bedside cleaning prior to insertion into the TEEClean®.
The TD-5® or TD-8® disinfectant bottles cannot be reused in the system.
TD-5® disinfectant is intended for use as a single use high-level disinfectant used exclusively in the TEEClean® automated cleaner disinfector for high-level disinfection of TEE ultrasound probes. TD-5® disinfectant should be used with the following contact conditions in the TEEClean® automated cleaner disinfector:
High-level disinfectant TD-5®
Time - 5 minutes
Temperature - 38° - 40°C
Minimum Recommended Concentration 1.7% glutaraldehyde
TD-8® disinfectant is intended for use as a single use high-level disinfectant used exclusively in the TEEClean® automated cleaner disinfector for high-level disinfection of TEE ultrasound probes. TD-8® disinfectant should be used with the following contact conditions in TEEClean® automated cleaner disinfector:
High-level disinfectant TD-8®
Time - 5 minutes
Temperature - 38° - 40°C Minimum Recommended Concentration 0.3% ortho-phthalaldehyde
TEEZyme® enzymatic cleaner, TD-5® and TD-8® high level disinfectant, and TEEClean® automated cleaner disinfector system are intended for use by qualified individuals trained in its use.
The TEEClean® cleaner disinfector provides cleaning and high-level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions and when used with TEEZyme® enzymatic cleaner and TD-5® or TD-8 disinfectant. The TEEClean® cleaner disinfector iss for use only with TEEZyme® enzymatic cleaner and TD-5® or TD-8® disinfectant. Thus, the TEEClean® cleaner disinfector, TEEZyme® enzymatic cleaner, and TD-5º or TD-8º disinfectant represent a dedicated system. Each soiled TEE probe is bedside cleaned to the TEE probe manufacturer's instructions before insertion into the TEEClean® cleaner disinfector. A fresh, unopened bottle of TD-5° or TD-8° disinfectant is loaded into the TEEClean® cleaner disinfector. The TEEClean® cleaner disinfector heats the TEEZyme®, soaks the TEE probe, and thoroughly rinses the enzymatic cleaner off the TEE probe before the cleaning cycle is complete. The TEEClean® cleaner disinfector then heats TD-5® or TD-® disinfectant to 38°-40°C, soaks the TEE probe at least five (5) minutes, and then thoroughly rinses the disinfectant off the TEE probe before the disinfection cycle is complete. The TEEClean® cleaner disinfector prints a verification report indicating a successful cleaning and disinfection cycles as well as the time and the average temperature during the disinfection. The TEE probe is then removed from the TEEClean® cleaner disinfector and dried according to the TEE probe manufacturer's instructions. The TEEClean® cleaner disinfector is ready for a new cycle immediately after the preceding cycle is completed. Because a fresh bottle of TD-5% or TD-80 disinfectant is used with each cycle, no monitoring of the disinfectant's potency is required, nor is there any requirement for daily testing of the disinfectant solution.
The provided document is a 510(k) summary for a medical device (TEEClean® Automated TEE Probe Cleaner Disinfector). It describes the device, its intended use, and comparisons to predicate devices, along with summaries of non-clinical testing.
However, the document does not contain the kind of detailed information about acceptance criteria and study results typically found for AI/ML-based medical devices, specifically:
- A table of acceptance criteria and reported device performance for an AI/ML model: The acceptance criteria here are related to physical device performance (e.g., disinfectant contact time, temperature, rinsing effectiveness, microbial kill) and safety (electrical safety, biocompatibility, vapor exposure), not AI/ML performance metrics like sensitivity, specificity, or AUC.
- Sample sizes used for a "test set" and "training set": While "simulated use studies" and "routine clinical use" studies are mentioned for performance testing, the sample sizes (number of probes or cycles) are not specified in the summary. There's no separate mention of training and test sets in the context of an AI/ML model for diagnostic or other AI-driven tasks.
- Number/qualifications of experts, adjudication methods for ground truth, MRMC studies, standalone AI performance, or ground truth types (pathology, outcomes data) for an AI/ML system. These are all concepts relevant to the validation of AI/ML algorithms in diagnostic or clinical decision support, which is not the primary function of this device as described.
Therefore, based on the provided text, it is not possible to describe the acceptance criteria and study that proves an AI/ML device meets the acceptance criteria. The document pertains to a physical automated cleaning and disinfection device, not an AI/ML system.
The "Performance Testing" section describes the studies done:
- Disinfectant vapor exposure studies: Performed in a room with zero air exchanges to demonstrate filter capacity.
- Automated Simulated use studies with TEEZyme® Cleaner: Showed measurable reduction of soils.
- Automated Simulated use studies with TD-5 and TD-8: Showed measurably complete kill of microorganisms.
- Routine Clinical Use studies: Soiled TEE probes subjected to cleaning and disinfection, showing measurable complete kill of microorganisms.
The acceptance criteria for these would be qualitative (e.g., "acceptable" soil reduction, "complete kill of microorganisms," "filter has capacity for 12 months"). Specific quantitative thresholds are not provided in this summary.
In summary, the provided document does not describe an AI/ML-based device or its validation.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.