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The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-12® disinfectant, which is designed to be used only with the TD 200® disinfector. The disinfectant bottles cannot be reused in the system.

TD-12® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 200® disinfector for high-level disinfection of TEE ultrasound probes.

TD-12® high level disinfectant and TD 200® disinfector is intended for use by qualified individuals trained in its use.

TD-12® disinfectant should be used with the following contact conditions in TD 200® disinfector:

High-level disinfectant: TD-12®
Time: 3 minutes
Temperature: 38°C
Minimum Recommended Concentration: 1.75% peracetic acid

The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant provides high-level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions and when used with TD-12® disinfectant. The TD 200® disinfector is for use only with TD-12® disinfectant. The TD-12® is for use only in the TD 200® disinfector. Thus, the TD 200® disinfector and TD-12® disinfectant represent a dedicated system. Each soiled TEE probe is bedside cleaned and manually cleaned according to the TEE probe manufacturer's instructions before insertion into the TD 200® disinfector. A fresh, unopened bottle of TD-12® disinfectant is loaded into the TD 200® disinfector. The TD 200® disinfector heats the TD-12® disinfectant to at least 38 C, soaks the TEE probe at least three (3) minutes, and then thoroughly rinses the disinfectant off the TEE probe before the cycle is complete. The TD 200® disinfector prints a verification report indicating a successful disinfection cycle, the time and the average temperature during the disinfection. The TEE probe is then removed from the TD 200 disinfector and dried according to the TEE probe manufacturer's instructions. The TD 200 disinfector is ready for a new cycle immediately after the preceding cycle is completed. A chemical indicator is used to ensure that the solution is above the MRC.

The provided document describes the FDA 510(k) clearance for the TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant. This device is a high-level disinfection system for transesophageal (TEE) ultrasound probes. The acceptance criteria and the study that proves the device meets them are detailed primarily through non-clinical performance testing rather than human-in-the-loop studies involving expert readers.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are demonstrated through its ability to achieve high-level disinfection, stability of the disinfectant, and safety aspects. The performance is reported as a "complete kill of microorganisms" or "measurable complete kill."

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

• Sample Size for Test Set: The document does not specify a precise numerical sample size for "Clinical In-Use Testing" or "Automated Simulated use studies." It states "In all cases" there was a complete kill, implying all tested units/probes/cycles met the criteria. For the specific test organisms, the results are presented for each organism type (e.g., Bacillus subtilis, Mycobacterium terrae).
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given it's an FDA submission, the implication is that the studies were conducted under controlled conditions to support regulatory clearance, likely prospective.

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

This device focuses on disinfection efficacy rather than diagnostic accuracy involving human image interpretation. Therefore, the "ground truth" is established through microbiological and chemical analysis, not expert human readers.

• Experts: Not applicable in the context of human interpretation. The "experts" would be qualified microbiologists, chemists, and engineers conducting the tests according to established standards.
• Qualifications: Not specified for individuals, but implied by the nature of regulatory testing (e.g., adherence to Good Laboratory Practices or similar standards).

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" for disinfection efficacy is determined by objective laboratory measurements (e.g., microbial counts, chemical residue analysis), not subjective human judgment requiring adjudication.

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 device is a high-level disinfector, not an AI-powered diagnostic imaging tool for human readers. There are no "human readers" involved in the direct purpose of the device.

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

The entire performance evaluation of the TD 200® Disinfector is "standalone" in the sense that its primary function (disinfection) is automated and assessed directly for its output (microbial kill, residue levels). There is no "human-in-the-loop" performance component for the disinfection process itself. The "Software Validation" section details the functioning of the algorithm/software controlling the device.

7. The Type of Ground Truth Used

The ground truth used is primarily microbiological efficacy (complete kill of specified microorganisms for bactericidal, tuberculocidal, fungicidal, sporicidal, and virucidal activity), supported by chemical analysis (disinfectant residue levels, stability) and mechanical/electrical performance (software validation, electrical safety, material compatibility). No pathology reports or outcomes data on patients were used; the focus is on the device's ability to disinfect a medical instrument.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/Machine Learning device that undergoes a "training phase" with a dataset in the typical sense. Its design and performance are based on chemical, microbiological, and engineering principles rather than learning from data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI model. The "ground truth" for the device's development would be established through scientific literature, industry standards (e.g., for disinfection efficacy), and internal research and development.

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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.

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