(91 days)
The TD-100 disinfector is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system uses the TD-5 disinfectant, which is designed to be used only with the TD-100. The disinfectant bottles cannot be reused in the system.
TD-5 is intended for use as a single use high-level disinfectant to be used exclusively in the TD-100 for the high-level disinfection of TEE ultrasound probes.
The TD-5 High Level Disinfectant and TD-100 disinfector system is intended for use by qualified individuals trained in its use.
The TD-100 disinfector provides high-level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions, and when used with TD-5 disinfectant. Each soiled TEE probe is pre-cleaned manually before insertion into the TD-100 disinfector. A fresh, unopened bottle of TD-5 disinfectant is loaded into the TD-100 disinfector. The TD-100 disinfector heats the TD-5 disinfectant to 38-40C, soaks the TEE probe at least fiveminutes, and then thoroughly rinses the disinfectant off the TEE probe before the cycle is complete. The TEE probe is then removed from the TD-100 disinfector and dried according to the TEE probe manufacturer's instructions. The TD-100 disinfector is ready for a new cycle immediately after the preceding cycle is completed. Because a fresh bottle of TD-5 disinfectant is used with each cycle no monitoring of the disinfectant's potency required, nor is there any requirement for daily testing of the disinfectant solution.
Here's a breakdown of the acceptance criteria and study information for the CS Medical TD-100 Transesophageal Probe Disinfector and TD-5 High-level Disinfectant, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Target Performance) | Reported Device Performance (Achieved) |
|---|---|
| High-Level Disinfection: | Simulated Use Testing: A 6-Log₁₀ reduction of M. terrae was achieved when disinfecting TEE probes dosed with artificial soil containing M. terrae. |
| Residual Disinfectant Toxicity: | Biocompatibility: Analysis indicated that the level of residue on the TEE probes following processing in the TD-100 using TD-5 is not likely to have toxic effects on humans. (Implicitly, the acceptance criterion is that there are no toxic levels of residue, and this was met). |
| Material Compatibility: | Material Compatibility: No observable adverse effects were seen on the materials used to construct the TD-100 after extended exposure to TD-5 High-level Disinfectant. (Implicitly, the acceptance criterion is no material degradation, and this was met). |
| Disinfectant Stability: | Stability: TD-5 High-level Disinfectant was tested and shown to be stable for a shelf life of one year. The concentration of the disinfectant at the end of 18 months of testing was well above the 1.7% minimum recommended concentration. (Implicitly, the acceptance criterion is stability for at least one year and maintaining minimum concentration, and this was met with exceedance on concentration over a longer period). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a numerical sample size for either the simulated use testing or the in-use clinical testing.
- Simulated Use Testing: It states, "In all cases a 6-Log₁₀ reduction of M. terrae was achieved." This implies multiple tests were conducted, but the specific number is not provided.
- In Use Testing: It states, "TEE Probes used in a clinical setting were examined. The probes were bioburden post cleaning and a new population of probes was examined for bioburden after disinfection. In all cases, there was a complete kill of microbes after disinfection." Again, "in all cases" implies multiple probes, but no specific number is given.
Data Provenance: The document does not explicitly state the country of origin for the data. The study appears to be retrospective for the "In Use Testing" as it refers to "probes used in a clinical setting" that were then examined. The "Simulated Use Testing" likely involved prospective testing in a lab environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The efficacy testing revolves around microbial reduction and absence of growth, which would typically involve laboratory analysis by microbiologists rather than interpretation by clinical experts like radiologists.
4. Adjudication Method for the Test Set:
Not applicable. The efficacy testing involves quantitative microbial reduction (Log reductions) and qualitative assessment of microbial kill, which are objective laboratory measurements, not subjective evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This type of study was not conducted. The device is a high-level disinfectant system, not an AI-powered diagnostic tool that assists human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This classification doesn't directly apply because the device is a physical disinfectant system, not a software algorithm. However, the "Efficacy Testing" sections (Simulated Use and In Use Testing) demonstrate the standalone performance of the device system itself (TD-100 plus TD-5) in achieving high-level disinfection without human intervention during the disinfection cycle (after manual pre-cleaning and probe loading).
7. Type of Ground Truth Used:
- Microbiological Culture/Counts: For efficacy testing, the ground truth was established by microbiological methods measuring the reduction of specific microorganisms (M. terrae for simulated use) and the complete kill of microbes (for in-use testing). This is a direct measurement of disinfection effectiveness.
- Chemical Analysis: For biocompatibility (residue) and material compatibility, the ground truth would be chemical analysis of residue levels and visual/physical inspection for material degradation.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML product developed with a training set. The "development" would involve chemical formulation and engineering design, not data training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 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.