(57 days)
The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant with QwikCheck™ Chemical Indicators 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 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: 1750 ppm peracetic acid
QwikCheck™ Chemical Indicators are used prior to the disinfection cycle to ensure that the disinfectant used is above the minimum recommended concentration (MRC) of 1750ppm peracetic acid.
The TD 200 disinfector 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 cvcle is completed. A chemical indicator is used to ensure that the solution is above the MRC.
This document describes the premarket notification (510(k)) for the TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant and QwikCheck™ Chemical Indicators. This device is intended for the high-level disinfection of Transesophageal (TEE) ultrasound probes. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (TD 200/TD-12 disinfector/disinfectant system, K192228), with the main change being a new supplier for the QwikCheck Chemical Indicator.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the demonstration of "high-level disinfection" and the equivalence to the predicate device. The performance is assessed through various non-clinical tests.
| Acceptance Criteria (Implicit from Indication and Predicate) | Reported Device Performance (TD 200 with TD-12) |
| High-Level Disinfection of TEE Probes | Automated Simulated Use Studies: Measurably complete kill of microorganisms after TEE probe processing. |
| QwikCheck Chemical Indicator accuracy for MRC | The QwikCheck Chemical Indicator, with its starch and iodide agents, produces a color change within 30 seconds. A color similar to the FAIL block indicates ≤ 1750 ppm, while a color similar to the PASS block indicates > 1750 ppm peracetic acid. This indicates it properly discriminates between concentrations above and below the MRC. |
| Safety and Compatibility (Electrical, Biocompatibility, Material, TEE Probe) | Electrical Safety: Passed testing according to UL 61010-1, 3rd Edition. Biocompatibility: TD-12 is not a sensitizer, irritant, and non-cytotoxic. Residue levels on TEE probes are deemed not likely to have toxic effects. Material Compatibility: No observable effects from exposure of TD 200 materials to TD-12 disinfectant. TEE Probe Compatibility: No cosmetic or functional deterioration observed in GE, Philips, and Siemens TEE probes after processing. TD-12 probe compatibility testing was performed using a use-suspension of 3% w/v (3000ppm) PAA TD-12 at 38°C. |
| Software Validation | All qualification activities defined in the TD 200 Automated TEE Probe Disinfector with TD-12 High Level Disinfectant Verification and Validation Plan were successfully completed, and documented evidence indicates that the TD 200 consistently performs as intended. All data collected met established acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
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TD 200/TD-12 Disinfection Performance:
- Automated Simulated Use Studies: The exact sample size (number of runs or probes) is not specified, but the results state "In all cases there was a measurably complete kill of microorganisms." This implies a sufficient number of tests were conducted to support the claim.
- Clinical In-Use Testing: The exact sample size (number of soiled TEE probes) is not specified. The results state "In all cases, there was a complete kill of microorganisms after TEE probe processing." This implies a sufficient number of tests were conducted.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It appears to be prospective testing conducted by the manufacturer.
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QwikCheck Chemical Indicator:
- Test Set Description: The summary describes its mechanism (starch and iodide agents, color change within 30 seconds) and how it visually indicates ppm levels (similar to FAIL block for ≤1750 ppm, similar to PASS block for >1750 ppm). No specific sample size for a test set proving its accuracy for this submission is provided, as the primary difference for this component is the change in supplier, implying the performance characteristics are already established and documented as part of that product's existing regulatory clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not suggest the use of human experts to establish ground truth for the disinfection or chemical indicator performance. The "ground truth" for disinfection is based on objective microbiological enumeration (complete kill of microorganisms), and for the chemical indicator, it's based on objective chemical concentration levels and colorimetric responses.
4. Adjudication Method for the Test Set
Not applicable, as there is no indication of human reader adjudication for these studies. The assessment of disinfection effectiveness and chemical indicator performance relies on objective laboratory methods.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The device is an automated disinfectant system and a chemical indicator, not an AI diagnostic tool requiring human interpretation comparison.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This refers to the performance of the automated disinfection system and the chemical indicator as standalone devices.
- TD 200/TD-12 Disinfector: Yes, the performance tests (automated simulated use studies, clinical in-use testing) assess the standalone performance of the TD 200 disinfector with TD-12 disinfectant in achieving high-level disinfection.
- QwikCheck Chemical Indicator: Yes, the description of its function and visual interpretation demonstrates its standalone capability to indicate disinfectant concentration.
7. The Type of Ground Truth Used
- For Disinfection Performance (TD 200/TD-12): The ground truth used is objective microbiological enumeration (i.e., "complete kill of microorganisms").
- For QwikCheck Chemical Indicator: The ground truth is objective chemical concentration levels (1750 ppm peracetic acid) and its associated colorimetric response.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The studies described are for verification and validation of the device's physical and chemical performance.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.