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510(k) Data Aggregation
(119 days)
Tec 820, Tec 850
The Tec 820 and Tec 850 vaporizers are designed for use in continuous flow techniques of inhalation anesthesia. They are available in isoflurane and sevoflurane. Each vaporizer is agent specific and is clearly labeled with the anesthetic agent for which it is designed. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures. The vaporizer is designed for use only with General Electric's Selectatec Series Manifolds.
The Datex-Ohmeda Tec™ 820 and Tec 850 vaporizers are designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. The vaporizers are available in Sevoflurane and Isoflurane variants. Each vaporizer is agent specific and is clearly labeled with the name of the anesthetic agent for which it is designed. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures. The vaporizer is designed to be used on Selectatec series mounted manifolds.
The output concentration of the Tec 820/850 vaporizer is regulated by the "variable flow-split" method, where a total flow of fresh gas from upstream enters the vaporizer where it is split into two streams. One stream flows into the fresh gas bypass circuit and the other stream flows through the vaporizing chamber where it is saturated with the vapor of the liquid anesthetic agent.
Both gas paths have methods to regulate the flow to achieve desired total output agent concentration. Before exiting the vaporizer through the gas outlet, the split gas streams are joined. The combined total flow then flows out from the vaporizer via the Selectatec circuitry to the anesthesia gas delivery system.
The provided text describes the 510(k) premarket notification for the Tec 820 and Tec 850 anesthetic vaporizers, demonstrating their substantial equivalence to a predicate device (Tec 7). This submission is for medical hardware, not a software-based AI/ML device. Therefore, the questions related to AI/ML device performance (like MRMC studies, standalone AI performance, number of experts, and training/test set details) are not applicable to this document.
However, I can extract the information relevant to the device's acceptance criteria and the non-clinical study that proves it meets those criteria.
1. A table of acceptance criteria and the reported device performance:
The document refers to "Design Inputs" as the acceptance criteria and "Result" as the reported device performance.
| Verification category | Design Inputs being verified | Reported Device Performance (Result) |
|---|---|---|
| Biocompatibility | Extractables | PASS |
| Leachables | PASS | |
| Particulate Matter (PM) | PASS | |
| Concentration accuracy | Accuracy of the concentration of agent delivered | PASS |
| Dial graduations are accurate | PASS | |
| Flow Range and Flow Resistance | PASS | |
| Requirements with drug | Liquid volume | PASS |
| Vaporizer filling time | PASS | |
| Vaporizer draining time from the maximum liquid level mark | PASS | |
| Temperature and Humidity | Operating temperature and humidity | PASS |
| Storage temperature and humidity | PASS | |
| MRI Compatibility | Performance after exposure to a magnetic field of at least 400 gauss | PASS |
| MR safety evaluation | PASS | |
| MR compatibility evaluation | PASS | |
| Physical Specifications and Configurations | Physical specifications, including weight, height, width, depth | PASS |
| Compatibility with the Selectatec backbar | PASS | |
| Compatibility of appropriate filling ports with the associated fillers | PASS | |
| Interlock mechanism | PASS |
2. Sample size used for the test set and the data provenance:
The document describes "non-clinical tests" and "functional testing" to verify and validate the performance of the vaporizer. It does not specify a "sample size for the test set" in terms of number of devices tested, but rather indicates that "The Tec 820 and Tec 850 have been fully verified and validated". There's no mention of country of origin for data as this relates to manufactured product testing, not patient data. The testing is retrospective in the sense that it's performed on manufactured devices after design, to prove the design meets specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not an AI/ML device requiring expert interpretation for ground truth. The "ground truth" here is the design specifications and functional requirements of the vaporizer, established through engineering design and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not an AI/ML device requiring human adjudication of performance outcomes. The outcomes are objective measurements against engineering specifications ("PASS" or "FAIL").
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 is a hardware device (anesthetic vaporizer), not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware device. Its performance is inherent to the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance validation is its design inputs and specifications, as established by the manufacturer, and meeting relevant recognized standards for medical devices of this type. The objective tests performed (e.g., concentration accuracy, flow range, temperature compensation) measured the actual device performance against these pre-defined engineering targets.
8. The sample size for the training set:
Not applicable. This is a hardware device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for a hardware device.
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