(152 days)
The Datex-Ohmeda Tec 7 vaporizer is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. It is available in halothane, isoflurane and sevoflurane variants. Each vaporizer is agent specific and is clearly labeled with the name of the anesthetic agent that it is designed for. 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 Datex-Ohmeda Tec 7 Anesthesia Vaporizer is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. It is available in halothane, isoflurane and sevoflurane variants. Each vaporizer is agent specific and is clearly labeled with the name of the anesthetic agent that it is designed for. 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.
Here's an analysis of the provided text, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a explicit table of acceptance criteria with specific numerical targets. Instead, it refers to compliance with voluntary standards. The "reported device performance" is essentially that it complies with these standards.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| EN 740: Anesthetic Work Stations | Complies |
| ISO 5358: Anesthetic Gas Machines | Complies |
| ASTM F1161: Specifications for Anesthetic Gas Machines | Complies |
| Functional Equivalence to Predicate Device (Datex-Ohmeda Tec 5) | Substantially equivalent in uses, design concepts, technologies, and materials. |
| Safety and Effectiveness (General) | Demonstrated through testing that supports compliance with mentioned standards. |
| Temperature Compensation | Output remains relatively constant despite cooling due to evaporation. |
| Flow Compensation | Output remains relatively constant despite variations in inlet flow. |
| Pressure Compensation | Output remains relatively constant despite fluctuating pressures. |
| Agent Specificity | Each vaporizer is agent specific and clearly labeled. |
| Compatibility with Selectatec Manifolds | Designed to be used on Selectatec series mounted manifolds. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical or performance data with a defined sample size. The testing mentioned is "validation through testing" related to compliance with engineering standards. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a test set is not available in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since there is no mention of a "test set" involving clinical data or expert review to establish ground truth, the number of experts and their qualifications for this purpose are not applicable and not available in the provided text. The device is a medical instrument, and its performance is evaluated against engineering standards rather than diagnostic accuracy.
4. Adjudication Method for the Test Set
As there is no mention of a "test set" requiring expert review or ground truth establishment based on clinical outcomes, an adjudication method is not applicable and not available in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No MRMC study is mentioned. This device is an anesthesia vaporizer, not an imaging or diagnostic AI requiring human interpretation. Therefore, this information is not applicable and not available.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
The device is a physical medical instrument, an anesthesia vaporizer, not a software algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The performance evaluation described is for the physical device itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by its compliance with internationally recognized engineering and safety standards (EN 740, ISO 5358, ASTM F1161) and its functional equivalence to a predicate device. This is a technical and engineering ground truth, not medical outcomes, pathology, or expert consensus on a diagnostic task.
8. The Sample Size for the Training Set
There is no mention of a "training set" as this device is a physical medical instrument, not a machine learning model. Therefore, this information is not applicable and not available.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of machine learning, the method for establishing its ground truth is not applicable and not available.
Summary of the Study:
The "study" in this context is the validation through engineering testing that demonstrates the Datex-Ohmeda Tec 7 Anesthesia Vaporizer complies with the specified voluntary standards (EN 740, ISO 5358, ASTM F1161) and is substantially equivalent to its predicate device, the Datex-Ohmeda Tec 5. This testing confirms its ability to provide metered delivery of anesthetic agents with temperature, flow, and pressure compensation, maintaining relatively constant output. The focus is on the device's technical specifications and safety profile as per established industry standards, rather than clinical trial data involving patient outcomes or expert diagnostic performance.
§ 868.5880 Anesthetic vaporizer.
(a)
Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.(b)
Classification. Class II (performance standards).