(116 days)
The Dräger-Vapor 2000 (Vapor 2000) is a non-heated calibrated vaporizer designed to enrich the fresh gas flow of an ancsthesia delivery system with a controlled amount of anesthetic vapor. Separate models of the single-agent vaporizer are intended for use with one of the following agents: isoflurane, halothane, cofluranc, or sevofiuranc. The vaporizer is not intended for use with desflurane, or for use within an anesthetic breathing system. Federal law restricts this device to sale by or on the order of a physician.
The Dräger-Vapor 2000 (Vapor 2000) is a concentration calibrated non-heated vaporizer for vaporizing liquid anesthetic agents.
The provided text describes the Dräger-Vapor® 2000, an anesthesia vaporizer, and its substantial equivalence to a predicate device, the Dräger-Vapor® 19.1. It details the device's features and the testing conducted to demonstrate compliance and performance, but it does not contain information typically associated with studies proving device performance against acceptance criteria for AI/ML-based medical devices.
Therefore, many of the requested fields cannot be filled as the information is not present in the provided document. The document describes a traditional medical device, not an AI/ML-based one.
Here's a breakdown of the available and unavailable information based on the prompt:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Result) |
|---|---|
| Compliance with ASTM Standard F 1161-88 | Testing was done to demonstrate compliance. (Specific results not detailed, but assumed to meet the standard for substantial equivalence). |
| Effect of Temperature on Concentration Output | Testing was done to demonstrate the effect. (Specific results not detailed, but assumed to meet performance criteria for substantial equivalence). |
| Effect of Gas Flow on Concentration Output | Testing was done to demonstrate the effect. (Specific results not detailed, but assumed to meet performance criteria for substantial equivalence). |
| Effect of Duration of Use on Concentration Output | Testing was done to demonstrate the effect. (Specific results not detailed, but assumed to meet performance criteria for substantial equivalence). |
| Effect of Tilting on Concentration Output | Testing was done to demonstrate the effect. (Specific results not detailed, but assumed to meet performance criteria for substantial equivalence). |
| Effect of Back Pressure on Concentration Output | Testing was done to demonstrate the effect. (Specific results not detailed, but assumed to meet performance criteria for substantial equivalence). |
| Functionality of Transport Mode (Vapor 2000 specific) | Secures the vaporizer from spillage of liquid agent, leakage of anesthetic vapor, and closes off the vaporizing chamber isolating liquid agent or vapors from the rest of the vaporizer. (Implied to function as designed for substantial equivalence). |
| Reservoir Size (Vapor 2000 vs. Vapor 19.1) | The Vapor 2000 has a larger reservoir than the Vapor 19.1. (A factual difference, not a performance metric per se, but contributes to design change). |
| Equivalence in Intended Use and Principle of Operation | The Vapor 2000 and Vapor 19.1 have the same intended use and principle of operation. (This is a core claim for substantial equivalence, not a direct performance test result). |
| Design for use with specific agents (Enflurane, Isoflurane, Halothane, Sevoflurane) | The Vapor 2000 is designed and labeled accordingly for use with these agents. (Implied that testing verifies compatibility and correct vaporization for these agents). |
| Not intended for use with Desflurane or within an anesthetic breathing system | Explicitly stated as a design limitation/intended use. (Implied that it would not perform correctly in these scenarios, and testing confirms this or it's a design choice). |
Study Proving Device Meets Acceptance Criteria:
The "study" proving the device meets acceptance criteria is a series of engineering tests and demonstrations of compliance and substantial equivalence to a predicate device (Dräger-Vapor® 19.1). The document explicitly states: "Qualification of the Vapor 2000 included testing to demonstrate compliance with ASTM Standard F 1161-88, and the effect of temperature, gas flow, duration of use, tilting, and back pressure on concentration output."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. For a physical device like this, "sample size" would refer to the number of units tested, and this detail is not provided.
- Data Provenance: Not applicable in the context of clinical data provenance. The testing would have been conducted by the manufacturer, Drägerwerk AG, in Germany. It's engineering test data, not patient data.
- Retrospective/Prospective: Not applicable. This refers to the type of clinical study, not engineering validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not applicable. Ground truth, in the context of AI/ML, refers to a label or outcome established by human experts or definitive tests. For a vaporizer, performance is determined by physical measurements and adherence to engineering standards, not expert interpretation of outputs.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Not applicable. This concept is relevant for reconciling discrepancies in expert opinion for ground truth, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is a type of clinical study, specifically for diagnostic algorithms often involving human interaction, which is not relevant for this physical device.
- Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used:
- Engineering Standards and Specifications: The "ground truth" for this device's performance is its measured output (e.g., concentration levels) against established engineering standards (like ASTM F 1161-88) and the manufacturing specifications for the device. It's objective physical measurement, not expert consensus or pathology in a clinical sense.
8. The Sample Size for the Training Set:
- Not applicable. This device does not use a training set as it's not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. This device does not use a training set.
§ 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).