(69 days)
The NM-MRI-2 can be used for spontaneous, manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. The NM-MRI-2 is intended for use with Dräger-Vapor® vaporizers. The NM-MRI-2 can be used in MRI scanner rooms with magnet strengths up to 3.0 tesla without distance limitations.
The Narkomed MRI-2 (NM-MRI-2) is a continuous flow gas anesthesia system.
The provided text describes a 510(k) premarket notification for the Narkomed MRI-2 Anesthesia System, focusing on expanding its indications for use in stronger MRI environments. However, it does not contain the level of detail regarding device performance metrics, study designs, sample sizes, or expert qualifications that would typically be found in a study proving a device meets specific acceptance criteria in the context of an AI/medical device performance study.
Based on the provided text, the device is an anesthesia system, not an AI or imaging diagnostic device, which explains the lack of certain types of information. The "study" here is essentially qualification testing to expand its operating environment.
Here's the information extracted and, where not available, noted as such:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Does not exceed attractive force limitations in a 3.0T MRI environment. | Qualification testing confirmed that, in a 3.0 tesla environment, the NM-MRI-2 does not exceed attractive force limitations. |
| Does not negatively impact diagnostic quality of MRI images. | Qualification testing confirmed that, in a 3.0 tesla environment, the NM-MRI-2 does not negatively impact the diagnostic quality of images produced by the MRI scanner. |
| Does not disturb the homogeneity of the main magnetic field. | Qualification testing confirmed that, in a 3.0 tesla environment, the NM-MRI-2 does not disturb the homogeneity of the main magnetic field. |
| 3.0T MRI scanner does not affect operation/functionality of NM-MRI-2. | Qualification testing confirmed that a 3.0 tesla MRI scanner does not affect the operation/functionality of the NM-MRI-2. |
| Ability to be used for spontaneous, manually assisted or automatic ventilation. | Stated as an indication for use, implying performance. (Implicitly met, as the primary change is the MRI compatibility, not the core ventilation functionality which is identical to the predicate K003579.) |
| Ability to deliver gases and anesthetic vapor. | Stated as an indication for use, implying performance. (Implicitly met, as the primary change is the MRI compatibility, not the core gas/vapor delivery functionality which is identical to the predicate K003579.) |
| Ability to monitor oxygen concentration, breathing pressure, and respiratory volume. | Stated as an indication for use, implying performance. (Implicitly met, as the primary change is the MRI compatibility, not the core monitoring functionality which is identical to the predicate K003579, with the addition of a MRI compatible breathing pressure gauge option.) |
| Compatibility with Dräger-Vapor® vaporizers. | Stated as an indication for use, implying performance. (Implicitly met, as the primary change is the MRI compatibility, not the core vaporizer compatibility which is identical to the predicate K003579.) |
| Expanded indication for use in MRI scanner rooms up to 3.0 Tesla without distance limitations. | Successfully met through qualification testing, expanding from previous 1.5 Tesla limitation to 3.0 Tesla. (This is the core objective of the submission and is stated as achieved through the qualification testing which confirmed the above performance metrics in a 3.0T environment). |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not applicable in the traditional sense for an AI/diagnostic device. The "test set" here would refer to the various scenarios and conditions under which the anesthesia system was tested in a 3.0 Tesla MRI environment. The document does not specify the number of tests, specific configurations, or duration of tests performed during "qualification testing."
- Data Provenance: Not specified. This "data" would be the results of the physical and functional tests conducted in MRI environments. It is presumably prospective testing specific to the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as this is a safety/performance validation of an anesthesia machine in an MRI environment, not an AI or diagnostic imaging device requiring expert interpretation for ground truth. The "ground truth" is established by physical measurements and functional checks against engineering specifications and MRI compatibility standards.
4. Adjudication method for the test set
- Not applicable for this type of device and testing. Test results would be compared directly against pre-defined engineering and safety limits, not adjudicated by human experts in the way that diagnostic image interpretations are.
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
- No. This is not an AI-powered device nor one that involves human readers interpreting diagnostic cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a medical device, an anesthesia system, not an algorithm. Its standalone performance is its functionality as an anesthesia machine. The qualification testing assesses its "standalone" performance within a 3.0T MRI environment.
7. The type of ground truth used
- The "ground truth" for this device's qualification testing would be derived from:
- Physical measurements: E.g., attractive force measurements using a force gauge, magnetic field distortion measurements using specific MRI sequences/phantoms.
- Functional tests: Verification that all device functions (ventilation, gas delivery, monitoring, alarms) operate correctly and within specifications while exposed to a 3.0T MRI field.
- Image quality assessment: Potentially using phantoms or standard test objects to ensure the device's presence does not degrade the diagnostic quality of MRI images.
- Hazard Analysis: The document mentions a hazard analysis, which would identify potential risks and verify mitigation.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no training set.
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).