(90 days)
The NM-MRI is a continuous flow anesthesia system. The NM-MRI may be used for spontaneous, manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of oxygen concentration, breathing pressure, and respiratory volume. The NM-MRI is indicated for use with the Dräger Vapor® 19.1. The NM- MRI may be used in MRI scanner rooms with magnets up to 1.5 tesla, and with magnets over 1.5 tesla when installed using the NM-MRI High field Mounting Kit. Federal law restricts this device to sale by, or on the order of, a physician.
The NM-MRI is a continuous flow gas anesthesia system. The NM-MRI utilizes non ferromagnetic materials for structural elements and certain components have been shielded and/or relocated. The monitoring system of the NM-MRI differs from the NM GS by using a specially adapted version of the Core-M Omicron Monitor.
The provided text describes the Narkomed MRI Anesthesia System (NM-MRI), its intended use, and its substantial equivalence to the Narkomed GS (NM GS). However, it does not contain a table of acceptance criteria or a detailed study that explicitly proves the device meets specific acceptance criteria in a quantitative manner as would be expected for an AI/ML medical device.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive performance data against predefined acceptance criteria for a new clinical efficacy study.
Therefore, I cannot fulfill all parts of your request with the provided input. I will extract the information that is present and indicate where information is missing.
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the document in the format of a table with specific acceptance criteria and corresponding performance metrics for the NM-MRI. The document focuses on demonstrating substantial equivalence by stating that the NM-MRI has the "same intended use and principal of operation as the NM GS."
The closest the document comes to defining "acceptance criteria" is through the "qualification" activities mentioned:
- Hazard analysis
- System level qualification testing
- Environmental testing
- Electromagnetic compatibility testing
- Testing in an MRI environment
The "reported device performance" is described qualitatively by stating that the NM-MRI "has been qualified to meet environmental requirements for use in MRI facilities" and "utilizes non ferromagnetic materials for structural elements and certain components have been shielded and/or relocated." However, no quantitative performance metrics (e.g., specific thresholds for electromagnetic interference, vibration tolerance, or gas delivery accuracy) are provided, nor are the results of these tests presented in detail.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes engineering and environmental qualification tasks rather than a clinical study with a "test set" in the context of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. As this is not a clinical study involving interpretation of patient data, the concept of "ground truth" established by experts for a test set is not applicable here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Not applicable given the nature of the document.
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
This information is not provided in the document. The device is an anesthesia system, not an AI/ML-driven diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided in the document. The device is an anesthesia system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. The concept of "ground truth" in the context of clinical data for AI/ML devices is not applicable to an anesthesia machine's qualification. The "ground truth" for the engineering qualification would be adherence to specified engineering standards and performance specifications, but these are not detailed in the document.
8. The sample size for the training set
This information is not provided in the document. The device is not an AI/ML system that undergoes training.
9. How the ground truth for the training set was established
This information is not provided in the document. Not applicable.
Summary of the available information from the document:
The provided document is a 510(k) premarket notification for the Narkomed MRI Anesthesia System (NM-MRI). Its primary purpose is to demonstrate substantial equivalence to previously cleared predicate devices (Narkomed GS Anesthesia System and Core-M Omicron Monitor).
- Acceptance Criteria/Performance Testing: The document states that "Qualification of the NM-MRI included a hazard analysis, system level qualification testing, environmental testing, electromagnetic compatibility testing, and testing in an MRI environment." It also notes that the device "has been qualified to meet environmental requirements for use in MRI facilities." Specific quantitative criteria or results are not detailed in this summary.
- Key Differences & Modifications: The NM-MRI uses non-ferromagnetic materials, certain components were shielded/relocated, and it uses a specially adapted version of the Core-M Omicron Monitor for its monitoring system.
- Intended Use & Equivalence: The NM-MRI has the "same intended use and principal of operation" as the predicate NM GS, with the added capability of being used in MRI environments (up to 1.5 tesla, and over 1.5 tesla with a special mounting kit).
- Nature of the Device: It is a continuous flow gas anesthesia system, not an AI/ML medical device, hence many of the requested criteria (test sets, training sets, ground truth from experts, MRMC studies) are not applicable to this type of submission.
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Kg72848
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Summary of Safety and Effectiveness Data Relating to Substantial Equivalence
| Proprietary Name: | Narkomed MRI Anesthesia System |
|---|---|
| Classification Name: | Gas-Machine, Anesthesia 73BSZ |
| Device Class: | Class II |
| Manufacturer: | North American Dräger3135 Quarry RoadTelford, Pennsylvania 18969 |
| Establishment Registration Number: | 2517967 |
| Devices to which substantial equivalence is claimed: | |
| Narkomed GS Anesthesia System | K963994 |
| Core-M Omicron Monitor | K960861 |
Device Description:
The NM-MRI is a continuous flow gas anesthesia system.
Intended Use:
ン
The NM-MRI 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 is intended for use with the Dräger Vapor® 19.1. The NM-MRI can be used in MRI scanner rooms with magnets of 1.5 tesla or less. It can also be used in MRI scanner rooms with magnets over 1.5 tesla when the Narkomed MRI High Field Mounting Kit installation procedure is followed.
Substantial Equivalence:
The NM-MRI is substantially equivalent to the Narkomed GS (NM GS).
The NM-MRI, like the NM GS is an anesthesia system capable of monitoring oxygen concentration, breathing pressure and respiratory volume. The gas delivery system, absorber and scavenger of the NM-MRI are the same design that is used on the NM GS.
The NM- MRI has been qualified to meet environmental requirements for use in MRI facilities, and like the Ohmeda Excel 210 MRI Compatible Anesthesia System, is intended for use in MRI scanner rooms.
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The NM-MRI utilizes non ferromagnetic materials for structural elements and certain components have been shielded and/or relocated.
The monitoring system of the NM-MRI differs from the NM GS by using a specially adapted version of the Core-M Omicron Monitor.
The NM-MRI has the same intended use and principal of operation as the NM GS. The intended environment of use is different in that the NM-MRI will additionally be usable in an MRI environment.
Qualification of the NM-MRI included a hazard analysis, system level qualification testing, environmental testing, electromagnetic compatibility testing, and testing in an MRI environment.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
- 1
OCT 30 1997
Mr. James J. Brennan North American Drager 3135 Ouarry Road Telford, Pennsylvania 18969
Re: K972848 Narkomed MRI Anesthesia System Regulatory Class: II (two) Product Code: 73 BSZ August 1, 1997 Dated: Received: August 1, 1997
Dear Mr. Hokanson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. James J. Brennan
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97).
Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Narkomed MRI Anesthesia System (NM-MRI)
Indications For Use:
The NM-MRI is a continuous flow anesthesia system. The NM-MRI may be used for spontaneous, manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of oxygen concentration, breathing pressure, and respiratory volume. The NM-MRI is indicated for use with the Dräger Vapor® 19.1. The NM- MRI may be used in MRI scanner rooms with magnets up to 1.5 tesla, and with magnets over 1.5 tesla when installed using the NM-MRI High field Mounting Kit. Federal law restricts this device to sale by, or on the order of, a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Chinty Shiman for HAC
'Division Sign-Off
sion of Cardiovascular, Respiratory,
Neurological Devices
Number K972848
§ 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).