(90 days)
No
The document describes a continuous flow anesthesia system with monitoring capabilities, focusing on its compatibility with MRI environments and its structural components. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
No
The device is an anesthesia system used for ventilation and delivery of gases, not a therapeutic device meant for treating or curing a disease.
No
The device is a continuous flow anesthesia system used for ventilation, delivery of gases, anesthetic vapor, and monitoring of oxygen concentration, breathing pressure, and respiratory volume; it does not diagnose medical conditions.
No
The device description clearly states it is a "continuous flow gas anesthesia system" and mentions utilizing "non ferromagnetic materials for structural elements and certain components have been shielded and/or relocated," indicating it is a hardware device with software components, not a software-only device.
Based on the provided text, the NM-MRI is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a system for delivering anesthesia gases, monitoring respiratory parameters, and providing ventilation. This is a system used on a patient, not for testing samples from a patient outside the body.
- Device Description: The description focuses on the mechanical and electronic components for gas delivery and monitoring, not on reagents, calibrators, or other components typically associated with IVD testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information based on laboratory tests.
The NM-MRI is a medical device used in a clinical setting for patient care during MRI procedures.
N/A
Intended Use / 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.
Product codes
73BSZ
Device Description
The NM-MRI is a continuous flow gas anesthesia system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Qualification of the NM-MRI included a hazard analysis, system level qualification testing, environmental testing, electromagnetic compatibility testing, and testing in an MRI environment.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Kg72848
30 1097
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 Dräger |
| 3135 Quarry Road | |
| Telford, 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.
1
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.
2
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.
3
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
4
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