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.

Device Description

The Narkomed MRI-2 (NM-MRI-2) is a continuous flow gas anesthesia system.

AI/ML Overview

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.

Summary

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K002031

SUMMARY OF SAFETY AND EFFECTIVENESS DATA RELATING TO SUBSTANTIAL EQUIVALENCE

Proprietary Name:	Narkomed MRI-2 Anesthesia System
Classification Name:	Gas Machine, Anesthesia - 73 BSZ
Device Class:	Class II
Initial Distributor:	Draeger Medical, Inc.3135 Quarry RoadTelford, Pennsylvania 18969 USA
Establishment Registration No.:	2517967
Predicate Device:	Narkomed MRI-2 Anesthesia System - K003579

Device Description:

The Narkomed MRI-2 (NM-MRI-2) is a continuous flow gas anesthesia system.

Indications for Use:

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 Drager-Vaporizers. The NM-MRI-2 can be used in MRI scanner rooms with magnet strengths up to 3.0 tesla without distance limitations.

Substantial Equivalence:

The NM-MRI-2 is identical to the currently distributed Narkomed MRI-2 Anesthesia System (K003579). Qualification testing has been performed to expand the indications for use from can be used in MRI scanner rooms with magnet strengths up to 1.5 tesla" to "can be used in MRJ scanner rooms with magnet strengths up to 3.0 tesla." A bain circuit adapter with a MRI compatible breathing pressure gauge has also beer added as an option.

Qualification of the NM-MRI-2 included the completion of a hazard analysis and system level qualification. Qualification testing confirmed that, in a 3.0 tesla environment, the NM-MRI-2 does not exceed attractive force limitations and does not negatively impact the diagnostic quality of images produced by the MRI scanner or disturb the homogeneity of the main magnetic field. Qualification testing also confirmed that a 3.0 tesla MRI scanner does not affect the operation/functionality of the NM-MRI-2.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of a bird or a symbol resembling a bird in flight, composed of three human profiles facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 9 2002

Mr. Michael Kelhart Regulatory Affairs Project Manager Draeger Medical, Incorporation 3135 Ouarry Road Telford, Pennsylvania 18969

Re: K022031

Trade/Device Name: Narkomed MRI-2 Anesthesia System, Model NM-MRI-2 Regulation Number: 868.5160 Regulation Name: Gas Machine, Anesthesia Regulatory Class: II Product Code: BSZ Dated: June 20, 2002 Received: June 21, 2002

Dear Mr. Kelhart:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 -- Mr. Kelhart

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours

Timothy A. Ulatowski

Timothy A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental 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-2 (NM-MRI-2) Anesthesia System__________________________________________________________________________________________________________________

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
(Per 21 CFR 801.109)

Over-The-Counter-Use
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(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:	K022031

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).