NARKOMED MRI ANESTHESIA SYSTEM

K972848 · Draeger Medical, Inc. · BSZ · Oct 30, 1997 · Anesthesiology

Device Facts

• Record ID: K972848
• Device Name: NARKOMED MRI ANESTHESIA SYSTEM
• Applicant: Draeger Medical, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Oct 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Continuous flow gas anesthesia system; provides ventilation, gas/anesthetic delivery, and patient monitoring (O2, pressure, volume). Used in MRI scanner rooms; operated by clinicians. Utilizes non-ferromagnetic materials; shielded/relocated components for MRI compatibility. Integrates adapted Core-M Omicron Monitor for physiological data. Output displayed to clinician to guide anesthetic management and patient monitoring during surgery. Benefits include safe anesthesia delivery within MRI environments.

Clinical Evidence

Bench testing only. Qualification included hazard analysis, system-level qualification testing, environmental testing, electromagnetic compatibility testing, and testing in an MRI environment.

Technological Characteristics

Continuous flow anesthesia system. Non-ferromagnetic materials for structural elements; shielded/relocated components for MRI compatibility. Includes gas delivery system, absorber, scavenger, and adapted Core-M Omicron Monitor. Compatible with Dräger Vapor® 19.1. Designed for MRI environments (up to 1.5T or higher with mounting kit).

Indications for Use

Indicated for patients requiring anesthesia during surgical procedures. Used for spontaneous, manually assisted, or automatic ventilation, gas/anesthetic vapor delivery, and monitoring of oxygen, pressure, and respiratory volume. Restricted to prescription use by a physician. Compatible with MRI environments up to 1.5T, or higher with specific mounting kit.

Regulatory Classification

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. 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).

Predicate Devices

• Narkomed GS Anesthesia System (K963994)
• Core-M Omicron Monitor (K960861)

Reference Devices

• Ohmeda Excel 210 MRI Compatible Anesthesia System

Submission Summary (Full Text)

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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<br>3135 Quarry Road<br>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.

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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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1. 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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):

K972848

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.

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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