NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2

K022031 · Draeger Medical, Inc. · BSZ · Aug 29, 2002 · Anesthesiology

Device Facts

• Record ID: K022031
• Device Name: NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2
• Applicant: Draeger Medical, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Aug 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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 Story

Continuous flow gas anesthesia system; provides ventilation, gas/anesthetic vapor delivery, and monitoring of oxygen, pressure, and volume. Used in MRI scanner rooms; operated by clinicians. System design allows operation in magnetic fields up to 3.0 tesla without distance limitations. Includes optional bain circuit adapter with MRI-compatible breathing pressure gauge. Benefits include safe anesthesia delivery and monitoring within high-field MRI environments without interfering with image quality or magnetic field homogeneity.

Clinical Evidence

Bench testing only. System-level qualification and hazard analysis performed to verify performance in 3.0 tesla MRI environments, confirming no interference with magnetic field homogeneity or diagnostic image quality.

Technological Characteristics

Continuous flow gas anesthesia system. MRI-compatible design for operation in 3.0 tesla fields. Includes Dräger-Vapor vaporizer interface and optional bain circuit adapter with MRI-compatible breathing pressure gauge.

Indications for Use

Indicated for patients requiring spontaneous, manually assisted, or automatic ventilation and anesthesia gas delivery during procedures in MRI scanner rooms with magnet strengths up to 3.0 tesla.

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 MRI-2 Anesthesia System (K003579)

Submission Summary (Full Text)

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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.<br>3135 Quarry Road<br>Telford, 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

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### 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 [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" (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 [phone] or [phone] 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:

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. 100 100

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | ✓ |
|----------------------|---|
| (Per 21 CFR 801.109) | |

OR

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

(Optional Format 1-2-96)