NARKOMED 6400, MODEL NM6400

K033498 · Draeger Medical, Inc. · BSZ · Apr 26, 2004 · Anesthesiology

Device Facts

• Record ID: K033498
• Device Name: NARKOMED 6400, MODEL NM6400
• Applicant: Draeger Medical, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Apr 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Narkomed 6400 w/ Integrated Patient Monitoring (NM6400 w/ IPM) may be used for spontaneous, manually assisted, or automatic ventilation of patients during anesthesia, and delivery of gases and anesthetic vapor. The NM6400 w/ IPM can monitor oxygen, breathing pressure, respiratory volume, CO2, N2O, cardiovascular parameters and anesthetic agent identification and concentration and provide portioned data.

Device Story

Narkomed 6400 is a continuous flow anesthesia workstation with integrated cardiovascular monitoring. Device delivers anesthetic gases/vapors and provides mechanical ventilation (spontaneous, manual, automatic). Inputs include patient physiological signals (via TRAM technology for cardiovascular parameters, including wedge pressure) and gas/agent concentrations. System processes these inputs to provide real-time monitoring, alarm management (including dual-agent detection), and cardiac trial calculations. Used in clinical settings by anesthesia providers. Output is displayed on-screen and via printed data, assisting clinicians in patient management during surgery. Benefits include integrated monitoring and ventilation control in a single platform.

Clinical Evidence

No clinical data provided. Evidence consists of hazard analysis and system-level qualification testing.

Technological Characteristics

Continuous flow anesthesia gas machine. Integrates TRAM (Transport Remote Acquisition) technology for cardiovascular monitoring. Features include gas/vapor delivery, ventilation control, and physiological parameter monitoring. Software provides alarm management and cardiac calculations.

Indications for Use

Indicated for patients requiring anesthesia via continuous flow gas system; provides spontaneous, manually assisted, or automatic ventilation; delivers gases and anesthetic vapor; monitors oxygen, breathing pressure, respiratory volume, CO2, N2O, cardiovascular parameters, and anesthetic agents. Prescription use only.

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 6000 w/ Cardiovascular and Strip Chart Recorder Pods (K993826)
• Marquette SL Series Transport Remote Acquisition (TRAM) (K921669)
• Solar 7000/8000 System (K993757)

Submission Summary (Full Text)

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# APR 2 6 2004

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# Summary of Safety and Effectiveness Data Relating to Substantial Equivalence

Proprietary Name:Narkomed 6400 w/ Integrated Patient Monitoring

Classification Name:Gas-Machine, Anesthesia 73BSZ

Device Class:Class II

Manufacturer:Draeger Medical Inc. 3135 Quarry Road Telford, Pennsylvania 18969

Establishment Registration Number:2517967

Devices to which substantial equivalence is claimed: Narkomed 6000 w/ Cardiovascular and Strip Chart Recorder Pods K993826 Marquette SL Series Transport Remote Acquisition (TRAM) K921669 Solar 7000/8000 System K993757

#### Device Description:

The Narkomed 6400 w/ Integrated Patient Monitoring is a continuous flow gas anesthessa system with cardiovascular monitoring.

## Intended Use:

The Narkomed 6400 w/ Integrated Patient Monitoring (NM6400 w/ IPM) may be used for spontaneous, manually assisted, or automatic ventilation of patients during anesthesia, and delivery of gases and anesthetic vapor. The NM6400 w/ IPM can monitor oxygen, breathing pressure, respiratory volume, CO2, N2O, cardiovascular parameters and anesthetic agent identification and concentration and provide portioned data.

#### Substantial Equivalence:

The base functionality of the product line remains essentially the same. Like the NM6000 w/ CV Pod, the NM6400 w/ IPM uses the TRAM technology for cardiovascular monitoring capabilities. The NM6400 w/ IPM differs in that it also uses TRAM technology to provide Wedge Pressure information.

The NM6400 w/ IPM also provides the ability to do cardiac trial calculations. Several messages for user clarification were added, along with an alarm indicating the presence of two agents.

Qualification of the NM6400 w/ IPM included a hazard ana!ysis and system level qualification testing.

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### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 2 6 2004

Mr. Gale Winarsky Regulatory Affairs Project Manager Draeger Medical, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

Re: K033498

Trade/Device Name: Narkomed 6400 Anesthesia Workstation w/IPM Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: February 23, 2004 Received: February 24, 2004

Dear Mr. Winarsky:

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 prodicate 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.

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Page 2 - Mr. Winarsky

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. 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), "You may obtain other general information on your responsibilities under the Act 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 vours.

CluR

Chiu Lin, Ph.D. 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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# Indications for Use

510(k) Number (if known): K033498

Device Name:

Indications for Use:

The NM6400 w/IPM is indicated as a continuous flow anesthesia system. The NM6400 w/IPM may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of; oxygen concentration, breathing pressure, respiratory volume, cardiovascular parameters, anesthetic agent identification and concentration and provides printed data. Federal law restricts this device to sale by or on the order of a physician.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

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(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number