NARKOMED ULTRASONIC FLOW SENSOR

K974193 · Draeger Medical, Inc. · BSZ · Jan 28, 1998 · Anesthesiology

Device Facts

• Record ID: K974193
• Device Name: NARKOMED ULTRASONIC FLOW SENSOR
• Applicant: Draeger Medical, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Jan 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2

Intended Use

The Narkomed Ultrasonic Flow Sensor is intended for measuring the flow rate of gas through the patient breathing circuit to determine tidal volume, minute volume, and respiratory rate.

Device Story

Narkomed Ultrasonic Flow Sensor mounts to expiratory valve fitting on Narkomed Anesthesia Systems; measures respiratory gas flow rate via ultrasonic pulses. Device calculates tidal volume, minute volume, and respiratory rate from flow data. Used in clinical anesthesia settings; operated by clinicians. Output displayed for provider monitoring to assist in patient ventilation management.

Clinical Evidence

Bench testing only. Qualification included hazard analysis, functional and communication testing, environmental testing, and electromagnetic compatibility testing.

Technological Characteristics

Ultrasonic flow sensing principle. Mounts to Narkomed Anesthesia System expiratory valve. Measures gas flow rate via ultrasonic pulses.

Indications for Use

Indicated for measuring respiratory gas flow rate through patient breathing circuits. 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

• Spiromed 2 (K851620)

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness Data Relating to Substantial Equivalence

Proprietary Name: Narkomed Ultrasonic Flow Sensor

Classification Name: Monitoring Spirometer

Class II Device Class:

North American Dräger Manufacturer: 3135 Quarry Road Telford, Pennsylvania 18969

Establishment Registration Number: 2517967

Devices to which substantial equivalence is claimed: Spiromed 2 K851620

## Device Description:

The Narkomed Ultrasonic Flow Sensor mounts to the expiratory valve fitting on Narkomed Anesthesia Systems and ultrasonically measures respiratory flow rate.

## Intended Use:

The Narkomed Ultrasonic Flow Sensor is intended for measuring the flow rate of gas through the patient breathing circuit to determine tidal volume, minute volume, and respiratory rate.

## Substantial Equivalence:

The Narkomed Ultrasonic Flow Sensor is substantially equivalent to the Spiromed 2.

The Narkomed Ultrasonic Flow Sensor and the Spiromed 2 have the same intended use. The principle of operation of the Narkomed Ultrasonic Flow Sensor differs in that it measures ultrasonic pulses while the Spiromed 2 measures electronic pulses generated by positive displacement. There have been no new questions of safety and efficacy raised as a result of the Narkomed Ultrasonic Flow Sensor technology. Therefore the Narkomed Ultrasonic Flow Sensor and the Spiromed 2 are substantially equivalent.

Qualification of the Narkomed Ultrasonic Flow Sensor included a hazard analysis, functional and communication testing, environmental testing, and electromagnetic compatibility testing.

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 1998

Mr. James J. Brennan North American Drager 3135 Quarry Road Telford, PA 18969

Re: K974193 Narkomed Ultrasonic Flow Sensor Regulatory Class: II (two) Product Code: 73 BSZ November 6, 1997 Dated: November 7, 1997 Received:

Dear Mr. Brennan:

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 against misbranding and adulteration.

If your device is classified (see above) into either class II (\$pecial 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 Regulations, 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 regulation 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. CallaMan, 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): __

K974193

Device Name: Narkomed Ultrasonic Flow Sensor

Indications For Use:

The Narkomed Ultrasonic Flow Sensor is indicated for measuring the respiratory flow rate of gas through the patient breathing circuit. 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 (Per 21 CFR 801.109) | <div> <span style="font-size: 2em;">✓</span> </div> | OR | Over-The-Counter Use (Optional Format 1-2-96) |
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| (Division Sign-Off) | |
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| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K974193 |