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.

Device Description

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

AI/ML Overview

The provided text is a U.S. FDA 510(k) summary for the Narkomed Ultrasonic Flow Sensor. It establishes substantial equivalence to a predicate device and includes information on device description, intended use, and general regulatory compliance.

However, the document does not contain specific details regarding acceptance criteria, a detailed study proving device performance against those criteria, sample sizes for test sets or training sets, ground truth establishment methods, or information about expert involvement (number, qualifications, adjudication) that would typically be found in a performance study report.

The summary states: "Qualification of the Narkomed Ultrasonic Flow Sensor included a hazard analysis, functional and communication testing, environmental testing, and electromagnetic compatibility testing." This indicates testing was performed, but the results of these tests and the acceptance criteria established for them are not described in the provided text.

Therefore, I cannot populate the requested table and answer many of the specific questions.

Here's a breakdown of what can be extracted or inferred based on the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the document	"Qualification of the Narkomed Ultrasonic Flow Sensor included a hazard analysis, functional and communication testing, environmental testing, and electromagnetic compatibility testing." (Specific performance metrics and results are not provided.)

2. Sample size used for the test set and the data provenance

Sample size for test set: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only mentions "functional and communication testing, environmental testing, and electromagnetic compatibility testing," implying laboratory or engineering tests rather than clinical data in the usual sense for an AI/ML context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. This device is a flow sensor, not a diagnostic imaging device typically requiring expert interpretation for ground truth in the context of this 510(k) summary. The testing mentioned appears to be engineering/hardware qualification.

4. Adjudication method for the test set

Not applicable/Not specified.

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/ML device, and no MRMC study is mentioned or relevant for this type of medical device's 510(k) submission as described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical sensor, not an algorithm in the AI/ML sense. The "functional testing" would represent its standalone performance, but details are not provided.

7. The type of ground truth used

Not explicitly stated, but for a flow sensor, ground truth would likely be established using highly accurate reference flow meters and calibrated gas mixtures under various controlled conditions to verify the sensor's accuracy, precision, and linearity across its intended operating range.

8. The sample size for the training set

Not applicable/Not specified. This is a physical sensor, not an AI/ML algorithm that requires a training set in the conventional sense.

9. How the ground truth for the training set was established

Not applicable/Not specified.

Summary

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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 (301) 594-4648. 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" (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 (800) 638-2041 or (301) 443-6597 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:

(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)	✓	OR	Over-The-Counter Use (Optional Format 1-2-96)
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(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K974193

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).