The Ultima Airflow Pressure Sensor™ is intended for use during sleep disorder studies as a qualitative measure of respiratory airflow for recording onto an FDA-cleared data acquisition system. Respiratory pressures are converted into voltage signals for input to a physiological recorder. The sensor uses a 3.6-volt lithium battery and plugs directly into the patient headbox or to an FDA-cleared DC amplifier. A disposable nasal cannula with a 0.2-micron hydrophobic filter attaches to the patient and connects to the input of the Ultima Airflow Pressure Sensor.

Device Description

The Ultima Airflow Pressure Sensors, Models #0580L, are small interface devices which convert levels of air pressure to corresponding levels of voltage which can be recorded on any FDA-cleared physiological recorder intended to record low-level electrical signals. The purpose of the device is to detect respiratory airflow. There is one pneumatic input for air pressure, and one set of electrical outputs representing the electrical equivalent of the pressure. The electrical outputs are the active or positive output and the reference or negative output. This device uses a disposable nasal cannula with a disposable 0.2 um hydrophobic filter. The cannula and filter attach to the patient and connect to the pressure input labeled "INPUT" using a standard luer connector. The electrical output connectors are made with 1.5 mm-safety connectors that connect to either an FDA-cleared AC amplifier or an FDA-cleared DC amplifier with a low frequency filter setting of less than 0.05 Hz and a high frequency filter setting of 15 -30 Hz. The Ultima Airflow Pressure Sensor consists of a red ABS plastic enclosure measuring approximately 1.5"(W) x 2.8"(L) x 0.6"(H). The device is battery powered with one 3.6 volt 1/2AA lithium cell. The estimated battery life is 450 hours (50 - eight hour uses), with an On/Off switch provided to conserve battery life when not in use. The device has a 0.14-Hz blinking status LED: green indicates proper operation, red indicates low battery. The battery can be replaced by removing the battery cover, removing the battery and inserting a new one in the orientation shown in the battery compartment of the unit. The pressure sensor is attached either to a bed frame or to a wall with a Velcro strap.

AI/ML Overview

The acceptance criteria for the Ultima Airflow Pressure Sensor and the study proving it meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Technological Characteristics relative to predicate device)	Reported Device Performance (Ultima Airflow Pressure Sensor)
Intended Use	No difference (Qualitative measure of respiratory airflow for recording onto an FDA-cleared data acquisition system).
Indication Statements	No difference (An indicator of respiratory airflow for recording onto a data acquisition system).
Population	No difference (Children and adult patients screened during sleep disorder studies).
Number of Input Channels	No difference (One input channel).
Number of Output Channels	No difference (One output channel).
Electrical Output Connectors	No difference (Uses 1.5-mm safety connectors).
Method of Connection to Patient	No significant difference (Both cannula style; uses plastic tubing and cannula set; no wires or metal parts connected to patient).
Composition of Plastic Battery Enclosure	No difference (Made of red ABS plastic).
Power Source	No significant difference (Uses replaceable lithium batteries only).
Safety Characteristics	No significant difference (Provides for patient isolation; plastic tubing used, no direct connection of wires to patient; connects to FDA cleared recorders using approved safety connectors).
Re-use Restrictions	Subject device is for single-use only. Predicate device requires disinfection and cleaning procedures for re-use. (This is a difference but the conclusion states "No difference" in performance data, implying this difference does not adversely affect safety/effectiveness).
Sensor Technology	Uses a solid-state pressure transducer (converts small changes in air pressure to small voltage changes). Predicate uses an electrical thermistor (converts small resistance changes caused by airflow to small voltage changes). (This is a difference but the conclusion states "No difference" in performance data, implying this difference does not adversely affect safety/effectiveness).
Performance data conclusions	No difference.

2. Sample Size Used for the Test Set and Data Provenance:

The document states "Laboratory testing has been performed using this device in place of the predicate device for respiratory airflow monitoring."
However, no specific sample size for the test set or information on data provenance (e.g., country of origin, retrospective/prospective) is provided in the given text.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

This information is not provided in the document. The testing mentioned is laboratory testing comparing the new device to the predicate.

4. Adjudication Method for the Test Set:

No information on adjudication methods is provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done or reported. This device is an airflow pressure sensor, not an AI-assisted diagnostic tool for human readers.

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

The device is a sensor, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed. The "standalone" performance here would refer to the sensor's ability to convert pressure to voltage accurately. The document states "These tests conclude that the electrical signals recorded using the Ultima Airflow Pressure Sensor provide equivalent informational content to the signals recorded using the predicate device." This implies a form of standalone performance evaluation against the predicate.

7. The type of ground truth used:

The ground truth used was comparison to a legally marketed predicate device (Ultima Airflow Sensor, Braebon Medical Corporation, K981445). The specific type of "ground truth" for respiratory airflow is implicitly the output of the predicate device. The claim is "equivalent informational content."

8. The sample size for the training set:

The document does not mention a training set sample size. This device is a hardware sensor, not a machine learning model, so the concept of a "training set" in the AI sense does not apply here. Development and calibration would have occurred, but the specifics are not detailed.

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

As this is not an AI/machine learning device, the concept of a "training set" with established ground truth in that context does not apply. If "training" refers to the device's design and calibration, then the ground truth would have been established through engineering specifications and potentially comparison to established reference standards for pressure and voltage measurement. However, this information is not provided in the document.

Summary

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Image /page/0/Picture/14 description: The image shows the logo for BRAEBON MEDICAL CORPORATION. The text is in all caps and is black. The word BRAEBON is on the top line, MEDICAL is on the second line, and CORPORATION is on the third line.

DEC 30 1998

K98 4431

P.O. Box 72094 Kanata, Ontario Canada K2K 2P4 Phone: (613) 591-8990 Fax: (613) 591-8991

SUMMARY AND CERTIFICATION

510(K) SUMMARY

SAFETY AND EFFECTIVENESS SUMMARY

Safety and effectiveness information concerning this airflow sensor is summarized below.

Because this is not a class III device, the special certification defined for this section is not required.

Prepared by:	BRAEBON Medical CorporationP.O. Box 72094Kanata, OntarioCanada, K2K 2P4
Telephone:	(613) 591-8990
Contact Person:	Richard A. Bonato, Ph.D.
Date on which this summary was prepared:	December 4, 1998
Common name:	Airflow Pressure Sensor
Classification name:	Breathing frequency monitor (per CFR 868.1860)

Predicate device: Ultima Airflow Sensor, Braebon Medical Corporation, K981445

Description of the Device:

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P.O. Box 72094 Kanata, Ontario Canada K2K 2P4 Phone: (613) 591-8990 Fax: (613) 591-8991

This device uses a disposable nasal cannula with a disposable 0.2 um hydrophobic filter. The cannula and filter attach to the patient and connect to the pressure input labeled "INPUT" using a standard luer connector. The electrical output connectors are made with 1.5 mm-safety connectors that connect to either an FDA-cleared AC amplifier or an FDA-cleared DC amplifier with a low frequency filter setting of less than 0.05 Hz and a high frequency filter setting of 15 -30 Hz.

The Ultima Airflow Pressure Sensor consists of a red ABS plastic enclosure measuring approximately 1.5"(W) x 2.8"(L) x 0.6"(H). The device is battery powered with one 3.6 volt 1/2AA lithium cell. The estimated battery life is 450 hours (50 - eight hour uses), with an On/Off switch provided to conserve battery life when not in use. The device has a 0.14-Hz blinking status LED: green indicates proper operation, red indicates low battery. The battery can be replaced by removing the battery cover, removing the battery and inserting a new one in the orientation shown in the battery compartment of the unit. The pressure sensor is attached either to a bed frame or to a wall with a Velcro strap.

Intended Use:

Patient Population:

The target population of the Ultima Airflow Pressure Sensor is all children and adult patients who are screened during sleep disorder studies. The maiority of the screenings occur at a sleep laboratory although the sensor can also be used in home studies.

Safety and Effectiveness:

The maximum voltage within the Ultima Airflow Pressure Sensor is 3.0 volts DC, based on the use of one 3.6 volt 1/2AA lithium battery. There is no direct electrical connection to the patient because a seven-foot non-conductive oxygen cannula attaches to the patient and connects to the pressure sensor. The sensor is plugged into an isolated FDA-cleared amplifier/recording system: no direct electrical contact is ever made with the patient. All circuitry is enclosed in a nonconductive ABS enclosure using a hex screw such that the patient can not accidentally remove

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the battery. Due to these low voltages, there is no risk of electrical shock to either the patient or health-care provider.

Laboratory testing has been performed using this device in place of the predicate device for respiratory airflow monitoring. These tests conclude that the electrical signals recorded using the Ultima Airflow Pressure Sensor provide equivalent informational content to the signals recorded using the predicate device.

The following comparison is provided as a summary of technological characteristics relative to the predicate device. This table demonstrates that the Ultima Airflow Pressure Sensor has no significant differences from the predicate device that would adversely affect product safety and effectiveness.

Intended Use	No difference
Indication Statements	No difference
Population	No difference
Number of Input Channels	No difference. Both the subject and predicatedevices have one input channel.
Number of Output Channels	No difference. Both the subject and predicatedevices output one channel.
Electrical Output Connectors	No difference. Both the subject and predicatedevices use 1.5-mm safety connectors.
Method of Connection to Patient	No significant difference. Both the subject andpredicate devices are cannula style. The subjectdevice uses a plastic tubing and cannula set forpatient connection. There are no wires or othermetal parts connected to the patient. The sensorassembly of the predicate device also attaches to thepatient in a manner similar to a cannula.
Composition of Plastic BatteryEnclosure	No difference. Both the subject and predicatedevices are made of red ABS plastic.
Power Source	No significant difference. Both the subject andpredicate devices use replaceable lithium batteries

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1

P.O. Box 72094 Kanata, Ontario Canada K2K 2P4 Phone: (613) 591-8990 Fax: (613) 591-8991

	only.
Safety Characteristics	No significant difference. Both the subject andpredicate devices provide for patient isolationbecause there is no direct connection of wires to thepatient in either case. The subject device usesplastic tubing; the predicate device uses an insulatedthermistor assembly. Both the subject and predicatedevices connect to FDA cleared recorders usingapproved safety connectors.
Re-use Restrictions	Subject device is for single-use only. Predicatedevice requires disinfection and cleaningprocedures for re-use.
Sensor Technology	The subject device uses a solid-state pressuretransducer, which converts small changes in airpressure into small voltage changes. The predicatedevice uses an electrical thermistor, which convertssmall resistance changes caused by the airflow intosmall voltage changes.
Performance data conclusions	No difference.

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 30 1998

Richard A. Bonato, Ph.D. Braebon Medical Corporation P.O. Box 72094 Kanata, ON, K2K 2P4 CANADA

Re : K984431 Ultima Airflow Pressure Sensor, 0580H and 0580L II (Two) Requlatory Class: 73 BZQ Product Code: Dated: December 18, 1998 December 22, 1998 Received:

Dear Dr. Bonato:

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 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). 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 (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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further regulatory action. 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 - Richard A. Bonato, Ph.D.

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/dsma/dsmamain.html."

Sincerely yours,

Ath. A. Cirk.

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Statement

K98 4431 ______(To be assigned) 510 (k) Number

Device Name:	Ultima Airflow Pressure Sensor, 0580H and 0580L
Indications for Use:	An indicator of respiratory airflow for recording onto a dataacquisition system.
Target Population:	Children and adult patients who are screened during sleepdisorder studies
Environment of Use:	The majority of screenings occur at a sleep laboratory.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Martz Krawe

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_

Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).