ULTIMA AIRFLOW SENSOR, 0510

K981445 · Braebon Medical Corp. · BZQ · Oct 5, 1998 · Anesthesiology

Device Facts

• Record ID: K981445
• Device Name: ULTIMA AIRFLOW SENSOR, 0510
• Applicant: Braebon Medical Corp.
• Product Code: BZQ · Anesthesiology
• Decision Date: Oct 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

A qualitative measure of respiratory airflow for recording onto a data acquisition system.

Device Story

Ultima Airflow Sensor is a respiratory monitoring device; inputs airflow signals during sleep; transforms signals into qualitative data for recording onto external data acquisition systems. Used in sleep laboratories or home-study environments; operated by sleep technicians or clinicians. Output allows healthcare providers to assess respiratory patterns; aids in diagnosis of sleep disorders. Benefits patients by facilitating objective monitoring of breathing during sleep studies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Qualitative airflow sensor; designed for integration with data acquisition systems; form factor suitable for sleep study monitoring; non-invasive.

Indications for Use

Indicated for children and adult patients undergoing sleep disorder studies to provide a qualitative measure of respiratory airflow.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 5 1898

Richard A. Bonato, Ph.D. Braebon Medical Corporation 63 Acklam Terrace Kanata, Ontario Canada K2K 2P4

Re: K981445 Ultima Airflow Sensor, 0510 Regulatory Class: II (two) Product Code: 73 BZQ Dated: July 8, 1998 Received: July 13, 1998

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, Druq, 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 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 - 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 requlation (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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, 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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## Indications for Use Statement

1981445 (To be assigned) 510 (k) Number_

| Device Name: | Ultima Airflow Sensor, 1051 |
|----------------------|---------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | A qualitative measure of respiratory airflow for recording<br>onto a data acquisition system. |
| Target Population: | Children and adult patients who are screened during sleep<br>disorder studies |
| Environment of Use: | The majority of the screenings occur at a sleep laboratory<br>although the sensor can also be used in home-studies. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lank Mador 10-4-98

(Division Sign-Off) Division of Cardiovascular and Neurological Devi

Prescription Use
(Per 21 CFR 801.109) OR

Over-The-Counter Use_

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