ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522

K982216 · Braebon Medical Corp. · BZQ · Sep 11, 1998 · Anesthesiology

Device Facts

• Record ID: K982216
• Device Name: ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522
• Applicant: Braebon Medical Corp.
• Product Code: BZQ · Anesthesiology
• Decision Date: Sep 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

An indicator of respiratory effort for recording onto a data acquisition system.

Device Story

Ultima Respiratory Effort Sensor (Models 0520 and 0522) functions as a transducer to detect respiratory effort; input signals are recorded onto a data acquisition system. Used in sleep laboratories by clinicians/technicians during sleep disorder screenings. Output provides respiratory effort data to assist in diagnosing sleep-related breathing disorders. Device facilitates patient monitoring during sleep studies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Respiratory effort sensor; transducer-based sensing; intended for integration with external data acquisition systems. No specific materials or software algorithms described.

Indications for Use

Indicated for children and adult patients undergoing sleep disorder studies to monitor respiratory effort.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle are three stylized human profiles facing to the right, with flowing lines above them that could represent hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEB I I 1998

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

Re: K982216 Ultima Respiratory Effort Sensor Models 0520 and 0522 Requlatory Class: II (two) Product Code: 73 BZQ Dated: June 15, 1998 Received: June 23, 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, 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 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.

{1}------------------------------------------------

## 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 diaqnostic 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. Callahan

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

Enclosure

{2}------------------------------------------------

## Indications for Use Statement

K9%2216__(To be assigned) 510 (k) Number__

| Device Name: | Ultima Respiratory Effort Sensor, 0520 and 0522 |
|----------------------|-------------------------------------------------------------------------------------|
| Indications for Use: | An indicator of respiratory effort for recording onto a data acquisition<br>system. |
| Target Population: | Children and adult patients who are screened during sleep disorder<br>studies |
| Environment of Use: | Sleep disorder screenings occur at a sleep laboratory. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

name

Prescription Use_ V

OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)