(166 days)
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Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description is simple and the intended use is a basic measurement.
No
The device measures respiratory airflow for recording purposes, which is a diagnostic function, not a therapeutic one.
No
The device measures respiratory airflow for recording, which is a measurement function, but the description does not indicate it interprets this data to diagnose a condition.
No
The device description explicitly states "Ultima Airflow Sensor, 1051", which implies a physical sensor component, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "A qualitative measure of respiratory airflow for recording onto a data acquisition system." This describes a device that measures a physiological parameter (airflow) directly from the patient, not a device that analyzes samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: The description "Ultima Airflow Sensor" further supports the idea of a sensor that interacts with the patient's respiratory system.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures typically associated with IVDs.
Therefore, this device falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A qualitative measure of respiratory airflow for recording onto a data acquisition system.
Target Population: Children and adult patients who are screened during sleep disorder studies
Environment of Use: The majority of the screenings occur at a sleep laboratory although the sensor can also be used in home-studies.
Product codes
73 BZQ
Device Description
Ultima Airflow Sensor, 1051
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Children and adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/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 a stylized image of a human figure, with three overlapping profiles facing to the right, representing health and well-being.
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.
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 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,
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
2
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 |
| onto a data acquisition system. | |
| Target Population: | Children and adult patients who are screened during sleep |
| disorder studies | |
| Environment of Use: | The majority of the screenings occur at a sleep laboratory |
| 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_
,