(401 days)
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No
The summary describes a simple mechanical device for measuring PEFR and contains no mention of AI, ML, or related concepts.
No
The device measures a physiological parameter (PEFR) but does not actively treat or restore health. While it aids in managing respiratory conditions, it is a diagnostic/monitoring tool, not a therapeutic one.
Yes
The device measures Peak Expiratory Flow Rate (PEFR) for people with respiratory conditions like asthma, which is a diagnostic indicator of lung function.
No
The device description explicitly states "Mini-Bell Peak Flow Meter/Low Range Model Peak Flow Meter," which are physical hardware devices used to measure PEFR.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device measures Peak Expiratory Flow Rate (PEFR) for people with respiratory conditions. This is a measurement taken directly from the patient's body (exhaled air), not a test performed on a sample of bodily fluid or tissue outside the body.
- Device Description: A peak flow meter is a mechanical device used for direct physiological measurement.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as analyzing blood, urine, tissue, or other biological samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device performs a direct physiological measurement.
N/A
Intended Use / Indications for Use
Measures Peak Expiratory Flow Rate (PEFR) for people who have respiratory conditions.
Product codes
73 BZH
Device Description
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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
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.1860 Peak-flow meter for spirometry.
(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle design with three curved lines representing the eagle's head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN | 3 1997
Mr. Robert L. James Avion Medical Products, Inc. 4361 Harvester Road, Unit 1 Burington, Ontario, CANADA L7L 5M4
Re: K961779 *Mini-Bell Peak Flow Meter Regulatory Class: II (two) Product Code: 73 BZH Dated: April 2, 1997 Received: April 4, 1997
Dear Mr. James:
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, qood 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 requlations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requiation (21 CFR Part 820) and that, through periodic GMP 2 inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 requlations.
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Page 2 - Mr. Robert L. James
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) 594-4646. 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. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510 (k) Number (if known) : __________________________________________________________________________________________________________________________________________________
Device Name:__Mini-Bell Peak Flow Meter/Low Range Model Peak Flow Meter
Indications For Use:
ત્ર્મ્
Measures Peak Expiratory Flow Rate (PEFR) for people who have respiratory conditions such hace (ruri) for people who nave
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 1
Concurrence of CDRH, Office of Device Evaluation (ODE) -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------erstralize
510(k) Number_
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
Prescription Use_ OR
Over-The-Counter Use,
(Per 21 CFR 801.109)
(Optional Format 1-2-96)