(84 days)
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No
The summary describes a simple, portable device for measuring peak expiratory flow rate, with no mention of AI, ML, or any complex data processing that would typically involve these technologies.
No
A therapeutic device is used to treat or cure a disease or condition. This device measures lung function for evaluation, which is diagnostic, not therapeutic.
Yes
The device is described as being for "evaluation of lung function of persons with asthma," which falls under the definition of a diagnostic purpose.
No
The description explicitly states "MINIMAX" Peak Flow Meter is a portable device for measurement of peak expiratory flow rate (PEFR), implying a physical device is involved in the measurement.
Based on the provided information, the "MINIMAX" Peak Flow Meter is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This typically includes blood, urine, tissue, etc.
- The "MINIMAX" Peak Flow Meter measures a physiological parameter directly from the patient. It measures the peak expiratory flow rate (PEFR), which is a measure of how fast air can be exhaled from the lungs. This is a direct measurement of lung function, not an analysis of a sample taken from the body.
Therefore, the "MINIMAX" Peak Flow Meter falls under the category of a medical device used for monitoring or diagnosis, but not specifically an IVD.
N/A
Intended Use / Indications for Use
"MINIMAX" Peak Flow Meter is a portable device for measurement of peak expiratory flow rate (PEFR) for the evaluation of lung function of persons with asthma.
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
lung
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 depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The bird is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 1998
Mr. George Debush The D&T, Inc. 86 Bedford Avenue Hamden, CT 06517
Re: K980443 Peak Flow Meter "miniMAX" Regulatory Class: II (two) Product Code: 73 BZH January 19, 1998 Dated: Received: February 5, 1998
Dear Mr. Debush:
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, 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 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 current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requiation (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 requlation may result in requlatory 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. George Debush
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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral 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. Callehan
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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K480443/Ai
Page 1 of 1
K980443 510(k) NUMBER (IF KNOWN): Flow Meter "MINIMAX = Peak DEVICE NAME:
INDICATIONS FOR USE:
"MINIMAX" Peak Flow Meter is a portable device for measurement of peak expiratory flow rate (PEFR) for the evaluation of lung function of persons with asthma.
/ / 300 / H 90 0
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Dea
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
Prescription Use
(Per 21 CFR 801.109)
510(k) Numberver-The-Counter-use
OR
(Optional Format 1-2-96)