(196 days)
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Not Found
No
The summary describes a standard peak flowmeter and explicitly states that AI, DNN, or ML were not found in the document.
No
The device measures a physiological parameter (peak expiratory flow rate) but does not provide therapy or treatment for the respiratory conditions mentioned. Its purpose is diagnostic or monitoring, not therapeutic.
Yes
The device is described as measuring the peak expiratory flow rate for patients with respiratory conditions, which is used to assess and monitor a patient's health status, making it a diagnostic tool.
No
The device is described as a "Peak Flowmeter," which is a physical device used to measure peak expiratory flow rate. The summary does not mention any software-only component or function.
Based on the provided information, the AirZone Peak Flowmeter is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens taken from the human body. The AirZone Peak Flowmeter measures peak expiratory flow rate directly from the patient's breath, which is a physiological measurement, not a specimen analysis.
- The intended use describes measuring a physiological function. The device measures how fast a patient can exhale, which is a direct measurement of lung function.
- There is no mention of analyzing biological samples. The description and intended use do not involve blood, urine, tissue, or any other bodily fluid or substance.
Therefore, the AirZone Peak Flowmeter falls under the category of a medical device used for monitoring a physiological parameter, not an IVD.
N/A
Intended Use / Indications for Use
The AirZone Peak Flowmeter is intended to measure the peak expiratory flow rate for patients who have respiratory conditions such as Asthma, Emphysema or Reversible Airway Obstruction.
Product codes (comma separated list FDA assigned to the subject device)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 1999
Mr. M.J. Wilkinson Clement Clarke International Ltd. Edinburgh Way, Harlow, Essex CM20 2TT ENGLAND
K982334 Re : AirZone Peak Flowmeter Regulatory Class: II (two) Product Code: 73 BZH Dated: October 28, 1998 Received: October 30, 1998
Dear Mr. Wilkinson:
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 Failure to comply with the GMP regulation may result in assumptions. 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 - Mr. M.J. Wilkinson
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 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,
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
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Appendix 3 Issue 2
510 (K) Number (if known)
K 982334
Device Name
AirZone Peak Flowmeter
The AirZone Peak Flowmeter is intended to measure the peak expiratory flow rate for patients who have respiratory conditions such as Asthma, Emphysema or Reversible Airway Obstruction.
:
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OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
Over-the-Counter Use .........................................................................................................................................................
Mark Kramer
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K182334
Optional Format 1-2-96
MW5626a
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IMAGE
CDRH Document Imaging System
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User: TXM: McDonald, Theresa M. (OSM/DID) Note :
K982152 Folder: Document: 510KSUM: 21-SEP-98
Pages : 1 - 4
Date Requested: Thu Mar 25 10:02:24 1999 Date Printed: Thu Mar 25 10:03:02 1999 Printer: 0K4IMG03