(83 days)
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Not Found
No
The summary describes a simple mechanical or electronic peak flow meter and does not mention any AI or ML terms or functionalities.
No.
The device measures a physiological parameter (peak expiratory flow) to monitor respiratory conditions, but it does not actively treat or intervene to alleviate the condition itself.
Yes
The device measures PEF to detect changes in airways, signaling a worsening or improvement of symptoms for respiratory conditions, which is a diagnostic function.
No
The device description explicitly states "TruZone™ Peak Flow Meter," which is a physical device used to measure peak expiratory flow. This indicates a hardware component is involved.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure peak expiratory flow (PEF) generated by the patient during a forced exhalation. This is a physiological measurement taken directly from the patient's body.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The TruZone™ Peak Flow Meter measures a physical parameter of the patient's breathing, not a substance or marker in a sample taken from the patient.
N/A
Intended Use / Indications for Use
Portable monitoring device which measures the peak expiratory flow (PEF) generated by the patient during a forced exhalation maneuver. This measurement is useful in detecting changes in airways that could signal a worsening of symptoms or an improvement in breathing function for people with respiratory conditions such as Asthma or emphysema.
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): 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract symbol of a human figure with three faces in profile, representing the department's focus on people and health. The seal is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 1999
Mr. James A. Cochie Monaghan Medical Corporation 5 Latour Avenue, Suite 1600 P.O. Box 2805 Plattsburgh, NY 12901-0299
K991212 Re: TruZone™ Peak Flow Meter Requlatory Class: II (two) Product Code: 73 BZH Dated: April 6, 1999 Received: April 9, 1999
Dear Mr. Cochie:
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 leqally 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 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 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.
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Page 2 - Mr. James A. Cochie
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,
Thomas J. Callahan
Thomas J. ( allahan, 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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Page 1 of 1
| 510(k) Number (if known): | K991212 |
|---|---|
| --------------------------- | --------- |
Device Name: __ TruZone™ Peak Flow Meter _____________________________________________________________________________________________________________________________________
Indications for Use:
Portable monitoring device which measures the peak expiratory flow (PEF) generated by the patient during a forced exhalation maneuver. This measurement is useful in detecting changes in airways that could signal a worsening of symptoms or an improvement in breathing function for people with respiratory conditions such as Asthma or emphysema.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Atl. A. Ciarkowski.
(Division Sign-Off) Division of Cardiovascular, Re and Neurological Devi 510(k) Number
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use_
or