(90 days)
926307
No
The device description explicitly states it is a "simple mechanical device" and details its operation based on physical principles (piston, spring, pressure). There is no mention of software, algorithms, or any computational processing that would suggest AI/ML.
No.
A peak flow meter measures lung function and is used for monitoring, not for providing therapy or treatment.
Yes
A peak flow meter measures Peak Expiratory Flow Rate (PEFR), which is a diagnostic indicator for respiratory conditions like asthma. It provides quantitative data that healthcare professionals use to determine the severity and control of lung diseases.
No
The device description explicitly states it is a "simple mechanical device" with an "internal piston" and a "scale," indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The TruZone Peak Flow Meter is a mechanical device that measures the rate of air exhaled from the lungs. It interacts directly with the user's breath, not with a sample taken from the body.
- Lack of IVD Indicators: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing performed outside of the body.
Therefore, the TruZone Peak Flow Meter is a medical device used for monitoring respiratory function, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Not Found
Product codes
73 BZH
Device Description
The TruZone Peak Flow Meter is a simple mechanical device that responds to and indicates the Peak Expiratory Flow Rate (PEFR) generated by the user during a forced exhalation maneuver.
inlet of the device is placed into the user's The mouth after which the maximum rate at exhalation is attempted from nearly full lungs. As this forced exhalation commences an internal piston extends ત્વ spring as reaction to an internal pressure spike. An indicator is pushed by the moving piston and remains at the maximum displacement position of the piston after the maneuver is terminated. This position corresponds to the PEFR and is quantified in liters per minute by reading a scale next to the indicator. piston displacement function is logarithmic The thereby providing greater resolution of scale at lower PEFR readings.
The TruZone Peak Flow Meter is identical in form and function to the TruZone Peak Flow Meter as described in its 510(k) #926307 except for changes in component dimensions necessary for the performance of the device to conform to the November 1994 ATS Standards update.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
TruZone Peak Flow Meter, 510(k) #926307
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
NOV - 6 1996
SECTION 2 - SUMMARY AND CERTIFICATION
510(k) SUMMARY
Monaqhan Medical Corporation 5 Latour Ave., Suite 1600 P.O. Box 2805 Plattsburgh, NY 12901-0299 Phone: 518-561-7330 Fax: 518-561-5660 Contact: James A. Cochie QA/RA Manager
Date Prepared: July 11, 1996
Device Proprietary Name: TruZone Peak Flow Meter
Flow Meter for Device Classification name: Peak Spirometry, 73 BZH
Legally Marketed Device Identity: TruZone Peak Flow Meter, 510(k) #926307, #955262
Device Description:
The TruZone Peak Flow Meter is a simple mechanical device that responds to and indicates the Peak Expiratory Flow Rate (PEFR) generated by the user during a forced exhalation maneuver.
inlet of the device is placed into the user's The mouth after which the maximum rate at exhalation is attempted from nearly full lungs. As this forced exhalation commences an internal piston extends ત્વ spring as reaction to an internal pressure spike. An indicator is pushed by the moving piston and remains at the maximum displacement position of the piston after the maneuver is terminated. This position corresponds to the PEFR and is quantified in liters per minute by reading a scale next to the indicator. piston displacement function is logarithmic The thereby providing greater resolution of scale at lower PEFR readings.
The TruZone Peak Flow Meter is identical in form and function to the TruZone Peak Flow Meter as described in its 510(k) #926307 except for changes in component dimensions necessary for the performance of the device to conform to the November 1994 ATS Standards update.