(114 days)
926307
926307
No
The device description explicitly states it is a "simple mechanical device" and details its purely mechanical operation. There is no mention of any computational or algorithmic components that would suggest AI or ML.
No
The device measures lung function (PEFR) but does not provide therapy or treatment. It is a diagnostic/monitoring tool.
Yes
A peak flow meter diagnostic device used to measure Peak Expiratory Flow Rate (PEFR), which indicates the maximum rate of air a person can exhale. This measurement is used to monitor respiratory conditions like asthma.
No
The device description explicitly states it is a "simple mechanical device" with an "internal piston" and "spring," indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section is "Not Found," which is a key indicator for IVDs. IVDs typically have specific intended uses related to diagnosing, monitoring, or screening for diseases or conditions using in vitro methods.
- Device Description: The description clearly states it's a "simple mechanical device" that measures "Peak Expiratory Flow Rate (PEFR)" generated by the user's forced exhalation. This is a direct measurement of a physiological function (lung capacity/airflow), not an analysis of a biological sample in vitro (outside the body).
- No mention of biological samples: The description focuses on the user's breath and the mechanical response of the device. There is no mention of blood, urine, tissue, or any other biological sample being used or analyzed.
- Mechanism of action: The device works by measuring the force of the user's breath pushing a piston, which is a mechanical process, not a chemical or biological reaction performed on a sample.
Therefore, the Truzone Peak Flow Meter, as described, is a medical device used for monitoring respiratory function in vivo (within the body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
BZH
Device Description
The Truzone Peak Flow Meter is a simple mechanical that responds to and indicates the Peak device 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. forced As this exhalation commences an internal piston extends a spring as reaction to an internal pressure spike. An indicator is pushed by the moving piston and remains the maximum displacement position of the piston at maneuver is terminated. This position the after 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 the addition of a separate package of Colorione tapes as an accessory to the TruZone Peak Flow Meter. The essence of the modification to this 510 (k) is adding the package for sale to aforementioned accessory physicians.
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)
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
K955262
SECTION 2 - SUMMARY AND CERTIFICATION
510 (k) Summary
Monaghan Medical Corporation 5 Latour Ave., Suite 1600 P.O. Box 2805 12901-0299 Plattsburgh, NY Phone: 518-561-7330 Fax: 518-561-5660 Contact: James A. Cochie QA/RA Manager
Date Prepared: October 31, 1995
Device Proprietary Name: TruZone Peak Flow Meter Meter for Device Classification name: Peak Flow Spirometry, 73 BZH
Legally Marketed Device Identity: TruZone Peak Flow Meter, 510(k) #926307
Device Description:
The Truzone Peak Flow Meter is a simple mechanical that responds to and indicates the Peak device 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. forced As this exhalation commences an internal piston extends a spring as reaction to an internal pressure spike. An indicator is pushed by the moving piston and remains the maximum displacement position of the piston at maneuver is terminated. This position the after 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 the addition of a separate package of Colorione tapes as an accessory to the TruZone Peak Flow Meter. The essence of the modification to this 510 (k) is adding the package for sale to aforementioned accessory physicians.