(125 days)
926307
Not Found.
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/ML.
No.
The device measures Peak Expiratory Flow Rate (PEFR) but does not provide therapy or treatment.
Yes
The device measures Peak Expiratory Flow Rate (PEFR), which indicates the maximum rate of airflow during exhalation. This measurement is used to assess lung function and can help diagnose or monitor 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-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: 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 TruPeak 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.
- Intended Use/Indications for Use: While not explicitly stated, the description clearly indicates it measures a physiological parameter (PEFR) through a physical maneuver, not by analyzing a biological sample.
- Anatomical Site: The anatomical site is the mouth, which is the point of interaction for the exhalation, not the source of a biological sample for analysis.
Therefore, the TruPeak Peak Flow Meter falls under the category of a medical device that measures a physiological function, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found.
Product codes
73 BZH
Device Description
The TruPeak 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 a 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. The The piston displacement function is logarithmic thereby providing greater resolution of scale at lower PEFR readings.
The TruPeak 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 use of zone management tapes. The essence of the modification to this 510(k) is changes in the device labeling to conform to the "Guidance for labeling Peak Flow Meters for Over the Counter Sale", dated June 1993.
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
K9553st
MAR 18 1996
SECTION 2 - SUMMARY AND CERTIFICATION
510(k) SUMMARY
Monaghan 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: October 30, 1995
Device Proprietary Name: TruPeak Peak Flow Meter Device Classification name: Peak Flow for Meter Spirometry, 73 BZH
Legally Marketed Device Identity: TruZone Peak Flow Meter, 510(k) #926307
Device Description:
The TruPeak 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 a 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. The The piston displacement function is logarithmic thereby providing greater resolution of scale at lower PEFR readings.
The TruPeak 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 use of zone management tapes. The essence of the modification to this 510(k) is changes in the device labeling to conform to the "Guidance for labeling Peak Flow Meters for Over the Counter Sale", dated June 1993.