(88 days)
955234
955234
No
The device description explicitly states it is a "simple mechanical device" and describes its operation based on physical principles (piston, spring, pressure spike). There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No
A therapeutic device intends to treat or cure a medical condition. This device, a peak flow meter, is used to measure peak expiratory flow rate, which is a diagnostic or monitoring function, not a treatment.
No
The device description indicates it measures Peak Expiratory Flow Rate (PEFR), which assesses lung function, but it doesn't state that it's used to diagnose a specific disease.
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 information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The description clearly states that the TruPeak Peak Flow Meter is a "simple mechanical device" that measures the "Peak Expiratory Flow Rate (PEFR) generated by the user during a forced exhalation maneuver." This involves the user breathing directly into the device.
- Anatomical Site: The anatomical site is the "mouth," which is the point of interaction for the user's breath, not a sample taken from the body.
- Lack of Sample Analysis: There is no mention of analyzing any biological sample (blood, urine, tissue, etc.). The device directly measures a physiological parameter (airflow rate).
Therefore, the TruPeak Peak Flow Meter is a medical device used for monitoring 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 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. As this forced commences an internal piston extends exhalation ਰ spring as reaction to an internal pressure spike. An indicator is pushed by the moving piston and remains position of the the maximum displacement piston at maneuver is terminated. This position after the corresponds to the PEFR and is quantified in liters per minute by reading a scale next to the indicator. displacement function is logarithmic The piston thereby providing greater resolution of scale at lower PEFR readings.
The TruPeak Peak Flow Meter is identical in form and function to the TruPeak Peak Flow Meter as described in its 510(k) #955234 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
955234
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
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: July 23, 1996
Device Proprietary Name: TruPeak Peak Flow Meter
Meter for Peak Flow Device Classification name: Spirometry, 73 BZH
Peak Legally Marketed Device Identity: TruPeak Flow Meter, 510(k) #955234
Device Description:
The TruPeak 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. As this forced commences an internal piston extends exhalation ਰ spring as reaction to an internal pressure spike. An indicator is pushed by the moving piston and remains position of the the maximum displacement piston at maneuver is terminated. This position after the corresponds to the PEFR and is quantified in liters per minute by reading a scale next to the indicator. displacement function is logarithmic The piston thereby providing greater resolution of scale at lower PEFR readings.
The TruPeak Peak Flow Meter is identical in form and function to the TruPeak Peak Flow Meter as described in its 510(k) #955234 except for changes in component dimensions necessary for the performance of the device to conform to the November 1994 ATS Standards update.