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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.
This K955262 submission is for a medical device called the TruZone Peak Flow Meter. However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The submission primarily focuses on:
- Identification of the device: TruZone Peak Flow Meter.
- Description of its function: A simple mechanical device that measures Peak Expiratory Flow Rate (PEFR).
- Comparison to a legally marketed predicate device: TruZone Peak Flow Meter (K926307).
- The nature of the current modification: The addition of a separate package of Colorzone tapes as an accessory.
Therefore, I cannot provide a table of acceptance criteria or details about a study as requested, because that information is not present in the given text. The provided text is a 510(k) summary, which often focuses on device description and substantial equivalence to a predicate device, rather than detailed performance study results and acceptance criteria.
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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.
§ 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).