TRUPEAK PEAK FLOW METER

K963095 · Monaghan Medical Corp. · BZH · Nov 4, 1996 · Anesthesiology

Device Facts

• Record ID: K963095
• Device Name: TRUPEAK PEAK FLOW METER
• Applicant: Monaghan Medical Corp.
• Product Code: BZH · Anesthesiology
• Decision Date: Nov 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2

Intended Use

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.

Device Story

Mechanical peak flow meter; measures Peak Expiratory Flow Rate (PEFR). User places inlet in mouth; performs forced exhalation from full lungs. Internal piston extends spring against pressure spike; indicator moves to maximum displacement position. Indicator remains at peak position for reading on logarithmic scale (liters per minute). Provides higher resolution at lower PEFR readings. Used by patients for self-monitoring or clinicians for assessment. Output informs respiratory status and clinical decision-making.

Clinical Evidence

No clinical data; bench testing only to verify conformance to November 1994 ATS Standards.

Technological Characteristics

Mechanical device; internal piston and spring mechanism. Logarithmic scale for PEFR quantification. Dimensions modified to meet November 1994 ATS Standards.

Indications for Use

Indicated for users requiring measurement of Peak Expiratory Flow Rate (PEFR) via forced exhalation maneuver.

Regulatory Classification

Identification

A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.

Predicate Devices

• TruPeak Peak Flow Meter (K955234)

Submission Summary (Full Text)

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K963095

NOV 4 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: [phone] Fax: [phone]
Contact: James A. Cochie
QA/RA Manager

**Date Prepared:** July 23, 1996

**Device Proprietary Name:** TruPeak Peak Flow Meter

**Device Classification name:** Peak Flow Meter for Spirometry, 73 BZH

**Legally Marketed Device Identity:** TruPeak Peak Flow Meter, 510(k) #955234

**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.

The inlet of the device is placed into the user's 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 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 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.