TRUPEAK PEAK FLOW METER

K955234 · Monaghan Medical Corp. · BZH · Mar 18, 1996 · Anesthesiology

Device Facts

• Record ID: K955234
• Device Name: TRUPEAK PEAK FLOW METER
• Applicant: Monaghan Medical Corp.
• Product Code: BZH · Anesthesiology
• Decision Date: Mar 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2

Indications for 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 device; measures Peak Expiratory Flow Rate (PEFR). User performs forced exhalation into device inlet; internal piston extends spring via pressure spike; indicator moves to maximum displacement position; position corresponds to PEFR value on scale. Logarithmic piston displacement provides higher resolution at lower flow rates. Used by patients for self-monitoring; provides quantitative feedback to assist in respiratory management.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical peak flow meter; logarithmic piston-spring mechanism; manual indicator; plastic housing; no electronic components; no software; no energy source.

Indications for Use

Indicated for patients requiring measurement of Peak Expiratory Flow Rate (PEFR) via forced exhalation maneuver to monitor respiratory status.

Regulatory Classification

Identification

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

Predicate Devices

• TruZone Peak Flow Meter (K926307)

Submission Summary (Full Text)

{0}

MAR 18 1996

K955235+

# 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: October 30, 1995

Device Proprietary Name: TruPeak Peak Flow Meter
Device Classification name: Peak Flow Meter for 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.

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 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.