MICRO SPIROMETER

K963035 · Micro Direct, Inc. · BZG · Nov 1, 1996 · Anesthesiology

Device Facts

• Record ID: K963035
• Device Name: MICRO SPIROMETER
• Applicant: Micro Direct, Inc.
• Product Code: BZG · Anesthesiology
• Decision Date: Nov 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2

Intended Use

The intended device takes spirometer readings of a patient during exhalation. The output readings are FEV1 and FVC.

Device Story

Hand-held portable electronic spirometer; measures FEV1 and FVC during patient exhalation. Uses flow-sensing turbine transducer; LCD display for output. Operated by clinicians in home or hospital settings. Device provides lung function measurements to assist clinical evaluation.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Hand-held electronic spirometer; flow-sensing turbine transducer; LCD display. Flow range 0-12 lps BTPS; volume range 0-9.99 liters. Accuracy +/- 3%. Utilizes paper mouthpiece; transducer requires cleaning after use.

Indications for Use

Indicated for patients requiring lung function evaluations; intended for use by clinicians in environments such as home or hospital.

Regulatory Classification

Identification

A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

Predicate Devices

• Spirometrics Model 2600 Micro Spirometer (K901057)

Submission Summary (Full Text)

{0}

K963035

Micro

Direct

NOV - 1 1996

# Non-Confidential Summary of Safety and Effectiveness

August 1, 1996

page 1 of 2

Micro Direct, Inc.
840 Pownal Rd.
Auburn, ME 04210
Tel - [phone]
Fax - [phone]

Official contact: David R. Staszak, President

Proprietary or Trade Name: Micro Spirometer

Common/Usual Name: Diagnostic Spirometer

Classification Name: 73 BZG - Diagnostic Spirometer

Intended device: Diagnostic spirometer

Predicate devices: Spirometrics Model 2600 Micro Spirometer - K901057

Device description: A hand-held portable electronic spirometer measuring FEV1 and FVC.

## Indicated use:

The intended device takes spirometer readings of a patient during exhalation. The output readings are FEV1 and FVC.

## Targeted population:

Patients requiring lung function evaluations.

## Environment of use:

Places where a qualified clinician desires to take these lung measurements - FEV1 and FVC.

## Comparison to predicate devices:

| Attribute | Intended device | Spirometrics Model 2600 |
| --- | --- | --- |
| Use | | |
| Intended as a spirometer | Yes | Yes |
| Intended to measure lung function FEV1 and FVC | Yes | Yes |

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Micro Direct, Inc. • 840 Pownal Road • P. O. Box 239 • Auburn, ME 04212-0239

{1}

Non-Confidential Summary of Safety and Effectiveness
August 1, 1996
page 2 of 2

Comparison to predicate devices: (continued)

| Attribute | Intended device | Spirometrics Model 2600 |
| --- | --- | --- |
| Use (continued) | | |
| Indicated for measuring patients lung function | Yes | Yes |
| Indicated for use by a clinician in environments such as the home or hospital | Yes | Yes |
| Manufactured by Micro Medical | Yes | Yes |
| Exact same unit as supplied to and marketed by Spirometrics and approved under K901057 | Yes | -- |
| Design | | |
| Transducer - flow sensing turbine | Yes | Yes |
| No output | Yes | Yes |
| Flow range Ips BTPS 0-12 | Yes | Yes |
| Volume range liters 0-9.99 | Yes | Yes |
| Measures - FVC - FEV1 | Yes | Yes |
| Accuracy + / - 3 | Yes | Yes |
| Display LCD | Yes | Yes |
| Transducer cleaned after use | Yes | Yes |
| Utilizes paper mouthpiece | Yes | Yes |
| Materials | | |
| Same materials as K901057 | Yes | Yes |
| Performance Testing | | |
| None applicable | Yes | Yes |

## Differences

There is no difference between the intended device and the listed predicate device.

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