MICRODL DIARYCARD SPIROMETER

K965042 · Micro Direct, Inc. · BZG · Jun 17, 1997 · Anesthesiology

Device Facts

• Record ID: K965042
• Device Name: MICRODL DIARYCARD SPIROMETER
• Applicant: Micro Direct, Inc.
• Product Code: BZG · Anesthesiology
• Decision Date: Jun 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2

Intended Use

To measure lung functions - FEV1, FVC, and PEF and to effect historical serial transfer of measured test indices to PC compatible computers

Device Story

MicroDL DiaryCard Spirometer is a hand-held portable electronic device for measuring lung function. It utilizes a flow-sensing turbine transducer to capture patient exhalation data. The device calculates FEV1, FVC, and PEF parameters. It features an LCD display for immediate results and internal memory for storing test values for later review. Data can be transferred to PC-compatible computers via an RS232 interface. Used by clinicians in environments such as hospitals or clinics to evaluate patient lung function. The device uses disposable paper mouthpieces and requires the transducer to be cleaned after use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hand-held electronic spirometer; flow-sensing turbine transducer; flow range 0-12 L/s BTPS; volume range 0-9.99 liters; accuracy +/- 3%; LCD display; RS232 connectivity; uses paper mouthpieces; materials identical to predicate K963035.

Indications for Use

Indicated for patients requiring lung function measurements (FEV1, FVC, PEF) in clinical settings where a qualified clinician performs the evaluation.

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

• Micro Medical Micro Spirometer (K963035)

Submission Summary (Full Text)

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K965042

JUN 17 1997

Non-Confidential Summary of Safety and Effectiveness
December 15, 1996
page 1 of 2

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

Official contact: David R. Staszak, President
Proprietary or Trade Name: MicroDL DiaryCard Spirometer
Common/Usual Name: Diagnostic Spirometer
Classification Name: 73 BZG - Diagnostic Spirometer
Intended device: Diagnostic Spirometer
Predicate devices: Micro Medical Micro Spirometer - K963035
Device description: A hand-held portable electronic spirometer measuring FEV1, FVC, and PEF.

## Indicated use:

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

## Targeted population:

Patients requiring lung function evaluations.

## Environment of use:

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

## Comparison to predicate devices:

| Attribute | Intended device | Micro Medical Micro Spirometer |
| --- | --- | --- |
| Use | Yes | Yes |
| Intended as a spirometer | | |
| Intended to measure lung function FEV1, FVC, and PEF | Yes | FEV1 and FVC |

page 3 of 44

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page 2 of 2
Non-Confidential Summary of Safety and Effectiveness
December 15, 1996

Comparison to predicate devices (continued)

| Attribute | Intended device | Micro Medical Micro Spirometer |
| --- | --- | --- |
| 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 |
| Design | | |
| Transducer - flow sensing turbine | Yes | Yes |
| Output | RS232 | No |
| Flow range LPs BTPS 0-12 | Yes | Yes |
| Volume range liters 0-9.99 | Yes | Yes |
| Test Parameters | FEV1, FVC, PEF | FEV1, FVC |
| Accuracy +/- 3 | Yes | Yes |
| Display LCD | Yes | Yes |
| Transducer cleaned after use | Yes | Yes |
| Utilizes paper mouthpiece | Yes | Yes |
| Materials | | |
| Same materials as K963035 | Yes | Yes |
| Performance Testing | | |
| None applicable | Yes | Yes |

## Differences

The only differences are the addition of the displayed test parameter of PEF (Peak Expired Flow) and the ability to retain the test values in memory for later review.

page 4 of 44

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 17 1997

Mr. David R. Staszak
Micro Direct, Inc.
840 Pownal Road
P.O. Box 239
Auburn, Maine 04212-0239

Re: K965042
MicroDL DiaryCard Spirometer
Regulatory Class: II (two)
Product Code: 73 BZG
Dated: March 17, 1997
Received: March 19, 1997

Dear Mr. Staszak:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. David R. Staszak

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular,
Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number K965042 (To be assigned)

Device Name: MicroDL DiaryCard Spirometer

Indications for Use: To measure lung functions - FEV₁, FVC, and PEF and to effect historical serial transfer of measured test indices to PC compatible computers

Targeted population: Patients requiring lung function measurements

Environment of use: Places where a qualified clinician desires to take these lung measurements - FEV₁, FVC, and PEF.

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use