PEAK FLOW METER MINIMAX

K980443 · The D&T, Inc. · BZH · Apr 30, 1998 · Anesthesiology

Device Facts

• Record ID: K980443
• Device Name: PEAK FLOW METER MINIMAX
• Applicant: The D&T, Inc.
• Product Code: BZH · Anesthesiology
• Decision Date: Apr 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2

Intended Use

MINIMAX Peak Flow Meter is a portable device for measurement of peak expiratory flow rate (PEFR) for the evaluation of lung function of persons with asthma.

Device Story

The miniMAX Peak Flow Meter is a portable, handheld device used to measure peak expiratory flow rate (PEFR). It is intended for use by patients with asthma to monitor lung function. The device operates mechanically to measure the maximum speed of expiration. The patient exhales into the device, which provides a measurement of airflow. This output allows patients and healthcare providers to assess lung function and manage asthma symptoms. It is designed for both clinical and home use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable, handheld mechanical peak flow meter. Designed for measurement of peak expiratory flow rate (PEFR).

Indications for Use

Indicated for persons with asthma to evaluate lung function by measuring peak expiratory flow rate (PEFR).

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 1998

Mr. George Debush The D&T, Inc. 86 Bedford Avenue Hamden, CT 06517

Re: K980443 Peak Flow Meter "miniMAX" Regulatory Class: II (two) Product Code: 73 BZH January 19, 1998 Dated: Received: February 5, 1998

Dear Mr. Debush:

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, Druq, 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 requlations 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 current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requiation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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 requlations.

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## Page 2 - Mr. George Debush

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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral 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. Callehan

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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K480443/Ai

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K980443 510(k) NUMBER (IF KNOWN): Flow Meter "MINIMAX = Peak DEVICE NAME:

INDICATIONS FOR USE:

"MINIMAX" Peak Flow Meter is a portable device for measurement of peak expiratory flow rate (PEFR) for the evaluation of lung function of persons with asthma.

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Concurrence of CDRH, Office of Dea

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices

Prescription Use
(Per 21 CFR 801.109)
510(k) Numberver-The-Counter-use
OR
(Optional Format 1-2-96)