MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER

K961779 · Avion Medical Products, Inc. · BZH · Jun 13, 1997 · Anesthesiology

Device Facts

• Record ID: K961779
• Device Name: MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER
• Applicant: Avion Medical Products, Inc.
• Product Code: BZH · Anesthesiology
• Decision Date: Jun 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2

Indications for Use

Measures Peak Expiratory Flow Rate (PEFR) for people who have respiratory conditions such as asthma or emphysema.

Device Story

Mini-Bell Peak Flow Meter is a handheld device used to measure Peak Expiratory Flow Rate (PEFR). Operated by patients or clinicians in home or clinical settings. Device captures exhaled air flow; mechanical mechanism translates flow into a visual PEFR reading. Output allows patients and healthcare providers to monitor respiratory function, track disease progression, and assess effectiveness of asthma or emphysema management. Provides objective data for clinical decision-making regarding medication adjustments or emergency care.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Handheld mechanical peak flow meter. Measures PEFR via airflow displacement. No electronic components, software, or external power source required.

Indications for Use

Indicated for individuals with respiratory conditions, including asthma or emphysema, requiring measurement of 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 13 1997

Mr. Robert L. James
Avion Medical Products, Inc.
4361 Harvester Road, Unit 1
Burlington, Ontario, CANADA L7L 5M4

Re: K961779
Mini-Bell Peak Flow Meter
Regulatory Class: II (two)
Product Code: 73 BZH
Dated: April 2, 1997
Received: April 4, 1997

Dear Mr. James:

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 2 - 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. Robert L. James

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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510(k) Number (if known): K961779

Device Name: Mini-Bell Peak Flow Meter/Low Range Model Peak Flow Meter

Indications For Use:

Measures Peak Expiratory Flow Rate (PEFR) for people who have respiratory conditions such as asthma or emphysema.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Jo A Weetestouse

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K961779

Prescription Use ☐ OR Over-The-Counter Use ☑

(Per 21 CFR 801.109)

(Optional Format 1-2-96)