PEAK FLOW METER

K970507 · Intl. Medical, Inc. · BZH · Jun 13, 1997 · Anesthesiology

Device Facts

• Record ID: K970507
• Device Name: PEAK FLOW METER
• Applicant: Intl. Medical, Inc.
• Product Code: BZH · Anesthesiology
• Decision Date: Jun 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2

Intended Use

The intended use of IMI Peak Flow Meter is for Hospital Respiratory Therapy Departments, and home monitoring used by the Asthma patient as prescribed by the physician. The device is for single patient use. However, the home patient can reuse the instrument himself after cleaning. The device is non-sterile. The device is for prescription use. See package label under Section 3, page 4. The device is not MRI compatible.

Device Story

IMI Peak Flow Meter is a handheld, non-sterile, prescription-only device used to measure peak expiratory flow. Designed for hospital respiratory therapy departments and home monitoring by asthma patients. Patient exhales into the device; mechanical mechanism measures airflow; output displayed on integrated scale. Used by patients for self-monitoring to track respiratory status; healthcare providers use data to assess asthma control and adjust treatment plans. Device is single-patient use; reusable by the same patient following cleaning. Not MRI compatible.

Technological Characteristics

Handheld mechanical peak flow meter. Non-sterile. Single-patient use, reusable by same patient. Not MRI compatible.

Indications for Use

Indicated for asthma patients in hospital respiratory therapy departments or home settings for monitoring peak expiratory flow as prescribed by a physician.

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
Focd and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 13

Mr. Warren V. Bigelow
International Medical, Inc.
14470 Burnsville Parkway
Burnsville, Minnesota 55337

Re: K970507
IMI Peak Flow Meter
Regulatory Class: II (two)
Product Code: 73 BZH
Dated: May 8, 1997
Received: May 12, 1997

Dear Mr. Bigelow:

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. Warren V. Bigelow

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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SECTION 3, STATEMENT OF INTENDED USE

The intended use of IMI Peak Flow Meter is for Hospital Respiratory Therapy Departments, and home monitoring used by the Asthma patient as prescribed by the physician. The device is for single patient use. However, the home patient can reuse the instrument himself after cleaning. The device is non-sterile. The device is for prescription use. See package label under Section 3, page 4. The device is not MRI compatible.


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

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