MODIFICATION TO TRUZONE PEAK FLOW METER

K991212 · Monaghan Medical Corp. · BZH · Jul 1, 1999 · Anesthesiology

Device Facts

• Record ID: K991212
• Device Name: MODIFICATION TO TRUZONE PEAK FLOW METER
• Applicant: Monaghan Medical Corp.
• Product Code: BZH · Anesthesiology
• Decision Date: Jul 1, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.1860
• Device Class: Class 2

Intended Use

Portable monitoring device which measures the peak expiratory flow (PEF) generated by the patient during a forced exhalation maneuver. This measurement is useful in detecting changes in airways that could signal a worsening of symptoms or an improvement in breathing function for people with respiratory conditions such as Asthma or emphysema.

Device Story

TruZone Peak Flow Meter is a portable device for measuring peak expiratory flow (PEF) during forced exhalation. Used by patients with respiratory conditions like asthma or emphysema to monitor airway function. Device captures expiratory airflow; provides quantitative PEF measurement. Helps patients and clinicians track changes in breathing, signaling symptom worsening or improvement. Operates as a mechanical monitoring tool for respiratory assessment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable mechanical peak flow meter designed for measuring peak expiratory flow (PEF). Device is a standalone, non-powered, handheld instrument.

Indications for Use

Indicated for patients with respiratory conditions, including asthma or emphysema, requiring monitoring of peak expiratory flow (PEF) to detect changes in airway function.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 1 1999

Mr. James A. Cochie Monaghan Medical Corporation 5 Latour Avenue, Suite 1600 P.O. Box 2805 Plattsburgh, NY 12901-0299

K991212 Re: TruZone™ Peak Flow Meter Requlatory Class: II (two) Product Code: 73 BZH Dated: April 6, 1999 Received: April 9, 1999

Dear Mr. Cochie:

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 leqally marketed predicate 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 regulation (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 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. James A. Cochie

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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. ( allahan, 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): | K991212 |
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Device Name: __ TruZone™ Peak Flow Meter _____________________________________________________________________________________________________________________________________

Indications for Use:

Portable monitoring device which measures the peak expiratory flow (PEF) generated by the patient during a forced exhalation maneuver. This measurement is useful in detecting changes in airways that could signal a worsening of symptoms or an improvement in breathing function for people with 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)

Atl. A. Ciarkowski.

(Division Sign-Off) Division of Cardiovascular, Re and Neurological Devi 510(k) Number

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use_

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