TRUEZONE PEAK FLOW METER

K023097 · Monaghan Medical Corp. · BZH · Mar 7, 2003 · Anesthesiology

Device Facts

• Record ID: K023097
• Device Name: TRUEZONE PEAK FLOW METER
• Applicant: Monaghan Medical Corp.
• Product Code: BZH · Anesthesiology
• Decision Date: Mar 7, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.1860
• Device Class: Class 2

Intended Use

The TruZone™ Peak Flow Meter (PFM) is a portable monitoring device that measures the peak expiratory flow (PEF) generated by a 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 and emphysema. This device is packaged and labeled so it can be used as a screening device in a hospital or other clinical setting. Labeling is also included for the use of the device if dispensed by a health care provider to a patient for personal use.

Device Story

TruZone Peak Flow Meter is a portable, handheld device for measuring peak expiratory flow (PEF). Patient performs forced exhalation maneuver into device; device captures airflow data to provide objective PEF measurement. Used in clinical settings for screening or by patients at home for monitoring respiratory conditions like asthma and emphysema. Output allows healthcare providers and patients to track airway changes, assess symptom worsening or improvement, and guide clinical decision-making regarding respiratory management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable, handheld peak flow meter. Mechanical measurement of peak expiratory flow. No electronic components, software, or external power source described.

Indications for Use

Indicated for patients with respiratory conditions, including asthma and emphysema, to monitor peak expiratory flow (PEF) during forced exhalation. Suitable for use in clinical settings or by patients for personal use when dispensed by a healthcare provider.

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

MAR 0 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James A. Cochie Regulatory Affairs Manager Monaghan Medical Corporation 5 Latour Avenue, Suite 1600 P.O. Box 2805 Plattsburgh, New York 12901-0299

Re: K023097

Trade/Device Name: TrueZone Peak Flow Meter™ Regulation Number: 868.1860 Regulation Name: Peak-flow Meter for Spirometry Regulatory Class: II Product Code: BZH Dated: January 8, 2003 Received: January 13, 2003

Dear Mr. Cochie:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Cochie

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runoer

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K023097 510(k) Number (if known):

TruZone™ Peak Flow Meter Device Name:

Indications for Use:

The TruZone™ Peak Flow Meter (PFM) is a portable monitoring device that measures the peak expiratory flow (PEF) generated by a 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 and emphysema.

This device is packaged and labeled so it can be used as a screening device in a hospital or other clinical setting. Labeling is also included for the use of the device if dispensed by a health care provider to a patient for personal use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

or

Over-The-Counter Use

F. Adnan

510(k) Numbe