MODIFICATION TO TRUZONE PEAK FLOW METER by MONAGHAN MEDICAL CORP.

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 Description

TruZone™ Peak Flow Meter

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the TruZone™ Peak Flow Meter. It describes the device and its indications for use, but it does not contain a detailed study report or acceptance criteria for the device's performance. The letter itself states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than a presentation of new performance data against specific acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided document. I can, however, extract the device name and indications for use.

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.

Missing Information (Not available in the provided text):

A table of acceptance criteria and the reported device performance: This information is not present in the FDA clearance letter. Such data would typically be found in a separate study report or a detailed section of the 510(k) submission itself.
Sample size used for the test set and the data provenance: Not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
Adjudication method for the test set: Not provided.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable as this is a peak flow meter, not an AI-assisted diagnostic tool. No MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical measurement device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
The sample size for the training set: Not applicable, as this is a physical measurement device, not a machine learning model.
How the ground truth for the training set was established: Not applicable.

Summary

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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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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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Page 1 of 1

510(k) Number (if known):	K991212
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Device Name: __ TruZone™ Peak Flow Meter _____________________________________________________________________________________________________________________________________

Indications for Use:

(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_

Regulation Number and Section

§ 868.1860 Peak-flow meter for spirometry.

(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).