MODIFICATION TO TRUPEAK PEAK FLOW METER by MONAGHAN MEDICAL CORP.

The TruPeak® 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 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 Description

The TruPeak® 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.

AI/ML Overview

The provided document is a 510(k) premarket notification letter for the TRUPEAK Peak Flow Meter. It is a regulatory approval document from the FDA and does not contain the detailed study information or acceptance criteria requested in the prompt.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulatory classifications, general controls, and compliance requirements, but it does not include performance data, study design, or ground truth establishment.

Therefore, I cannot extract the following information from the provided text:

A table of acceptance criteria and the reported device performance: This information is not present.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
If a standalone study was done: Not mentioned.
The type of ground truth used: Not mentioned.
The sample size for the training set: Not mentioned (as this is a medical device, not an AI/ML model, training sets are not typically applicable in the same way).
How the ground truth for the training set was established: Not mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2003

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

Re: K031514

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Trade/Device Name: TRUPEAK Peak Flow Meter Regulation Number: 868.1860 Regulation Name: Peak Flow Meter for Spirometry Regulatory Class: II Product Code: BZH Dated: May 9, 2003 Received: May 14, 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 (OS) 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) i 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), please contact the Office of Compliance at (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Suser Runre

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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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:

Indications for Use:

The TruPeak® 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. t This measurement is useful in detecting changes 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


	(Division Sign-Off)
	Division of Anesthesiology, General Hospital,
	Infection Control, Dental Devices
510(k) Number:	K031514
Prescription Use(Per 21 CFR 801.109)	or 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).