The Strive™ Dual Zone PFM is a monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation maneuver. The device will monitor the PEF of patients whose doses of medication are dependent upon a measured obstruction in PEF.

The Strive™ Peak Flow Meter is designed for children five years or older and adults. The intended environments for use include home, hospitals and clinics.

Device Description

The Strive™ Dual Zone Peak Flow Meter (PFM) is a hand-held monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation mancuver. It can be used to objectively measure PEF by tracking day-to-day changes in breathing patterns.

The Strive™ PFM meets the Standards of Spirometry, 2005 revision, for portable peak flow meters as established by the American Thoracic Society and also meets ISO23747, First edition 2007-07-15, for Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans. The Strive™ PFM and product insert meets the educational guidelines recommended by the National Asthma Educational Prevention Program (NAEPP) of the National Institutes of Health.

The Strive™ PFM has two scale ranges to make the device suitable for both pediatric (+5 yrs) and adult patients who use a peak flow meter as part of their treatment program for respiratory conditions. A range selector is used to select the scale that best fits the patient's needs as determined by a healthcare provider. The device incorporates the NAEPP three zone color codes. The color-coded zone indicators on the side of the device adjust to define the patient's red, yellow and green zones. They can be readjusted as recommended by a healthcare provider.

AI/ML Overview

The provided text describes a 510(k) summary for the Strive™ Dual Zone Peak Flow Meter (PFM). It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific acceptance criteria through clinical trials. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance and AI-specific metrics is not available in the provided document.

However, based on the non-clinical testing sections, we can infer the acceptance criteria for performance and the type of evaluation conducted.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Functional Performance:
- Conformance to ATS Standard of Spirometry: 2005	The Strive™ Dual Zone PFM was tested for performance, including Functional testing per the American Thoracic Society (ATS) Standard of Spirometry: 2005. The Strive™ Dual Zone PFM meets the same ATS standard as the predicate device, the TruZone® PFM.
- Conformance to ISO 23747 International Standard (First edition 2007-07-15) for peak expiratory flow meters	The Strive™ Dual Zone PFM was tested for performance, including ISO 23747 International Standard for peak expiratory meter. The Strive™ PFM meets ISO23747, First edition 2007-07-15, for Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans.
- Improved accuracy at low flow-rates (compared to predicate)	The Strive™ PFM has improved accuracy at low flow-rates. (This is a design improvement, not a specific quantifiable acceptance criterion with a numerical value in the document, but it's stated as a characteristic.)
Environmental Performance:	Environmental Testing was conducted. (No specific results or acceptance criteria are detailed, but the conclusion states it "meets performance requirements.")
Operational Performance:	Operational Testing was conducted. (No specific results or acceptance criteria are detailed, but the conclusion states it "meets performance requirements.")
Mechanical Life Cycle:	Mechanical Life Cycle testing was conducted. (No specific results or acceptance criteria are detailed, but the conclusion states it "meets performance requirements.")
Comparison to Predicate Device (TruZone® PFM):	All other testing (beyond ATS standard) was found to be comparable to the TruZone® PFM. The Strive™ Dual Zone PFM has the same function and intended use as the predicate device, TruZone® PFM. The Strive™ Dual Zone PFM meets the same ATS standard as the predicate device, the TruZone® PFM.
Safety and Effectiveness:	The Strive™ Dual Zone PFM ... raises no new issues of safety or effectiveness. (This is the overarching conclusion required for 510(k) clearance, implying that all tests met criteria such that safety and effectiveness are maintained, and it is substantially equivalent to the predicate.)

2. Sample size used for the test set and the data provenance

The document describes non-clinical performance and functional testing against established standards (ATS, ISO 23747). It does not mention a "test set" in the context of clinical data or patient samples. The testing would have involved physical units of the Strive™ Dual Zone PFM and potentially simulated exhalation profiles, as per the standards. Specific sample sizes of devices or simulated breath cycles for these non-clinical tests are not provided in this summary. There is no data provenance in terms of country of origin or retrospective/prospective for clinical data, as no clinical study was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical expert-based ground truth was established for a "test set" as no clinical study was conducted. The "ground truth" for the non-clinical tests would be the specifications and requirements defined by the ATS and ISO standards.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication was used.

5. 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. This device is a physical medical device (peak flow meter) and does not involve AI or human readers for diagnostic interpretation. Therefore, no MRMC study or AI-assisted improvement analysis was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device and does not involve an algorithm for standalone performance evaluation in the context of AI. Its "standalone performance" is its accuracy and reliability in measuring PEF, which was evaluated against the ATS and ISO standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical and functional testing, the "ground truth" was established by recognized industry and medical standards: the American Thoracic Society (ATS) Standard of Spirometry: 2005 and ISO 23747 International Standard. These standards define the acceptable range of accuracy and performance for peak flow meters.

8. The sample size for the training set

Not applicable. This device is a physical medical device and does not involve machine learning or AI models, so there is no training set in that context.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for AI/machine learning, this question is not relevant.

Summary

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K123945

APR 1 7 2013

510(k) SUMMARY

· Date Prepared: March 12, 2013

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.

1. Submitter Information

Name:	Monaghan Medical Corporation
Address:	5 Latour Avenue; Suite 1600Plattsburgh, New York 12901
Telephone#:	518-561-7330
Fax#:	518-561-5660
Contact Person:	Cari J. ReilRegulatory Affairs Manager

Device Information Device Trade Name: Common Name: Classification Name: Classification Number: Classification Product Code:

Strive™ Dual Zone Peak Flow Meter Peak Flow Meter Peak-flow meter for spirometry 868.1860 BZH

1. Legally Marketed Predicate Device

Device Trade Name:	TruZone® Peak Flow Meter
510(k) Number:	K023097
Manufacturer:	Monaghan Medical Corporation

Device Description

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5. Intended Use

The Strive™ Peak Flow Meter is designed for children five years or older and adults. The intended environments for use include home, hospitals and clinics.

6. Technological Characteristics

The Strive™ Dual Zone PFM has the same function and intended use as the predicate device, TruZone® PFM.

The Strive™ PFM is a dual zone device suitable for both pediatric (5+ years) and adult patients who use a PFM as part of their treatment program. It has improved accuracy at low flow-rates.

The device has color-coded zone markers that can be adjusted by the patient so readings can be taken quickly and easily and can be readjusted as recommended by their healthcare provider.

The Strive™ Dual Zone PFM has an ergonomically shaped mouthpiece to assist in creating a secure seal and has an optional disposable mouthpiece with one-way valve for clinical applications.

7. Non-Clinical Test Summary

The Strive™ Dual Zone PFM was tested for performance, including: Functional testing per the American Thoracic Society (ATS) Standard of Spirometry: 2005, ISO 23747 International Standard for peak expiratory meter, Environmental Testing, Operational Testing, Mechanical Life Cycle.

The Strive™ Dual Zone PFM meets the same ATS standard as the predicate device, the TruZone® PFM. All other testing was found to be comparable to the TruZone® PFM.

8. Clinical Performance Summary

Clinical testing was not completed as it is not required to show substantial equivalence.

9. Conclusions

The Strive™ Dual Zone PFM meets performance requirements and raises no new issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design with three wavy lines emanating from a central point. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 17, 2013

Mr. Carl J. Reil Regulatory Affairs Manager Monaghan Medical Corporation 5 Latour Avenue, Suite 1600 PLATTABURGH NY 12901

Re: K123945

Trade/Device Name: Strive™ Dual Zone Peak Flow Meter (PFM) Regulation Number: 21 CFR 868.1860 Regulation Name: Peak-Flow Meter for Spirometry Regulatory Class: II Product Code: BZH Dated: March 12, 2013 Received: March 18, 2013

Dear Mr. Reil:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note

the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kwame O. Ulme
-S FDA

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the word "monaghan" in a bold, sans-serif font. To the left of the word is a circular logo. The logo contains a stylized letter "M" inside the circle, with the word "monaghan" written around the inside of the circle.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K123945

Strive™ Dual Zone Peak Flow Meter (PFM) Device Name:

Indications for Use:

The Strive™ Peak Flow Meter is designed for children five years or older and adults. The intended environments for use include home, hospitals and clinics.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
	Albert EMoyal -SFIL c=US, o=U.S. Government, ou=HHS; ou=FDA, ou=People, 0.9.2342:19200300.100.1.1=1300 059331; cn=Albert E. Moyal -S 2013.04.17 12:31:33 -04'00' (for LS)
(Division Sign-Off)
Division of Anestheslology, General HospitalInfection Control, Dental Devices
510(k) Number:	K123945

Prescription Use
✓
or
Over-The-Counter Use

(Per 21 CFR 801.109)

Monaghan Medical Corporation · 5 Latour Avenue, Suite 1600 · Platisburgh, NY 12901 · Toll Free 800-833-9853 · Fax 518-561-5088 · www.monaghanmed.com

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).