The DynamiPeak™ Peak Flow Meter is designed as a single-patient use device to measure the Peak Expiratory Flow Rate (PEFR). The device is intended for use by children to adults.

Device Description

The DynamiPeak™ Peak Flow Meter is a simple mechanical device that responds to and indicates the peak expiratory flow rate (PEFR) generated by the user during a forced exhalation maneuver. The inlet of the device is placed into the user's mouth after which the maximum rate at exhalation is attempted from nearly full lungs. As this forced exhalation commences, and internal piston extends a spring as it reacts to an internal pressure spike. An indicator is pushed by the moving piston and remains at the maximum displacement position of the piston after the maneuver is terminated. This position corresponds to the PEFR and is quantified in liters per minute by reading a scale next to the indicator. The piston displacement function is logarithmic, thereby providing greater resolution of the scale at lower PEFR readings.

AI/ML Overview

The provided text is for a 510(k) premarket notification for a medical device, the "DynamiPeak™ Peak Flow Meter," and its acceptance by the FDA. It does not describe a study for a device meeting acceptance criteria in the way a clinical trial or algorithm validation study would. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory approval.

Therefore, many of the requested elements for a study proving device acceptance criteria cannot be extracted because such a study, with distinct acceptance criteria for performance metrics, ground truth, and expert evaluation, is not presented in this document.

However, I can extract the available information related to the device and its regulatory acceptance.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" that the DynamiPeak™ Peak Flow Meter had to meet from a specific performance study. Instead, the basis for acceptance is stated as substantial equivalence to predicate devices. The "reported device performance" is broadly described as functioning adequately and effectively.

Acceptance Criteria (Inferred from Substantial Equivalence and Standards)	Reported Device Performance (from document)
General
Functional Equivalence to Predicate Devices	Both devices (DynamiPeak™ and MICROPEAK) function adequately as peak flow meters (4.7.3) and have been demonstrated to function effectively in measuring patients' peak expiratory flow rates (4.7.5).
Meeting ATS Standardization of Spirometry Recommendations	The devices meet the recommendations of the American Thoracic Society's Standardization of Spirometry (4.7.6).
Design/Manufacturing Equivalence
Same Design Specifications	DynamiPeak™ and MICROPEAK share the same design specifications (4.8.1).
Fabricated from Same Materials	DynamiPeak™ and MICROPEAK are fabricated from the same materials (4.8.1).
Manufactured by Same Contract Supplier	DynamiPeak™ and MICROPEAK are manufactured by the same contract manufacturing supplier (Fyne Dynamics, Ltd., UK) (4.7.1.1, 4.8.1).
Substantially Equivalent Components	Assembled from substantially equivalent components and raw materials (4.7.1.2, 4.7.1.3).
Intended Use Equivalence
Same Indications for Use as Predicates	The DynamiPeak™ Peak Flow Meter has the same indications for use as the predicate devices (4.8.2). Intended as a single-patient use device to measure PEFR for children to adults (4.6, Indications for Use Statement).
Mechanism of Action Equivalence
Simple Mechanical Device Indicating PEFR	Both DynamiPeak™ and predicate devices are simple mechanical devices that respond to and indicate the peak expiratory flow rate (PEFR) generated by a patient during a forced exhalation maneuver (4.8.3, 4.8.4).
Validation/Verification
Undergone and Passed Equivalent Clinical Testing Criteria	Have undergone and have passed substantially equivalent clinical testing criteria (4.7.1.5).

1. A table of acceptance criteria and the reported device performance:
(See table above)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document states that the devices (DynamiPeak™ and MICROPEAK) "have under gone and have passed substantially equivalent clinical testing criteria" (4.7.1.5). However, no details about a specific sample size for a test set, data provenance, or retrospective/prospective nature of this "clinical testing" are provided in the document. The focus is on the equivalence of testing, not the specifics of the test itself for the DynamiPeak™ device. Given the context of a peak flow meter, this "testing" likely refers to engineering performance validation against standards rather than patient data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. The document does not describe a study involving expert-established ground truth for performance. The "ground truth" for a peak flow meter would be its accurate measurement of airflow against a calibrated standard, not an expert assessment of a medical image or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method is described as this is not a study focused on subjective expert assessment or diagnosis.

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 mechanical peak flow meter, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a standalone mechanical instrument; there is no "algorithm" in the sense of software for analysis being evaluated. Its performance is inherently "standalone" as it mechanically measures PEFR.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The document does not explicitly state the "ground truth" used for any specific testing of the DynamiPeak™ device. However, regulatory acceptance for peak flow meters typically relies on calibration against known flow rates (e.g., using a spirometer or flow simulator) to ensure accuracy, and adherence to recognized industry standards such as those from the American Thoracic Society (ATS) (4.7.6). This would be the implied "ground truth" for its function.

8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning or AI device that requires a training set.

Summary

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page 1 of 5

MAR 1 0 2009

4.0 510(k) SUMMARY:

In accordance with 21 CFR Section 807.92, DynamiTech Medical, Inc. is submitting the following 510(k) summary:

4.1 Submitter Information:

DynamiTech Medical, Inc. Company Representative: John Snobarger, President 1307 Suffolk Street Bakersfield, CA 93312 USA FDA Registration No .: 3007102815 Owner / Operator No .: 10026476

Preparer of Submission and Contact for Information: 4.2

4.2.1 Solutions MDI, Inc.

Gus Bock, Managing Director 26847 Chamomile Street Murrieta, CA 92562 Telephone: (909) 641-2203

4.2.2 Keith Lowrey, Partner & Consultant (contact for correspondence and information) 611 South Schoolhouse Creek Rd. Grants Pass, OR 97526 Telephone: (541) 476-1628 / Cell: (805) 403-6977

4.3 Name of Device:

Proprietary Name:	DynamiPeak™ Peak Flow Meter
Common Name:	Peak Flow Meter.
Classification Name:	Peak Flow Meter for Spirometry.

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Regulation Number:	21, CFR 868.1860.
Product Code:	BZH
Class:	Class II (performance standards)

4.4 Substantial Equivalence:

This submission establishes the substantial equivalence of the DynamiTech Medical, Inc. DynamiPeak™ Peak Flow Meter to five predicate devices:

(1) Micro Direct, Inc., MICROPEAK Peak Flow Meter, K030586, SE Date: 08/27/2003.
(2) Monaghan Medical Corp., TRUPEAK Peak Flow Meter, K963095, SE Date: 11/04/1996.
(3) Galemed Corp., GALEMED Peak Flow Meter, Models 3754/3752, SE Date: 04/03/2003.
(4) Monaghan Medical Corp., TRUPEAK Peak Flow Meter, K955234, SE Date: 11/14/1996.
(5) Vitalograph Ltd., PULMONARY MONITOR, K781922, SE Date: 02/13/1979.

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4.5 Description of the Device:

The DynamiPeak™ Peak Flow Meter is a simple mechanical device that responds to and indicates the peak expiratory flow rate (PEFR) generated by the user during a forced exhalation maneuver.

The inlet of the device is placed into the user's mouth after which the maximum rate at exhalation is attempted from nearly full lungs. As this forced exhalation commences, and internal piston extends a spring as it reacts to an internal pressure spike. An indicator is pushed by the moving piston and remains at the maximum displacement position of the piston after the maneuver is terminated. This position corresponds to the PEFR and is quantified in liters per minute by reading a scale next to the indicator. The piston displacement function is logarithmic, thereby providing greater resolution of the scale at lower PEFR readings.

Image /page/2/Picture/4 description: The image shows the DynamiPEAK device and its technical specifications. The range of the device is 60-900 l/mn, and the scale increment is 10 l/mn. The device is made from medical-grade polymers and stainless steel for durability and accuracy. The device comes complete with a detachable mouthpiece, a one-month peak flow chart, and instructions for use.

0013A (revised 02/03/2009)

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Intended Use of the Device: 4.6

The DynamiPeak™ Peak Flow Meter is designed as a single-patient use device to measure the Peak Expiratory Flow Rate (PEFR). Device is intended for use by children to Adults.

4.7 Technological Characteristics in Comparison to the Predicates:

The DynamiPeak™ Peak Flow Meter is substantially equivalent to the predicate device, Micro Direct, Inc., MICROPEAK Peak Flow Meter with respect to all of the following design characteristics and functions:

4.7.1 Although labeled differently with their respective "final manufacturer and distributor" names, both the DynamiPeak™ Peak Flow Meter and the MICROPEAK Peak Flow Meter.
- 4.7.1.1 Are fabricated by the same contract supplier, Fyne Dynamics, Ltd., a manufacturer of peak flow meters in the UK. Fyne Dynamics, Ltd. manufactures the Pinnacle Peak Flow Meter (P/N 72000) which is not marketed in the U.S. Both the DynamiPeak™ Peak Flow Meter and the MICROPEAK Peak Flow Meter are substantially equivalent to the Pinnacle Peak Flow Meter.
- Are assembled from substantially equivalent components. 4.7.1.2
- 4.7.1.3 Are assembled from substantially equivalent components fabricated from substantially equivalent raw materials.
- 4.7.1.4 Have substantially equivalent design specifications which have been validated and verified.
- 4.7.1.5 Have under gone and have passed substantially equivalent clinical testing criteria.
4.7.2 Both devices are intended for use as a single-patient use device to measure the Peak Expiratory Flow Rate (PEFR) of a patient with Asthma or other lung disease. The PEFR is a recognized value of lung function and changes in PEFR assist patient in managing asthma and lung disease and provides information for patient to reference physician instructions on medication and other actions in plan based on changes.
4.7.3 The devices both function adequately as peak flow meters.

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The devices have been demonstrated to function effectively in measuring 4.7.5 patients' peak expiratory flow rates
4.7.6 The devices meet the recommendations of the American Thoracic Society's Standardization of Spirometry.

4.8 Conclusions drawn from the Non-Clinical Tests:

Data provided in this submission indicate that the basic functional characteristics of the DynamiPeak™Peak Flow Meter are substantially equivalent to those of the predicate devices.

4.8.1 The DynamiPeak™Peak Flow Meter and the MICROPEAK Peak Flow Meter share the same design specifications, fabricated from the same materials, and are manufactured by the same contract manufacturing supplier.
4.8.2 The DynamiPeak™Peak Flow Meter has the same indications for use as the predicate devices.
4.8.3 The DynamiPeak™Peak Flow Meter and predicate device are both simple mechanical devices that respond to and indicate the peak expiratory flow rate (PEFR) generated by the patient during a forced exhalation maneuver.
4.8.4 The DynamiPeak™Peak Flow Meter and predicate devices are designed with inlets that are placed into the patient's mouth. The patient attempts maximum the maximum rate of exhalation from nearly full lungs. As this forced exhalation commences, an internal piston extends an indicator which is pushed by the moving piston and remains at the piston's maximum displacement position after the exhalation is completed. This position corresponds to the PEFR and is quantified in liters per minute which is indicated by a scale on the side of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with outstretched wings, symbolizing the department's mission to protect and promote the health and well-being of Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Public Health Service

MAR 1 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DynamiTech Medical, Incorporated C/o Mr. Keith Lowrey Partner and Consultant Solutions MDI, Incorporated Pacific Northwest Branch 611 South Schoolhouse Creek Road Grants Pass, Oregon 97526

Re: K082899

Trade/Device Name: DynamicPeak™ Peak Flow Meter Regulation Number: 21 CFR 868.1860 Regulation Name: Peak-Flow Meter for Spirometry Regulatory Class: II Product Code: BZH Dated: March 3, 2009 Received: March 5, 2009

Dear Mr. Lowrey:

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. Lowrey

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) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Syrite Y. Michael Omd.

Ginette Y. Michaud, M.D. Acting 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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INDICATIONS FOR USE STATEMENT

510(k) Number: K082899

Device Name: DynamiPeak™ Peak Flow Meter

Indications for Use:

The DynamiPeak™ Peak Flow Meter is designed as a single-patient use device to measure the Peak Expiratory Flow Rate (PEFR). The device is intended for use by children to adults.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Gunser

0009B (revised 03/09/2009)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Numb

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).