Peak.me is intended for monitoring FEVI (Forced exhalation in the first second) and PEF (peak expiratory flow) for home use. The device is designed for adult users and pediatric children over 5 years of age with caregiver supervision. Peak.me is not recommended for children under 5 years of age.

Device Description

Peak.me is a hand-held Peak Flow Meter device that is intended for monitoring FEV1 (forced exhalation in the first second) and PEF (peak expiratory flow) for home use. The device is designed for pediatric to adult users. Peak.me is not recommended for children under 5 years of age.

Peak.me consists of a mechanical unit, which physically attaches to the user's smartphone, and a software application which analyzes the measurements and serves as a disease management platform. The device uses the smartphone's internal upper microphone as a sensor and does not include any electrical parts.

As the user exhales through the mechanical unit, it produces acoustic waves with a frequency proportional to the exhalation airflow rate, which then propagates to the smartphone's internal upper microphone.

Peak.me software application analyzes the sound and displays the results. Furthermore, the application includes a review of past measurements. It enables manual input of symptoms and medication usage and provides guidance for correct usage and more.

AI/ML Overview

The provided text describes the 510(k) summary for the "Peak.me" device, a peak-flow meter for spirometry. The document focuses on demonstrating substantial equivalence to a predicate device ("Wing Smart FEV1 and Peak Flow Meter," K152276) rather than a comprehensive de novo validation study. Therefore, some of the requested information regarding detailed study methodology (e.g., sample size for training set, number of experts for ground truth, adjudication methods, MRMC studies) is not explicitly present.

However, based on the provided text, here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Peak.me device are primarily based on the American Thoracic Society (ATS) Standardization of Spirometry, 1994 Update for accuracy and precision.

Acceptance Criteria (from ATS Standardization of Spirometry, 1994 Update)	Reported Device Performance (from "Performance Data" section)
FEV1 (Forced Expiratory Volume in 1 second) Accuracy	± 0.1 L or ± 5%
PEF (Peak Expiratory Flow) Accuracy	± 20 L/min or ± 10%
Resistance Requirements	Validation that the device meets the Resistance requirements according to the ATS Standardization of Spirometry, 1994 Update. (No specific numerical value provided, but performance is stated as meeting the standard)
Lifetime Validation	Validation of Peak.me lifetime. (No specific numerical value or duration provided, but validation was performed)
Background Noise Validation	Validation of Peak.me's accuracy in the presence of potentially disruptive noises. (No specific numerical value provided, but performance is stated as accurate)
Drop Test Validation	Essential performance tests were conducted following drop test according to IEC 60601-1. The tests were passed successfully. (No specific pass/fail criteria or numerical results provided beyond "passed successfully")

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not explicitly state a specific "test set" sample size for either the accuracy/precision validation or the other performance tests. The performance data section broadly indicates that "Lab performance tests, design validation and software verification and validation tests were conducted."
Data Provenance: The studies were laboratory-based performance tests, not clinical studies involving patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable. The device validation included testing with specific smartphone models: Samsung Galaxy S6, Samsung Galaxy S6 edge, Samsung Galaxy S7, and Samsung Galaxy S7 edge.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The performance data describes lab tests against a known standard (ATS 1994 Update), which would typically be measured using calibrated equipment rather than expert consensus on medical images or patient data.

4. Adjudication Method for the Test Set

This information is not provided as the device's validation was based on objective performance measurements against a standard, not expert review or adjudication of data points.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "No clinical study was conducted. Peak.me has the same intended use, clinical indication and technology and no clinical studies were necessary to show substantial equivalency with its predicate device."

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

The performance data primarily focuses on the standalone mechanical unit's ability to accurately measure PEF and FEV1 when connected to a smartphone and using the application. The measurements themselves are generated by the device's mechanism and software analysis of the acoustic signal. While the user interacts with the device, the core performance validation (accuracy of measurements) is essentially standalone performance against a gold standard.

7. The Type of Ground Truth Used

The ground truth used for the performance evaluation was based on objective measurements against the accuracy and precision requirements defined by the American Thoracic Society (ATS) Standardization of Spirometry, 1994 Update. This implies the use of calibrated spirometry equipment as a gold standard for comparison during lab testing.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The Peak.me device is a mechanical unit that uses a smartphone's microphone to derive measurements through physical principles (acoustic waves proportional to airflow). It is not an AI/machine learning device that requires a "training set" in the conventional sense for model development. The software "analyzes the sound and displays the results" based on established algorithms for converting acoustic signals to flow rates and volumes, not via a learned model from a dataset.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no mention of a training set for an AI/machine learning model. The device's operation is based on physical principles and signal processing, not a trained statistical model.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 26, 2018

Breathe me LTD % Yoram Levy KQsite General Manager Osite 31 Haavoda St. Binyamina, 30500 Il

Re: K180487

Trade/Device Name: Peak.me Regulation Number: 21 CFR 868.1860 Regulation Name: Peak-Flow Meter For Spirometry Regulatory Class: Class II Product Code: BZH Dated: September 20, 2018 Received: September 27, 2018

Dear Yoram Levy:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Amy K. Levelle -S

for

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

Device Name Peak.me

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for "Breathe.me". The text is in a light blue color and is written in a simple, sans-serif font. Above the text is a stylized graphic that resembles a stream of air or breath, composed of many small dots that gradually increase in size and density as they move away from the text. The dots are also in a light blue color, creating a sense of lightness and airiness.

510(K) SUMMARY

Peak.me

510(k) Number K180487

Applicant's Name:	Breathe.me Ltd.13 Zarchin st., Ra'anana 4366241,P.O.B. 2219, ISRAELTel: +972-76-889-9800Fax: +972-76-889-9801
Contact Person:	Yoram Levy, Qsite31 Haavoda St.Binyamina, Israel 30500Tel (972)4-638-8837; Fax (972)4-638-0510Yoram@qsitemed.com
Trade Name:	Peak.me
Common Name:	Meter, Peak Flow, Spirometry

510(k) Summary Preparation Date: October 25, 2018
Classification: Name: Peak-flow meter for spirometry Product Code: BZH Regulation No: 21 CFR 868.1860 Class: II Panel: Anesthesiology

Device Description:

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image contains the logo for "Breathe.me". The text is in a light gray color. Above the text is a graphic of dots that are also light gray and blue. The dots are arranged in a curved shape.

Intended Use Statement:

Peak.me is intended for monitoring FEV1 (Forced exhalation in the first second) and PEF (peak expiratory flow) for home use. The device is designed for adult users and pediatric children over 5 years of age with caregiver supervision. Peak.me is not recommended for children under 5 years of age.

Predicate Devices: Substantial equivalence to the following predicate device is claimed:

Device Name	510(k) No.	Date of Clearance
Wing Smart FEV1 and Peak Flow	K152276	June 3, 2016
Meter

Performance Standards:

Peak.me complies with the following voluntary standard: American Thoracic Society, Standardization of Spirometry, 1994 Update for accuracy and precision.

A detailed description of additional bench performance tests performed appears in Section 14.

Summary of Technological Characteristics:

Peak.me device induces acoustic waves from airstreams, with a frequency proportional to the exhalation air flow rate. This enables to determine the respiratory flow using the smartphone's microphone as an acoustic sensor, in order to achieve the device intended use.

The device includes a mouthpiece, mechanical core, a holding mechanism and a SW application.

Principle of Operation

The user activates the smartphone software application ● and sets it to initiate a test.
The user physically attaches the mechanical unit to the smartphone.
The user places the mouthpiece in his/her mouth and exhales forcefully - the software records the acoustic sound produced by the mechanical unit.
Upon calculation of PEF and FEV1, the software displays and records the results, both numerically and graphically.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for "Breathe.me". The logo consists of the text "Breathe.me" in a light blue, sans-serif font. Above the text is a graphic of a cluster of small, blue circles that appear to be dispersing or moving away from the text, creating a sense of air or breath. The overall design is clean and modern, suggesting a focus on wellness or health.

Comparison of the technological characteristics between the Peak.me and it's predicate device

	Peak.me	Wing Smart FEV1 and Peak FlowMeterK152276
Intended Use	Peak.me is intended for monitoringFEV1 (Forced exhalation in the firstsecond) and PEF (Peak ExpiredFlow) for home use.The device is designed for pediatricto adult users. Peak.me is notrecommended for children under 5years of age.	Wing is intended for monitoring FEV1(Forced exhalation in the first second)and PEF (Peak Expired Flow Rate) forhome use.The device is designed for pediatric toadult users.Wing is not recommended for childrenunder 5 years of age.
DeviceDescription	Peak.me is a hand-held a Peak Flowmonitor that measures the PeakFlow and FEV1.The device consists of a mechanicalunit, which physically attaches to theuser's smartphone and a softwareapplication, which analyzes themeasurements and serves as adisease management platform. Thedevice uses the smartphone'sinternal upper microphone as thesensor and does not include anyelectrical parts.As the user exhales through themechanical unit, it produces acousticwaves with a frequency proportionalto the exhalation air flow rate, whichthen propagates to the smartphone'smicrophone.Peak.me software applicationanalyzes the sound and displays theresults. Furthermore, the applicationincludes past measurements' review,enables manual input of symptomsand medication usage, showsguidance for correct usage and more.	Wing® Smart FEV1 and Peak FlowMeter (Wing) is an electronic peakflow monitor that measures Peak Flowand FEV1.The Wing Sensor consists of a plasticshell and a detachable electronicsmodule.The plastic shell includes a built-inmouthpiece and an acoustic transducer.The electronics module houses a PCBAwith a microphone and a 3.5mm audiocable. The audio cable is plugged intothe 3.5mm audio jack (headphone jack)of a smartphone to transmit audio datato the Wing Software.As the user blows through WingSensor, the acousticTransducer induces oscillations in theairstream and an acoustic tone iscreated by the airstream and themicrophone detects this acoustic tone.The frequency of the acoustic tone isproportional to flow rate of the air.Wing Software, which includes theWing MobileApplication (Wing App), Wing SignalProcessing Engine, and the Sparo LabsData Management System, is used tocollect, transmit, manage, store, andcalculate FEV1 and Peak Flowmeasurements.
	Peak.me	Wing Smart FEV1 and Peak FlowMeterK152276
Device Class	Class II	Class II
ClassificationPanel	Anesthesiology	Anesthesiology
ProductCode	BZH	BZH
RegulationDescription	Peak-flow meter for spirometry	Peak-flow meter for spirometry
Regulationnumber	21 CFR 868.1860	21 CFR 868.1860
Intendeduser	The device is designed for pediatricto adult users. Peak.me is notrecommended for children under 5years of age.	The device is designed for pediatric toadult users. is not recommended forchildren under 5 years of age.
Method ofOperation	As the user exhales throughPeak.me , the rotor induces choppingof the airstream; an acoustic tone iscreated by the airstream and themicrophone detects this acoustictone. The frequency of the acoustictone is proportional to air exhalationflow rate.	As the user blows through WingSensor, the acousticTransducer induces oscillations in theairstream and an acoustic tone iscreated by the airstream and themicrophone detects this acoustic tone.The frequency of the acoustic tone isproportional to flow rate of the air.
Principles ofOperation	Following smartphone SWactivation and exhalation into theconnected device the PEF and FEV1values are calculated by recordingthe acoustic tone.	Following smartphone SW activationand exhalation into the connecteddevice the PEF and FEV1 values arecalculated by recording the acoustictone.
UserInterface	Mobile application	Mobile application
Main SWapplicationFeatures	Measure, view and store FEV1 andPEF values; includes Personal BestPeak Flow and Traffic Light Zone.	Measure, view and store FEV1 andPEF values; includes Personal BestPeak Flow and Stoplight Zone.
MeasureRange	PEF: 50-900 L/minFEV1: 0.01-9.99 L	PEF: 50-900 L/minFEV1: 0.01-9.99 L
ParametersAccuracy	FEV1: ±0.1L or ±5%Peak Flow: ±20L/min or ±10%	FEV1: ±0.1L or ±5%Peak Flow: ±20L/min or ±10%
MeasuringResolution	FEV1: 0.01 [L]PEF: 1 [L/min]	FEV1: 0.01 [L]PEF: 1 [L/min]
	Peak.me	Wing Smart FEV1 and Peak FlowMeterK152276
Method ofConnectionto phone	Direct physical attachment.	3.5mm audio jack that plugged into theaudio jack (headphone jack).
Home Use	Yes	Yes
Prescription/Over theCounter(OTC) use	OTC	OTC
Wight	60 gr/0.13 lb.	70 gr/ 0.15 lb.
Dimensions	2 X 2 X 4.3 inches (50 X 50 X 110mm)	3.2 X 2.4 X 1.5 inches (81 x 61 x37mm)
Optionalapplications	Monitoring and management ofasthma or COPD by measuring andrecording PEF and FEV1 values.	Monitoring and management of asthmaor COPD by measuring and recordingPEF and FEV1 values.
Biocompatibility	All parts that are in contact withpatient comply with therequirements of ISO 10993-1.	All parts that are in contact with patientcomply with the requirements of ISO10993-1.
Software	Verified and validated according tothe FDA guidance.	Verified and validated according to theFDA guidance.
Standards	American Thoracic Society (ATS)Standardization of Spirometry, 1994Update.	American Thoracic Society (ATS)Standardization of Spirometry, 1994Update.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for "Breathe.me". The logo is in a light blue color. Above the text is a graphic of small blue circles that are arranged in a curved line.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image contains the logo for "Breathe.me". The logo features the text "Breathe.me" in a simple, sans-serif font. Above the text, there is a stylized graphic composed of small, blue-toned circles that form a curved, flowing shape, resembling a breath or vapor trail. The overall design is clean and modern, suggesting a focus on health, wellness, or air quality.

Performance Data:

The following Lab performance tests, design validation and software verification and validation tests were conducted:

Test Name	Purpose
Peak.meAccuracy andPrecision PEFand FEV 1validation	Validation that the device meets the accuracy and precisionrequirements according to the ATS Standardization ofSpirometry, 1994 Update.
Peak.meResistanceValidation	Validation that the device meets the Resistancerequirements according to the ATS Standardization ofSpirometry, 1994 Update.
Peak.meLifetimeValidation	Validation of Peak.me lifetime.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for Breathe.me. The logo features the text "Breathe.me" in a light gray sans-serif font. Above the text is a stylized graphic of a stream of blue-green dots that appear to be emanating from the right side of the text, creating a sense of movement and breath.

Test Name	Purpose
Peak.meBackgroundNoiseValidation	Validation of Peak.me's accuracy in the presence ofpotentially disruptive noises.
Peak.me DropTest Validation	Essential performance tests were conducted following droptest according to IEC 60601-1. The tests were passedsuccessfully.

Verification and testing have shown that Peak.me device performs according to its specifications.

The Peak.me device was tested and validated with the Samsung Galaxy S6, Samsung Galaxy S6 edge, Samsung Galaxy S7 and Samsung Galaxy S7 edge.

Summary of Clinical performance data:

No clinical study was conducted.

Peak.me has the same intended use, clinical indication and technology and no clinical studies were necessary to show substantial equivalency with its predicate device.

Human Factor (Usability) Study

A usability study was designed to address the usability concerns and clearness of the Instructions for Use (IFU) and Graphic User Interface (GUI) of Peak.me application and device, while operated by intended users - any person who wishes to monitor his/her lung function. All study participants (15 out of 15 -100%) completed the scenario tasks alone with ease and confidence.

The study results of this usability study demonstrate that the Peak.me device and application are as safe and as effective as its predicate device.

Substantial Equivalence:

Peak.me and the predicate device have the same intended use. Both of them have the same clinical indication.

Peak.me device has the same technological characteristic and measuring principles as the Wing Smart FEV1 and Peak Flow Meter (K152276). Both devices induce acoustic waves from airstreams, with a frequency proportional to the exhalation air flow rate.

The design and components of Peak.me device are similar to those of the Wing Smart FEV1 and Peak Flow Meter. Both include a mouthpiece and a mechanical core. The only difference is the sensor's type. While Peak.me is a mechanical

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for "Breathe.me". The logo features the text "Breathe.me" in a light, sans-serif font. Above the text, there is a stylized graphic that resembles a stream of air or particles, with the particles gradually increasing in size as they move away from the text. The color scheme is primarily light blue and white, giving the logo a clean and airy feel.

device only that uses the smartphone's upper microphone as an acoustic sensor, in order to record the acoustic tone, the Wing also has an electronic module.

The differences in the design and configuration between the Peak.me and the Wing do not influence the core technology in achieving their intended use.

Both Peak.me device and Wing have a mobile application (App) as the user interface.

Any minor differences in the design do not raise any new types of safety and effectiveness issues. Therefore, Peak.me is substantially equivalent to its predicate device.

Conclusions:

As a result, Peak.me device is substantially equivalent to the Wing Smart FEV1 and Peak Flow Meter (K152276) predicate devices.

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).