Peak.me

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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) 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. | 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. 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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.<br>13 Zarchin st., Ra'anana 4366241,<br>P.O.B. 2219, ISRAEL<br>Tel: +972-76-889-9800<br>Fax: +972-76-889-9801 | |-------------------|----------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Yoram Levy, Qsite<br>31 Haavoda St.<br>Binyamina, Israel 30500<br>Tel (972)4-638-8837; Fax (972)4-638-0510<br>Yoram@qsitemed.com | | Trade Name: | <i>Peak.me</i> | | 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: 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. {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 | | <i>Peak.me</i> | Wing Smart FEV1 and Peak Flow<br>Meter<br>K152276 | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | <i>Peak.me</i> is intended for monitoring<br>FEV1 (Forced exhalation in the first<br>second) and PEF (Peak Expired<br>Flow) for home use.<br>The device is designed for pediatric<br>to adult users. <i>Peak.me</i> is not<br>recommended for children under 5<br>years of age. | Wing is intended for monitoring FEV1<br>(Forced exhalation in the first second)<br>and PEF (Peak Expired Flow Rate) for<br>home use.<br>The device is designed for pediatric to<br>adult users.<br>Wing is not recommended for children<br>under 5 years of age. | | Device<br>Description | <i>Peak.me</i> is a hand-held a Peak Flow<br>monitor that measures the Peak<br>Flow and FEV1.<br>The device consists of a mechanical<br>unit, which physically attaches to the<br>user's smartphone and a software<br>application, which analyzes the<br>measurements and serves as a<br>disease management platform. The<br>device uses the smartphone's<br>internal upper microphone as the<br>sensor and does not include any<br>electrical parts.<br>As the user exhales through the<br>mechanical unit, it produces acoustic<br>waves with a frequency proportional<br>to the exhalation air flow rate, which<br>then propagates to the smartphone's<br>microphone.<br><i>Peak.me</i> software application<br>analyzes the sound and displays the<br>results. Furthermore, the application<br>includes past measurements' review,<br>enables manual input of symptoms<br>and medication usage, shows<br>guidance for correct usage and more. | Wing® Smart FEV1 and Peak Flow<br>Meter (Wing) is an electronic peak<br>flow monitor that measures Peak Flow<br>and FEV1.<br>The Wing Sensor consists of a plastic<br>shell and a detachable electronics<br>module.<br>The plastic shell includes a built-in<br>mouthpiece and an acoustic transducer.<br>The electronics module houses a PCBA<br>with a microphone and a 3.5mm audio<br>cable. The audio cable is plugged into<br>the 3.5mm audio jack (headphone jack)<br>of a smartphone to transmit audio data<br>to the Wing Software.<br>As the user blows through Wing<br>Sensor, the acoustic<br>Transducer induces oscillations in the<br>airstream and an acoustic tone is<br>created by the airstream and the<br>microphone detects this acoustic tone.<br>The frequency of the acoustic tone is<br>proportional to flow rate of the air.<br>Wing Software, which includes the<br>Wing Mobile<br>Application (Wing App), Wing Signal<br>Processing Engine, and the Sparo Labs<br>Data Management System, is used to<br>collect, transmit, manage, store, and<br>calculate FEV1 and Peak Flow<br>measurements. | | | <i>Peak.me</i> | Wing Smart FEV1 and Peak Flow<br>Meter<br>K152276 | | Device Class | Class II | Class II | | Classification<br>Panel | Anesthesiology | Anesthesiology | | Product<br>Code | BZH | BZH | | Regulation<br>Description | Peak-flow meter for spirometry | Peak-flow meter for spirometry | | Regulation<br>number | 21 CFR 868.1860 | 21 CFR 868.1860 | | Intended<br>user | The device is designed for pediatric<br>to adult users. Peak.me is not<br>recommended for children under 5<br>years of age. | The device is designed for pediatric to<br>adult users. is not recommended for<br>children under 5 years of age. | | Method of<br>Operation | As the user exhales through<br><i>Peak.me</i> , the rotor induces chopping<br>of the airstream; an acoustic tone is<br>created by the airstream and the<br>microphone detects this acoustic<br>tone. The frequency of the acoustic<br>tone is proportional to air exhalation<br>flow rate. | As the user blows through Wing<br>Sensor, the acoustic<br>Transducer induces oscillations in the<br>airstream and an acoustic tone is<br>created by the airstream and the<br>microphone detects this acoustic tone.<br>The frequency of the acoustic tone is<br>proportional to flow rate of the air. | | Principles of<br>Operation | Following smartphone SW<br>activation and exhalation into the<br>connected device the PEF and FEV1<br>values are calculated by recording<br>the acoustic tone. | Following smartphone SW activation<br>and exhalation into the connected<br>device the PEF and FEV1 values are<br>calculated by recording the acoustic<br>tone. | | User<br>Interface | Mobile application | Mobile application | | Main SW<br>application<br>Features | Measure, view and store FEV1 and<br>PEF values; includes Personal Best<br>Peak Flow and Traffic Light Zone. | Measure, view and store FEV1 and<br>PEF values; includes Personal Best<br>Peak Flow and Stoplight Zone. | | Measure<br>Range | PEF: 50-900 L/min<br>FEV1: 0.01-9.99 L | PEF: 50-900 L/min<br>FEV1: 0.01-9.99 L | | Parameters<br>Accuracy | FEV1: ±0.1L or ±5%<br>Peak Flow: ±20L/min or ±10% | FEV1: ±0.1L or ±5%<br>Peak Flow: ±20L/min or ±10% | | Measuring<br>Resolution | FEV1: 0.01 [L]<br>PEF: 1 [L/min] | FEV1: 0.01 [L]<br>PEF: 1 [L/min] | | | Peak.me | Wing Smart FEV1 and Peak Flow<br>Meter<br>K152276 | | Method of<br>Connection<br>to phone | Direct physical attachment. | 3.5mm audio jack that plugged into the<br>audio jack (headphone jack). | | Home Use | Yes | Yes | | Prescription/<br>Over the<br>Counter<br>(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 110<br>mm) | 3.2 X 2.4 X 1.5 inches (81 x 61 x<br>37mm) | | Optional<br>applications | Monitoring and management of<br>asthma or COPD by measuring and<br>recording PEF and FEV1 values. | Monitoring and management of asthma<br>or COPD by measuring and recording<br>PEF and FEV1 values. | | Biocompatibi<br>lity | All parts that are in contact with<br>patient comply with the<br>requirements of ISO 10993-1. | All parts that are in contact with patient<br>comply with the requirements of ISO<br>10993-1. | | Software | Verified and validated according to<br>the FDA guidance. | Verified and validated according to the<br>FDA guidance. | | Standards | American Thoracic Society (ATS)<br>Standardization of Spirometry, 1994<br>Update. | American Thoracic Society (ATS)<br>Standardization of Spirometry, 1994<br>Update. | {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.me<br>Accuracy and<br>Precision PEF<br>and FEV 1<br>validation | Validation that the device meets the accuracy and precision<br>requirements according to the ATS Standardization of<br>Spirometry, 1994 Update. | | Peak.me<br>Resistance<br>Validation | Validation that the device meets the Resistance<br>requirements according to the ATS Standardization of<br>Spirometry, 1994 Update. | | Peak.me<br>Lifetime<br>Validation | 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 | |-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | <b>Peak.me</b><br>Background<br>Noise<br>Validation | Validation of <i>Peak.me's</i> accuracy in the presence of<br>potentially disruptive noises. | | <b>Peak.me</b> Drop<br>Test Validation | Essential performance tests were conducted following drop<br>test according to IEC 60601-1. The tests were passed<br>successfully. | 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.