WesperO2

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 10, 2022 Wesper Inc. Amir Reuveny CEO 234 5th Ave New York, New York 10001 Re: K213515 Trade/Device Name: WesperO2 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: May 11, 2022 Received: May 12, 2022 Dear Amir Reuveny: 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/cdrh/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. 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Respiratory and Anesthsia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K213515 Device Name WesperO2 #### Indications for Use (Describe) WesperO2 is a finger-worn pulse oximeter in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/or continuous data collection, and not continuous monitoring. It can be used in sleep labs and home use. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### 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. 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The overall design is minimalist and professional. # Section 5. 510(k) Summary WesperO2 Pulse Oximeter Date Prepared: October 29, 2021 #### Name of Device and Sponsor Information Device Name: WesperO2 Sponsor Name: Wesper Inc. (formerly Tatch Inc.) Sponsor Address: 234 5th Ave., New York, USA, 10001 Phone: 917-841-4830 Contact Person: Amir Reuveny #### Classification Name Classification Name: Oximeter Product Code: DQA Regulation: 21 CFR 870.2700 Device Class: Class II #### Predicate Device Name: Oxiband (Checkme) O2 Pulse Oximeter K-Number: K191088 Classification Name: Oximeter Product Code: DQA Regulation: 21 CFR 870.2700 Device Class: Class II Sponsor Name: Shenzhen Viatom Technology Co., Ltd. #### Indications for Use WesperO2 is a finger-worn pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/or continuous data collection, and not continuous monitoring. It can be used in sleep labs and home use. #### Device Description WesperO2 ("the device") is a pulse oximeter, meant to be worn on the finger of an adult patient over the age of 21. The device is intended for spot checking or continuous collection of functional oxygen saturation of arterial hemoglobin by way of sensing peripheral capillary perfusion ("SpO2") and Pulse Rate. It is intended to be used in the patient's home or in a sleep lab. The device's core technology is based on collecting reflected light from the intact skin of the patient's finger to form Photoplethysmography ("PPG") waveforms. These waveforms can then be used to extract a measurement of SpO2 and Pulse Rate. {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the word "WESPER" in a sans-serif font. To the left of the word is a gray circle that is partially filled in, resembling a crescent moon. The text is black and the background is white. The image is simple and clean, with a focus on the text and the circular graphic. The sensing component is carried by an electronics assembly, which is comprised of a batterypowered Printed Circuit Board ("PCB"). The electronics assembly is housed inside of a soft, flexible casing, which encapsulates the entirety of the assembly, except for the actual optical front-end of the sensing component, which exposes an array, consisting of two LEDs and a photodiode. The entire assembly is referred to as "the WesperO2 probe." The silicone housing has a "thimble-style" form factor, such that the patient can wear it on their fingertip, with the optical sensor pointed at the pad of their finger. The probe is then meant to create a snuq, yet comfortable fit to ensure consistent positioning of the optical sensor throughout the usage period. The probe has a Bluetooth interface through which it sends SpO2 and Pulse Rate measurements to a companion mobile application ("WesperO2 app"), which resides on the patient's mobile device. The application can both record the data and display it in real-time to the patient. Recordings are saved on the mobile device and can be shared later through the application with a healthcare provider over the internet. #### Performance Data #### Software Wesper's software development life cycle is in accordance with the following standards: - FDA Guidance: General Principles of Software Validation, January 2002 ● - FDA Guidance: Guidance for the Content of Premarket Submissions for Software ● Contained in Medical Devices, May 2005 - FDA Guidance: Off-The-Shelf Software Use in Medical Devices, September 2019 ● - IEC 62304:2006+AMD1:2015 CSV, Medical Device Software Software Life-Cycle ● Processes - ISO 14971:2019, Medical Devices Application of Risk Management to Medical Devices ● Based on this process, Wesper has established it has a Moderate Level of Concern for its software used in the WesperO2 pulse oximeter. Therefore, Wesper has performed a detailed Risk Analysis and developed a Software Requirement Specification and Software Detailed Design which were verified and validated and shown to have full traceability back to all risk mitigations, which reduce the level of residual risk in the software to an acceptable level. Wesper has also performed Off-The-Shelf (OTS) Software validation. In addition, Wesper has performed a full Cybersecurity Threat Analysis based on recommendations provided in FDA Guidance: "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," October 2014. #### Electromagnetic Compatibility (EMC) and Electrical Safety The following standards were met for EMC and Electrical Safety: - IEC 60601-1:2005+AMD 2012, 3rd Ed. Part 1: General Requirements for Basic Safety . and Essential Performance - IEC 60601-1, Part 11:2015 General requirements for basic safety and essential ● performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment {5}------------------------------------------------ # OWESPER - IEC 60601-1-2:2014 General requirements for basic safety and essential performance -● Collateral Standard: Electromagnetic disturbances - Requirements and tests - ISO 80601-2-61:2017 - Particular requirements for basic safety and essential performance of pulse oximeter equipment [selected sections pertaining to safety] - IEEE/ANSI C63.27-2017 American National Standard for Evaluation of Wireless . Coexistence #### Biocompatibility All skin-contacting materials in the WesperO2 probe have been tested to comply with ISO 10993-1 with conditions which meet Wesper's intended use of up to 24 hours at 37°C on intact skin. ### Performance Testing - Bench Validation of the Range of Heart Rate Measurement: Testing was performed to ensure that the WesperO2 pulse oximeter measures heart rate accurately over its targeted range. One heart rate measurement accuracy test was applied to three independently generated datasets. The test passed for every dataset. Based on these three successful tests. WesperO2 is validated for measuring heart rate across its target range of 30 to 230 BPM. This full range was not observed in clinical testing of the device. Therefore, bench testing was performed to supplement clinical testing in demonstrating the accuracy across the full tarqet range. ### Performance Testing - Animal No animal testing was conducted for this 510(k) submission. ### Performance Testing - Clinical An SpO2 accuracy comparison was conducted as part of the final validation of the WesperO2 pulse oximeter. The study was conducted in accordance with the following standards: - ISO 80601-2-61:2019, Medical electrical equipment Particular requirements for basic . safety and essential performance of pulse oximeter equipment - FDA-2007-D-0205, Pulse Oximeters Premarket Notification Submissions [510(k)s] ● Guidance for Industry and Food and Drug Administration Staff The objective of the study was to validate the SpO2 accuracy of the WesperO2 pulse oximeter over the range of 70-100% SaQ2 as compared to arterial blood sample CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximeter would meet the required specification of ARMS of 3.5% or less. A secondary goal was to evaluate the Pulse Rate (PR) performance simultaneously collected over the SpO2 range covered. The PR ARMs performance of the WesperO2 pulse oximeter was expected to meet a specification of 3 Beats per Minute (BPM). {6}------------------------------------------------ Image /page/6/Picture/2 description: The image shows the word "WESPER" in black, bold, sans-serif font. To the left of the word is a gray circle that is partially filled in, resembling a crescent moon. The word is horizontally aligned and centered. #### Table 1: Summary of SpO2 Accuracy Results | Comparison to Reference CO-Oximetry<br>(functional SaO2) | SpO2<br>Range | SpO2 ARMS | ARMS Spec <<br>3.5% | |----------------------------------------------------------|---------------|--------------|---------------------| | WesperO2 | 70-100% | 2.56 (N=223) | Pass | #### Table 2: Summary of Pulse Rate Accuracy Data | Comparison to Reference Oximeter<br>Pulse Rate | Pulse Rate<br>Range | Pulse Rate<br>ARMS | ARMS Spec <<br>3BPM | |------------------------------------------------|---------------------|--------------------|---------------------| | WesperO2 | 59-122 BPM | 2.2 (N=235) | Pass | The results of the study show that the WesperO2 pulse oximeter outperforms the ARMS specification of 3.5% for the range 70-100%. WesperO2 provides accurate PR values over the range 59-122 BPM, meeting a specification of 3 BPM. The validated pulse rate range was extended beyond the limits of clinical observation to 30-230 BPM using bench testing. #### Substantial Equivalence Both devices use light absorption in the finger to measure SpO2 and Pulse Rate, and both use Red and Infra-Red as their working wavelength bands. The subject device uses reflected energy to measure absorption, while the predicate device uses transmitted energy to accomplish that. Both methods are well understood and accepted methodologies to accurately measure Sp02 and Pulse Rate. Both devices have identical SpO2 and Pulse Rate ranges (70% - 100%, and 30BPM – 250BPM, respectively), with the subject device having a maximum resolution of 2BPM against the predicate's 1BPM resolution. This difference in resolutions is not clinically significant. The subject device has an overall Arms of 2.56%, while the predicate has an Arms of 1.88%. Both results are within the necessary acceptance criteria, making them clinically equivalent. Both devices use silicone-based housings and are applied to the finger. The subject device is entirely contained in the fingertip unit and the predicate device attaches to a wrist-worn unit. Since both devices have biocompatible patient-contacting materials and similar form factors, they are functionally equivalent. Both devices have capabilities to record, and display in real time, SpO2 and Pulse Rate. The subject device uses the companion mobile application via Bluetooth to achieve this, while the predicate has an on-board LCD display. The displayed measurements are the same both units perform the same function, and the subject device's software has been fully validated to meet the necessary functional requirements. A substantial equivalence chart comparing the similarities and differences between WesperO2, and its predicate device is provided in Table 1. Differences in technology as described above do not raise new type questions of safety and effectiveness. Furthermore, clinical performance testing per ISO 80601-2-61:2019 and Pulse Oximeters - Premarket Notification Submissions [510(k)s] - Guidance for Industry and Food and Drug Administration {7}------------------------------------------------ ## O WESPER Staff, March 4, 2013 has shown that WesperO2 successfully meets the accuracy criteria for Pulse Oximeters intended for marketing in the US. | Characteristic | Subject Device<br>WesperO2 | Predicate Device<br>Oxiband (Checkme)<br>O2 Pulse Oximeter<br>(K191088) | Comparison | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | DQA | DQA | Same. | | Class | II | II | Same. | | Indications For Use | WesperO2 is a finger-<br>worn pulse oximeter<br>indicated for use in<br>measuring, displaying,<br>storing and transmitting<br>functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and<br>pulse rate for adult<br>patients. It is intended<br>for spot-check and/or<br>continuous data<br>collection, and not<br>continuous monitoring.<br>It can be used in sleep<br>labs and home use. | The Oxiband Pulse<br>Oximeter is a wrist<br>pulse oximeter<br>indicated for use in<br>measuring, displaying,<br>storing, and<br>transmitting functional<br>oxygen saturation of<br>arterial hemoglobin<br>(SpO2) and pulse rate<br>for adult patients. It is<br>intended for spot-check<br>and/or continuous data<br>collection, and not<br>continuous monitoring.<br>It can be used in sleep<br>labs, long-term care,<br>hospitals and home<br>use. | Indications for use are<br>similar between the<br>two devices. The<br>subject device is only<br>indicated for sleep<br>labs and home use<br>which is a subset of<br>the predicate's<br>indications. | | Intended application site | Finger | Finger | Same. | | Continuous collection | Yes | Yes | Same. | | Sensor form<br>factor | Self-contained, wireless<br>finger unit | Detachable, wired<br>finger unit | Both devices target<br>the finger, where the<br>detachable design of<br>the predicate does not<br>affect the accuracy of<br>the measurement. | | Table 3: Substantial Equivalence Table | | | | |----------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sp02<br>measurement<br>accuracy | 70 - 100%: Arms = 2.56<br>70 - 80%: Arms = 3.6<br>80 - 90%: Arms = 2.05<br>90 - 100%: Arms = 1.84 | 70 - 100%: Arms = 1.88<br>70- 80%: ±3%<br>80- 90%: ±2%<br>90- 100%: ±2% | Both devices meet the<br>necessary accuracy<br>requirements for 70-<br>100% and have similar<br>error profiles decade-<br>by-decade, therefore<br>they have equivalent<br>SpO2 measurement<br>accuracies. | | SpO2 display<br>range | 70 - 100% | 0 - 100% | The predicate's<br>extended display<br>range has no practical<br>significance, as both<br>devices claim the<br>same SpO2 range,<br>which is the same as<br>the subject's display<br>range. The subject<br>device's display range<br>is within the range of<br>the predicate device. | | SpO2 resolution | 1% | 1% | Same. | | Pulse Rate<br>measurement<br>range | 30 - 230 BPM | 30 - 250 BPM | Similar. | | Pulse Rate<br>accuracy | ±3 BPM RMSE | ±2 BPM or ± 2%<br>(whichever is greater) | In the worst-case<br>scenario, the two<br>devices differ in 1<br>BPM on average,<br>which is not clinically<br>significant. | | Pulse Rate<br>resolution | 2 BPM | 1 BPM | 1 BPM does not<br>constitute a clinically<br>significant difference. | | Display method | In-app via Bluetooth | On-unit OLED screen | Both devices will<br>display the same type<br>of live data. Both<br>displays rely on<br>software components<br>to render the<br>measurements, and<br>Wesper performed<br>software validation of<br>the integrity and real-<br>time response of the<br>app display to<br>demonstrate<br>equivalence. | | Wireless<br>connectivity | Bluetooth | Bluetooth | Same. | | Storage | Yes, on-probe and in-<br>app | Yes, on-probe | Similar. | | Contact duration | Up to 24h | Up to 24h | Same. | {8}------------------------------------------------ Image /page/8/Picture/2 description: The image shows the word "WESPER" in black font. To the left of the word is a gray circle that is partially shaded, resembling a crescent moon. The font is simple and sans-serif, giving the logo a clean and modern look. The overall design is minimalist and professional. {9}------------------------------------------------ Image /page/9/Picture/2 description: The image shows the word "WESPER" in black font. To the left of the word is a gray circle that is partially filled in, resembling a crescent moon. The font is simple and sans-serif. The image is clean and minimalist. #### Conclusion The information provided in this submission, in accordance with the requirements of 21 CFR 807 Subpart E, supports the conclusion that WesperO2 is substantially equivalent to the predicate device, the Oxiband (Checkme) O2 Pulse Oximeter.