The Study Watch with Irregular Pulse Monitor is indicated for use by adult patients (22 years and older) who have been diagnosed with, or are susceptible to developing, atrial fibrillation enabling them to monitor and record their heart rhythms. Study Watch is also intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms.

The Study Watch is intended for prescription use only.

Device Description

The Study Watch with Irregular Pulse Monitor is a miniaturized physiological data monitoring device that is intended to record, store, transfer and display single-channel electrocardiogram (ECG) rhythms. The Study Watch with Irregular Pulse Monitor is intended to notify the user in the event of an irregular pulse, such as atrial fibrillation (AF), and recommend acquisition of an ECG. The device utilizes a band and proprietary watch that incorporates two dedicated sensing electrodes to obtain a single-channel ECG measurement. In practice, a healthcare professional (HCP) may prescribe the Study Watch with Irregular Pulse Monitor to a patient and recommend the capture and transmission of one or more ECG rhythms on a daily basis for analysis by the HCP. The patient uses prompts provided on the graphical user interface (GUI) of the watch to collect a real-time 45-second ECG measurement. The patient is able to capture an ECG rhythm on-demand by navigation to the ECG menu, upon receipt of an irregular pulse notification. While an animated ECG waveform is briefly displayed on the GUI of the watch, the patient will not have direct access to the collected waveform. Using the provided charging dock (Cradle) and Verily's Study Hub or Watch App, the ECG measurements are securely transferred to Verily's cloud server and are viewed by the HCP using a web portal. Additionally, data may be securely transferred to interoperable devices for further analysis. The web portal is solely intended for use by the HCP to view time-stamped ECG waveforms collected by the patient and does not include any analysis features. Collectively, the Study Watch consists of the wearable watch and band, the Study Hub or Watch app (used to transfer data from the watch to the cloud), a Cradle, and the web portal.

AI/ML Overview

Below is a detailed description of the acceptance criteria and the study proving the device meets these criteria, based on the provided document.

Device Name: Study Watch with Irregular Pulse Monitor

1. Table of Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (Threshold)	Reported Device Performance (Home Use)
Per-interval Sensitivity	Not explicitly stated (only "exceeds pre-specified thresholds")	96.1% (95% CI: 92.7 - 98.0)
Per-interval Specificity	Not explicitly stated (only "exceeds pre-specified thresholds")	98.1% (95% CI: 97.2 - 99.1)

Note: The document states the algorithm "exceeds the pre-specified per-interval performance thresholds for sensitivity and specificity," but the exact numerical thresholds are not provided within the given text.

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

Sample Size for Test Set: The document mentions "thousands of ECG data collected from iRhythm Technologies' Zio devices" for algorithm training but does not explicitly state the sample size for the validation (test) set. However, it describes the "Study Watch AF Detection At Home (NCT04546763) data" as consisting of "free-living, multi-day PPG recordings obtained from the Study Watch, along with ECG-based rhythm labels obtained from reference iRhythm Technologies Zio XT Patches worn simultaneously."
Data Provenance: The study was conducted in the USA, with regional demographics provided: Midwest (8%), Mountain (32%), West (32%), Northeast (14%), South (13%). The data was collected prospectively in a "free-living (home use) setting."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not specified.
Qualifications of Experts: The algorithm was trained using ECG data that had undergone "Certified Cardiographic Technician (CCT) review." It can be inferred that similar qualified personnel were involved in establishing the ground truth for the validation set, as the reference standard (Zio XT Patches) typically requires expert interpretation.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It only mentions that ECG-based rhythm labels were "obtained from reference iRhythm Technologies Zio XT Patches worn simultaneously" and that the training data underwent "Certified Cardiographic Technician (CCT) review."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. This study focused on the standalone performance of the irregular pulse monitoring algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The described "Clinical Performance Data" section focuses solely on the algorithm's performance (sensitivity and specificity) in detecting irregular pulses based on PPG data, using a reference ECG as ground truth, without human-in-the-loop evaluation.

7. The Type of Ground Truth Used

Clinical Ground Truth: The ground truth for validation was established using ECG-based rhythm labels obtained from reference iRhythm Technologies Zio XT Patches worn simultaneously with the Study Watch. This is a robust clinical ground truth for cardiac rhythm analysis.

8. The Sample Size for the Training Set

The algorithm was trained using "thousands of ECG data collected from iRhythm Technologies' Zio devices." A specific number is not provided beyond "thousands."

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

The ground truth for the training set was established through "ECG data collected from iRhythm Technologies' Zio devices, which have undergone Certified Cardiographic Technician (CCT) review." This indicates human expert review by qualified professionals.

Summary

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July 19, 2022

Verily Life Sciences LLC Dinesh Puppala Regulatory Affairs Specialist 269 East Grand Avenue South San Francisco, California 94080

Re: K213357

Trade/Device Name: Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter And Receiver Regulatory Class: Class II Product Code: DXH, DPS Dated: July 18, 2022 Received: July 18, 2022

Dear Dinesh Puppala:

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. 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

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213357

Device Name Study Watch with Irregular Pulse Monitor

Indications for Use (Describe)

The Study Watch is intended for prescription use only.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared:	July 15, 2022
Submitter:	Verily Life Sciences LLC
Official Contact:	Dinesh PuppalaSenior Regulatory Affairs Specialist269 East Grand AveSouth San Francisco, CA 94080, USATelephone: (650)-267-1263E-mail: puppalad@google.com
Proprietary Name:	Study Watch with Irregular Pulse Monitor
Common Name:	Telephone Electrocardiograph Transmitter and Receiver
Classification:	Class II Medical DeviceRegulation Number: 21 CFR 870.2920Product Code: DXH, DPS
Predicate Device:	Study Watch with Irregular Pulse Monitor (K192415)
Reason For Submission:	Additional or Expanded IndicationsInteroperability with ZEUS System (Zio Watch), an iRhythmTechnologies, Inc. software system

Indications for Use

The Study Watch with Irregular Pulse Monitor is intended for prescription use only.

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Device Description

Irregular Pulse Monitoring Algorithm

The Irregular Pulse Monitoring Algorithm is responsible for processing PPG-based data collected by the Study Watch device to provide detection of irregular pulses over the patient's wear period. The algorithm operates on a continuous basis by analyzing - once every 15 minutes - the prior 15-minutes of PPG-based data to detect the presence of an irregular rhythm, such as AF.

Algorithm Training

The algorithm was developed using machine learning techniques. The source of training data for the algorithm is continuous cardias from compatible cardiac monitors. The algorithm was trained using thousands of ECG data collected from iRhythm Technologies' Zio devices, which have undergone Certified Cardiographic Technician (CCT) review. In addition, the algorithm was tuned using PPG data intervals recorded from devices similar to the Study Watch.

Algorithm Validation

The Study Watch AF Detection At Home (NCT04546763) data consists of free-living, multi-day PPG recordings obtained from the Study Watch, along with ECG-based rhythm labels obtained from reference iRhythm Technologies Zio XT Patches worn simultaneously.

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Recording device	Study Watch with Irregular Pulse Monitor
Channel	Wrist-based PPG
Recording Length	Up to 14 days
Environment	Ambulatory*
Demographics	Patients at least 22 years or older who are at risk of having an AFevent, as determined by having a diagnosis of paroxysmal AF.Age: Median = 67 years; Range: 23-86 yearsGender: 45.5% FemaleRegional Demographics (USA):Midwest: 8%,Mountain: 32%,West: 32%,Northeast: 14%,South: 13%

*In-clinic during enrollment

Substantial Equivalence Discussion

Study Watch with Irregular Pulse Monitor is substantially equivalent to the predicate Study Watch (K192415) as both the proposed and predicate are intended to record, store, transfer, and display single-channel ECG rhythms in adults with known or suspected heart conditions. Both devices are indicated to detect irregular pulse in adults with a diagnosis of, or are susceptible to, AF. Similar to the predicate device, the proposed device is classified as a Telephone Electrocardiograph Transmitter and Receiver in accordance with 21 CFR 870.2920, Product Code DXH, DPS. It is of importance to note that both the Study Watch with Irregular Pulse Notification and the predicate device use two (2) dedicated sensing electrodes to obtain a single-channel ECG measurement.

A comparative summary of the similarities and differences between the Study Watch with Irregular Pulse Monitor and the predicate Study Watch (K192415).

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Table. Predicate Device Comparison Table

Topic	Proposed Device	Predicate Device
Manufacturer	Verily Life Sciences, LLC	Verily Life Sciences, LLC
Model Name	Study Watch with Irregular PulseMonitor (Home)	Study Watch with Irregular PulseMonitor
510(k) Number	Subject Device: K213357	Predicate: K192415
Intended Use/Indicationsfor Use	The Study Watch with IrregularPulse Monitor is indicated for useby adult patients (22 years andolder) who have been diagnosedwith, or are susceptible todeveloping, atrial fibrillationenabling them to monitor andrecord their heart rhythms. StudyWatch is also intended to record,store, transfer, and displaysingle-channel electrocardiogram(ECG) rhythms.	The Study Watch with IrregularPulse Monitor is indicated for useby adult patients (22 years andolder) who have been diagnosedwith, or are susceptible todeveloping, atrial fibrillationenabling them to monitor andrecord their heart rhythms. StudyWatch is also intended to record,store, transfer, and displaysingle-channel electrocardiogram(ECG) rhythms.The Irregular Pulse Monitor isindicated for use in professionalhealthcare facilities.
PrescriptionDevice for HomeUse	Yes (Both Home use & In-clinicuse)	No (Only In-clinic use)
Regulation Number	21 CFR 870.2920	21 CFR 870.2920
Device ClassificationName	Telephone ElectrocardiographTransmitterAnd Receiver	Telephone ElectrocardiographTransmitterAnd Receiver
Product Code	DXH, DPS	DXH, DPS
Target Population	Adults diagnosed with, or aresusceptible to developing, atrialfibrillation	Adults diagnosed with, or aresusceptible to developing, atrialfibrillation
Anatomical Site	Left hand fingers to right wrist orvice versa (ECG); Wrist (PPG)	Left hand fingers to right wrist orvice versa (ECG); Wrist (PPG)
Where Used	Mobile/active users at rest(ambulatory)	Mobile/active users at rest(ambulatory)
Device Design	Study Watch is a wearableminiaturized physiological datamonitoring and data collection	Study Watch is a wearableminiaturized physiological datamonitoring and data collection

	device for continuous recordingof physiological andenvironmental data. The watchfeatures single-lead ECGcapability and a PPG sensoramong other sensors. The watchalso includes an electronic circuitboard, batteries, GUI that displayswatch features and enables menunavigation.	device for continuous recordingof physiological andenvironmental data. The watchfeatures single-lead ECGcapability and a PPG sensoramong other sensors. The watchalso includes an electronic circuitboard, batteries, GUI that displayswatch features and enables menunavigation.
Mechanism of Action	PPG: The Study Watch containsan optical sensor that collects thePPG waveform from blood flowand this PPG raw data is utilizedfor non-medical heart rate data aswell as irregular pulsenotification.ECG: User completes circuit withskin contact and hardwaremeasures ECG waveform, whichis stored and securely transferredto the cloud via the proprietaryStudy Hub.Additionally, data may besecurely transferred to the cloudvia Bluetooth and a mobile app.	PPG: The Study Watch containsan optical sensor that collects thePPG waveform from blood flowand this PPG raw data is utilizedfor non-medical heart rate data aswell as irregular pulsenotification.ECG: User completes circuit withskin contact and hardwaremeasures ECG waveform, whichis stored and securely transferredto the cloud via the proprietaryStudy Hub.
User Interface	Patient: Study WatchHCP: Web Portal	Patient: Study WatchHCP: Web Portal
Interoperability withthird party ECG & PPGAnalysis Softwaresystems	Zio Watch (Branded StudyWatch) is interoperable with theZEUS System (iRhythmTechnologies)	Not Interoperable with any thirdparty systems
Principles of Operation	PPG data collection (to detectirregular pulse)ECG: acquisition (for rhythm)	PPG data collection (to detectirregular pulse)ECG: acquisition (for rhythm)
Recording Length	45 Seconds	60 Seconds
Irregular PulsePerformance ( interval -level)	In-clinic Use:Sensitivity: 98.3%Specificity: 100.0%	In-clinic Use:Sensitivity: 85%Specificity: 96%
Home Use:Sensitivity: 96.1%Specificity: 98.1%

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The differences in technological characteristics associated with the proposed device in comparison to the predicate (K192415) have been evaluated through performance testing for the target population and there are no new questions of safety and effectiveness. Therefore, the proposed device is substantially equivalent to the predicate device.

Non-Clinical Performance Data

Performance Testing Bench

Performance testing for the Study Watch with Irregular Pulse Monitor comprises verification and validation completed in a software environment using raw data collected via a prospective clinical study. Bench testing includes verification and validation of specifications related to software development and hardware sensor performance for the Study Watch with Irregular Pulse Monitor. All tests confirmed that the product met the predetermined acceptance criteria and that the features driving performance are substantially equivalent to those present in the specified predicate device.

Clinical Performance Data

Clinical validation performance testing was conducted to demonstrate that Study Watch with Irregular Pulse Monitor generates data that meets the clinical requirements for irregular pulse monitoring in target patients. Specifically, the prospective clinical study Watch PPG waveform (Test) data in a free-living (home use) setting from patients at risk of having AF and applied the PPG-based irregular pulse algorithm, using contemporaneous Zio Patch (Reference) ECG data as the ground truth. The presented data include the primary endpoints [per-interval sensitivity 96.1% (95% Cl: 92.7 - 98.0) and specificity 98.1% (95% CI: 97.2 - 99.1)] showing that the PPG-based irregular pulse monitoring algorithm exceeds the pre-specified per-interval performance thresholds for sensitivity and specificity for continuous monitoring. This study demonstrated that the Study Watch with Irregular Pulse Monitor in a home use environment is substantially equivalent to the predicate Study Watch (K192415) and as safe and as effective as the predicate device for the specified intended use.

Conclusion

In summary, the comprehensive performance testing demonstrates that the Study Watch with Irregular Pulse Monitor is as safe and as effective as the predicate device for the specified intended use. This testing, in addition to the comprehensive comparison to the predicate Study Watch (K192415), demonstrates the Study Watch with Irregular Pulse Monitor is substantially equivalent to the named predicate device for the specified intended use.

Regulation Number and Section

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).