(135 days)
Yes
The summary explicitly mentions and describes the "PPG-based Irregular Pulse Monitor algorithm" and its performance evaluation using sensitivity and specificity metrics against a reference standard (Holter ECG). While the terms "AI" or "ML" are not explicitly used, the description of an "algorithm" that processes physiological data (PPG) to identify irregular pulses (like AF) and its evaluation using performance metrics common in ML/algorithmic validation strongly suggests the use of an algorithmic approach, likely involving ML, for pattern recognition in the PPG data. The clinical study description further reinforces this by detailing the application of this algorithm to test data.
Yes
The device is described as "a miniaturized physiological data monitoring device that is intended to record, store, transfer and display single-channel electrocardiogram (ECG) rhythms" and to "notify the user in the event of irregular pulse, such as atrial fibrillation (AF)". It is used by patients "who have been diagnosed with, or are susceptible to developing, atrial fibrillation enabling them to monitor and record their heart rhythms." This indicates a medical purpose to monitor a medical condition and help in its management, thus qualifying it as a therapeutic device.
Yes
The device is intended to monitor and record heart rhythms, notify users of irregular pulses like atrial fibrillation, and recommend ECG acquisition. While the ECG waveforms are viewed by a healthcare professional (HCP) and the web portal for HCPs does not include analysis features, the core function of identifying and alerting to irregular heart rhythms (e.g., atrial fibrillation) directly relates to identifying a health condition, which is a diagnostic purpose. The performance metrics provided (sensitivity and specificity) further reinforce its role in identifying a medical condition.
No
The device description explicitly states that the "Study Watch consists of the wearable watch and band, the Study Hub (used to transfer data from the watch to the cloud), a Cradle, and the web portal." This indicates the device includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device function: The Study Watch with Irregular Pulse Monitor collects physiological data directly from the patient's body (ECG and PPG rhythms) through external sensors. It does not analyze samples taken from the body.
- Intended Use: The intended use is to monitor and record heart rhythms and notify the user of irregular pulses. While this information can be used by a healthcare professional for diagnosis, the device itself is not performing an in vitro diagnostic test.
The device is a medical device that provides physiological monitoring data, which can be used in conjunction with other clinical information by a healthcare professional for diagnostic purposes.
No
The provided text does not contain any explicit statements indicating that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section explicitly states "Not Found".
Intended Use / Indications for Use
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 Irregular Pulse Monitor is indicated for use in professional healthcare facility environments, while worn as a wrist watch.
Product codes
DXH, DPS
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 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 realtime 60-second ECG measurement. The patient is able to capture an ECG rhythm on-demand by navigation to the ECG menu, in response to a daily ECG reminder, or 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 wave form.
Using the provided charging dock (Cradle) and Verily's Study Hub device, the ECG measurements are securely transferred to Verily's cloud server and are viewed by the HCP using a web portal. 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 (used to transfer data from the watch to the cloud), a Cradle, and the web portal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Left hand fingers to right wrist or vice versa (ECG); Wrist (PPG)
Indicated Patient Age Range
22 years and older
Intended User / Care Setting
professional healthcare facility environments, while worn as a wrist watch.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical performance testing was conducted to demonstrate that Study Watch with Irregular Pulse Monitor generates data that meet the clinical requirements for irregular pulse monitoring in target patients. Specifically, the primary clinical study collected Study Watch PPG waveform (Test) data in clinic from patients with a history of AF and applied the PPG-based Irregular Pulse Monitor algorithm, using contemporaneous Holter ECG (Reference) data as ground truth. The presented data include the primary endpoints [per-interval sensitivity 0.85 (0.79-0.90) and specificity 0.96 (0.93-0.99)] showing that the PPG-based Irregular Pulse Monitor algorithm exceeds the pre-specified per-interval performance thresholds for sensitivity and specificity for continuous monitoring. This study demonstrates that the Study Watch with Irregular Pulse Monitor is substantially equivalent to primary predicate Study Watch (K182456) and secondary predicate FibriCheck (K173872) and substantially equivalent to the predicate device for the specified intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 85%
Specificity: 96%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 17, 2020
Verily Life Sciences LLC Richard Stewart Head of Regulatory Affairs 269 E Grand Avenue South San Francisco, California 94080
Re: K192415
Trade/Device Name: 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: December 4, 2019 Received: December 6, 2019
Dear Richard Stewart:
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 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/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 mediation-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 Assistant Director (Acting) 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
2
Indications for Use
510(k) Number (if known) K192415
Device Name Study Watch with Irregular Pulse Monitor
Indications for Use (Describe)
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 Irregular Pulse Monitor is indicated for use in professional healthcare facility environments, while worn as a wrist watch.
| 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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3
510(k) Summary
This summary of 510(k) information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Date Prepared: | January 17, 2020 |
|---|---|
| Submitter: | Verily Life Sciences LLC |
| Official Contact: | Richard M. Stewart, Ph.D. |
| Head of Regulatory Affairs | |
| 269 East Grand Ave | |
| South San Francisco, CA 94080, USA | |
| Telephone: (650) 379-5200 | |
| Fax: +1 650-618-1499 | |
| E-Mail: rmstewart@verily.com | |
| Proprietary Name: | Study Watch with Irregular Pulse Monitor |
| Common Name: | Telephone Electrocardiograph Transmitter and Receiver |
| Classification: | Class II Medical Device |
| Regulation Number: 21 CFR 870.2920 | |
| Product Code: DXH, DPS | |
| Predicate Device: | Primary: Study Watch (K182456) |
| Secondary: FibriCheck (K173872) | |
| Reason For Submission: | New Device |
Indications for Use
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 with Irregular Pulse Monitor is indicated for use in professional healthcare facility environments, while worn as a wrist watch.
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 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 realtime 60-second ECG measurement. The patient is able to capture an ECG rhythm on-demand by navigation to the ECG menu, in response to a daily ECG reminder, or 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 wave form.
4
Using the provided charging dock (Cradle) and Verily's Study Hub device, the ECG measurements are securely transferred to Verily's cloud server and are viewed by the HCP using a web portal. 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 (used to transfer data from the watch to the cloud), a Cradle, and the web portal.
Substantial Equivalence Discussion
Study Watch with Irregular Pulse Monitor is substantially equivalent to the selected primary predicate Study Watch (K182456) and secondary predicate FibriCheck (K173872) in terms of intended use, fundamental scientific technology and operating principle as it relates to K182456 and indication for use and the primary modes of data collection as it relates to K173872. Specifically, both the proposed and primary predicate are intended to record, store, transfer, and display single-channel ECG rhythms in adults with known or suspected heart conditions. Also, both the proposed and secondary predicate are specifically indicated to detect irregular pulse in adults with a diagnosis of, or are susceptible to, AF. Similar to the primary 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 primary 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 primary predicate Study Watch (K182456) and secondary predicate FibriCheck (K173872).
| Manufacturer | Verily Life Sciences, LLC | Verily Life Sciences, LLC | Qompium |
|---|---|---|---|
| Model Name | Study Watch w/ Irregular | ||
| Pulse Monitor | Study Watch | FibriCheck | |
| 510(k) Number | Proposed Device: Kxxxxxx | Primary Predicate: K182456 | Secondary Predicate: |
| K173872 | |||
| Intended | |||
| Use/Indications | |||
| for Use | 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 with Irregular Pulse | |||
| Monitor is indicated for use in professional | |||
| healthcare facility environments, while | |||
| worn as a wrist watch. | The Study Watch is intended to | ||
| record, store, transfer, and display | |||
| single-channel electrocardiogram | |||
| (ECG) rhythms. The Study Watch is | |||
| intended for use by healthcare | |||
| professionals, adult patients with | |||
| known or suspected heart conditions. | |||
| and health conscious individuals. | FibriCheck is indicated for self- | ||
| testing by patients who have been | |||
| diagnosed with, or are susceptible to | |||
| developing, atrial fibrillation and | |||
| who would like to monitor and | |||
| record their heart rhythms on an | |||
| intermittent basis. | |||
| Prescription | |||
| Device for | |||
| Home Use | No | Yes | Yes |
| Regulation | |||
| Number | 21 CFR 870.2920 | 21 CFR 870.2920 | 21 CFR 870.2920 |
| Device | |||
| Classification | |||
| Name | Telephone Electrocardiograph | ||
| Transmitter And Receiver | Telephone Electrocardiograph | ||
| Transmitter And Receiver | Telephone | ||
| Electrocardiograph | |||
| Transmitter And Receiver | |||
| Product Code | DXH, DPS | DXH, DPS | DXH |
| Manufacturer | Verily Life Sciences, LLC | Verily Life Sciences, LLC | Qompium |
| Model Name | Study Watch w/ Irregular | ||
| Pulse Monitor | Study Watch | FibriCheck | |
| 510(k) Number | Proposed Device: Kxxxxxx | Primary Predicate: K182456 | Secondary Predicate: |
| K173872 | |||
| Target | |||
| Population | Adults diagnosed with, or are | ||
| susceptible to developing, atrial | |||
| fibrillation | Adults with known or | ||
| suspected heart conditions, | |||
| and health conscious | |||
| individuals. | Adults diagnosed with, or are | ||
| susceptible to developing, | |||
| atrial fibrillation | |||
| Anatomical | |||
| Site | Left hand fingers to right wrist | ||
| or vice versa (ECG); Wrist | |||
| (PPG) | Left hand fingers to right wrist | ||
| or vice versa (ECG); Wrist | |||
| (PPG) | Finger (PPG) | ||
| Where Used | Mobile/active users at rest | ||
| (ambulatory) | Mobile/active users at rest | ||
| (ambulatory) | Mobile/active users at rest | ||
| (ambulatory) | |||
| Device Design | Study Watch is a wearable | ||
| miniaturized physiological data | |||
| monitoring and data collection | |||
| device for continuous recording | |||
| of physiological and | |||
| environmental data. The | |||
| features single-lead ECG | |||
| capability and a PPG sensor | |||
| among other sensors. The | |||
| watch also includes an | |||
| electronic circuit board, | |||
| batteries, GUI that displays | |||
| watch features and enables | |||
| menu navigation. | Same as proposed device. | FibriCheck obtains | |
| waveform via Mobile | |||
| Platform camera and | |||
| displays signal in real time | |||
| on the Mobile Platform | |||
| device with an arrhythmia | |||
| index. Text display (green, | |||
| amber, or blue) indicates | |||
| heart regularity or | |||
| irregularity. All tests are | |||
| stored. | |||
| Mechanism of | |||
| Action | PPG: The Study Watch | ||
| contains an optical sensor that | |||
| collects the PPG waveform | |||
| from blood flow and this PPG | |||
| raw data is utilized for non- | |||
| medical heart rate data as well | |||
| as irregular pulse notification. | |||
| ECG: User completes circuit | |||
| with skin contact and hardware | |||
| measures ECG waveform, | |||
| which is stored and securely | |||
| transferred to the cloud via the | |||
| proprietary Study Hub. | PPG: The Study Watch | ||
| contains an optical sensor that | |||
| collects the PPG waveform | |||
| from blood flow and this PPG | |||
| raw data is utilized for non- | |||
| medical heart rate data. | |||
| ECG: Same as proposed | |||
| device. | PPG: Uses optical camera | ||
| of a mobile device to collect | |||
| photoplethysmogram data | |||
| (PPG data). FibriCheck | |||
| receives data from the | |||
| Mobile Platform device, | |||
| from which the waveform is | |||
| directly created. The | |||
| irregularity is indicated with | |||
| a text indicator. | |||
| User Interface | Patient: Study Watch | ||
| HCP: Web Portal | Same as proposed device | Patient: Mobile Computing | |
| Platform / Web application | |||
| Principles of | |||
| Operation | PPG data collection (to detect | ||
| irregular pulse) | |||
| ECG: acquisition (for rhythm) | PPG data collection (to | ||
| measure heart rate) | |||
| ECG: Same as proposed | |||
| device. | PPG data collection | ||
| (to detect irregular pulse) | |||
| Recording | |||
| length | 60 Seconds | Same as proposed device. | Same as proposed device. |
| Irregular Pulse | |||
| Performance | Sensitivity: 85% | ||
| Specificity: 96% | N/A | Sensitivity: 96% | |
| Specificity: 97% |
Table 1. Predicate Device Comparison Table
5
6
The differences in technological characteristics associated with the proposed device in comparison to the primary predicate (K182456) and secondary predicate (K173872) have been evaluated through performance testing for target population and there are no new questions of safety and effectiveness. Therefore, the proposed device is substantially equivalent to the predicate devices.
Non-Clinical Performance Data
Performance Testing Bench
Design validation and verification activities were performed for the Study Watch with Irregular Pulse Monitor as a result of the risk analysis assessment and product requirements. Hardware verification completed for the Study Watch with Irregular Pulse Monitor covers performance assessment for the PPG sensor, battery life and memory capacity.
The Firmware verification includes test cases for performance assessment associated with ECG feature per K182456 as well as performance associated with the Irregular Pulse Monitoring feature. Testing completed follows the same software verification approach for the FW as to what was provided in the predicate device Study Watch K182456.
Successfully completed bench performance testing demonstrates the Study Watch with Irregular Pulse Monitor is substantially equivalent to the predicate device for the specified intended use.
Performance Testing Human Factors
The 510(k)-cleared Study Watch per K182456 underwent a human factors assessment demonstrating that the Study Watch is substantially equivalent to the predicate device for the specified intended use (for the ECG feature). This previously completed human factors assessment per K182456 is still applicable as there are no changes to user interface or how the ECG waveform is displayed. Additional human factors assessments were conducted to assess that the system as it relates to the Study Watch with Irregular Pulse Monitor meets user needs and that the Instructions for Use (IFU) support the effective use of the system including specific risk management measures. Two formative studies assessed the instructions for two user groups: Study Watch users and Web Portal users (HCP) and demonstrate that IFU for the Study Watch with Irregular Pulse Monitor can be well comprehended by users, supporting the effective use of the irregular pulse notification feature.
Clinical Performance Data
Clinical performance testing was conducted to demonstrate that Study Watch with Irregular Pulse Monitor generates data that meet the clinical requirements for irregular pulse monitoring in target patients. Specifically, the primary clinical study collected Study Watch PPG waveform (Test) data in clinic from patients with a history of AF and applied the PPG-based Irregular Pulse Monitor algorithm, using contemporaneous Holter ECG (Reference) data as ground truth. The presented data include the primary endpoints [per-interval sensitivity 0.85 (0.79-0.90) and specificity 0.96 (0.93-0.99)] showing that the PPG-based Irregular Pulse Monitor algorithm exceeds the pre-specified per-interval performance thresholds for sensitivity and specificity for continuous monitoring. This study demonstrates that the Study Watch with Irregular Pulse Monitor is substantially equivalent to primary predicate Study Watch (K182456) and secondary predicate FibriCheck (K173872) and substantially equivalent to 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 substantially equivalent to the predicate device for the specified intended use. This testing in addition to the comprehensive comparison to the primary predicate Study Watch (K182456) and secondary predicate FibriCheck (K173872) demonstrate the Study Watch with Irregular Pulse Monitor is substantially equivalent to the named predicate devices for the specified intended use.