(280 days)
Not Found
Yes
The document explicitly states that "The algorithm was developed using machine learning techniques" and describes the training and testing data used for this algorithm.
No.
The device is intended for monitoring and recording heart rhythms, notifying the user of irregular pulses like atrial fibrillation, and recommending ECG acquisition. It does not actively treat or intervene in the disease process.
Yes
The device is intended to monitor and record heart rhythms, notify the user of an irregular pulse (like atrial fibrillation), and recommend ECG acquisition, which are diagnostic functions. It also provides ECG measurements for analysis by a healthcare professional.
No
The device description explicitly states that the Study Watch consists of a wearable watch and band, a Study Hub or Watch app, a Cradle (charging dock), and a web portal. The watch itself incorporates dedicated sensing electrodes for ECG measurement, indicating a significant hardware component beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This device directly measures physiological signals (ECG and PPG) on the body.
- The intended use is to monitor and record heart rhythms and detect irregular pulses. This is a physiological monitoring function, not an analysis of a biological sample.
- The device description focuses on sensing electrodes and waveform acquisition. This aligns with physiological monitoring devices.
While the device uses data collected from the body and employs machine learning for analysis, the fundamental nature of its operation and intended use falls under the category of a physiological monitoring device, not an IVD.
No
The input states "Control Plan Authorized (PCCP) and relevant text: Not Found", which directly indicates that no PCCP was authorized or mentioned in the letter.
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 is intended for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
The algorithm was developed using machine learning techniques.
Input Imaging Modality
Wrist-based PPG, single-channel electrocardiogram (ECG)
Anatomical Site
Left hand fingers to right wrist or vice versa (ECG); Wrist (PPG)
Indicated Patient Age Range
adult patients (22 years and older)
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Home use & In-clinic use
HCP: Web Portal
Description of the training set, sample size, data source, and annotation protocol
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.
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Irregular Pulse Performance (interval-level) In-clinic Use: Sensitivity: 98.3%, Specificity: 100.0%. Home Use: Sensitivity: 96.1%, Specificity: 98.1%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Study Watch with Irregular Pulse Monitor (K192415)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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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.
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
1
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 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.
| 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 Puppala |
| Senior Regulatory Affairs Specialist | |
| 269 East Grand Ave | |
| South San Francisco, CA 94080, USA | |
| Telephone: (650)-267-1263 | |
| E-mail: puppalad@google.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: | Study Watch with Irregular Pulse Monitor (K192415) |
| Reason For Submission: | Additional or Expanded Indications |
| Interoperability with ZEUS System (Zio Watch), an iRhythm | |
| Technologies, Inc. software system |
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 intended for prescription use only.
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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.
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 AF |
| event, as determined by having a diagnosis of paroxysmal AF. | |
| Age: Median = 67 years; Range: 23-86 years | |
| Gender: 45.5% Female | |
| Regional 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 Pulse | |
| Monitor (Home) | Study Watch with Irregular Pulse | |
| Monitor | ||
| 510(k) Number | Subject Device: K213357 | Predicate: K192415 |
| 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 | ||
| 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 facilities. |
| Prescription
Device for Home
Use | Yes (Both Home use & In-clinic
use) | No (Only In-clinic use) |
| Regulation Number | 21 CFR 870.2920 | 21 CFR 870.2920 |
| Device Classification
Name | Telephone Electrocardiograph
Transmitter
And Receiver | Telephone Electrocardiograph
Transmitter
And Receiver |
| Product Code | DXH, DPS | DXH, DPS |
| Target Population | Adults diagnosed with, or are
susceptible to developing, atrial
fibrillation | 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) |
| Where Used | 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 | Study Watch is a wearable
miniaturized physiological data
monitoring and data collection |
| | | |
| | device for continuous recording
of physiological and
environmental data. The watch
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. | device for continuous recording
of physiological and
environmental data. The watch
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. |
| 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.
Additionally, data may be
securely transferred to the cloud
via Bluetooth and a mobile app. | 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. |
| User Interface | Patient: Study Watch
HCP: Web Portal | Patient: Study Watch
HCP: Web Portal |
| Interoperability with
third party ECG & PPG
Analysis Software
systems | Zio Watch (Branded Study
Watch) is interoperable with the
ZEUS System (iRhythm
Technologies) | Not Interoperable with any third
party systems |
| Principles of Operation | PPG data collection (to detect
irregular pulse)
ECG: acquisition (for rhythm) | PPG data collection (to detect
irregular pulse)
ECG: acquisition (for rhythm) |
| Recording Length | 45 Seconds | 60 Seconds |
| Irregular Pulse
Performance ( 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.