(132 days)
Not Found
No
The description focuses on data acquisition, storage, transfer, and display without mentioning any analytical or interpretive functions performed by the device itself using AI/ML. The analysis is explicitly stated to be performed by the healthcare professional using a web portal that "does not include any analysis features."
No.
The device's intended use is to "record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms" for monitoring and diagnostic purposes, not for direct treatment or therapy.
Yes
The device records and displays single-channel ECG rhythms for healthcare professionals to view, which is used for assessing known or suspected heart conditions. This data collection serves as a tool for diagnosis, even though the device itself doesn't perform automated analysis or provide a diagnostic output to the patient.
No
The device description explicitly states that the Study Watch consists of a wearable watch and band, the Study Hub, a Cradle, and a web portal. This includes hardware components beyond just software.
Based on the provided information, the Study Watch is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Study Watch Function: The Study Watch directly measures electrical activity of the heart (ECG) from the surface of the skin. It does not analyze biological specimens.
- Intended Use: The intended use is to record, store, transfer, and display ECG rhythms for use by healthcare professionals and individuals. This is a physiological measurement, not an analysis of a biological sample.
Therefore, the Study Watch falls under the category of a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
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 (22 years or older) with known or suspected heart conditions, and health conscious individuals.
Product codes (comma separated list FDA assigned to the subject device)
DXH, DPS
Device Description
The Study Watch is a miniaturized physiological data monitoring device that is intended to record, store, transfer and display single-channel electrocardiogram (ECG) rhythms. 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 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 60-second ECG measurement. 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 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
Indicated Patient Age Range
adult patients (22 years or older)
Intended User / Care Setting
healthcare professionals, adult patients (22 years or older) with known or suspected heart conditions, and health conscious individuals.
Mobile/active users at rest (ambulatory)
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 the Study Watch generates data that meets the clinical quality requirements for an accurate ECG waveform display. The presented data shows qualitative clinical equivalence and inter-beat interval Bland-Altman analysis with Bias of 1.2ms and 95% limits-of-agreement
§ 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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January 17, 2019
Verily Life Sciences LLC Shilpa Mydur Sr. Principal, Regulatory Affairs 269 E Grand Avenue South San Francisco, California 94080
Re: K182456
Trade/Device Name: Study Watch Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter And Receiver Regulatory Class: Class II Product Code: DXH, DPS Dated: December 20, 2018 Received: December 20, 2018
Dear Shilpa Mydur:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica E. Paulsen -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182456
Device Name Study Watch
Indications for Use (Describe)
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 (22 years or older) with known or suspected heart conditions, and health conscious individuals.
| 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 -Study Watch
| Date Prepared: | January 11, 2019 |
|---|---|
| Submitter: | Verily Life Sciences LLC |
| Official Contact: | Shilpa Mydur |
| Sr. Principal, Regulatory | |
| Affairs 269 E Grand Ave | |
| South San Francisco, CA 94080, USA | |
| Telephone: +1-415-736-0652 | |
| Fax: +1650-618-1499 | |
| E-Mail: smydur@google.com | |
| Proprietary Name: | Study Watch |
| Common Name: | Telephone Electrocardiograph Transmitter and Receiver |
| Classification: | Class II Medical Device |
| Requlation Number: 21 CFR 870.2920 | |
| Product Code: DXH, DPS | |
| Predicate Device: | AliveCor Kardia Band (K171816) |
| Reason For Submission: | New Device |
Indications for Use
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 (22 years or older) with known or suspected heart conditions, and health conscious individuals.
Device Description
The Study Watch is a miniaturized physiological data monitoring device that is intended to record, store, transfer and display single-channel electrocardiogram (ECG) rhythms. 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 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 60-second ECG measurement. 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 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.
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Substantial Equivalence Discussion
The Study Watch has the following similarities to the previously cleared predicate device:
- Similar Intended Use A
- ♪ Similar Technological Characteristics
- ハ Similar Performance Specifications
A comparative summary of the technological characteristics of the Study Watch with the predicate device AliveCor Kardia Band (K171816) is presented below:
| Characteristic | AliveCor Kardia Band (K171816) | Study Watch (New Device) |
|---|---|---|
| Indications for | ||
| Use | The Kardia Band System is intended to | |
| record, store and transfer single-channel | ||
| electrocardiogram (ECG) rhythms. The | ||
| Kardia Band System also displays ECG | ||
| rhythms and detects the presence of | ||
| atrial fibrillation and normal sinus rhythm | ||
| (when prescribed or used under the care | ||
| of a physician). The Kardia Band | ||
| System is intended for use by | ||
| healthcare professionals, adult patients | ||
| with known or suspected heart | ||
| conditions, and health conscious | ||
| individuals. | 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 (22 years or older) with | ||
| known or suspected heart conditions, | ||
| and health conscious individuals. | ||
| Product Code | DXH, DPS | DXH, DPS |
| Mechanism of | ||
| Action | User completes circuit with skin contact | |
| and hardware transmits audio signal to | ||
| MCP to convert and display ECG | ||
| waveform | 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 | ||
| Where Used | Mobile/active users at rest (ambulatory) | Same |
| Anatomical Sites | Left hand fingers to right wrist or vice | |
| versa | Same | |
| Data Acquisition: | ||
| Frequency | ||
| Response | 0.5 Hz - 40 Hz | 0.16 Hz - 40 Hz |
| ECG Channels | Single Channel | Same |
| Resolution | 16 bit | Same |
| Sample Rate | 300 Samples/Second | 240 Samples/Second |
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Image /page/5/Picture/0 description: The image shows the word "verily" in red font. The font is sans-serif and has a modern, clean look. The letters are evenly spaced and the word is easy to read. There is a red line under the "ve" in the word.
| Memory Capacity | Essentially unlimited due to real-time
transmission to MCP memory (size of
ECG file is miniscule - kilobytes
compared to device memory capacity –
gigabytes) | 512 MB |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Number of ECG
Leads | Single lead, 2 sensing electrodes | Single lead, 2 sensing electrodes and 1
right-leg drive (RLD) electrode |
| Power Supply:
Battery | 1 Lithium Manganese Dioxide Coin Cells | 1 Lithium Polymer Rechargeable
Battery |
| Battery Life | 100 hours operational | 112 Hours Per Full Charge |
| User Interface: | Lead I, Left to Right | Same |
| Primary Lead | Ultrasonic acoustics | USB |
| Data Acquisition | Apple Watch Band and Sensor | Study Watch |
| Hardware
Software
Interface | Apple iOS based software and Apple
WatchOS based software | Study Watch Graphical User Interface,
Web Portal |
| Physical Specs:
Dimensions | 24.5 x 24.5 x 6.5 mm | 42.6 x 42.3 x 11 mm |
| Weight | 9 grams | 22 grams (without watch band) |
| Prescribed | Prescription and OTC | Prescription |
| Environmental:
Operating Temp
Storage Temp | 10 to 40 degrees C
-20 to 60 degrees C | -5 to 40 degrees C
-25 to 70 degrees C |
| Communications | Ultrasonic Acoustics acquired by watch | USB via Study Hub |
The major differences between the Study Watch and the AliveCor Kardia Band are as follows:
-
Indications for Use: The Indications for Use statement for Study Watch is not identical to that of the predicate device. The intended use of the predicate device includes detection of atrial fibrillation and normal sinus rhythm based on a system analysis of the collected ECG waveform. These analysis features are not present in the Study Watch, and the proposed device is solely intended to record, store, transfer and display ECG waveforms. The Study Watch patient uses the device to record and transfer ECG waveforms to the healthcare provider, but does not have direct access to independently view these data. Accordingly, the Study Watch is only intended for prescription use.
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- Δ Data Collection: The Study Watch features a band and proprietary watch that incorporates two dedicated sensing electrodes to enable single-channel ECG measurement. The first of the sensing electrodes is positioned on the top of the watch, and the other sensing electrode is at the bottom of the watch contacting the user's wrist. When the user wears the watch on one wrist and contacts the top of the watch with the other hand, an acquisition loop is created and an ECG measurement is generated. The watch also includes a third electrode known as a right-leq drive (RLD) electrode which functions to reduce electrical interference from the environment to improve signal quality. The predicate device functions similarly to acquire ECG data from two sensing electrodes on a proprietary watch band, but does not incorporate the RLD electrode. The addition of the RLD electrode does not affect the stated intended use or fundamental scientific technology of the proposed device.
- A Data Transmission: The Study Watch uses a system whereby ECG data is collected by the wearable watch and is then transferred to Verily's Study Hub device via a USB connection to the included charging dock (Cradle). The data are then transferred from the Study Hub to Verily's cloud server for storage using the Study Hub and are then viewed by the HCP using a web portal. The predicate device uses a system that transfers the ECG signal from its electrodes to mobile medical application on the Apple Watch to be analyzed and presented directly to the user.
- A User Access: For the Study Watch, the ECG data is collected by the patient, but is only viewable in its final form by an HCP using the web portal. The predicate device enables viewing of the ECG waveform data by the patient using a dedicated mobile medical application.
The differences in technological characteristics have been evaluated through performance testing and do not raise any new questions of safety and effectiveness, and therefore the proposed device is substantially equivalent to the predicate device.
Non-Clinical Performance Data
Design validation and verification activities were performed for the Study Watch as a result of the risk analysis assessment and product requirements. Testing included validation of specifications related to software development, sensor performance, stability and material properties. All tests confirmed that the product met the predetermined acceptance criteria. In particular, non-clinical performance testing demonstrated that the Study Watch is substantially equivalent to the predicate device when taking into account its intended use.
The Study Watch was designed and tested in accordance with the applicable requirements in relevant FDA guidance documents and international standards including:
- ISO 14971 (2012): Medical Devices - Application of Risk Managementto Medical Devices.
- . IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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- . IEC 60601-2-47:2012/ (R)2016 Medical electrical equipment - Part 2-47:Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
- IEC 62133 Battery Safety Testing
- . IEC 62304:2006 Medical device software -- Software life cycle processes
- . ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
- . ISTA 2A (2011): Partial Simulation Performance Tests (Packaging). Packaged-Products 150 lb (68 kg) Or Less.
Clinical Performance Data
Clinical performance testing was conducted to demonstrate that the Study Watch generates data that meets the clinical quality requirements for an accurate ECG waveform display. The presented data shows qualitative clinical equivalence and inter-beat interval Bland-Altman analysis with Bias of 1.2ms and 95% limits-of-agreement