(30 days)
Not Found
Unknown
The document mentions an "ECG analysis algorithm" at the server, but does not explicitly state whether this algorithm utilizes AI or ML. It could be a traditional rule-based algorithm.
No.
The "Intended Use" section explicitly states, "The device does not deliver any therapy, administer any drugs, provide interpretative or diagnostic statements or provide for any life support." This indicates it is a monitoring device, not a therapeutic one.
No
The device collects ECG data and transfers it to a server for analysis, but the description explicitly states, "The device does not deliver any therapy, administer any drugs, provide interpretative or diagnostic statements or provide for any life support." While it aids in the diagnostic process by collecting data for a medical professional to review, it does not, by itself, provide a diagnostic statement.
No
The device description explicitly states that the SENTINEL monitoring device is a dedicated electronic device consisting of an electronic circuit board, batteries, a plastic enclosure, and lead wires, indicating it includes hardware components beyond just software.
Based on the provided information, the SENTINEL System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- SENTINEL System Function: The SENTINEL System is an ECG monitoring device. It records electrical activity of the heart directly from the patient's body (in vivo). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it records ECG data for monitoring cardiac activity and transferring it for review by a medical professional. This is a physiological measurement, not an in vitro test.
Therefore, the SENTINEL System falls under the category of a physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SENTINEL System is intended for use by patients who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis.
The device continuously records the ECG data and transfers the data to the Server. Upon detection by an ECG analysis algorithm at the Server the recorded cardiac activity is flagged for review by a medical professional. The data received from the SENTINEL device can be used by another cleared device for arrhythmia analysis, reporting and signal measurements. The SENTINEL System is not intended to sound any alarms.
The device does not deliver any therapy, administer any drugs, provide interpretative or diagnostic statements or provide for any life support.
The SENTINEL System is for prescription use only.
Product codes
DXH
Device Description
Cardiomedix ECG SENTINEL System is a self-use, 2-lead ECG continuous acquisition and transmission system. The SENTINEL device connects via Bluetooth to a proprietary mobile phone-based, dedicated ECG acquisition, storage, and transmission application. The phone application facilitates the self-use of the device by providing messages and alerts for specific parameters.
ECG SENTINEL System refers to the complete system with all component parts.
SENTINEL refers to the monitoring device only. The SENTINEL data is continuously (long-term) transmitted by the phone to a designated server for storage, analysis, decision support, and response by a qualified and dedicated team.
The ECG SENTINEL System component parts include:
The SENTINEL monitoring device
SENTINEL carrying pouch
Smart phone with pre-installed dedicated application for SENTINEL ECG acquisition, storage and transmission
Smart phone charger and cable
Package of FDA Cleared ECG Electrodes
Replacement batteries
User guide
The SENTINEL monitoring device is a dedicated electronic device that records ECG and consists of electronic circuit board, batteries, a plastic enclosure, and lead wires. The data transmission to the smart phone is via low energy Bluetooth transmission. The smart phone mobile device acts as in in-home communication relay, stores the data, and transfers the data via the WEB, using secure communication, to a call center. The Call Center provides a service platform to monitor, analyze, store, and report ECG data sent from the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The SENTINEL is intended for use by adult or children when supervised by an adult. The Sentinel is intended for use on adults and infants weighing more than 10 kg (22 lbs.).
Intended User / Care Setting
The SENTINEL is intended for home use. The review and analysis of data is intended for use by an appropriately trained medical practitioner.
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)
Performance Testing: The ECG SENTINEL System conforms to the following performance and safety tests:
- AAMI/ANSI/IEC 60601-2-47:2012 Medical -Electrical Equipment - Part 2-47: Particular Requirements for the Basic Safety and Essential Performance of Ambulatory Electrocardiographic Systems
- AAMI/ANSI ES 60601-1:2005/(R) 2012 & -A1:2012- Medical Electrical Equipment -Part 1: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, mod). (General II (ES/EMC))
- IEC 60601-1-2, 4th Edition:2014-02 Medical -Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances-Requirements and Tests
- IEC 60601-1-11 Edition 2.0 2015-01 -Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems used in the Home Healthcare Environment
- IEC 62304 Edition 1.1 2015-06, medical device software - software life cycle processes.
Bench testing verifies that the ECG SENTINEL System can record ECG signal, store data, transmit data to the Call Center, where the data can be analyzed.
Test results confirm that the ECG SENTINEL System performs as designed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
RhythmStar System (K141813)
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 18, 2017
Cardiomedix, Inc. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K172801
Trade/Device Name: ECG SENTINEL System Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II Product Code: DXH Dated: September 14, 2017 Received: September 18, 2017
Dear Mark Job:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
M.A. Wilhelm
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172801
Device Name
ECG SENTINEL System
Indications for Use (Describe)
The SENTINEL System is intended for use by patients who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis.
The device continuously records the ECG data and transfers the data to the Server. Upon detection by an ECG analysis algorithm at the Server the recorded cardiac activity is flagged for review by a medical professional. The data received from the SENTINEL device can be used by another cleared device for arrhythmia analysis, reporting and signal measurements. The SENTINEL System is not intended to sound any alarms.
The device does not deliver any therapy, administer any drugs, provide interpretative or diagnostic statements or provide for any life support.
The SENTINEL System is for prescription use only.
User Population:
The SENTINEL is intended for use by adult or children when supervised by an adult. The Sentinel is intended for use on adults and infants weighing more than 10 kg (22 lbs.).
Intended Operator Profile:
The SENTINEL is intended for home use. The review and analysis of data is intended for use by an appropriately trained medical practitioner.
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
TRADITIONAL 510(K) SUMMARY
| Submitted by: | Cardiomedix, Inc. |
|---|---|
| Contact Person: | Zipora David |
| President | |
| Cardiomedix, Inc. | |
| 1840 Oak Ave. | |
| Evanston, IL 60201 | |
| Ph: 847 869 0230 x100 | |
| Fax: 847 869 0850 | |
| Email: zipora@cardiomedix.com | |
| Date of Summary: | October 17, 2017 |
| Device Trade Name: | ECG SENTINEL System |
| Common or Usual Name: | Mobile Cardiac Monitor |
| Classification Name: | Telephone electrocardiograph transmitter and |
| receiver (21 CFR 870.2920) | |
| Class: | II |
| Product Code: | DXH |
| Predicate Device(s): | RhythmStar System (K141813) |
| Device Description: | Cardiomedix ECG SENTINEL System is a self-use, |
| 2-lead ECG continuous acquisition and transmission | |
| system. The SENTINEL device connects via | |
| Bluetooth to a proprietary mobile phone-based, | |
| dedicated ECG acquisition, storage, and | |
| transmission application. The phone application | |
| facilitates the self-use of the device by providing | |
| messages and alerts for specific parameters. | |
| ECG SENTINEL System refers to the complete | |
| system with all component parts. | |
| SENTINEL refers to the monitoring device only. | |
| The SENTINEL data is continuously (long-term) | |
| transmitted by the phone to a designated server for | |
| storage, analysis, decision support, and response by | |
| a qualified and dedicated team. | |
| The SENTINEL is intended for use on patients with | |
| weighing more than 10 kg (22lbs) |
4
Intended Use: The SENTINEL System is intended for use by patients who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis. The device continuously records the ECG data and transfers the data to the Server. Upon detection by an ECG analysis algorithm at the Server the recorded cardiac activity is flagged for review by a medical professional. The data received from the SENTINEL device can be used by another cleared device for arrhythmia analysis, reporting and signal measurements. The SENTINEL System is not intended to sound any alarms. The device does not deliver any therapy, administer any drugs, provide interpretative or diagnostic statements or provide for any life support. The SENTINEL System is for prescription use only. User Population: The SENTINEL is intended for use by adult or children when supervised by an adult. The Sentinel is intended for use on adults and infants weighing more than 10 kq (22 lbs.). Intended Operator Profile: The SENTINEL is intended for home use. The review and analysis of data is intended for use by an appropriately trained medical practitioner. Technoloqical Characteristics: The ECG SENTINEL System component parts include: The SENTINEL monitoring device --SENTINEL carrying pouch Smart phone with pre-installed dedicated । application for SENTINEL ECG acquisition, storage and transmission Smart phone charger and cable --Package of FDA Cleared ECG Electrodes Replacement batteries -
- -User guide
The SENTINEL monitoring device is a dedicated electronic device that records ECG and consists of
5
electronic circuit board, batteries, a plastic enclosure, and lead wires. The data transmission to the smart phone is via low energy Bluetooth transmission. The smart phone mobile device acts as in in-home communication relay, stores the data, and transfers the data via the WEB, using secure communication, to a call center. The Call Center provides a service platform to monitor, analyze, store, and report ECG data sent from the patient.
Performance Testing: The ECG SENTINEL System conforms to the following performance and safety tests:
- AAMI/ANSI/IEC 60601-2-47:2012 Medical -Electrical Equipment - Part 2-47: Particular Requirements for the Basic Safety and Essential Performance of Ambulatory Electrocardiographic Systems
- AAMI/ANSI ES 60601-1:2005/(R) 2012 & -A1:2012- Medical Electrical Equipment -Part 1: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, mod). (General II (ES/EMC))
- IEC 60601-1-2, 4th Edition:2014-02 Medical -Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances-Requirements and Tests
- IEC 60601-1-11 Edition 2.0 2015-01 -Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems used in the Home Healthcare Environment
- -IEC 62304 Edition 1.1 2015-06, medical device software - software life cycle processes.
Bench testing verifies that the ECG SENTINEL System can record ECG signal, store data, transmit data to the Call Center, where the data can be analyzed.
Test results confirm that the ECG SENTINEL System performs as designed.
6
Substantial Equivalence The ECG SENTINEL System is substantially equivalent to the RhythmStar System (K141813), Rationale: manufactured by Rhythmedix, LLC.
The table, below, provides a side-by-side comparison between the ECG SENTINEL System and the RhythmStar System, with regards to the intended use, technology characteristics, principles of operation, and performance specifications. There are no fundamental differences between the ECG SENTINEL System and the predicate product, therefore supporting the final determination of substantial equivalence.
| Device Attribute | ECG SENTINEL System
Cardiomedix, Inc. | RhythmStar System
Rhythmedix
(K141813) | Substantial Equivalence
Discussion |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The ECG SENTINEL System is
intended for use by patients who
either have or are at risk of having
cardiac disease and those that
demonstrate intermittent
symptoms indicative of cardiac
disease and require cardiac
monitoring on a continuing basis.
The device continuously records
the ECG data and transfers the
data to the Server. Upon detection
by an ECG analysis algorithm at
the Server the recorded cardiac
activity is flagged for review by a
medical professional. | The RhythmStar System is
intended for use by patients who
either have or are at risk of having
cardiac disease and those that
demonstrate intermittent systems
indicative of cardiac disease and
require cardiac monitoring on a
continuing basis.
The device continuously records
ECG data and upon detection by
an ECG analysis algorithm or
manually initiated by the patient,
automatically delivers the
recorded cardiac activity to the
server where it is presented and
can be reviewed by a medical
professional | The intended use is
essentially the same. The
difference is that the
RhythmStar provides an
arrhythmia detection
algorithm on the data prior to
it being sent to the Server,
while the SENTINEL sends
all the data to the server and
performs arrhythmia analysis
at the server. Both devices
present the analyzed data to
a medical professional for
review. |
| | The data received from the
SENTINEL device can be used by
another cleared device for
arrhythmia analysis, reporting and
signal measurements. The | The data received from the
RhythmStar device can be used
by another device for arrhythmia
analysis, reporting and signal
measurements. The RhythmStar | |
| | SENTINEL System is not intended
to sound any alarms.
The device does not deliver any
therapy, administer any drugs,
provide interpretative or diagnostic
statements or provide for any life
support.
The SENTINEL System is for
prescription use only. | system is not intended to sound
any alarms.
The device does not deliver any
therapy, administer any drugs,
provide interpretive or diagnostic
statements or provide any life
support.
RhythmStar is for prescription use
only | |
| Product Code | DXH | DXH | Same |
| Regulation Name
and Number | Transmitters And Receivers,
Electrocardiograph, Telephone. 21
CFR 870.2920 | Same | |
| Patient population | Adults and Infants weighing more
than 10Kg | Same | |
| Environment for
Intended Use | Ambulatory, outpatient | Same | |
| Ambulatory ECG
performance
standards | IEC 60601-2-47:2012 | Same | |
| System
Description | 3 off the shelf electrodes, patient
pendant, cell phone, server,
display and reporting | 3 or 5 off the shelf electrodes,
ECG device, server, display and
reporting | The SENTINEL provides two
channels of ECG, using 3
ECG leads, while the
RhythmStar offers and
optional 5 lead cable for 3
channels of ECG. In
addition the RhythmStar has
a GPRS transmitter built into
the device to connect to the
WEB and the SENTINEL
uses an external Mobile
Phone as a bridge to the
WEB |
| Basic Technology | Analog ECG front-end, flash data
storage, BT transmission to
(Android) cell phone, cellular
transmission to central server,
arrhythmia analysis on central
server | Analog ECG front-end together
with an Cellular GPRS modem
built into the device | The overall technology is the
same, Analog ECG front-end
to collect data that is sent to
the WEB. The main
technological difference is
that the ECG device worn by
the user transmits data via
Bluetooth to a Cell Phone
that then passes the data to
the Server, while the
RhythmStar contains the
Cellular modem inside the
device to directly send the
data to the Server. |
| Energy Source | Two non-chargeable Zinc-Air
hearing aid batteries | Li-Ion externally chargeable
battery. | Both units require that the
user replace the batteries
periodically |
| AC Powered | No | No
Uses an external battery charger
to charge the battery. | |
| Channel
Recording | 2 | 2 or 3 | |
| Bandwidth | 0.5Hz to 35Hz | 0.05Hz to 40Hz | Both units provide a
standard monitoring
bandwidth. The lower 0.05
provided by the RhythmStar
is typically required for S-T
measurements, but neither
units provides S-T
measurements |
| Common-mode
rejection ratio
(CMRR) | Meets IEC60601-2-47 standards | same | |
| Sampling Rate | Minimum 125 typical 250 Hz | same | |
| Patient Cable | Built-in 3 lead cable | Detachable 3 or 5 lead cable | |
| Lead off Detection | Yes | Yes | |
| Accelerometer | No | Yes | |
| Data
Transmission | Wireless, via mobile network using
Android phone | Same | |
| Overall System
Design | PEMS and Software | PEMS and Software | |
| Sterile | non-sterile | Same | |
| Single Use | No | Same | |
| Arrhythmia
Detection
Algorithm | On server, only. | In Device | |
| Alarms | None | Same | |
| User Event
Trigger | Continuous Recording and
Transmission | Algorithm based or user triggered
transmission | Continuous Transmission
allows all events to be seen
by the medical staff. |
| Battery life | Typically 5 days | 72 hours (3 Days) | |
| Dimensions | 7cm x 5cm x 1.5cm | 10cm x 6.6cm x 1.3cm | |
| Weight
(with battery) | 85 gm | 90 gm | |
| Operating
temperature | 10 °C to 45 °C | 0 °C to 40°C | |
| Transport and
storage
temperature | -25 °C to 70 °C | -25 °C to 70 °C | |
| Relative humidity | 10 % to 95 %, without
condensation | 10 % to 95 %, without
condensation | |
Substantial Equivalence Table
7
8
K172801
9
K172801
10
SUBSTANTIAL EQUIVALENCE ANALYSIS
Similarities between the ECG SENTINEL System and the RhythmStar System:
-
- Both devices are small, lightweight ambulatory cardiac monitors, intended for the same patient population.
-
- Both devices have at least 2 channels and 3 ECG electrodes.
-
- The overall technology is the same, with analog ECG front-end to collect data that is sent to the WEB.
-
- RhythmStar has a GPRS transmitter built into the device to connect to the WEB and the ECG SENTINEL System uses an external Mobile Phone as a bridge to the WEB.
-
- Both devices are battery powered. The RhythmStar System utilizes a rechargeable Li-lon battery, while the ECG SENTINEL System used replaceable Zinc-Air batteries.
-
- Both units provide the standard monitoring bandwidth.
There are known differences between the ECG SENTINEL System and the RhythmStar System that do not impact the safety or effectiveness:
-
- RhythmStar provides an arrhythmia detection algorithm on the data prior to it being sent to the server, while the ECG SENTINEL device sends all the data to the server and performs arrhythmia analysis at the server. Both devices present the analyzed data to a medical professional for review.
-
- The ECG SENTINEL System transmits data via Bluetooth to a Cell Phone that then passes the data to the server, while the RhythmStar contains the Cellular modem inside the device to directly send the data to the server. Both devices utilize a mobile network to deliver data to the server.
-
- The RhythmStar System incorporates an algorithm based or user triggered event trigger. The ECG SENTINEL System provides continuous recording and transmission of the data with an ECG analysis algorithm at the server. Both devices provide the ability for detection of arrhythmia events and activity identified for subsequent review by a medical professional.
The analysis of the differences between the ECG SENTINEL System and RhythmStar system do not raise any new questions of safety and effectiveness. Both devices have or very similar functional, environmental, and electrical characteristics. The ECG SENTINEL System is safe, effective, performs within the design specifications, and is substantially equivalent to the predicate, RhythmStar System.
11
Conclusion: Based on the non-clinical testing conducted, the ECG SENTINEL System is considered safe, and is effective when used as indicated. Therefore, ECG SENTINEL System is substantially equivalent to the legally marketed predicate device, RhythmStar System (K141813).