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.

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)

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.

AI/ML Overview

The provided text describes the ECG SENTINEL System and its review for substantial equivalence to a predicate device, the RhythmStar System. The document focuses on demonstrating that the new device is as safe and effective as the predicate, rather than providing detailed acceptance criteria and a study to prove the device meets these criteria in the traditional sense of a diagnostic performance study.

Instead, the "acceptance criteria" appear to be compliance with various safety and performance standards for medical electrical equipment, and the "study" is a comparison to a predicate device.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present explicit "acceptance criteria" in the form of quantitative performance targets tied to a diagnostic accuracy study. Instead, the performance is demonstrated through compliance with established industry standards and a comparison of features and technical characteristics with a legally marketed predicate device.

Acceptance Criteria (Implied from Standards & Predicate Comparison)	Reported Device Performance (ECG SENTINEL System)
Safety and Essential Performance Standards
AAMI/ANSI/IEC 60601-2-47:2012 (Ambulatory ECG Systems)	Conforms to this standard.
AAMI/ANSI ES 60601-1:2005/(R) 2012 & A1:2012 (General Safety)	Conforms to this standard.
IEC 60601-1-2, 4th Edition:2014-02 (Electromagnetic Disturbances)	Conforms to this standard.
IEC 60601-1-11 Edition 2.0 2015-01 (Home Healthcare Environment)	Conforms to this standard.
IEC 62304 Edition 1.1 2015-06 (Medical Device Software)	Conforms to this standard.
Functional Performance (Bench Testing)
Ability to record ECG signal	Confirmed.
Ability to store data	Confirmed.
Ability to transmit data to Call Center	Confirmed.
Data can be analyzed at Call Center	Confirmed.
Overall performance as designed	Confirmed.
Substantial Equivalence (Comparison to Predicate: RhythmStar System (K141813))
Intended Use	Essentially the same: patients at risk of cardiac disease, requiring continuous monitoring; records ECG, transfers data to server for review by medical professional.
Product Code	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 (Predicate uses 3 or 5 electrodes, ECG device, server, display and reporting) - Difference: Sentinel uses 2 channels/3 leads, Predicate offers optional 5-lead cable for 3 channels. Not considered a fundamental difference.
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 (Predicate: Analog ECG front-end with Cellular GPRS modem built into device) - Difference: Sentinel uses external mobile phone as bridge to WEB, Predicate has GPRS transmitter built-in. Not considered a fundamental difference.
Energy Source	Two non-chargeable Zinc-Air hearing aid batteries (Predicate: Li-Ion externally chargeable battery) - Both require periodic battery replacement.
AC Powered	No (Same)
Channel Recording	2 (Predicate: 2 or 3)
Bandwidth	0.5Hz to 35Hz (Predicate: 0.05Hz to 40Hz) - Both provide standard monitoring bandwidth. Predicate's lower frequency is for S-T measurements, but neither 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 (Predicate: Detachable 3 or 5 lead cable)
Lead off Detection	Yes (Same)
Accelerometer	No (Predicate: Yes)
Data Transmission	Wireless, via mobile network using Android phone (Same)
Overall System Design	PEMS and Software (Same)
Sterile	Non-sterile (Same)
Single Use	No (Same)
Arrhythmia Detection Algorithm	On server, only (Predicate: In Device) - Both present analyzed data to medical professional. Not considered a fundamental difference.
Alarms	None (Same)
User Event Trigger	Continuous Recording and Transmission (Predicate: Algorithm based or user triggered transmission) - Sentinel's continuous transmission allows all events to be seen by medical staff. Not considered a fundamental difference.
Battery life	Typically 5 days (Predicate: 72 hours (3 Days))
Dimensions	7cm x 5cm x 1.5cm (Predicate: 10cm x 6.6cm x 1.3cm)
Weight (with battery)	85 gm (Predicate: 90 gm)
Operating temperature	10 °C to 45 °C (Predicate: 0 °C to 40°C)
Transport and storage temperature	-25 °C to 70 °C (Same)
Relative humidity	10 % to 95 %, without condensation (Same)

2. Sample size used for the test set and the data provenance

The document does not describe a clinical performance study with a "test set" in the context of diagnostic accuracy. The performance testing section mentions "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." This suggests laboratory-based functional testing, not a clinical study involving a patient sample size. Therefore, sample size and data provenance for a clinical test set are not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As noted above, there is no clinical diagnostic accuracy test set described.

4. Adjudication method for the test set

Not applicable. There is no clinical diagnostic accuracy test set described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study is mentioned. The device's "ECG analysis algorithm at the Server" flags cardiac activity for review by a medical professional, implying a human-in-the-loop system. However, the document does not include a study comparing human performance with and without AI assistance, nor does it quantify any effect size. The focus is on the device's ability to transmit data for professional review.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes "an ECG analysis algorithm at the Server" that flags recorded cardiac activity for review. It explicitly states that the analyzed data is presented to a medical professional for review. The system is designed such that the automated analysis serves to flag events for human review, indicating it's not a standalone diagnostic device. The document does not describe a standalone performance evaluation of the algorithm independent of human review.

7. The type of ground truth used

For the bench testing, the ground truth would inherently be the known, controlled electrical signals or simulated ECG patterns injected into the device to verify its basic functionalities (recording, storage, transmission).
For the "ECG analysis algorithm at the Server," the document states that the flagged activity is reviewed by a "medical professional." While the implication is that the professional's review establishes the ground truth for the flagged events, the document doesn't detail any specific ground truth methodology (e.g., expert consensus, pathology, outcome data) for validating the algorithm's flagging accuracy. The goal is to ensure the data is available for review, not necessarily to validate the algorithm's diagnostic accuracy against a definitive ground truth in this submission.

8. The sample size for the training set

Not mentioned. The document focuses on performance relative to standards and a predicate device, not on the development or training of the ECG analysis algorithm.

9. How the ground truth for the training set was established

Not mentioned. As above, the details of the algorithm's training are not provided in this submission.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K172801

Device Name

ECG SENTINEL System

Indications for Use (Describe)

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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TRADITIONAL 510(K) SUMMARY

Submitted by:	Cardiomedix, Inc.
Contact Person:	Zipora DavidPresidentCardiomedix, Inc.1840 Oak Ave.Evanston, IL 60201Ph: 847 869 0230 x100Fax: 847 869 0850Email: 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 andreceiver (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 transmissionsystem. The SENTINEL device connects viaBluetooth to a proprietary mobile phone-based,dedicated ECG acquisition, storage, andtransmission application. The phone applicationfacilitates the self-use of the device by providingmessages and alerts for specific parameters.
	ECG SENTINEL System refers to the completesystem 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 forstorage, analysis, decision support, and response bya qualified and dedicated team.
	The SENTINEL is intended for use on patients withweighing more than 10 kg (22lbs)

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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

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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.

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K172801

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 SystemCardiomedix, Inc.	RhythmStar SystemRhythmedix(K141813)	Substantial EquivalenceDiscussion
Intended use	The ECG SENTINEL System isintended for use by patients whoeither have or are at risk of havingcardiac disease and those thatdemonstrate intermittentsymptoms indicative of cardiacdisease and require cardiacmonitoring on a continuing basis.The device continuously recordsthe ECG data and transfers thedata to the Server. Upon detectionby an ECG analysis algorithm atthe Server the recorded cardiacactivity is flagged for review by amedical professional.	The RhythmStar System isintended for use by patients whoeither have or are at risk of havingcardiac disease and those thatdemonstrate intermittent systemsindicative of cardiac disease andrequire cardiac monitoring on acontinuing basis.The device continuously recordsECG data and upon detection byan ECG analysis algorithm ormanually initiated by the patient,automatically delivers therecorded cardiac activity to theserver where it is presented andcan be reviewed by a medicalprofessional	The intended use isessentially the same. Thedifference is that theRhythmStar provides anarrhythmia detectionalgorithm on the data prior toit being sent to the Server,while the SENTINEL sendsall the data to the server andperforms arrhythmia analysisat the server. Both devicespresent the analyzed data toa medical professional forreview.
	The data received from theSENTINEL device can be used byanother cleared device forarrhythmia analysis, reporting andsignal measurements. The	The data received from theRhythmStar device can be usedby another device for arrhythmiaanalysis, reporting and signalmeasurements. The RhythmStar
	SENTINEL System is not intendedto sound any alarms.The device does not deliver anytherapy, administer any drugs,provide interpretative or diagnosticstatements or provide for any lifesupport.The SENTINEL System is forprescription use only.	system is not intended to soundany alarms.The device does not deliver anytherapy, administer any drugs,provide interpretive or diagnosticstatements or provide any lifesupport.RhythmStar is for prescription useonly
Product Code	DXH	DXH	Same
Regulation Nameand Number	Transmitters And Receivers,Electrocardiograph, Telephone. 21CFR 870.2920	Same
Patient population	Adults and Infants weighing morethan 10Kg	Same
Environment forIntended Use	Ambulatory, outpatient	Same
Ambulatory ECGperformancestandards	IEC 60601-2-47:2012	Same
SystemDescription	3 off the shelf electrodes, patientpendant, cell phone, server,display and reporting	3 or 5 off the shelf electrodes,ECG device, server, display andreporting	The SENTINEL provides twochannels of ECG, using 3ECG leads, while theRhythmStar offers andoptional 5 lead cable for 3channels of ECG. Inaddition the RhythmStar hasa GPRS transmitter built intothe device to connect to theWEB and the SENTINELuses an external MobilePhone as a bridge to theWEB
Basic Technology	Analog ECG front-end, flash datastorage, BT transmission to(Android) cell phone, cellulartransmission to central server,arrhythmia analysis on centralserver	Analog ECG front-end togetherwith an Cellular GPRS modembuilt into the device	The overall technology is thesame, Analog ECG front-endto collect data that is sent tothe WEB. The maintechnological difference isthat the ECG device worn bythe user transmits data viaBluetooth to a Cell Phonethat then passes the data tothe Server, while theRhythmStar contains theCellular modem inside thedevice to directly send thedata to the Server.
Energy Source	Two non-chargeable Zinc-Airhearing aid batteries	Li-Ion externally chargeablebattery.	Both units require that theuser replace the batteriesperiodically
AC Powered	No	NoUses an external battery chargerto charge the battery.
ChannelRecording	2	2 or 3
Bandwidth	0.5Hz to 35Hz	0.05Hz to 40Hz	Both units provide astandard monitoringbandwidth. The lower 0.05provided by the RhythmStaris typically required for S-Tmeasurements, but neitherunits provides S-Tmeasurements
Common-moderejection 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
DataTransmission	Wireless, via mobile network usingAndroid phone	Same
Overall SystemDesign	PEMS and Software	PEMS and Software
Sterile	non-sterile	Same
Single Use	No	Same
ArrhythmiaDetectionAlgorithm	On server, only.	In Device
Alarms	None	Same
User EventTrigger	Continuous Recording andTransmission	Algorithm based or user triggeredtransmission	Continuous Transmissionallows all events to be seenby 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
Operatingtemperature	10 °C to 45 °C	0 °C to 40°C
Transport andstoragetemperature	-25 °C to 70 °C	-25 °C to 70 °C
Relative humidity	10 % to 95 %, withoutcondensation	10 % to 95 %, withoutcondensation

Substantial Equivalence Table

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K172801

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K172801

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SUBSTANTIAL EQUIVALENCE ANALYSIS

Similarities between the ECG SENTINEL System and the RhythmStar System:

1. Both devices are small, lightweight ambulatory cardiac monitors, intended for the same patient population.
1. Both devices have at least 2 channels and 3 ECG electrodes.
1. The overall technology is the same, with analog ECG front-end to collect data that is sent to the WEB.
1. 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.
1. Both devices are battery powered. The RhythmStar System utilizes a rechargeable Li-lon battery, while the ECG SENTINEL System used replaceable Zinc-Air batteries.
1. 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:

1. 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.
1. 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.
1. 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.

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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).

Regulation Number and Section

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

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