The Rhythm Express remote cardiac monitoring system is intended for use by adult 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 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 data received from the Rhythm Express device can be used by another device for arrhythmia analysis, reporting and signal measurements. The Rhythm Express device is not intended to sound any alarms.

The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support. The Rhythm Express system communicates events from the patient to the monitoring center within one to seven minutes (assuming cell service is available) and hence is not suitable for use as a real-time arrhythmia event monitor.

Device Description

The Rhythm Express RX-1 will be worn by adult patients for a period of time as prescribed by a physician, typically 1 day to 4 weeks, and will continuously monitor ECG. RX-1 will function in one of three modes: a) Mobile Cardiac Telemetry (MCT), b) Event Recorder (ER), and Wireless Holter (WH). The device will connect to standard ECG electrodes to capture 2 channel ECGs. An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. RX-1 incorporates a cellular modem to communicate with the RS-1 Web Service. The RX-1 device uses an embedded cellular modem on the Verizon LTE network.

The RX-1 device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data.

AI/ML Overview

The provided text is a 510(k) Summary for the VivaQuant Inc. RX-1 Rhythm Express Remote Cardiac Monitoring System. It outlines the device's indications for use, comparison with a predicate device, and a summary of performance testing. However, it does not include specific acceptance criteria for the device features, nor does it detail a study that defines these criteria and reports the device's performance against them in a quantitative way (e.g., sensitivity, specificity, accuracy for arrhythmia detection).

The document mentions "Bench test results verify that RX-1 Monitor system can continuously record ECG signal, store ECG data in the device memory, and transmit manual or auto activated event recordings to the server via mobile network connection for evaluation by a medical professional. Test results verify that all requirements were met and that the RX-1 Monitor performs as designed." However, these are general statements and do not provide the detailed information requested regarding specific acceptance criteria and performance metrics for the device's core functionality (e.g., arrhythmia detection accuracy).

Therefore, I cannot fully answer your request based on the provided text.

Here's a breakdown of what can and cannot be extracted from the document:

1. Table of acceptance criteria and the reported device performance:

Cannot be provided. The document states that "Test results verify that all requirements were met and that the RX-1 Monitor performs as designed," but it does not specify what those requirements (acceptance criteria) are in a measurable way (e.g., a specific sensitivity or specificity for detecting an arrhythmia type). It also does not present numerical performance results against such criteria.

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

Cannot be provided. The document mentions "Bench test results" but does not specify any sample sizes (e.g., number of ECG recordings, duration of recordings) or the provenance (country of origin, retrospective/prospective) of any data used for testing the device's analytical capabilities. The testing listed focuses on electrical safety, EMC, usability, and biocompatibility.

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

Cannot be provided. There is no mention of an expert panel or their qualifications for establishing ground truth for any performance evaluation in the provided summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Cannot be provided. No adjudication method is described, as there's no detailed mention of a test set where adjudication would be applicable specifically for algorithm performance.

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:

Cannot be provided. The document does not describe any MRMC study or any study evaluating the improvement of human readers with AI assistance. The device is described as capturing and transmitting data for review by a medical professional, implying human-in-the-loop, but no comparative effectiveness data is presented.

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

Cannot be directly confirmed with metrics. The document states "An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology." This indicates a standalone algorithmic function. However, no performance metrics (e.g., sensitivity, specificity, accuracy) for this standalone algorithm's detection capabilities are provided. The only statement is that "Test results verify that all requirements were met and that the RX-1 Monitor performs as designed," which is not specific enough.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Cannot be provided. Since no specific performance study with metrics is detailed for the arrhythmia detection algorithm, the type of ground truth used is not mentioned.

8. The sample size for the training set:

Cannot be provided. There is no information in the document about a training set or its sample size.

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

Cannot be provided. There is no information about how ground truth was established for a training set.

In summary, the provided 510(k) Summary focuses on substantial equivalence to a predicate device and general safety/performance testing (electrical, EMC, usability, biocompatibility) rather than detailed algorithmic performance for arrhythmia detection with specific acceptance criteria and study results.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 16, 2019

VivaQuant Inc. % Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K183704

Trade/Device Name: RX-1 Rhythm Express Remote Cardiac Monitoring System Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter And Receiver Regulatory Class: Class II Product Code: DXH Dated: February 7, 2019 Received: February 11, 2019

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 mav, 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 avare 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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.

Arielle Drummond -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)

K183704

Device Name

RX-1 Rhythm Express Remote Cardiac Monitoring System

Indications for Use (Describe)

The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

(as required by 21CFR 807.92)

SUBMITTER l.

VivaQuant Inc. 4339 Nancy Place, Suite 100, St. Paul, MN 55126 Contact Person: Brian Brockway bbrockway@vivaquant.com Phone: 651-217-2176 Date Prepared: February 15, 2019

II. DEVICE

Name of Device: RX-1 Rhythm Express Remote Cardiac Monitoring System Classification Name: 870.2920 Telephone electrocardiograph transmitter and receiver. Common or Usual Name: Mobile Cardiac Monitor Device Panel: Cardiovascular Regulatory Class: Class 2 Product Code: DXH

PREDICATE DEVICE III.

The RX-1 system is substantially equivalent in intended use and similar technological characteristics to the following device, Rhythmedix, LLC. RhythmStar System which was cleared under K141813.

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IV. DEVICE DESCRIPTION

The RX-1 device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data.

V. INTENDED USE

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SUMMARY OF TECHNOLIGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The RX-1 system is substantially equivalent in intended use and similar technological characteristics of RhythmStar System cleared under K141813.

Category	Identical/Different	RX-1	RhythmStar
510(k) Number		K183704	K141813
Classification	Identical	Medical	Medical
Name		Mobile Cardiac Monitor	Mobile Cardiac Monitor
Product Code	Similar	DXH	DXH
Intended Use	Similar	The Rhythm Express remotecardiac monitoring system isintended for use by adult patientswho either have or are at risk ofhaving cardiac disease and thosethat demonstrate intermittentsymptoms indicative of cardiacdisease and require cardiacmonitoring on a continuing 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 data received from theRhythm Express device can beused by another device forarrhythmia analysis, reporting andsignal measurements. The RhythmExpress device is not intended to	The RhythmStar 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 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 data received from theRhythmStar device can be used byanother device for arrhythmiaanalysis, reporting and signalmeasurements. The RhythmStarsystem is not intended to soundany alarms. The device does not
Category	Identical/Different	RX-1	RhythmStar
		sound any alarms.The device does not deliver anytherapy, administer any drugs,provide interpretive or diagnosticstatements or provide for any lifesupport. The Rhythm Expresssystem communicates eventsfrom the patient to the monitoringcenter within one to sevenminutes (assuming cell service isavailable) and hence is notsuitable for use as a real-timearrhythmia event monitor.	deliver any therapy, administerany drugs, provide interpretive ordiagnostic statements or providefor any life support. RhythmStar isfor prescription use only.
Delivered deviceincludes	Similar	RX-1 device-patient 2 lead 4 wire ECG cable-internal rechargeable battery-Wall Battery charger	RhythmStar monitor- Patient 3 lead ECG lead cable— 2 externally re-chargeablebatteries- Wall battery charger
Monitor functionalblocks	Similar	analog ECG front end,DSPMCU,flash data storage,RF modem fordata transmission,LCD screen, andkeypad,	analog ECG front end,MCU,flash data storage,RF modem fordata transmission,LCD screen, andkeypad,accelerometer
The server:	Similar	facilitate data communicationwith the RX-1 device,	facilitate data communicationwith the RhythmStar device,
Category	Identical/Different	RX-1	RhythmStar
		provide data storage, andpresent the data for evaluation bya medical professional	provide data storage, andpresent the data for evaluation bya medical professional
Device form factor	Similar	small, lightweightambulatory cardiac monitors.	small, lightweightambulatory cardiac monitors.
Wireless technologyused to transmit datato server	Identical	Yes	Yes
Device is batterypowered by arechargeable Li-Ionbattery	Identical	Yes	Yes
using a server, canadjust deviceprogrammingparameters such aspre-post recordingtimes and auto-triggeringconfiguration.	Identical	Yes	Yes
Devices incorporatean accelerometer tocapture activity leveldata related topatient motion anddevice orientation.	Different	No	Yes
devices have keypadfor manual eventrecordings and a userinterface to indicatedevice status andmode of operation.	similar	Yes	Yes
Category	Identical/Different	RX-1	RhythmStar
Device incorporateembedded ECGanalysis algorithm toauto-captureBradycardia,Tachycardia, AtrialFibrillation/AtrialFlutter andarrhythmia eventsbetween the signalacquisition point andthe server.	Similar	Yes	Yes
device has at least 2ECG channels and 3-lead electrodes	Similar	Yes	Yes
Functional,Environmental andElectricalcharacteristics	Similar	Yes	Yes
USB connection	Different	Yes, used to charge the battery,cannot be connected during ECGrecording, not used for datadownload.	Yes, used only for data downloadand secondary communication,cannot be connected during ECGrecording

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PERFORMANCE TESTING VII.

The following performance and safety tests have been passed successfully:

. IEC 60601-2-47:2012 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
. IEC 60601-1-2:2014 4th Edition, Medical Electrical Equipment -Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility -Requirements and tests.
IEC 60601-1-11:2015 Edition 1.1, Medical electrical equipment -●

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Part 1-11: 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.

ANSI/AAMI TIR57:2015, Principles for medical device security-● Risk management
IEC 62366-1:2015 Edition 1.0. Medical devices - Part 1: Application of usability engineering to medical devices
ANSI IEEE C63.27-2017 Evaluation of Wireless Coexistence ●
Biocompatibility testing of patient contacting materials according . to ISO 10993-1.
Bench test results verify that RX-1 Monitor system can continuously record ECG signal, store ECG data in the device memory, and transmit manual or auto activated event recordings to the server via mobile network connection for evaluation by a medical professional. Test results verify that all requirements were met and that the RX-1 Monitor performs as designed.

VIII. SUBSTANTIAL EQUIVALENCE RATIONALE

The intended use. performance and technological characteristics of the RX-1 Monitor system compared to the named predicate device demonstrates that the RX-1 Monitor is substantially equivalent to the predicate.

CONCLUSIONS IX.

The analysis of the differences between RX-1 Monitor and the predicate device does not raise new questions of safety and effectiveness. Based on device performance test results, it can be concluded that the RX-1 Monitor system performs within its design specifications and is substantially equivalent to the predicate devices.

The information in this 510(k) submission demonstrates that the RX-1 Monitor system is substantially equivalent to the predicate device.

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).