The Rhythm Express remote cardiac monitoring system is intended for use by patients greater than 10 kg 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 for review 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 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 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) Pre-market Notification for the RX-1 Rhythm Express Remote Cardiac Monitoring System. It does not contain a detailed study report with acceptance criteria and a comprehensive breakdown of device performance as one might find in a clinical trial summary.

However, based on the information provided, here's a summary of the performance testing and how it relates to general acceptance in regulatory submissions:

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

The document does not present a formal table of explicit acceptance criteria and corresponding performance metrics for the device's accuracy in arrhythmia detection or analysis. Instead, it refers to successful completion of various performance and safety standards, and general functional verification.

Acceptance Criteria Category (Inferred from regulatory standards)	Reported Device Performance
General Safety and Performance	- IEC 60601-2-47:2012: Passed. (Particular requirements for basic safety and essential performance of ambulatory electrocardiographic systems) - IEC 60601-1-1:2012 Ed. 3.1: Passed. (General requirements for basic safety and essential performance) - IEC 60601-1-2:2014 4th Edition: Passed. (Electromagnetic compatibility) - IEC 60601-1-11:2015 Edition 1.1: Passed. (Requirements for home healthcare environment) - ISO 10993-1: Biocompatibility testing of patient contacting materials passed.
Software Life Cycle	- IEC 62304:2015 Ed. 1.1: Passed. (Medical Device Software Software Life Cycle Processes)
Security Risk Management	- ANSI/AAMI TIR57:2015: Passed. (Principles for medical device security-Risk management)
Usability	- IEC 62366-1:2015 Edition 1.0: Passed. (Application of usability engineering to medical devices)
Wireless Coexistence	- ANSI IEEE C63.27-2017: Passed. (Evaluation of Wireless Coexistence)
Functional Performance (Specific to Monitoring System)	- Bench test results verified: The 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. - Conclusion: All requirements were met, and the RX-1 Monitor performs as designed. (Does not explicitly list quantitative performance metrics for arrhythmia detection accuracy, sensitivity, specificity, etc.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses bench testing and compliance with standards. There is no mention of a clinical test set involving human subjects, nor any details about data provenance (country of origin, retrospective/prospective). The performance claims are based on engineering bench tests and adherence to recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since the testing primarily involved bench tests and compliance with standards, the concept of "ground truth" as established by medical experts for a clinical dataset is not applicable here. The "ground truth" for the functional tests would be the expected behavior of the device as per its design specifications.

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

Not applicable, as there's no mention of a clinical test set requiring expert adjudication.

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 such study is mentioned or implied in the provided text. The device is referred to as an "ECG analysis algorithm" that detects arrhythmias, but its impact on human reader performance is not evaluated in this submission summary.

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

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." It also mentions that "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 for review by a medical professional."

This indicates that the algorithm performs standalone detection, and then the data is presented for human review. However, the submission does not provide specific performance metrics for this standalone algorithm (e.g., sensitivity, specificity, PPV for various arrhythmias). The "bench test results verify that RX-1 Monitor system can continuously record ECG signal... and transmit manual or auto activated event recordings to the server for evaluation by a medical professional" confirms the functional aspect of the algorithm's automatic detection and transmission.

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

For the functional bench tests, the "ground truth" would be the engineering specifications and expected signal characteristics. For instance, testing noise reduction or signal recording accuracy would compare the device's output against known input signals or precise measurement standards. There's no mention of medical ground truth (e.g., expert-annotated ECGs, pathology, or outcomes) used to validate the arrhythmia detection algorithm's accuracy.

8. The sample size for the training set

The document does not provide details about a training set for the embedded ECG analysis algorithm. It is a 510(k) submission focused on substantial equivalence to predicate devices and adherence to performance standards, rather than a detailed algorithm validation report.

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

Not applicable, as no information regarding a training set is provided.

Summary

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September 2, 2020

VivaQuant Inc. % Brodie Pedersen Consultant Borderless Compliance, LLC 7118 Teakwood Cir Maple Grove, Minnesota 55369

Re: K200833

Trade/Device Name: RX-1 Rhythm Express Remote Cardiac Monitoring System Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MLO, DSI Dated: July 31, 2020 Received: August 3, 2020

Dear Brodie Pedersen:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Jennifer Shih Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200883

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. The Rhythm Express system communicates events from 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.

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

(as required by 21CFR 807.92)

SUBMITTER 1.

VivaQuant Inc. 4339 Nancy Place, Suite 100, St. Paul, MN 55126 Contact Person: Brian Brockway bbrockway@vivaquant.com Phone: 651-217-2176 Date Prepared: July 31, 2020

II. DEVICE

RX-1 Rhythm Express Remote Cardiac Monitoring System Name of Device: Classification Name: 870.2800. 870.1025 Electrocardiograph, Ambulatory, With Analysis Algorithm Detector and Alarm, Arrhythmia, Common or Usual Name: Ambulatory Cardiac Monitor Device Panel: Cardiovascular Regulatory Class: Class 2 Product Code: MLO, DSI

PREDICATE DEVICE III.

The RX-1 system is substantially equivalent in intended use and similar technological characteristics to the following devices: RX-1 Rhythm Express Remote Cardiac Monitoring System cleared under K183704, and PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System, cleared under K152550.

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DEVICE DESCRIPTION IV.

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

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.

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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The RX-1 system is substantially equivalent in intended use and similar technological characteristics of RX-1 system cleared under K183704.

Category	Identical/Different	RX-1	RX-1 predicate	PocketECG III
510(k) Number		Pending	K183704	K152550
ClassificationName	Identical	Electrocardiograph,Ambulatory, WithAnalysis Algorithm	MedicalMobile CardiacMonitor	Arrhythmia Detectorand Alarm
Product Code	Identical	MLO, DSI	DXH	DSI
Intended Use	Similar	The Rhythm Expressremote cardiacmonitoring system isintended for use bypatients greater than 10kg who either have orare at risk of havingcardiac disease andthose that demonstrateintermittent symptomsindicative of cardiacdisease and requirecardiac monitoring on acontinuing basis. Thedevice continuouslyrecords ECG data andupon detection by anECG analysis algorithm ormanually initiated by thepatient, automaticallydelivers the recordedcardiac activity to theserver where it ispresented for review by	The Rhythm Expressremote cardiacmonitoring system isintended for use byadult patients whoeither have or are atrisk of having cardiacdisease and those thatdemonstrateintermittent symptomsindicative of cardiacdisease and requirecardiac monitoring ona continuing basis. Thedevice continuouslyrecords ECG data andupon detection by anECG analysis algorithmor manually initiatedby the patient,automatically deliversthe recorded cardiacactivity to the serverwhere it is presented	1. Patients who have ademonstrated need forcardiac monitoring. Thesemay include but are notlimited to patients whorequire monitoring for: a)non-life threateningarrhythmias such assupraventriculartachycardias (e.g. atrialfibrillation, atrial flutter,PACS, PSVT) andventricular ectopy; b)evaluation of bradyarrhythmias andintermittent bundlebranch block, includingafter cardiovascularsurgery and myocardialinfarction; and c)arrhythmias associatedwith co-morbid conditionssuch as hyperthyroidismor chronic lung disease;
Category	Identical/Different	RX-1	RX-1 predicate	PocketECG III
		a medical professional.	and can be reviewedby a medicalprofessional.	2. Patients with symptomsthat may be due to cardiacarrhythmias. These mayinclude but are not limitedto symptoms such as: a)dizziness orlightheadedness; b)syncope of unknownetiology in whicharrhythmias are suspectedor need to be excluded;and c) dyspnea (shortnessof breath).
		The data received fromthe Rhythm Expressdevice can be used byanother device forarrhythmia analysis,reporting and signalmeasurements. TheRhythm Express device isnot intended to soundany alarms.	The data received fromthe Rhythm Expressdevice can be used byanother device forarrhythmia analysis,reporting and signalmeasurements. TheRhythm Express deviceis not intended tosound any alarms.	3. Patients withpalpitations with orwithout knownarrhythmias to obtaincorrelation of rhythm withsymptoms.
		The device does notdeliver any therapy,administer any drugs,provide interpretive ordiagnostic statements orprovide for any lifesupport. The RhythmExpress systemcommunicates eventsfrom the patient to themonitoring center withinone to seven minutes(assuming cell service isavailable) and hence isnot suitable for use as areal-time arrhythmiaevent monitor.	The device does notdeliver any therapy,administer any drugs,provide interpretive ordiagnostic statementsor provide for any lifesupport. The RhythmExpress systemcommunicates eventsfrom the patient to themonitoring centerwithin one to sevenminutes (assuming cellservice is available) andhence is not suitablefor use as a real-timearrhythmia eventmonitor.	4. Patients who requiremonitoring of effect ofdrugs to controlventricular rate in variousatrial arrhythmias (e.g.atrial fibrillation).5. Patients recoveringfrom cardiac surgery whoare indicated foroutpatient arrhythmiamonitoring.6. Patients with diagnosedsleep disorderedbreathing including sleepapnea (obstructive,central) to evaluatepossible nocturnalarrhythmias.7. Patients requiringarrhythmia evaluation ofetiology of stroke ortransient cerebralischemia, possiblysecondary to atrialfibrillation or atrial flutter.
Category	Identical/Different	RX-1	RX-1 predicate	PocketECG III
Delivered deviceincludes, patientECG cable- rechargeablebattery-Wall Batterycharger	Similar	Yes	Yes	Yes
Monitorfunctionalblocks: ECGfront end,DSPMCU,flash datastorage,RF modem fordatatransmission,LCD screen, andkeypad,	Similar	Yes	Yes	Yes
The serverfacilitates datacommunicationwith the device,provide datastorage, andpresent the datafor evaluationby a medicalprofessional:	Similar	Yes	Yes	Yes
				8. Data from the devicemay be used by anotherdevice to analyze,measure or report QTinterval. The device is notintended to sound anyalarms for QT intervalchanges.
Category	Identical/Different	RX-1	RX-1 predicate	PocketECG III
Device formfactor: small,lightweightambulatorycardiacmonitors.	Similar	Yes	Yes	Yes
Wirelesstechnology usedto transmit datato server	Similar	LTE	LTE	GSM
Device is batterypowered by arechargeable Li-Ion battery	Similar	For 7 Days	For 7 Days	For 24 hours
using a server,can adjustdeviceprogrammingparameterssuch as pre-postrecording timesand auto-triggeringconfiguration.	Similar	Yes	Yes	Yes
devices havekeypad formanual eventrecordings and auser interface toindicate devicestatus and modeof operation.	Similar	Yes	Yes	Yes
Deviceincorporateembedded ECG	Similar	Yes	Yes	Yes
Category	Identical/Different	RX-1	RX-1 predicate	PocketECG III
analysisalgorithm toauto-capturearrhythmiaevents betweenthe signalacquisition pointand the server.
device has atleast 2 ECGchannels and 3-lead electrodes	Identical	Yes	Yes	Yes
Functional,Environmentaland Electricalcharacteristics	Similar	Ambulatory use, chargefrom ac adapter0-45C	Ambulatory use, chargefrom ac adapter0-45C	Ambulatory use, chargefrom ac adapter0-43C
Power Port	Different	Yes, USB port to chargethe battery, cannot beconnected during ECGrecording, not used fordata download.	Yes, USB port to chargethe battery, cannot beconnected during ECGrecording, not used fordata download.	No, Separate Batterycharger to rechargeremovable battery pack.
Storageconditions	Similar	-25 to 45 C10 to 95% RH	-25 to 45 C10 to 95% RH	-20 to 60 C15 to 93% RH

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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 60601-1-1:2012 Ed. 3.1 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
IEC 62304:2015 Ed. 1.1 Medical Device Software Software Life Cvcle ● Processes.
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 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 characterics 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, VivaQuant determines that the RX-1 Monitor system performs within its design specifications and is

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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

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).