RX-1 Rhythm Express Remote Cardiac Monitoring System

K200833 · VivaQuant, Inc. · MLO · Sep 2, 2020 · Cardiovascular

Device Facts

• Record ID: K200833
• Device Name: RX-1 Rhythm Express Remote Cardiac Monitoring System
• Applicant: VivaQuant, Inc.
• Product Code: MLO · Cardiovascular
• Decision Date: Sep 2, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

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 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 Story

RX-1 Rhythm Express is a wearable ambulatory cardiac monitor for patients >10 kg; used in Mobile Cardiac Telemetry (MCT), Event Recorder (ER), or Wireless Holter (WH) modes. Device captures 2-channel ECG via standard electrodes; embedded algorithm processes signals to detect arrhythmias, compress data, and remove in-band noise. Device uses cellular modem to transmit data to RS-1 Web Service for review by medical professionals. Operated by patient; worn for 1 day to 4 weeks. Output is raw/processed ECG data for clinical review; no alarms, therapy, or diagnostic statements provided. Benefits include remote monitoring of cardiac activity for patients with suspected or known arrhythmias. Not for real-time event monitoring.

Clinical Evidence

Bench testing only. Testing included compliance with IEC 60601-2-47 (ambulatory ECG systems), IEC 60601-1 (safety), IEC 62304 (software lifecycle), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare), ANSI/AAMI TIR57 (security), IEC 62366-1 (usability), ANSI IEEE C63.27 (wireless coexistence), and ISO 10993-1 (biocompatibility).

Technological Characteristics

Ambulatory cardiac monitor; 2-channel ECG; rechargeable Li-Ion battery (7-day life); cellular (LTE) connectivity; USB charging port. Functional blocks: ECG front end, DSP, MCU, flash storage, RF modem, LCD, keypad. Software: embedded algorithm for arrhythmia detection and noise removal. Sterilization: not specified. Standards: IEC 60601 series, ISO 10993-1, ANSI/AAMI TIR57.

Indications for Use

Indicated for patients >10 kg with or at risk of cardiac disease, or those with intermittent symptoms requiring continuous cardiac monitoring.

Regulatory Classification

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.

Predicate Devices

• RX-1 Rhythm Express Remote Cardiac Monitoring System (K183704)
• PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System (K152550)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 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 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) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| <div> <span> <svg height="16" width="16"> <path d="M2 2 L14 14 M14 2 L2 14" stroke="black" stroke-width="2"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>□</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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 [e-mail] Phone: [phone] 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 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.

#### V. INTENDED USE

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.

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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/<br>Different | RX-1 | RX-1 predicate | PocketECG III |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | Pending | K183704 | K152550 |
| Classification<br>Name | Identical | Electrocardiograph,<br>Ambulatory, With<br>Analysis Algorithm | Medical<br>Mobile Cardiac<br>Monitor | Arrhythmia Detector<br>and Alarm |
| Product Code | Identical | MLO, DSI | DXH | DSI |
| Intended Use | Similar | The Rhythm Express<br>remote cardiac<br>monitoring system is<br>intended for use by<br>patients greater than 10<br>kg who either have or<br>are at risk of having<br>cardiac disease and<br>those that demonstrate<br>intermittent symptoms<br>indicative of cardiac<br>disease and require<br>cardiac monitoring on a<br>continuing basis. The<br>device continuously<br>records ECG data and<br>upon detection by an<br>ECG analysis algorithm or<br>manually initiated by the<br>patient, automatically<br>delivers the recorded<br>cardiac activity to the<br>server where it is<br>presented for review by | The Rhythm Express<br>remote cardiac<br>monitoring system is<br>intended for use by<br>adult patients who<br>either have or are at<br>risk of having cardiac<br>disease and those that<br>demonstrate<br>intermittent symptoms<br>indicative of cardiac<br>disease and require<br>cardiac monitoring on<br>a continuing basis. The<br>device continuously<br>records ECG data and<br>upon detection by an<br>ECG analysis algorithm<br>or manually initiated<br>by the patient,<br>automatically delivers<br>the recorded cardiac<br>activity to the server<br>where it is presented | 1. Patients who have a<br>demonstrated need for<br>cardiac monitoring. These<br>may include but are not<br>limited to patients who<br>require monitoring for: a)<br>non-life threatening<br>arrhythmias such as<br>supraventricular<br>tachycardias (e.g. atrial<br>fibrillation, atrial flutter,<br>PACS, PSVT) and<br>ventricular ectopy; b)<br>evaluation of brady<br>arrhythmias and<br>intermittent bundle<br>branch block, including<br>after cardiovascular<br>surgery and myocardial<br>infarction; and c)<br>arrhythmias associated<br>with co-morbid conditions<br>such as hyperthyroidism<br>or chronic lung disease; |
| Category | Identical/<br>Different | RX-1 | RX-1 predicate | PocketECG III |
| | | a medical professional. | and can be reviewed<br>by a medical<br>professional. | 2. Patients with symptoms<br>that may be due to cardiac<br>arrhythmias. These may<br>include but are not limited<br>to symptoms such as: a)<br>dizziness or<br>lightheadedness; b)<br>syncope of unknown<br>etiology in which<br>arrhythmias are suspected<br>or need to be excluded;<br>and c) dyspnea (shortness<br>of breath). |
| | | The data received from<br>the Rhythm Express<br>device can be used by<br>another device for<br>arrhythmia analysis,<br>reporting and signal<br>measurements. The<br>Rhythm Express device is<br>not intended to sound<br>any alarms. | The data received from<br>the Rhythm Express<br>device can be used by<br>another device for<br>arrhythmia analysis,<br>reporting and signal<br>measurements. The<br>Rhythm Express device<br>is not intended to<br>sound any alarms. | 3. Patients with<br>palpitations with or<br>without known<br>arrhythmias to obtain<br>correlation of rhythm with<br>symptoms. |
| | | The device does not<br>deliver any therapy,<br>administer any drugs,<br>provide interpretive or<br>diagnostic statements or<br>provide for any life<br>support. The Rhythm<br>Express system<br>communicates events<br>from the patient to the<br>monitoring center within<br>one to seven minutes<br>(assuming cell service is<br>available) and hence is<br>not suitable for use as a<br>real-time arrhythmia<br>event monitor. | The device does not<br>deliver any therapy,<br>administer any drugs,<br>provide interpretive or<br>diagnostic statements<br>or provide for any life<br>support. The Rhythm<br>Express system<br>communicates events<br>from the patient to the<br>monitoring center<br>within one to seven<br>minutes (assuming cell<br>service is available) and<br>hence is not suitable<br>for use as a real-time<br>arrhythmia event<br>monitor. | 4. Patients who require<br>monitoring of effect of<br>drugs to control<br>ventricular rate in various<br>atrial arrhythmias (e.g.<br>atrial fibrillation).<br>5. Patients recovering<br>from cardiac surgery who<br>are indicated for<br>outpatient arrhythmia<br>monitoring.<br>6. Patients with diagnosed<br>sleep disordered<br>breathing including sleep<br>apnea (obstructive,<br>central) to evaluate<br>possible nocturnal<br>arrhythmias.<br>7. Patients requiring<br>arrhythmia evaluation of<br>etiology of stroke or<br>transient cerebral<br>ischemia, possibly<br>secondary to atrial<br>fibrillation or atrial flutter. |
| Category | Identical/<br>Different | RX-1 | RX-1 predicate | PocketECG III |
| Delivered device<br>includes, patient<br>ECG cable<br>- rechargeable<br>battery<br>-Wall Battery<br>charger | Similar | Yes | Yes | Yes |
| Monitor<br>functional<br>blocks: ECG<br>front end,<br>DSP<br>MCU,<br>flash data<br>storage,<br>RF modem for<br>data<br>transmission,<br>LCD screen, and<br>keypad, | Similar | Yes | Yes | Yes |
| The server<br>facilitates data<br>communication<br>with the device,<br>provide data<br>storage, and<br>present the data<br>for evaluation<br>by a medical<br>professional: | Similar | Yes | Yes | Yes |
| | | | | 8. Data from the device<br>may be used by another<br>device to analyze,<br>measure or report QT<br>interval. The device is not<br>intended to sound any<br>alarms for QT interval<br>changes. |
| Category | Identical/<br>Different | RX-1 | RX-1 predicate | PocketECG III |
| Device form<br>factor: small,<br>lightweight<br>ambulatory<br>cardiac<br>monitors. | Similar | Yes | Yes | Yes |
| Wireless<br>technology used<br>to transmit data<br>to server | Similar | LTE | LTE | GSM |
| Device is battery<br>powered by a<br>rechargeable Li-<br>Ion battery | Similar | For 7 Days | For 7 Days | For 24 hours |
| using a server,<br>can adjust<br>device<br>programming<br>parameters<br>such as pre-post<br>recording times<br>and auto-<br>triggering<br>configuration. | Similar | Yes | Yes | Yes |
| devices have<br>keypad for<br>manual event<br>recordings and a<br>user interface to<br>indicate device<br>status and mode<br>of operation. | Similar | Yes | Yes | Yes |
| Device<br>incorporate<br>embedded ECG | Similar | Yes | Yes | Yes |
| Category | Identical/<br>Different | RX-1 | RX-1 predicate | PocketECG III |
| analysis<br>algorithm to<br>auto-capture<br>arrhythmia<br>events between<br>the signal<br>acquisition point<br>and the server. | | | | |
| device has at<br>least 2 ECG<br>channels and 3-<br>lead electrodes | Identical | Yes | Yes | Yes |
| Functional,<br>Environmental<br>and Electrical<br>characteristics | Similar | Ambulatory use, charge<br>from ac adapter<br>0-45C | Ambulatory use, charge<br>from ac adapter<br>0-45C | Ambulatory use, charge<br>from ac adapter<br>0-43C |
| Power Port | Different | Yes, USB port to charge<br>the battery, cannot be<br>connected during ECG<br>recording, not used for<br>data download. | Yes, USB port to charge<br>the battery, cannot be<br>connected during ECG<br>recording, not used for<br>data download. | No, Separate Battery<br>charger to recharge<br>removable battery pack. |
| Storage<br>conditions | Similar | -25 to 45 C<br>10 to 95% RH | -25 to 45 C<br>10 to 95% RH | -20 to 60 C<br>15 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.