RX-1 Rhythm Express Remote Cardiac Monitoring System

K183704 · VivaQuant, Inc. · DXH · Feb 16, 2019 · Cardiovascular

Device Facts

• Record ID: K183704
• Device Name: RX-1 Rhythm Express Remote Cardiac Monitoring System
• Applicant: VivaQuant, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Feb 16, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

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.

Device Story

RX-1 Rhythm Express is a wearable ambulatory cardiac monitor for adult patients; used for 1 day to 4 weeks. Device captures 2-channel ECG via electrodes; processes signals using embedded algorithm to detect arrhythmias, compress data, and remove noise. Features cellular modem (Verizon LTE) to transmit data to RS-1 Web Service. Operated by patient; monitored by medical professionals at a remote center. Output presented on server for clinical review; supports arrhythmia analysis and signal measurements. Does not provide real-time alarms, therapy, or diagnostic statements. Benefits include continuous cardiac monitoring for patients with intermittent symptoms.

Clinical Evidence

Bench testing only. Testing included compliance with IEC 60601-2-47 (ambulatory ECG systems), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare environment), ANSI/AAMI TIR57 (security), IEC 62366-1 (usability), ANSI IEEE C63.27 (wireless coexistence), and ISO 10993-1 (biocompatibility). Results verified continuous ECG recording, storage, and transmission capabilities.

Technological Characteristics

Ambulatory cardiac monitor; 2-channel ECG; rechargeable Li-Ion battery; cellular modem (Verizon LTE). Includes LCD screen and keypad. Materials biocompatibility per ISO 10993-1. Connectivity via cellular network to cloud-based server. Software includes embedded ECG analysis algorithm for arrhythmia detection and data compression.

Indications for Use

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

Regulatory Classification

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.

Predicate Devices

• RhythmStar System (K141813)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known)

K183704

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 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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 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 [e-mail] Phone: [phone] 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.

{4}------------------------------------------------

#### IV. 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.

#### V. INTENDED USE

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.

{5}------------------------------------------------

## 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/<br>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 remote<br>cardiac monitoring system is<br>intended for use by adult patients<br>who either have or are at risk of<br>having cardiac disease and those<br>that demonstrate intermittent<br>symptoms indicative of cardiac<br>disease and require cardiac<br>monitoring on a continuing basis.<br>The device continuously records<br>ECG data and upon detection by<br>an ECG analysis algorithm or<br>manually initiated by the patient,<br>automatically delivers the<br>recorded cardiac activity to the<br>server where it is presented and<br>can be reviewed by a medical<br>professional.<br>The data received from the<br>Rhythm Express device can be<br>used by another device for<br>arrhythmia analysis, reporting and<br>signal measurements. The Rhythm<br>Express device is not intended to | The RhythmStar system is<br>intended for use by patients who<br>either have or are at risk of having<br>cardiac disease and those that<br>demonstrate intermittent<br>symptoms indicative of cardiac<br>disease and require cardiac<br>monitoring on a continuing basis.<br>The device continuously records<br>ECG data and upon detection by<br>an ECG analysis algorithm or<br>manually initiated by the patient,<br>automatically delivers the<br>recorded cardiac activity to the<br>server where it is presented and<br>can be reviewed by a medical<br>professional.<br>The data received from the<br>RhythmStar device can be used by<br>another device for arrhythmia<br>analysis, reporting and signal<br>measurements. The RhythmStar<br>system is not intended to sound<br>any alarms. The device does not |
| Category | Identical/<br>Different | RX-1 | RhythmStar |
| | | sound any alarms.<br>The device does not deliver any<br>therapy, administer any drugs,<br>provide interpretive or diagnostic<br>statements or provide for any life<br>support. The Rhythm Express<br>system communicates events<br>from the patient to the monitoring<br>center within one to seven<br>minutes (assuming cell service is<br>available) and hence is not<br>suitable for use as a real-time<br>arrhythmia event monitor. | deliver any therapy, administer<br>any drugs, provide interpretive or<br>diagnostic statements or provide<br>for any life support. RhythmStar is<br>for prescription use only. |
| Delivered device<br>includes | Similar | RX-1 device<br>-patient 2 lead 4 wire ECG cable<br>-internal rechargeable battery<br>-Wall Battery charger | RhythmStar monitor<br>- Patient 3 lead ECG lead cable<br>— 2 externally re-chargeable<br>batteries<br>- Wall battery charger |
| Monitor functional<br>blocks | Similar | analog ECG front end,<br>DSP<br>MCU,<br>flash data storage,<br>RF modem for<br>data transmission,<br>LCD screen, and<br>keypad, | analog ECG front end,<br>MCU,<br>flash data storage,<br>RF modem for<br>data transmission,<br>LCD screen, and<br>keypad,<br>accelerometer |
| The server: | Similar | facilitate data communication<br>with the RX-1 device, | facilitate data communication<br>with the RhythmStar device, |
| Category | Identical/<br>Different | RX-1 | RhythmStar |
| | | provide data storage, and<br>present the data for evaluation by<br>a medical professional | provide data storage, and<br>present the data for evaluation by<br>a medical professional |
| Device form factor | Similar | small, lightweight<br>ambulatory cardiac monitors. | small, lightweight<br>ambulatory cardiac monitors. |
| Wireless technology<br>used to transmit data<br>to server | Identical | Yes | Yes |
| Device is battery<br>powered by a<br>rechargeable Li-Ion<br>battery | Identical | Yes | Yes |
| using a server, can<br>adjust device<br>programming<br>parameters such as<br>pre-post recording<br>times and auto-<br>triggering<br>configuration. | Identical | Yes | Yes |
| Devices incorporate<br>an accelerometer to<br>capture activity level<br>data related to<br>patient motion and<br>device orientation. | Different | No | Yes |
| devices have keypad<br>for manual event<br>recordings and a user<br>interface to indicate<br>device status and<br>mode of operation. | similar | Yes | Yes |
| Category | Identical/<br>Different | RX-1 | RhythmStar |
| Device incorporate<br>embedded ECG<br>analysis algorithm to<br>auto-capture<br>Bradycardia,<br>Tachycardia, Atrial<br>Fibrillation/Atrial<br>Flutter and<br>arrhythmia events<br>between the signal<br>acquisition point and<br>the server. | Similar | Yes | Yes |
| device has at least 2<br>ECG channels and 3-<br>lead electrodes | Similar | Yes | Yes |
| Functional,<br>Environmental and<br>Electrical<br>characteristics | Similar | Yes | Yes |
| USB connection | Different | Yes, used to charge the battery,<br>cannot be connected during ECG<br>recording, not used for data<br>download. | Yes, used only for data download<br>and secondary communication,<br>cannot be connected during ECG<br>recording |

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

#### 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 -●

{9}------------------------------------------------

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.