(47 days)
Not Found
No
The document mentions an "ECG analysis algorithm" and an "embedded algorithm" for processing ECG data and detecting arrhythmias, but it does not explicitly state that these algorithms utilize AI or ML techniques. The description focuses on standard signal processing and communication functionalities.
No
The device explicitly states, "The device does not deliver any therapy." Its primary function is to record and transmit ECG data for review by a medical professional.
No
The device records ECG data and delivers it to a server for review by a medical professional. While it uses an ECG analysis algorithm to detect cardiac activity, the "Intended Use / Indications for Use" section explicitly states, "The device ... does not provide interpretive or diagnostic statements." Its function is data gathering and transmission for a medical professional to review, not to make a diagnosis itself.
No
The device description explicitly states that the RX-1 device connects to standard ECG electrodes and incorporates a cellular modem, indicating it includes hardware components beyond just software.
Based on the provided information, the Rhythm Express remote cardiac monitoring system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The Rhythm Express system directly monitors the electrical activity of the heart (ECG) from the patient's body using electrodes. It does not analyze biological specimens.
- The intended use and device description clearly state that the device records and transmits ECG data from the patient. This is a form of physiological monitoring, not in vitro analysis.
- The device description mentions connecting to standard ECG electrodes to capture 2 channel ECGs. This further confirms it's a device for capturing physiological signals from the body.
Therefore, the Rhythm Express system falls under the category of a physiological monitoring device, not an IVD.
N/A
Intended Use / 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.
Product codes
DXH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 -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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 (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
2
Indications for Use
510(k) Number (if known)
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)
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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 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 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.
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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 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 | The RhythmStar system is
intended for use by patients who
either have or are at risk of having
cardiac disease and those that
demonstrate intermittent
symptoms indicative of cardiac
disease and require cardiac
monitoring on a continuing basis.
The device continuously records
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
RhythmStar device can be used by
another device for arrhythmia
analysis, reporting and signal
measurements. The RhythmStar
system is not intended to sound
any alarms. The device does not |
| Category | Identical/
Different | RX-1 | RhythmStar |
| | | 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. | deliver any therapy, administer
any drugs, provide interpretive or
diagnostic statements or provide
for any life support. RhythmStar is
for prescription use only. |
| Delivered device
includes | 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-chargeable
batteries - Wall battery charger |
| Monitor functional
blocks | Similar | analog ECG front end,
DSP
MCU,
flash data storage,
RF modem for
data transmission,
LCD screen, and
keypad, | analog ECG front end,
MCU,
flash data storage,
RF modem for
data transmission,
LCD screen, and
keypad,
accelerometer |
| The server: | Similar | facilitate data communication
with the RX-1 device, | facilitate data communication
with the RhythmStar device, |
| Category | Identical/
Different | RX-1 | RhythmStar |
| | | provide data storage, and
present the data for evaluation by
a medical professional | provide data storage, and
present the data for evaluation by
a medical professional |
| Device form factor | Similar | small, lightweight
ambulatory cardiac monitors. | small, lightweight
ambulatory cardiac monitors. |
| Wireless technology
used to transmit data
to server | Identical | Yes | Yes |
| Device is battery
powered by a
rechargeable Li-Ion
battery | Identical | Yes | Yes |
| using a server, can
adjust device
programming
parameters such as
pre-post recording
times and auto-
triggering
configuration. | Identical | Yes | Yes |
| Devices incorporate
an accelerometer to
capture activity level
data related to
patient motion and
device orientation. | Different | No | Yes |
| devices have keypad
for manual event
recordings and a user
interface to indicate
device status and
mode of operation. | similar | Yes | Yes |
| Category | Identical/
Different | RX-1 | RhythmStar |
| Device incorporate
embedded ECG
analysis algorithm to
auto-capture
Bradycardia,
Tachycardia, Atrial
Fibrillation/Atrial
Flutter and
arrhythmia events
between the signal
acquisition point and
the server. | Similar | Yes | Yes |
| device has at least 2
ECG channels and 3-
lead electrodes | Similar | Yes | Yes |
| Functional,
Environmental and
Electrical
characteristics | Similar | Yes | Yes |
| USB connection | Different | Yes, used to charge the battery,
cannot be connected during ECG
recording, not used for data
download. | Yes, used only for data download
and secondary communication,
cannot be connected during ECG
recording |
6
7
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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 -●
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.