(156 days)
Not Found
No
The document mentions an "ECG analysis algorithm" and an "embedded algorithm" for processing ECG data and detecting arrhythmias. While algorithms are fundamental to AI/ML, the description does not explicitly state or imply the use of AI, machine learning, deep learning, or neural networks. The focus is on standard signal processing and arrhythmia detection algorithms, which are common in cardiac monitoring devices and do not necessarily involve AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device explicitly states, "The device does not deliver any therapy". Its purpose is monitoring and data transmission for professional review, not treatment.
Yes.
The device continuously records ECG data and performs an ECG analysis algorithm to detect cardiac activity, which is then sent for review by a medical professional to diagnose cardiac disease.
No
The device description explicitly states that the RX-1 device connects to standard ECG electrodes to capture 2 channel ECGs and incorporates a cellular modem, indicating it includes hardware components beyond just software.
Based on the provided text, the Rhythm Express remote cardiac monitoring system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body. IVDs typically involve testing blood, urine, tissue, or other biological samples in a laboratory setting to diagnose or monitor a condition.
- The Rhythm Express system monitors physiological signals from the body. It directly records ECG data from the patient's body using electrodes. It does not analyze samples taken from the patient.
- The intended use and device description clearly focus on continuous ECG recording and transmission. The system's purpose is to capture and send electrical activity of the heart for review by a medical professional.
Therefore, the Rhythm Express system falls under the category of a medical device that monitors physiological signals, rather than an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MLO, DSI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ECG
Anatomical Site
Cardiac
Indicated Patient Age Range
patients greater than 10 kg
Intended User / Care Setting
medical professional / 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)
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
§ 870.2800 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
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
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/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 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) | |
|---|---|
| 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 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 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.
5
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 |
| Classification
Name | Identical | Electrocardiograph,
Ambulatory, With
Analysis Algorithm | Medical
Mobile Cardiac
Monitor | Arrhythmia Detector
and Alarm |
| Product Code | Identical | MLO, DSI | DXH | DSI |
| Intended Use | Similar | 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 | 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 | 1. Patients who have a
demonstrated need for
cardiac monitoring. These
may include but are not
limited to patients who
require monitoring for: a)
non-life threatening
arrhythmias such as
supraventricular
tachycardias (e.g. atrial
fibrillation, atrial flutter,
PACS, PSVT) and
ventricular ectopy; b)
evaluation of brady
arrhythmias and
intermittent bundle
branch block, including
after cardiovascular
surgery and myocardial
infarction; and c)
arrhythmias associated
with co-morbid conditions
such as hyperthyroidism
or chronic lung disease; |
| Category | Identical/
Different | RX-1 | RX-1 predicate | PocketECG III |
| | | a medical professional. | and can be reviewed
by a medical
professional. | 2. Patients with symptoms
that may be due to cardiac
arrhythmias. These may
include but are not limited
to symptoms such as: a)
dizziness or
lightheadedness; b)
syncope of unknown
etiology in which
arrhythmias are suspected
or need to be excluded;
and c) dyspnea (shortness
of breath). |
| | | 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 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. | 3. Patients with
palpitations with or
without known
arrhythmias to obtain
correlation of rhythm with
symptoms. |
| | | 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. | 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. | 4. Patients who require
monitoring of effect of
drugs to control
ventricular rate in various
atrial arrhythmias (e.g.
atrial fibrillation).
5. Patients recovering
from cardiac surgery who
are indicated for
outpatient arrhythmia
monitoring.
6. Patients with diagnosed
sleep disordered
breathing including sleep
apnea (obstructive,
central) to evaluate
possible nocturnal
arrhythmias.
7. Patients requiring
arrhythmia evaluation of
etiology of stroke or
transient cerebral
ischemia, possibly
secondary to atrial
fibrillation or atrial flutter. |
| Category | Identical/
Different | RX-1 | RX-1 predicate | PocketECG III |
| Delivered device
includes, patient
ECG cable
- rechargeable
battery
-Wall Battery
charger | Similar | Yes | Yes | Yes |
| Monitor
functional
blocks: ECG
front end,
DSP
MCU,
flash data
storage,
RF modem for
data
transmission,
LCD screen, and
keypad, | Similar | Yes | Yes | Yes |
| The server
facilitates data
communication
with the device,
provide data
storage, and
present the data
for evaluation
by a medical
professional: | Similar | Yes | Yes | Yes |
| | | | | 8. Data from the device
may be used by another
device to analyze,
measure or report QT
interval. The device is not
intended to sound any
alarms for QT interval
changes. |
| Category | Identical/
Different | RX-1 | RX-1 predicate | PocketECG III |
| Device form
factor: small,
lightweight
ambulatory
cardiac
monitors. | Similar | Yes | Yes | Yes |
| Wireless
technology used
to transmit data
to server | Similar | LTE | LTE | GSM |
| Device is battery
powered by a
rechargeable Li-
Ion battery | Similar | For 7 Days | For 7 Days | For 24 hours |
| using a server,
can adjust
device
programming
parameters
such as pre-post
recording times
and auto-
triggering
configuration. | Similar | Yes | Yes | Yes |
| devices have
keypad for
manual event
recordings and a
user interface to
indicate device
status and mode
of operation. | Similar | Yes | Yes | Yes |
| Device
incorporate
embedded ECG | Similar | Yes | Yes | Yes |
| Category | Identical/
Different | RX-1 | RX-1 predicate | PocketECG III |
| analysis
algorithm to
auto-capture
arrhythmia
events between
the signal
acquisition point
and the server. | | | | |
| device has at
least 2 ECG
channels and 3-
lead electrodes | Identical | Yes | Yes | Yes |
| Functional,
Environmental
and Electrical
characteristics | Similar | Ambulatory use, charge
from ac adapter
0-45C | Ambulatory use, charge
from ac adapter
0-45C | Ambulatory use, charge
from ac adapter
0-43C |
| Power Port | Different | Yes, USB port to charge
the battery, cannot be
connected during ECG
recording, not used for
data download. | Yes, USB port to charge
the battery, cannot be
connected during ECG
recording, not used for
data download. | No, Separate Battery
charger to recharge
removable battery pack. |
| Storage
conditions | Similar | -25 to 45 C
10 to 95% RH | -25 to 45 C
10 to 95% RH | -20 to 60 C
15 to 93% RH |
6
7
8
9
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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
11
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.