(244 days)
Not Found
No
The document mentions an "ECG analysis algorithm" and an "embedded arrhythmia detection algorithm" but does not use terms like AI, ML, DNN, or describe any training or testing of such models.
No
The "Intended Use" section explicitly states, "The device does not deliver any therapy, administer any drugs, or provide for life support."
Yes
The device continuously records ECG and detects events such as Bradycardia, Tachycardia, and Atrial Fibrillation, which are then sent to a cloud server for review and analysis by a medical professional. This collection and analysis of physiological data for the purpose of identifying health conditions constitutes a diagnostic function. Although it does not provide "interpretive or diagnostic statements" directly, it provides the data necessary for a physician to make a diagnosis.
No
The device description explicitly states that the RhythmStar system includes a "portable, battery-powered, wireless cardiac monitor," which is a hardware component.
Based on the provided information, the RhythmStar system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- RhythmStar's Function: The RhythmStar system directly monitors and records electrical activity of the heart (ECG) from the patient's body. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for monitoring cardiac activity in patients and providing this data for retrospective review by a medical professional. It does not involve the analysis of biological samples.
Therefore, the RhythmStar system falls under the category of a medical device that performs physiological monitoring, but it is not an IVD.
N/A
Intended Use / Indications for Use
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 and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers all recorded cardiac activity to the cloud server where it is presented and can be retrospectively reviewed by a medical professional at a monitoring center. The RhythmStar system is not intended for real-time monitoring.
The data received from the RhythmStar device can be used for retrospective review, arrhythmia analysis, and further evaluation, reporting and signal measurements using RhythmStar system or a compatible arrhythmia analysis software that has been FDA cleared for Lead II analysis using nontraditional wet electrode placement. The RhythmStar system is not intended to sound any alarms.
The device does not deliver any therapy, administer any drugs, or provide for life support. The RhythmStar system does not provide interpretive or diagnostic statements. Interpretation and diagnosis are the responsibility of a physician. RhythmStar is for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
OYX
Device Description
The RhythmStar system consists of the RhythmStar device and the server. The RhythmStar device is a portable, battery-powered, wireless cardiac monitor which may be worn by a patient to record ECG and activity level data for up to 30 consecutive days. The device can capture patient activated and autotriggered events such as Bradycardia, Tachycardia, and Atrial Fibrillation as identified by an embedded arrhythmia detection algorithm. The device is capable of automatically delivering the collected ECG data to the server using a built-in 4G LTE wireless data modem, or the data can be transferred from the device using a USB connection. The data transmitted by the RhythmStar device can be stored, evaluated, and presented for review, analysis and reporting by a medical professional using a server, such as the RhvthmStar Svstem server.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest
Indicated Patient Age Range
Patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety.
Intended User / Care Setting
Medical professional at a monitoring center. Ambulatory, Outpatient.
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 testing confirmed that the RhythmStar RS-10003 can continuously record ECG signal, store ECG data, and transmit manual or auto-activated event recordings to the server via mobile network or USB connection for evaluation by a medical professional.
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
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 8, 2024
RhythMedix LLC Stan Biletsky Cto 5000 Atrium Way Ste 1 Mount Laurel, New Jersey 08054
Re: K233584
Trade/Device Name: RhythmStar System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: OYX Dated: June 7, 2024 Received: June 7, 2024
Dear Stan Biletsky:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Kimberly N. Crowley -S
For: Jennifer Shih Kozen Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
RhythmStar System
Indications for Use (Describe)
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 and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers all recorded cardiac activity to the cloud server where it is presented and can be retrospectively reviewed by a medical professional at a monitoring center. The RhythmStar system is not intended for real-time monitoring.
The data received from the RhythmStar device can be used for retrospective review, arrhythmia analysis, and further evaluation, reporting and signal measurements using RhythmStar system or a compatible arrhythmia analysis software that has been FDA cleared for Lead II analysis using nontraditional wet electrode placement. The RhythmStar system is not intended to sound any alarms.
The device does not deliver any therapy, administer any drugs, or provide for life support. The RhythmStar system does not provide interpretive or diagnostic statements. Interpretation and diagnosis are the responsibility of a physician. RhythmStar is for prescription use only.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Type of Use (Select one or both, as applicable)
(Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
4
Summary of 510(k) RhythMedix, LLC
This 510(k) Summary is in conformance with 21 CFR 807.92
- Submitter: RhythMedix, LLC 5000 Atrium Way Ste. 1 Mount Laurel, NJ 08054 United States
- Primary Contact: Rita King, CEO MethodSense, Inc. Email: ritaking@methodsense.com Phone: 919-313-3961 Fax: 919-313-3979
- Company Contact: Stan Biletsky, CTO RhythMedix, LLC Email: Phone:
Device Name and Classification
| Trade Name: | RhythmStar System |
|---|---|
| Common Name: | Outpatient cardiac telemetry |
| Classification: | Class II |
| Regulation Number: | 21 CFR 870.1025 |
| Classification Panel: | Cardiovascular |
| Product Code: | QYX |
Predicate Device:
| Primary Predicate | |
|---|---|
| Trade Name | RhythmStar System |
| Common Name | Telephone electrocardiograph transmitter and receiver |
| 510(k) Submitter / Holder | RhythMedix, LLC |
| 510(k) Number | K141813 |
| Regulation Number | 21 CFR Part 870.2920 |
| Classification Panel | Cardiovascular |
| Product Code | DXH |
| Secondary Predicate | |
| Trade Name | Zio AT ECG Monitoring System |
| Common Name | Outpatient cardiac telemetry |
| 510(k) Submitter / Holder | iRhythm Technologies, Inc. |
| 510(k) Number | K163512 |
| Regulation Number | 21 CFR Part 870.1025 |
| Classification Panel | Cardiovascular |
| Product Code | QYX, DQK, DSH, DSI, DXH |
5
Device Description
The RhythmStar system consists of the RhythmStar device and the server. The RhythmStar device is a portable, battery-powered, wireless cardiac monitor which may be worn by a patient to record ECG and activity level data for up to 30 consecutive days. The device can capture patient activated and autotriggered events such as Bradycardia, Tachycardia, and Atrial Fibrillation as identified by an embedded arrhythmia detection algorithm. The device is capable of automatically delivering the collected ECG data to the server using a built-in 4G LTE wireless data modem, or the data can be transferred from the device using a USB connection. The data transmitted by the RhythmStar device can be stored, evaluated, and presented for review, analysis and reporting by a medical professional using a server, such as the RhvthmStar Svstem server.
Indications for Use
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 and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers all recorded cardiac activity to the cloud server where it is presented and can be retrospectively reviewed by a medical professional at a monitoring center. The RhythmStar system is not intended for real-time monitoring.
The data received from the RhythmStar device can be used for retrospective review, arrhythmia analysis, and further evaluation, reporting and signal measurements using RhythmStar system, or a compatible arrhythmia analysis software that has been FDA cleared for Lead II analysis using non-traditional wet electrode placement. The RhythmStar system is not intended to sound any alarms.
The device does not deliver any therapy, administer any drugs, or provide for life support. The RhythmStar system does not provide interpretive or diagnostic statements. Interpretation and diagnosis are the responsibility of a physician. RhythmStar is for prescription use only.
Risk Analysis Method
The updated RhythmStar monitoring device was assessed to determine the risks of the device as it relates to the hardware changes. A risk analysis was conducted in accordance with ISO 14971:2019, Medical devices - Application of risk management to medical devices.
6
Substantial Equivalence Discussion
The table below provides a side-by-side comparison between RhythmStar RS-10003 and the predicate devices with respect to the intended use, technological characteristics, and principles of operation.
| Characteristic | Subject Device
RhythmStar RS-10003 | Primary Predicate Device
RhythmStar RS-10002
(K141813) | Secondary Predicate
Device
Zio® QX ECG Monitoring
System (K163512) | Comparison |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use
Intended Use | The RhythmStar System is
intended for continuous
ECG monitoring and
arrhythmia detection. | The RhythmStar System is
intended for continuous
ECG monitoring and
arrhythmia detection. | The Zio® QX ECG
Monitoring System is
intended for continuous
ECG monitoring and
arrhythmia detection. | Identical |
| Indications for Use
Indications for Use | The RhythmStar RS-10003
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 all recorded cardiac
activity to the cloud server
where it is presented and
can be reviewed by a | 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 | The Zio® QX ECG Monitoring
System is intended to
capture, analyze and report
symptomatic and
asymptomatic cardiac
events and continuous
electrocardiogram (ECG)
information for long-term
monitoring. While
continuously recording
patient ECG, both patient-
triggered and automatically
detected arrhythmia events
are transmitted to a
monitoring center for
reporting. After wear, a final
report is generated based
on beat-to-beat information
from the entire ECG
recording. It is indicated for | Equivalent |
7
| Characteristic | Subject Device
RhythmStar RS-10003 | Primary Predicate Device
RhythmStar RS-10002
(K141813) | Secondary Predicate
Device
Zio® QX ECG Monitoring
System (K163512) | Comparison |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | medical professional at a
monitoring center. The
RhythmStar system is not
intended for real-time
monitoring.
The data received from the
RhythmStar device can be
used for retrospective
review, arrhythmia analysis,
reporting and signal
measurements by
RhythmStar system, or a
compatible arrhythmia
analysis software that has
been FDA cleared for Lead
II analysis using non-
traditional wet electrode
placement. The RhythmStar
is not intended to sound any
alarms.
The device does not deliver
any therapy, administer any
drugs, or provide for life
support. The RhythmStar
system does not provide
interpretive or diagnostic
statements. Interpretation
and diagnosis are the
responsibility of a physician.
RhythmStar is for
prescription use only. | 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 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.
RhythmStar is for
prescription use only. | use on patients 18 years or
older who may be
asymptomatic or who may
suffer from transient
symptoms such as
palpitations, shortness of
breath, dizziness, light-
headedness, pre-syncope,
syncope, fatigue, or anxiety.
The reports are provided for
review by the intended user
to render a diagnosis based
on clinical judgment and
experience. It is not
intended for use on critical
care patients. | |
8
| Characteristic | Subject Device
RhythmStar RS-10003 | Primary Predicate Device
RhythmStar RS-10002
(K141813) | Secondary Predicate
Device
Zio® QX ECG Monitoring
System (K163512) | Comparison |
|-------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Use | | | | |
| Prescription / OTC | Prescription | Prescription | Prescription | Identical |
| Intended
Population | Patients requiring cardiac
monitoring who are
ambulatory and without life-
threatening conditions | Patients requiring cardiac
monitoring who are
ambulatory and without life-
threatening conditions | Patients requiring cardiac
monitoring who are
ambulatory and without life-
threatening conditions | Identical |
| Environment of
Use | Ambulatory, Outpatient | Ambulatory, Outpatient | Ambulatory, Outpatient | Identical |
| Technological Characteristics | | | | |
| Dimensions | 59mm x 50mm x 15mm | 101mm x 66mm x 13mm | Patch
5.2 x 2.0 x 0.5 in
(132mm x 51mm x 13mm)
Gateway
6.2 x 3.4 x 0.8 in
(157mm x 86mm x 20mm) | Different - This difference
does not change the
intended use of the device.
Both devices are wearable
and portable. The safety
and effectiveness of the size
has been demonstrated
through testing. |
| Weight | 38 g | 90 g | 24.7 g | Different - This difference
does not change the
intended use of the device.
The safety and
effectiveness of the size has
been demonstrated through
testing. |
| Material | ABS and TPU plastic | ABS and TPU plastic | Proprietary patch and
plastic | Identical to primary
predicate |
| Duration of Use | Up to 30 days | Up to 30 days | Up to 14 days | Identical to primary
predicate |
| Type of Wear | Device worn on chest | Device worn over belt /
waistband | Device worn on chest | Identical to secondary
predicate |
9
| Characteristic | Subject Device
RhythmStar RS-10003 | Primary Predicate Device
RhythmStar RS-10002
(K141813) | Secondary Predicate
Device
Zio® QX ECG Monitoring
System (K163512) | Comparison |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Basic Technology | Analog ECG front-end,
accelerometer, MCU, flash
data storage, built-in cellular
modem for data
transmission | Analog ECG front-end,
accelerometer, MCU, flash
data storage, built-in cellular
modem for data
transmission | Analog ECG recorded on
patch and transmitted via
Bluetooth to Gateway with
built-in cellular modem for
data transmission | Identical to primary
predicate |
| Battery Powered | Yes | Yes | Yes | Identical |
| Energy Source | Rechargeable 3.7V Li-ion
battery | Rechargeable 3.7V Li-ion
battery | Patch
Lithium Manganese Dioxide
Coin Cells
Gateway
1 Lithium Polymer Cell | Identical to primary
predicate |
| Battery Life | 72 hours | 72 hours | 14 days | Identical to primary
predicate |
| Removable Battery | No | Yes | No | Identical to secondary
predicate |
| Bandwidth | 0.05 ... 40 Hz | 0.05 ... 40 Hz | 0.5 ... 30 Hz | Identical to primary
predicate |
| Common-mode
rejection ratio
(CMRR) | 100 dB minimum, 115 dB
typical | 90 dB minimum, 100 dB
typical | Information not available | Different - The subject
device has a higher CMRR
to improve common mode
rejection. This difference
does not change the
intended use of the device.
The safety and
effectiveness of the CMRR
difference has been
demonstrated via IEC
60601-2-47. |
10
| Characteristic | Subject Device
RhythmStar RS-10003 | Primary Predicate Device
RhythmStar RS-10002
(K141813) | Secondary Predicate
Device
Zio® QX ECG Monitoring
System (K163512) | Comparison |
|-----------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sampling Rate | 256 Hz | 250 Hz | 200 Hz | Different - This change
does not change the
intended use of the device.
Both devices support a 125
Hz sampling rate, which is
the minimum sample rate
needed to support the
bandwidth requirement cited
in IEC 60601-2-47 for
ambulatory arrhythmia
monitoring. |
| ECG leads | 2 | 2, 3, 4, 5 | 2 | Identical to secondary
predicate device. |
| ECG Acquisition | Body worn monitoring
device | Body worn monitoring
device | Body worn monitoring
device | Identical |
| Lead off Detection | Yes | Yes | Patch off detection | Identical to primary
predicate device |
| Accelerometer | Yes | Yes | Information not available | Identical to primary
predicate |
| Display | LED lights | LCD | LED lights | Identical to secondary
predicate |
| User Event Trigger | Double tap on monitoring
device | Button push on monitoring
device | Button push on patch | Different - This difference
does not change the
intended use of the device.
The subject device and
predicate devices provide a
method of manual event
triggering. |
| Wireless
Communication
Technology | Yes - 4G mobile network
using embedded cellular
data modem | Yes - 3G mobile network
using embedded cellular
data modem | Yes | Equivalent - Both devices
use cellular communication
technology and operate on
the same mobile networks. |
| System Design | PEMS and software | PEMS and software | PEMS and software | Identical |
11
| Characteristic | Subject Device
RhythmStar RS-10003 | Primary Predicate Device
RhythmStar RS-10002
(K141813) | Secondary Predicate
Device
Zio® QX ECG Monitoring
System (K163512) | Comparison |
|------------------------------------------------|----------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------------------|------------------------------------------|
| Sterile | Non-sterile | Non-sterile | Non-sterile | Identical |
| Use Type | Multi-Patient Use | Multi-Patient Use | Single Use Only | Identical to primary
predicate device |
| Arrhythmia
Detection
Algorithm | Yes | Yes | Yes | Identical |
| Alarms | None | None | None | Identical |
| Adjustable Device
Programming
Parameters | Yes | Yes | No | Identical to primary
predicate device |
| Review of ECG
Data | ECG Technicians at 24/7
Monitoring Center | ECG Technicians at 24/7
Monitoring Center | ECG Technicians at 24/7
Monitoring Center | Identical |
In conclusion, the intended use for RhythmStar RS-10003 is identical to the intended use of the primary predicate (RhythmStar System (K141813)) and secondary predicate (Zio® QX ECG Monitoring System (K163512)) with regard to continuous ECG monitoring and arrhythmia detection. Additionally, the technological characteristics are equivalent to those of the primary predicate (RhythmStar System (K141813)) and the secondary predicate (Zio® QX ECG Monitoring System). Testing demonstrates that RhythmStar RS-10003 is substantially equivalent to the predicate devices (RhythmStar System (K1413) and Zio® QX ECH Moritoring System (K163512)) and is as safe and effective as the predicate devices.
12
Testing
Biocompatibility
Biocompatibility of the RhythmStar device was evaluated in accordance with ISO 10993 (see K141813).
Electrical Safety and EMC Testing
The RhythmStar RS-10003 was tested and conforms to the following FDA recognized consensus standards:
-
- I EC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
-
- IEC 60601-1-6: Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-1-11: Medical electrical equipment Part 1-11: Medical electrical equipment Part 1-ধ: 11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical systems used in the home healthcare environment
-
- ANSI/AAMI/IEC 60601-2-47: Medical electrical equipment Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
-
- AIM 7351731: Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers
-
- IEEE ANSI USEMCSC C63.27 American National Standard for Evaluation of Wireless Coexistence.
The RhythmStar RS-10003 was also evaluated in accordance with the following FDA quidance documents.
-
- Electromagnetic Compatibility (EMC) of Medical Devices, Guidance for Industry and Food and Druq Administration Staff
- Radio Frequency Wireless Technology in Medical Devices, Guidance for Industry and Staff 2.
The RhythmStar RS-10003 is not defibrillation proof but was tested to demonstrate safety in case of defibrillation.
Software Verification and Validation
The RhythmStar RS-10003 software was developed and is maintained in accordance with IEC 62304 Medical device software - Software life cycle processes.
Software used in the RhythmStar RS-10003 went through unit testing, and systemlevel testing.
Performance Testing
The RhythmStar System was tested in accordance with ANSI/AAMI EC57 (see K141813).
Bench testing also confirmed that the RhythmStar RS-10003 can continuously record ECG signal, store ECG data, and transmit manual or auto-activated event recordings to the server via mobile network or USB connection for evaluation by a medical professional.
13
The RhythmStar RS-10003 monitoring device was tested in accordance with ANSI/AAMI EC53: ECG trunk cables and patient leadwires.
The RhythmStar RS-10003 monitoring device was tested in accordance with ANSI/AAMI EC12: Disposable ECG electrodes.
Cybersecurity Testing
Cybersecurity activities were performed in accordance with Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.
Conclusion
The intended use of the RhythmStar RS-10003 is identical to the intended use of the predicate device (K141813). Additionally, the technological characteristics of the subject device and predicate device (K141813) are equivalent and any differences do not raise new questions of safety and effectiveness. Based on device performance test results, RhythMedix determines that the RhythmStar RS-10003 performs within its design specifications, and is substantially equivalent to the predicate device.