RhythmStar System
Device Facts
| Record ID | K233584 |
|---|---|
| Device Name | RhythmStar System |
| Applicant | RhythMedix, LLC |
| Product Code | QYX · Cardiovascular |
| Decision Date | Jul 8, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
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.
Device Story
Portable, battery-powered, wearable cardiac monitor; records ECG and activity data for up to 30 days. Inputs: ECG signals via electrodes, accelerometer data. Processing: Embedded arrhythmia detection algorithm identifies events (Bradycardia, Tachycardia, Atrial Fibrillation). Outputs: Recorded cardiac activity transmitted via 4G LTE or USB to cloud server. Usage: Ambulatory/outpatient setting; patient-worn. Operation: Patient initiates events via double-tap; device auto-triggers on algorithm detection. Healthcare providers review data retrospectively at monitoring centers to support diagnosis. Benefits: Enables long-term monitoring of intermittent cardiac symptoms without real-time alarm requirements.
Clinical Evidence
Bench testing only. Performance verified per ANSI/AAMI EC57, EC53, and EC12. Electrical safety and EMC testing conducted per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-47. Cybersecurity evaluated per FDA guidance. No clinical trial data presented.
Technological Characteristics
Materials: ABS and TPU plastic. Sensing: Analog ECG front-end, accelerometer. Energy: Rechargeable 3.7V Li-ion battery. Connectivity: 4G LTE cellular modem, USB. Dimensions: 59mm x 50mm x 15mm. Weight: 38g. Sampling: 256 Hz. Bandwidth: 0.05-40 Hz. CMRR: 100 dB min. Software: IEC 62304 compliant.
Indications for Use
Indicated for patients 18+ years or older, ambulatory, with or at risk of cardiac disease, or demonstrating intermittent symptoms (e.g., palpitations, dizziness, syncope) requiring continuous cardiac monitoring. Not for critical care or real-time monitoring.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
Submission Summary (Full Text)
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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"
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(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
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
Submission Number (if known)
K233584
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)
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# 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 |
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#### 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.
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# 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<br>RhythmStar RS-10003 | Primary Predicate Device<br>RhythmStar RS-10002<br>(K141813) | Secondary Predicate<br>Device<br>Zio® QX ECG Monitoring<br>System (K163512) | Comparison |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use<br>Intended Use | The RhythmStar System is<br>intended for continuous<br>ECG monitoring and<br>arrhythmia detection. | The RhythmStar System is<br>intended for continuous<br>ECG monitoring and<br>arrhythmia detection. | The Zio® QX ECG<br>Monitoring System is<br>intended for continuous<br>ECG monitoring and<br>arrhythmia detection. | Identical |
| Indications for Use<br>Indications for Use | The RhythmStar RS-10003<br>System is intended for use<br>by patients who either have<br>or are at risk of having<br>cardiac disease and those<br>that demonstrate<br>intermittent symptoms<br>indicative of cardiac disease<br>and require cardiac<br>monitoring on a continuing<br>basis. The device<br>continuously records ECG<br>data and upon detection by<br>an ECG analysis algorithm<br>or manually initiated by the<br>patient, automatically<br>delivers all recorded cardiac<br>activity to the cloud server<br>where it is presented and<br>can be reviewed by a | The RhythmStar System is<br>intended for use by patients<br>who either have or are at<br>risk of having cardiac<br>disease and those that<br>demonstrate intermittent<br>symptoms indicative of<br>cardiac disease and require<br>cardiac monitoring on a<br>continuing basis. The<br>device continuously records<br>ECG data and upon<br>detection by an ECG<br>analysis algorithm or<br>manually initiated by the<br>patient, automatically<br>delivers the recorded<br>cardiac activity to the server<br>where it is presented and | The Zio® QX ECG Monitoring<br>System is intended to<br>capture, analyze and report<br>symptomatic and<br>asymptomatic cardiac<br>events and continuous<br>electrocardiogram (ECG)<br>information for long-term<br>monitoring. While<br>continuously recording<br>patient ECG, both patient-<br>triggered and automatically<br>detected arrhythmia events<br>are transmitted to a<br>monitoring center for<br>reporting. After wear, a final<br>report is generated based<br>on beat-to-beat information<br>from the entire ECG<br>recording. It is indicated for | Equivalent |
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| Characteristic | Subject Device<br>RhythmStar RS-10003 | Primary Predicate Device<br>RhythmStar RS-10002<br>(K141813) | Secondary Predicate<br>Device<br>Zio® QX ECG Monitoring<br>System (K163512) | Comparison |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | medical professional at a<br>monitoring center. The<br>RhythmStar system is not<br>intended for real-time<br>monitoring.<br>The data received from the<br>RhythmStar device can be<br>used for retrospective<br>review, arrhythmia analysis,<br>reporting and signal<br>measurements by<br>RhythmStar system, or a<br>compatible arrhythmia<br>analysis software that has<br>been FDA cleared for Lead<br>II analysis using non-<br>traditional wet electrode<br>placement. The RhythmStar<br>is not intended to sound any<br>alarms.<br>The device does not deliver<br>any therapy, administer any<br>drugs, or provide for life<br>support. The RhythmStar<br>system does not provide<br>interpretive or diagnostic<br>statements. Interpretation<br>and diagnosis are the<br>responsibility of a physician.<br>RhythmStar is for<br>prescription use only. | can be reviewed by a<br>medical professional.<br>The data received from the<br>RhythmStar device can be<br>used by another device for<br>arrhythmia analysis,<br>reporting and signal<br>measurements. The<br>RhythmStar is not intended<br>to sound any alarms.<br>The device does not deliver<br>any therapy, administer any<br>drugs, provide interpretive<br>or diagnostic statements, or<br>provide for any life support.<br>RhythmStar is for<br>prescription use only. | use on patients 18 years or<br>older who may be<br>asymptomatic or who may<br>suffer from transient<br>symptoms such as<br>palpitations, shortness of<br>breath, dizziness, light-<br>headedness, pre-syncope,<br>syncope, fatigue, or anxiety.<br>The reports are provided for<br>review by the intended user<br>to render a diagnosis based<br>on clinical judgment and<br>experience. It is not<br>intended for use on critical<br>care patients. | |
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| Characteristic | Subject Device<br>RhythmStar RS-10003 | Primary Predicate Device<br>RhythmStar RS-10002<br>(K141813) | Secondary Predicate<br>Device<br>Zio® QX ECG Monitoring<br>System (K163512) | Comparison |
|-------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Use | | | | |
| Prescription / OTC | Prescription | Prescription | Prescription | Identical |
| Intended<br>Population | Patients requiring cardiac<br>monitoring who are<br>ambulatory and without life-<br>threatening conditions | Patients requiring cardiac<br>monitoring who are<br>ambulatory and without life-<br>threatening conditions | Patients requiring cardiac<br>monitoring who are<br>ambulatory and without life-<br>threatening conditions | Identical |
| Environment of<br>Use | Ambulatory, Outpatient | Ambulatory, Outpatient | Ambulatory, Outpatient | Identical |
| Technological Characteristics | | | | |
| Dimensions | 59mm x 50mm x 15mm | 101mm x 66mm x 13mm | Patch<br>5.2 x 2.0 x 0.5 in<br>(132mm x 51mm x 13mm)<br><br>Gateway<br>6.2 x 3.4 x 0.8 in<br>(157mm x 86mm x 20mm) | Different - This difference<br>does not change the<br>intended use of the device.<br>Both devices are wearable<br>and portable. The safety<br>and effectiveness of the size<br>has been demonstrated<br>through testing. |
| Weight | 38 g | 90 g | 24.7 g | Different - This difference<br>does not change the<br>intended use of the device.<br>The safety and<br>effectiveness of the size has<br>been demonstrated through<br>testing. |
| Material | ABS and TPU plastic | ABS and TPU plastic | Proprietary patch and<br>plastic | Identical to primary<br>predicate |
| Duration of Use | Up to 30 days | Up to 30 days | Up to 14 days | Identical to primary<br>predicate |
| Type of Wear | Device worn on chest | Device worn over belt /<br>waistband | Device worn on chest | Identical to secondary<br>predicate |
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| Characteristic | Subject Device<br>RhythmStar RS-10003 | Primary Predicate Device<br>RhythmStar RS-10002<br>(K141813) | Secondary Predicate<br>Device<br>Zio® QX ECG Monitoring<br>System (K163512) | Comparison |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Basic Technology | Analog ECG front-end,<br>accelerometer, MCU, flash<br>data storage, built-in cellular<br>modem for data<br>transmission | Analog ECG front-end,<br>accelerometer, MCU, flash<br>data storage, built-in cellular<br>modem for data<br>transmission | Analog ECG recorded on<br>patch and transmitted via<br>Bluetooth to Gateway with<br>built-in cellular modem for<br>data transmission | Identical to primary<br>predicate |
| Battery Powered | Yes | Yes | Yes | Identical |
| Energy Source | Rechargeable 3.7V Li-ion<br>battery | Rechargeable 3.7V Li-ion<br>battery | Patch<br>Lithium Manganese Dioxide<br>Coin Cells<br>Gateway<br>1 Lithium Polymer Cell | Identical to primary<br>predicate |
| Battery Life | 72 hours | 72 hours | 14 days | Identical to primary<br>predicate |
| Removable Battery | No | Yes | No | Identical to secondary<br>predicate |
| Bandwidth | 0.05 ... 40 Hz | 0.05 ... 40 Hz | 0.5 ... 30 Hz | Identical to primary<br>predicate |
| Common-mode<br>rejection ratio<br>(CMRR) | 100 dB minimum, 115 dB<br>typical | 90 dB minimum, 100 dB<br>typical | Information not available | Different - The subject<br>device has a higher CMRR<br>to improve common mode<br>rejection. This difference<br>does not change the<br>intended use of the device.<br>The safety and<br>effectiveness of the CMRR<br>difference has been<br>demonstrated via IEC<br>60601-2-47. |
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| Characteristic | Subject Device<br>RhythmStar RS-10003 | Primary Predicate Device<br>RhythmStar RS-10002<br>(K141813) | Secondary Predicate<br>Device<br>Zio® QX ECG Monitoring<br>System (K163512) | Comparison |
|-----------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sampling Rate | 256 Hz | 250 Hz | 200 Hz | Different - This change<br>does not change the<br>intended use of the device.<br>Both devices support a 125<br>Hz sampling rate, which is<br>the minimum sample rate<br>needed to support the<br>bandwidth requirement cited<br>in IEC 60601-2-47 for<br>ambulatory arrhythmia<br>monitoring. |
| ECG leads | 2 | 2, 3, 4, 5 | 2 | Identical to secondary<br>predicate device. |
| ECG Acquisition | Body worn monitoring<br>device | Body worn monitoring<br>device | Body worn monitoring<br>device | Identical |
| Lead off Detection | Yes | Yes | Patch off detection | Identical to primary<br>predicate device |
| Accelerometer | Yes | Yes | Information not available | Identical to primary<br>predicate |
| Display | LED lights | LCD | LED lights | Identical to secondary<br>predicate |
| User Event Trigger | Double tap on monitoring<br>device | Button push on monitoring<br>device | Button push on patch | Different - This difference<br>does not change the<br>intended use of the device.<br>The subject device and<br>predicate devices provide a<br>method of manual event<br>triggering. |
| Wireless<br>Communication<br>Technology | Yes - 4G mobile network<br>using embedded cellular<br>data modem | Yes - 3G mobile network<br>using embedded cellular<br>data modem | Yes | Equivalent - Both devices<br>use cellular communication<br>technology and operate on<br>the same mobile networks. |
| System Design | PEMS and software | PEMS and software | PEMS and software | Identical |
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| Characteristic | Subject Device<br>RhythmStar RS-10003 | Primary Predicate Device<br>RhythmStar RS-10002<br>(K141813) | Secondary Predicate<br>Device<br>Zio® QX ECG Monitoring<br>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<br>predicate device |
| Arrhythmia<br>Detection<br>Algorithm | Yes | Yes | Yes | Identical |
| Alarms | None | None | None | Identical |
| Adjustable Device<br>Programming<br>Parameters | Yes | Yes | No | Identical to primary<br>predicate device |
| Review of ECG<br>Data | ECG Technicians at 24/7<br>Monitoring Center | ECG Technicians at 24/7<br>Monitoring Center | ECG Technicians at 24/7<br>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.
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## 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:
- 1. I EC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- 2. 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
- 3. 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
- 5. 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
- 6. AIM 7351731: Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers
- 7. 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.
- 1. 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.
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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.
