(29 days)
The RhythmStar system is intended for use by patients who cither have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis. The device continuously records ECG data and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers the recorded cardiac activity to the server where it is presented and can be reviewed by a medical professional.
The data received from the RhythmStar device can be used by another device for arrhythmia analysis, reporting and signal measurements. The RhythmStar system is not intended to sound any alarms.
The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support. RhythmStar is for prescription use only.
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 auto-triggered events such as Bradycardia, Tachycardia, and Atrial Fibrillation as identified by an embedded arrhythmia detection algorithm. The device is capable to automatically deliver the data to the server. The data can be delivered to the server wirelessly via mobile network or via USB connection. A medical professional, using the server, can adjust and program the device configuration and auto-triggering parameters.
The provided text describes the RhythmStar System, a cardiac monitor. While it outlines extensive performance and safety testing against various IEC and ANSI/AAMI standards, it does not contain details about specific acceptance criteria for a device's performance (e.g., sensitivity, specificity for arrhythmia detection) or a study that specifically proves the device meets such criteria.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and general compliance with regulatory standards for medical electrical equipment. It emphasizes that the device functions as intended and meets design specifications.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document lists general performance and safety tests passed, but not specific performance metrics (e.g., detection accuracy for arrhythmias) with corresponding acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided. The document mentions "bench test results verify that RhythmStar system can continuously record ECG signal, store ECG data in the device memory, and transmit manual or auto activated event recordings to the server..." However, it does not detail a "test set" in the context of clinical data for performance evaluation (e.g., for arrhythmia detection accuracy). The performance tests described (IEC/ANSI standards) are typically bench or lab-based rather than involving patient data in a test set for diagnostic accuracy.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable/Not provided. Since no specific clinical test set for diagnostic performance is described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set
Not applicable/Not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. The document does not describe a MRMC study or any study comparing human reader performance with and without AI assistance. The RhythmStar system uses an embedded arrhythmia detection algorithm, but its interaction with human interpretation and any performance improvement metrics are not discussed.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Implied, but details are absent. The device has an "embedded arrhythmia detection algorithm" that auto-triggers events. "The data received from the RhythmStar device can be used by another device for arrhythmia analysis, reporting and signal measurements." This suggests standalone algorithm capability. However, no specific performance metrics (e.g., sensitivity, specificity, accuracy) for this algorithm are provided in the document. The statement "The device continuously records ECG data and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers the recorded cardiac activity to the server where it is presented and can be reviewed by a medical professional" indicates the algorithm acts as a trigger, with subsequent review by a professional.
7. The Type of Ground Truth Used
Not explicitly stated for diagnostic performance. For the functional and safety tests, the "ground truth" would be the specifications and requirements of the standards themselves (e.g., electrical safety, EMC limits, usability requirements). If the "embedded arrhythmia detection algorithm" performance was evaluated, the type of ground truth (e.g., expert-adjudicated ECGs, pathology, clinical outcomes) is not mentioned.
8. The Sample Size for the Training Set
Not provided. The document does not discuss any machine learning model training or training set sizes for the embedded arrhythmia detection algorithm.
9. How the Ground Truth for the Training Set was Established
Not provided.
Summary of available information:
The document focuses on regulatory compliance and substantial equivalence to predicate devices, emphasizing that the RhythmStar System passes various electrical, safety, and performance standards relevant to ambulatory electrocardiographic systems. It details the device's technological characteristics and differences from predicates, stating these differences do not impact safety or effectiveness. However, it does not provide specific clinical performance metrics or studies directly demonstrating the accuracy of its arrhythmia detection algorithm against predefined acceptance criteria using clinical data. The "performance testing" section primarily references compliance with general medical device standards.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2014
Rhythmedix, LLC c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K141813
Trade/Device Name: RhythmStar System Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone electrocardiograph transmitter and receiver Regulatory Class: Class II Product Code: DXH Dated: July 3, 2014 Received: July 7, 2014
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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
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Page 2 - Mr. Mark Job
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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en Skodacek for Bram D. Zuckerman, MD. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141813
Device Name
RhythmStar System
Indications for Use (Describe)
The RhythmStar system is intended for use by patients who cither have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis. The device continuously records ECG data and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers the recorded cardiac activity to the server where it is presented and can be reviewed by a medical professional.
The data received from the RhythmStar device can be used by another device for arrhythmia analysis, reporting and signal measurements. The RhythmStar system is not intended to sound any alarms.
The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support. RhythmStar is for prescription use only.
Type of Use (Select one or both, as applicable)
الا Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
|---|---|
| Ken Skodacek for | |
| Bram Zuckerman |
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Image /page/3/Picture/0 description: The image shows the logo for "RhythMedix". The logo is in gray and features a stylized font. To the right of the word "Medix" is a small trademark symbol and a graphic of three curved lines emanating from a corner, resembling radio waves.
| Submitted by | Rhythmedix, LLCHorizon Corporate Center5000 Atrium Way, Suite 1Mt. Laurel, NJ 08054 |
|---|---|
| Contact | Stan Biletskysbiletsky@rhythmedix.com |
| Establishment RegistrationNumber | N/A |
| Date Prepared | June 20, 2014 |
| Trade Name | RhythmStar System |
| Common Name | Mobile Cardiac Monitor |
| Device Classification (regulation) | 870.2920 Telephone electrocardiograph transmitter andreceiver. |
| Class | II |
| Product Code | DXH |
| Classification Panel | Cardiovascular |
| Equivalent Marketed Device(s)(Predicate device(s)) | K131699, eMotion ECG Mobile, Mega Electronics LtdK083535, Heartrak Smart ECAT, Universal Medical, Inc. |
| Device Description (abbreviated) | The RhythmStar system consists of the RhythmStardevice and the server. The RhythmStar device is aportable, battery-powered, wireless cardiac monitor whichmay be worn by a patient to record ECG and activity leveldata for up to 30 consecutive days. The device cancapture patient activated and auto-triggered events suchas Bradycardia, Tachycardia, and Atrial Fibrillation asidentified by an embedded arrhythmia detection algorithm.The device is capable to automatically deliver the data tothe server. The data can be delivered to the serverwirelessly via mobile network or via USB connection. Amedical professional, using the server, can adjust andprogram the device configuration and auto-triggeringparameters. |
| Intended Use | The RhythmStar system is intended for use by patientswho either have or are at risk of having cardiac diseaseand those that demonstrate intermittent symptomsindicative of cardiac disease and require cardiacmonitoring on a continuing basis. The device continuously |
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records ECG data and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers the recorded cardiac activity to the server where it is presented and can be reviewed by a medical professional.
The data received from the RhythmStar device can be used by another device for arrhythmia analysis, reporting and signal measurements. The RhythmStar system is not intended to sound any alarms.
The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support. RhythmStar is for prescription use only.
Technological Characteristics
The RhythmStar device patient kit includes:
- RhythmStar monitor -
- Patient ECG lead cable (3-lead cable included, 5-lead cable optional)
- -2 externally re-chargeable batteries
- -Wall battery charger (the charger cannot be connected to the device)
The monitor consists of an analog ECG front end, accelerometer, MCU, flash data storage, RF modem for data transmission, LCD screen, and Record button. The server components facilitate data communication with the RhythmStar device, provide data storage, and present the data for evaluation by a medical professional.
There are known similarities between the new device and the predicate devices:
- . All devices are small, lightweight ambulatory cardiac monitors.
- . All devices use the same wireless technology to deliver data to a server.
- . All devices are battery powered and have a rechargeable Li-lon battery.
- . The RhythmStar and Heartrak Smart ECAT (K083535), using a server, can adjust device programming parameters such as pre-post recording times and autotriggering configuration.
- The RhythmStar and eMotion ECG Mobile (K131699) ● devices incorporate an accelerometer to capture activity level data related to patient motion and device orientation.
- . All devices have Record button for manual event recordings and a user interface capabilities to indicate device status and mode of operation.
- The RhythmStar and Heartrak Smart ECAT (K083535) ● incorporate embedded ECG analysis algorithm to auto-
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capture Bradycardia. Tachycardia and Atrial Fibrillation. The eMotion ECG Mobile (K131699) detects arrhythmia events on the server. All devices detect arrhythmia events between the signal acquisition point and the reviewer of the data.
- . All devices have at least 2 ECG channels and 3-lead electrodes.
- All devices have identical or very similar Functional, Environmental and Electrical characteristics
There are known differences between the new device and the predicate devices that do not impact safety or effectiveness:
- Predicate devices use external RF component (cell . phone) between ECG sensor and the server for long range data transmission and transmit ECG data to the cell phone communicator using a close range RF link such as Bluetooth connection. Essentially, the predicate devices utilize two different RF technologies (BT and Mobile Network) and two separate components – ECG sensor to collect ECG data and a wireless communicator (cell phone) to deliver the data to the server. The new device integrates a wireless modem module into a single unit design to improve reliability of the overall system, reduce risks related to delayed data delivery, improve patient compliance by reducing complexity of the device, and lower production costs. The RhythmStar uses the same wireless technology (Mobile Network) as the predicate devices to deliver data to the server and is therefore substantially equivalent to the predicates.
- Predicate devices can recharge the internal battery onboard. The new device utilizes batteries that are charged externally in a wall charger made by a thirdparty. This design eliminates any risks of electrical shock during charging because the charger cannot be connected to the device and the patient is never connected to the charger directly or indirectly. All devices use the same energy source - rechargeable Li-lon battery and require the patient to recharge it and are therefore substantially equivalent.
- The new device supports USB connectivity in addition ● to being able to transmit data to the server via the mobile network. The predicate devices deliver data to the server via the mobile network only. The RhythmStar's ability to deliver and/or receive data to/from the server in more than one way addresses risks related to potential failures to deliver data wirelessly due to: wireless service unavailability,
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wireless component malfunction, and issues that arise from misuse of the device. According to the RhythmStar System Requirements Specification, the physical design of the cable connector on the device makes it physically impossible to connect the RhythmStar to a USB or any other device while patient ECG lead cable is plugged-in. Adding USB capability in RhythmStar device does not introduce any new risks, change the intended use, or pose any questions concerning safety or effectiveness.
- . There are several minor differences related to electrical and environmental characteristics between the new and predicate devices. All devices meet minimum requirements for the corresponding parameters as sited in AAMI-EC38/IEC 60601-2:47 standards for ambulatory arrhythmia monitoring and are therefore substantially equivalent.
Performance Testing (Bench, Animal, Clinical)
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 60601-1:2005 3rd Edition, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- -IEC 60601-1-2:2007 300 Edition, Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60601-1-11:2010 Edition 1.0. 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-EC 57:2012, Testing and Reporting -Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms.
- -IEC 60601-2-25:2011 standard (Particular requirements for the basic safety and essential performance of electrocardiographs).
- -IEC 60601-1-6:2010 Edition 3.0, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
- -Biocompatibility testing of patient contacting materials according to ISO 10993.
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| Bench test results verify that RhythmStar 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 or USB connection for evaluation by a medical professional. | |
|---|---|
| Test results verify that all requirements were met and that the RhythmStar performs as designed. | |
| Substantial Equivalence Rationale | The intended use, performance and technological characteristics of the RhythmStar system compared to the named predicate devices demonstrates that the RhythmStar is substantially equivalent to the predicates. |
| Conclusions | The analysis of the differences between RhythmStar and the predicate deices does not raise new questions of safety and effectiveness. Based on device performance test results, Rhythmedix determines that the RhythmStar system is safe, effective, performs within its design specifications, and is substantially equivalent to the predicate devices. |
| The information in this 510(k) submission demonstrates that the RhythmStar system is substantially equivalent to the predicate devices, with respect to safety, effectiveness, and performance. |
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).