(244 days)
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.
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.
The provided document, an FDA 510(k) summary for the RhythmStar System (K233584), describes the device and its indications for use, but it does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance metrics.
The document primarily focuses on demonstrating substantial equivalence to predicate devices (RhythmStar System K141813 and Zio AT ECG Monitoring System K163512) by comparing intended use, indications for use, and technological characteristics. While it mentions various types of testing performed (Biocompatibility, Electrical Safety, EMC, Software V&V, Performance Testing, Cybersecurity), it does not present the acceptance criteria for these tests or the quantitative results of the device's performance against those criteria.
Specifically, the following information, crucial for addressing your request, is not available in the provided text:
- A table of acceptance criteria and reported device performance: This is the most significant missing piece. The document states that performance testing was done in accordance with ANSI/AAMI EC57 and that bench testing confirmed certain functionalities, but it does not quantify the performance (e.g., sensitivity, specificity, accuracy for arrhythmia detection) or list the specific target acceptance values.
- Sample size used for the test set and data provenance: No information on the actual test dataset size, age group, or whether the data was retrospective or prospective.
- Number of experts used to establish ground truth and their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The device's primary function is to record and transmit data for retrospective review by a medical professional; it is not presented as an AI-assisted diagnostic tool for human readers itself.
- Standalone (algorithm only) performance: While an embedded arrhythmia detection algorithm is mentioned, its standalone performance metrics (e.g., accuracy for AFib detection) are not provided. The document states: "The RhythmStar system does not provide interpretive or diagnostic statements. Interpretation and diagnosis are the responsibility of a physician." This suggests the algorithm's output is raw data or simple event flags, not a diagnostic interpretation.
- Type of ground truth used: Not specified, as no detailed performance study results are provided.
- Sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Conclusion based on the provided text:
The document serves as a 510(k) summary, demonstrating the substantial equivalence of the RhythmStar System to existing legally marketed devices, primarily the RhythmStar RS-10002 (K141813). It asserts that the device is safe and effective based on various conformance tests to recognized standards (IEC, ANSI/AAMI, ISO) and bench testing, but it does not disclose the specific quantitative acceptance criteria or the numerical performance results that would fulfill your request for detailed proof of meeting acceptance criteria for its core functions (like arrhythmia detection accuracy).
To obtain the information you requested about device performance against acceptance criteria, one would typically need access to the full 510(k) submission, which contains the detailed testing reports and results.
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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"
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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)
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 DeviceRhythmStar RS-10003 | Primary Predicate DeviceRhythmStar RS-10002(K141813) | Secondary PredicateDeviceZio® QX ECG MonitoringSystem (K163512) | Comparison |
|---|---|---|---|---|
| Intended UseIntended Use | The RhythmStar System isintended for continuousECG monitoring andarrhythmia detection. | The RhythmStar System isintended for continuousECG monitoring andarrhythmia detection. | The Zio® QX ECGMonitoring System isintended for continuousECG monitoring andarrhythmia detection. | Identical |
| Indications for UseIndications for Use | The RhythmStar RS-10003System is intended for useby patients who either haveor are at risk of havingcardiac disease and thosethat demonstrateintermittent symptomsindicative of cardiac diseaseand require cardiacmonitoring on a continuingbasis. The devicecontinuously records ECGdata and upon detection byan ECG analysis algorithmor manually initiated by thepatient, automaticallydelivers all recorded cardiacactivity to the cloud serverwhere it is presented andcan be reviewed by a | The RhythmStar System isintended for use by patientswho either have or are atrisk of having cardiacdisease and those thatdemonstrate intermittentsymptoms indicative ofcardiac disease and requirecardiac monitoring on acontinuing basis. Thedevice continuously recordsECG data and upondetection by an ECGanalysis algorithm ormanually initiated by thepatient, automaticallydelivers the recordedcardiac activity to the serverwhere it is presented and | The Zio® QX ECG MonitoringSystem is intended tocapture, analyze and reportsymptomatic andasymptomatic cardiacevents and continuouselectrocardiogram (ECG)information for long-termmonitoring. Whilecontinuously recordingpatient ECG, both patient-triggered and automaticallydetected arrhythmia eventsare transmitted to amonitoring center forreporting. After wear, a finalreport is generated basedon beat-to-beat informationfrom the entire ECGrecording. It is indicated for | Equivalent |
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| Characteristic | Subject DeviceRhythmStar RS-10003 | Primary Predicate DeviceRhythmStar RS-10002(K141813) | Secondary PredicateDeviceZio® QX ECG MonitoringSystem (K163512) | Comparison |
|---|---|---|---|---|
| medical professional at amonitoring center. TheRhythmStar system is notintended for real-timemonitoring.The data received from theRhythmStar device can beused for retrospectivereview, arrhythmia analysis,reporting and signalmeasurements byRhythmStar system, or acompatible arrhythmiaanalysis software that hasbeen FDA cleared for LeadII analysis using non-traditional wet electrodeplacement. The RhythmStaris not intended to sound anyalarms.The device does not deliverany therapy, administer anydrugs, or provide for lifesupport. The RhythmStarsystem does not provideinterpretive or diagnosticstatements. Interpretationand diagnosis are theresponsibility of a physician.RhythmStar is forprescription use only. | can be reviewed by amedical professional.The data received from theRhythmStar device can beused by another device forarrhythmia analysis,reporting and signalmeasurements. TheRhythmStar is not intendedto sound any alarms.The device does not deliverany therapy, administer anydrugs, provide interpretiveor diagnostic statements, orprovide for any life support.RhythmStar is forprescription use only. | use on patients 18 years orolder who may beasymptomatic or who maysuffer from transientsymptoms such aspalpitations, shortness ofbreath, dizziness, light-headedness, pre-syncope,syncope, fatigue, or anxiety.The reports are provided forreview by the intended userto render a diagnosis basedon clinical judgment andexperience. It is notintended for use on criticalcare patients. |
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| Characteristic | Subject DeviceRhythmStar RS-10003 | Primary Predicate DeviceRhythmStar RS-10002(K141813) | Secondary PredicateDeviceZio® QX ECG MonitoringSystem (K163512) | Comparison |
|---|---|---|---|---|
| Device Use | ||||
| Prescription / OTC | Prescription | Prescription | Prescription | Identical |
| IntendedPopulation | Patients requiring cardiacmonitoring who areambulatory and without life-threatening conditions | Patients requiring cardiacmonitoring who areambulatory and without life-threatening conditions | Patients requiring cardiacmonitoring who areambulatory and without life-threatening conditions | Identical |
| Environment ofUse | Ambulatory, Outpatient | Ambulatory, Outpatient | Ambulatory, Outpatient | Identical |
| Technological Characteristics | ||||
| Dimensions | 59mm x 50mm x 15mm | 101mm x 66mm x 13mm | Patch5.2 x 2.0 x 0.5 in(132mm x 51mm x 13mm)Gateway6.2 x 3.4 x 0.8 in(157mm x 86mm x 20mm) | Different - This differencedoes not change theintended use of the device.Both devices are wearableand portable. The safetyand effectiveness of the sizehas been demonstratedthrough testing. |
| Weight | 38 g | 90 g | 24.7 g | Different - This differencedoes not change theintended use of the device.The safety andeffectiveness of the size hasbeen demonstrated throughtesting. |
| Material | ABS and TPU plastic | ABS and TPU plastic | Proprietary patch andplastic | Identical to primarypredicate |
| Duration of Use | Up to 30 days | Up to 30 days | Up to 14 days | Identical to primarypredicate |
| Type of Wear | Device worn on chest | Device worn over belt /waistband | Device worn on chest | Identical to secondarypredicate |
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| Characteristic | Subject DeviceRhythmStar RS-10003 | Primary Predicate DeviceRhythmStar RS-10002(K141813) | Secondary PredicateDeviceZio® QX ECG MonitoringSystem (K163512) | Comparison |
|---|---|---|---|---|
| Basic Technology | Analog ECG front-end,accelerometer, MCU, flashdata storage, built-in cellularmodem for datatransmission | Analog ECG front-end,accelerometer, MCU, flashdata storage, built-in cellularmodem for datatransmission | Analog ECG recorded onpatch and transmitted viaBluetooth to Gateway withbuilt-in cellular modem fordata transmission | Identical to primarypredicate |
| Battery Powered | Yes | Yes | Yes | Identical |
| Energy Source | Rechargeable 3.7V Li-ionbattery | Rechargeable 3.7V Li-ionbattery | PatchLithium Manganese DioxideCoin CellsGateway1 Lithium Polymer Cell | Identical to primarypredicate |
| Battery Life | 72 hours | 72 hours | 14 days | Identical to primarypredicate |
| Removable Battery | No | Yes | No | Identical to secondarypredicate |
| Bandwidth | 0.05 ... 40 Hz | 0.05 ... 40 Hz | 0.5 ... 30 Hz | Identical to primarypredicate |
| Common-moderejection ratio(CMRR) | 100 dB minimum, 115 dBtypical | 90 dB minimum, 100 dBtypical | Information not available | Different - The subjectdevice has a higher CMRRto improve common moderejection. This differencedoes not change theintended use of the device.The safety andeffectiveness of the CMRRdifference has beendemonstrated via IEC60601-2-47. |
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| Characteristic | Subject DeviceRhythmStar RS-10003 | Primary Predicate DeviceRhythmStar RS-10002(K141813) | Secondary PredicateDeviceZio® QX ECG MonitoringSystem (K163512) | Comparison |
|---|---|---|---|---|
| Sampling Rate | 256 Hz | 250 Hz | 200 Hz | Different - This changedoes not change theintended use of the device.Both devices support a 125Hz sampling rate, which isthe minimum sample rateneeded to support thebandwidth requirement citedin IEC 60601-2-47 forambulatory arrhythmiamonitoring. |
| ECG leads | 2 | 2, 3, 4, 5 | 2 | Identical to secondarypredicate device. |
| ECG Acquisition | Body worn monitoringdevice | Body worn monitoringdevice | Body worn monitoringdevice | Identical |
| Lead off Detection | Yes | Yes | Patch off detection | Identical to primarypredicate device |
| Accelerometer | Yes | Yes | Information not available | Identical to primarypredicate |
| Display | LED lights | LCD | LED lights | Identical to secondarypredicate |
| User Event Trigger | Double tap on monitoringdevice | Button push on monitoringdevice | Button push on patch | Different - This differencedoes not change theintended use of the device.The subject device andpredicate devices provide amethod of manual eventtriggering. |
| WirelessCommunicationTechnology | Yes - 4G mobile networkusing embedded cellulardata modem | Yes - 3G mobile networkusing embedded cellulardata modem | Yes | Equivalent - Both devicesuse cellular communicationtechnology and operate onthe same mobile networks. |
| System Design | PEMS and software | PEMS and software | PEMS and software | Identical |
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| Characteristic | Subject DeviceRhythmStar RS-10003 | Primary Predicate DeviceRhythmStar RS-10002(K141813) | Secondary PredicateDeviceZio® QX ECG MonitoringSystem (K163512) | Comparison |
|---|---|---|---|---|
| Sterile | Non-sterile | Non-sterile | Non-sterile | Identical |
| Use Type | Multi-Patient Use | Multi-Patient Use | Single Use Only | Identical to primarypredicate device |
| ArrhythmiaDetectionAlgorithm | Yes | Yes | Yes | Identical |
| Alarms | None | None | None | Identical |
| Adjustable DeviceProgrammingParameters | Yes | Yes | No | Identical to primarypredicate device |
| Review of ECGData | ECG Technicians at 24/7Monitoring Center | ECG Technicians at 24/7Monitoring Center | ECG Technicians at 24/7Monitoring 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:
-
- 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.
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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.
§ 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.