MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION July 29, 2025 InfoBionic, Inc. % Rita King CEO MethodSense, Inc. 1 Copley Pkwy Suite 130 Morrisville, North Carolina 27560 Re: K250356 Trade/Device Name: MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: DSI Dated: July 1, 2025 Received: July 1, 2025 Dear Rita King: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K250356 - Rita King Page 2 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" (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 QS 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 (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-reporting-combination-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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K250356 - Rita King Page 3 assistance/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, JENNIFER W. SHIH -S Jennifer Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K250356 Device Name MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) Indications for Use (Describe) MoMe ARC® is indicated for: 1. Patients who experience transient symptoms that may suggest cardiac arrhythmia. 2. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation) 3. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath) 4. Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring. 5. ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports. MoMe ARC® is contraindicated for: 1. MoMe ARC® is contraindicated for those patients requiring attended, in hospital monitoring for life threatening arrhythmias. 2. MoMe ARC® is not intended for use on infants weighing less than 10kg (22lbs.). Clinical judgement is necessary to determine if the MoMe ARC® is appropriate for specific pediatric patients. 3. The patch configuration of the MoMe ARC® is contraindicated for monitoring QT intervals for patients taking Class III antiarrhythmic drugs. Note: MoMe ARC® does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician. 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4} K250356 510(k) Premarket Notification: MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System INFOBIONIC # Summary of 510(k) # InfoBionic K250356 This 510(k) Summary is in conformance with 21CFR 807.92 | Submitter: | InfoBionic, Inc. | | --- | --- | | | 312 Billerica Rd. Office Link #5 | | | Chelmsford, MA 02184 | | | Phone: 1-978-674-8304 | | | Fax: 1-888-447-4593 | | Primary Contact: | Rita King, CEO MethodSense, Inc. Email: ritaking@methodsense.com Phone: 919-313-3961 Fax: 919-313-3979 | | --- | --- | | Company Contact: | Laura Leal | | --- | --- | | | Quality and Regulatory, Sr. Director | | | Email: lleal@infobionic.com | | | Phone: 1-707-694-4905 | Date Prepared: June 30, 2025 # Device Name and Classification | Trade Name: | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System | | --- | --- | | Common Name: | Continuous ECG Monitor and Arrhythmia Detection | | Classification: | Class II | | Regulation Number: | 21 CFR Part 870.1025 | | Classification Panel: | Cardiovascular | | Product Code: | DSI | Predicate Device: | | Predicate Device | Reference Device | | --- | --- | --- | | Trade Name | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | Braemar Telemetry Patch System Model BTPS-1000 | | Common Name | Continuous ECG monitor and Arrhythmia Detection | Arrhythmia detector and alarm | | 510(k) Submitter / Holder | InfoBionic, Inc. | Braemar Manufacturing, LLC | | 510(k) Number | K230265 | K153473 | | Regulation Number | 21 CFR Part 870.1025 | 21 CFR Part 870.1025 | | Classification Panel | Cardiovascular | Cardiovascular | | Product Code | DSI | DSI | The predicate and reference devices have not been subject to design-related recalls. InfoBionic MoMe ARC® Traditional 510(k) K250356 {5} K250356 510(k) Premarket Notification: MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System # Device Description The MoMe ARC® device consists of a Sensor Pod, Leads, Gateway, and Charging Cradle with accessories. The body worn Sensor Pod acquires, stores and forwards electrocardiogram (ECG) data from Leads in a Wired Lead-Set or in a Patch to the Gateway using a 2.4GHz BLE wireless link. The Gateway consists of an OTS mobile device running the MoMe ARC® Gateway Mobile App. The Gateway is a Medical Device Data System (MDDS) which stores and forwards the ECG signal data to the MoMe Software Platform (K152491) via a wireless cellular link. The MoMe ARC® communicates with the MoMe Software Platform (K152491), a web-based remote server software with proprietary algorithms for analysis, using the MoMe Device Communications Protocol. The MoMe Software System (K152491) analyzes the data via the embedded algorithm and, when indicated, data identified by the algorithm is flagged for physician review. Once activated and operating normally, the system requires no patient intervention to capture or analyze data. However, the MoMe ARC® has an optional patient triggered event feature that allows for manual selection and recording of patient symptoms, if and when desired. The device is intended for use under prescription only (Rx only) for monitoring patients with suspected cardiac arrhythmias. # The MoMe ARC®: - Is non-invasive and poses no significant safety issues; - Uses existing electrode and patch ECG technology; and - Is used in an adjunctive fashion, where physicians also use patient symptoms and other tests, in the diagnosis or monitoring of patients with suspected cardiac arrhythmias. MoMe ARC® is not an emergency service. If the patient is experiencing symptoms that he/she is concerned about, the patient needs to seek immediate medical attention. # Indications for Use MoMe ARC® is indicated for: 1. Patients who experience transient symptoms that may suggest cardiac arrhythmia. 2. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation) 3. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath) 4. Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring. 5. ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports. MoMe ARC® is contraindicated for: 1. MoMe ARC® is contraindicated for those patients requiring attended, in hospital monitoring for life threatening arrhythmias. InfoBionic MoMe ARC® Traditional 510(k) K250356 {6} K250356 510(k) Premarket Notification: MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System 2. MoMe ARC® is not intended for use on infants weighing less than 10kg (22lbs.). Clinical judgement is necessary to determine if the MoMe ARC® is appropriate for specific pediatric patients. 3. The patch configuration of the MoMe ARC® is contraindicated for monitoring QT intervals for patients taking Class III antiarrhythmic drugs. Note: MoMe ARC® does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician. InfoBionic MoMe ARC® Traditional 510(k) K250356 Page 3 of 11 {7} K250356 infoBionic MoMe ARC® Traditional 510(k) K250356 # 510(k) Premarket Notification: MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System ## Substantial Equivalence The table below provides a detailed comparison of MoMe ARC® to the predicate and reference devices. | Characteristic | Subject Device MoMe ARC® | Predicate Device MoMe ARC® (K230265) | Reference Device Braemar Telemetry Patch System, Model BTPS-1000 (K153473) | Comparison | | --- | --- | --- | --- | --- | | Intended Use | | | | | | Intended Use | For ECG reporting and arrhythmia detection in patients with non-life threatening arrhythmias | For ECG reporting and arrhythmia detection in patients with non-life threatening arrhythmias | For ECG reporting and arrhythmia detection in patients with non-life threatening arrhythmias | Identical | | Indications for Use | | | | | | Indications for Use | MoMe ARC® is indicated for: 1. Patients who experience transient symptoms that may suggest cardiac arrhythmia. 2. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation) 3. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath) 4. Patients recovering from cardiac surgery or interventional procedures who are indicated for | MoMe ARC® is indicated for: 1. Patients who experience transient symptoms that may suggest cardiac arrhythmia. 2. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation) 3. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath) 4. Patients recovering from cardiac surgery or interventional procedures who are indicated for | The device is designated as Rx only. Its indications for use are as follows: 1. Patients who have a demonstrated need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease. | Equivalent to the predicate. | InfoBionic MoMe ARC® Traditional 510(k) K250356 Page 4 of 11 {8} K250356 INFOBIONIC 510(k) Premarket Notification: MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System | | outpatient arrhythmia monitoring. 5. ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports. MoMe ARC® is contraindicated for: 1. MoMe ARC® is contraindicated for those patients requiring attended, in hospital monitoring for life threatening arrhythmias. 2. MoMe ARC® is not intended for use on infants weighing less than 10kg (22lbs.). Clinical judgement is necessary to determine if the MoMe ARC® is appropriate for specific pediatric patients. 3. The patch configuration of the MoMe ARC® is contraindicated for monitoring QT intervals for patients taking Class III anti arrhythmic drugs. Note: MoMe ARC® does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician. | outpatient arrhythmia monitoring. 5. ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports. MoMe ARC® is contraindicated for: 1. MoMe ARC® is contraindicated for those patients requiring attended, in hospital monitoring for life threatening arrhythmias. Note: MoMe ARC® does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician. | 2. Patients with symptoms that may be due to cardiac arrhythmias. They may include by are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; c) dyspnea (shortness of breath). 3. Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms. 4. Patients who require outpatient monitoring of antiarrhythmic therapy: a) Monitoring of therapeutic and potential proarrhythmic effects of membrane active drugs, b) Monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation) 5. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring 6. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias 7. Patients requiring arrhythmia evaluation of etiology of stroke or | | --- | --- | --- | --- | InfoBionic MoMe ARC® Traditional 510(k) K250356 Page 5 of 11 {9} K250356 # INFOBIONIC 510(k) Premarket Notification: MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System | Characteristic | Subject Device MoMe ARC® | Predicate Device MoMe ARC® (K230265) | Reference Device Braemar Telemetry Patch System, Model BTPS-1000 (K153473) | Comparison | | --- | --- | --- | --- | --- | | | | | transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter. 8. Patients requiring measurement, analysis and reporting of QT interval, excluding patients with a documented history of sustained atrial fibrillation or atrial flutter 9. Patients who require monitoring for potential arrhythmias based on risk factors (e.g. atrial fibrillation). 10. Patients requiring measurement of ST segment changes. The device is not intended to sound any alarms for ST segment changes. Contraindications: 1. Patients with potentially life-threatening arrhythmias who require inpatient monitoring. 2. Patients who the attending physician recommends should be hospitalized for ECG monitoring. 3. This device should not be used for monitoring of QT interval during the initiation of antiarrhythmic therapy, where in-hospital monitoring is required by the labeling of that drug. | | InfoBionic MoMe ARC® Traditional 510(k) K250356 Page 6 of 11 {10} K250356 infoBionic MoMe ARC® 510(k) Premarket Notification: MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System | Characteristic | Subject Device MoMe ARC® | Predicate Device MoMe ARC® (K230265) | Reference Device Braemar Telemetry Patch System, Model BTPS-1000 (K153473) | Comparison | | --- | --- | --- | --- | --- | | | | | 4. The device does not replace the QT interval measurement by a trained observer using diagnostic 12 lead ECG in a clinical environment. This device is not intended to sound any alarms for QT interval changes. 5. The device does not annotate QT interval for QRS durations > 160ms or for T wave amplitudes less than or equal to 5% of the peak amplitude. | | | Product Code | | | | | | Product Code | DSI (21 CFR 870.1025) | DSI (21 CFR 870.1025) | DSI (21 CFR 870.1025) | Identical | | Device Use | | | | | | Prescription Use | Prescription only | Prescription only | Prescription only | Identical | | Intended Population | Patients > 10kg (22lbs) | Patients > 10kg (22lbs) | Patients > 10kg (22lbs) | Identical | | Environment of Use | Physician practices, clinic, research institutions, home environments | Physician practices, clinic, research institutions, home environments | Physician practices, clinic, home environments | Identical | | Environment Where Device Data is Stored and Reports are Generated | Remote (cloud-based) server | Remote (cloud-based) server | Remote server | Identical | | Technological Characteristics | | | | | InfoBionic MoMe ARC® Traditional 510(k) K250356 Page 7 of 11 {11} K250356 infoBionic MoMe ARC® Traditional 510(k) K250356 # 510(k) Premarket Notification: MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System | Characteristic | Subject Device MoMe ARC® | Predicate Device MoMe ARC® (K230265) | Reference Device Braemar Telemetry Patch System, Model BTPS-1000 (K153473) | Comparison | | --- | --- | --- | --- | --- | | Patient Contacting Material | • Polycarbonate • 3M 1774W Thin White Polyolefin Foam Tape • 3M 4076 SC White Spunlace Nonwoven Extended Wear Tape • Axelgard AG600 Hydrogel • TPV thermoplastic vulcanizate (Celanese, Santoprene TPV 8281-90MED) • TPE thermoplastic elastomer (GLS Corp, Versaflex OM 3060-1) | • Polycarbonate • Soda-Lime Glass • TPU – thermoplastic polyurethane (DIOSHY TPU-T995M) • TPV thermoplastic vulcanizate (Celanese, Santoprene TPV 8281-90MED) • TPE thermoplastic elastomer (GLS Corp, Versaflex OM 3060-1) | • 3M Siliconized Backing Paper (3M 9834) • 3M Non-Woven PET Film (3M 2476P) • Hydro Gel Pad AG602 • PET: Kemafoil HSPL 80W | Different – This difference does not change the intended use of the device. No additional questions of safety and effectiveness are introduced compared to the predicate. | | Size | 59 mm x 39 mm x 11 mm | 108 mm x 67 mm x 17 mm | 50.8 mm x 40.64 mm x 9.144 mm | Different – The dimensions of the predicate device included the Gateway Device. The difference does not change the intended use of the device. No additional question of safety and effectiveness are introduced compared to the predicate. | | Energy Source | Rechargeable Li-ion | Rechargeable Li-ion | Rechargeable Li-ion | Identical | | Device Components | Body-worn Sensor, Handheld Gateway, Patch | Body-worn Sensor, Handheld Gateway | Body-worn Sensor, Monitor, Patch | Equivalent to reference device. | | Software / Firmware | Yes | Yes | Yes | Identical | | Sterilization Method | Non-sterile | Non-sterile | Non-sterile | Identical | | Use Type | Multi-patient use (Sensor, Gateway, Leads) and disposable patch | Multi-patient use (Sensor, Gateway, Leads) and disposable electrodes | Multi-patient use (Sensor, Monitor) and disposable patch | Identical | InfoBionic MoMe ARC® Traditional 510(k) K250356 Page 8 of 11 {12} K250356 INFOBIONIC 510(k) Premarket Notification: MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System | Characteristic | Subject Device MoMe ARC® | Predicate Device MoMe ARC® (K230265) | Reference Device Braemar Telemetry Patch System, Model BTPS-1000 (K153473) | Comparison | | --- | --- | --- | --- | --- | | Number of electrodes | 1 Patch, or 3 disposable electrodes | 3 Disposable Electrodes | 1 Patch | Equivalent to reference device. | | Number of ECG channels | 1 or 2 Channels | 2 Channels | 1, 2, or 3 Channels | Equivalent to reference device. | | Ambulatory ECG Performance Standards | IEC 60601-2-47 | IEC 60601-2-47 | IEC 60601-2-47 | Identical | | ECG Acquisition | Body worn sensor, handheld device with cellular module | Body worn sensor, handheld device with cellular module | Body worn sensor; handheld device with cellular module | Identical | | ECG Transmission to Cellular | Bluetooth | Bluetooth | Bluetooth | Identical | | ECG Transmission to Monitoring Center | 4G Cellular | 4G Cellular | Cellular | Identical | | User Event Trigger | Handheld device user interface | Handheld device user interface | Handheld device user interface | Identical | | Physician Access to Patient Physiological and Event Information | Yes | Yes | Yes | Identical | | Arrhythmia Detection Algorithm | Proprietary / Server Side | Proprietary / Server Side | Proprietary | Identical | InfoBionic MoMe ARC® Traditional 510(k) K250356 Page 9 of 11 {13} K250356 510(k) Premarket Notification: MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System INFOBIO NIC # Performance Testing – Nonclinical The MoMe ARC® submission was written according to and in conformance with FDA Guidance “Class II Special Controls Guidance Documents: Arrhythmia Detector and Alarm” (October 2003). The test reports in the submission demonstrate that MoMe ARC® meets its intended use and design requirements. The MoMe ARC® was tested and conforms to the following voluntary FDA recognized standards: 1. ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) Note: Has been tested and complies with the requirements of Clause 8.5.5.2 - Energy reduction test. 2. ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests 3. ANSI/AAMI/IEC 60601-2-47:2012/(R)2016 Medical electrical equipment – Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems 4. IEC /TR 60601-4-2 Edition 1.0 2016-05 Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems 5. FIRST CVSS v4.0 Common Vulnerability Scoring System version 4.0 6. IEEE ANSI USEMCSC C63.27-2021 American National Standard for Evaluation of Wireless Coexistence 7. ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process 8. ISO 10993-2:2022 Biological evaluation of medical devices – Part 2: Animal welfare requirements 9. ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity 10. ISO 10993-10:2021 Biological evaluation of medical devices – Part 10: Tests for skin sensitization 11. ISO 10993-12:2021 Biological evaluation of medical devices – Part 12: Sample preparation and reference material 12. ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation 13. IEC 60601-1-11:2015 + A1:2020 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 14. ANSI/AAMI EC12:2000(R) 2020 - Disposable ECG electrodes 15. ASTM F1980 – 21: Accelerated Aging of Sterile Barrier Systems and Medical Devices 16. ANSI AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms # Performance Testing – Clinical Clinical testing was performed to validate the performance of the Software Platform (K152491) with the MoMe ARC® 1-lead patch system (Subject Device). InfoBionic MoMe ARC® Traditional 510(k) K250356 {14} K250356 510(k) Premarket Notification: MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System Clinical data were prospectively collected from 87 adult subjects at a single U.S. clinic. Each subject served as their own control and was assigned to one of two cohorts: - Inpatient (n = 75): Patients admitted to the hospital and undergoing continuous cardiac telemetry monitoring - Outpatient (n = 12): Patients undergoing prescribed ambulatory monitoring for cardiac arrhythmia detection and analysis. ## Demographics - Sex: 64 male, 23 female - Age: 21-87 years (mean 65.2 years) ## Study Objectives - Primary: Collect data from a single-lead ECG patch device for evaluation using InfoBionic ECG automated algorithms (FDA 510(k) = K152491). - Secondary: Collection of data on a single-lead ECG patch device in patients admitted to a hospital that are currently being monitored with continuous cardiac telemetry. No adverse events occurred during or after enrollment. Data from all 87 subjects were adjudicated by Certified Cardiac Technicians (CCTs) using Holter software, with beat locations, morphologies, and arrhythmia annotations serving as the reference standard. The Software Platform's sensitivity and positive predictivity were calculated using ANSI/AMI/IEC EC57:2012 methods. ## Key Results - Sensitivity: Met predefined acceptance criteria for arrhythmia detection. - Positive Predictivity (+P): Met predefined acceptance criteria versus CCT reference. - Heart-Rate Accuracy: Mean absolute error of ± 0.247 bpm compared to reference. These results provide objective evidence that the MoMe Software platform algorithm accurately detects and triggers abnormal rhythms noted on MoMe ARC® 1-Lead Patch ECG tracings in both inpatient and outpatient environments, supporting the subject device's safety and effectiveness for its intended use as compared to the predicate. ## Conclusion In conclusion, the intended use of the MoMe ARC® is identical to the intended use of the predicate device (K230265). The technological characteristics of the MoMe ARC® are equivalent to those of the predicate (K230265) and reference (K153473) devices. Testing has demonstrated that the MoMe ARC® is substantially equivalent to, and as safe and effective as, the predicate (K230265) and reference (K153473) devices. InfoBionic MoMe ARC® Traditional 510(k) K250356 Page 11 of 11