Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia.
Patients with dizziness or lightheadedness.
Patients with palpitations.
Patients with syncope of unknown etiology.
Patients who require monitoring for non-life threatening arrhythmias, such as atrial fibrillation, other supraventricular arrhythmias, evaluation of various bradyarrhythmias and intermittent bundle branch block.
Patients recovering from coronary artery bypass graft (CABG) surgery who require monitoring for arrhythmias.
Patients requiring monitoring for arrhythmias inducing co-morbid conditions such as hyperthyroidism or chronic lung disease.
Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias.
Patients requiring arrhythmia evaluation for etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation.

Device Description

The MoMeTM Continuous ECG Monitor and Arrhythmia Detector System (abbreviated to MoMe System in this section) is a remote physiologic monitoring system that detects non-life threatening arrhythmias. The MoMeTM System incorporates a front end device worn by the patient that collects and streams ECG, heart rate and motion (activity) to a dedicated smartphone that continuously transmits the data to remote server. The system then uses proprietary algorithms to continually analyze data and provide reports of detected events. These reports can be accessed anytime, anywhere by a physician using a standard browser or a MoMe iPad App.

AI/ML Overview

The provided text includes a 510(k) Summary for the MoMe™ Continuous ECG Monitor and Arrhythmia Detector System, which details its performance data and the studies conducted to demonstrate substantial equivalence to predicate devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to the FDA Guidance "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" (October 2003) for the acceptance criteria, and states that the device was tested using "standard industry practices and in accordance" with this guidance. However, the specific acceptance criteria (e.g., minimum sensitivity, specificity for certain arrhythmia types) and corresponding reported device performance values are not explicitly detailed in the provided text. The document broadly states: "The MoMe Arrhythmia detection algorithm has been tested using standard industry practices and in accordance with the FDA Guidance 'Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm', released October 2003. The Software Verification and Validation reports, MoMe System Verification and Validation report, Algorithm validation report, Transceiver Verification and Validation report, Usability test reports all demonstrate that the MoMe System meets its intended use and design input requirements."

Without the specific performance targets from the FDA Guidance and the numeric results from the MoMe system's validation reports, a detailed table cannot be created.

2. Sample size used for the test set and the data provenance:

The document mentions "Algorithm validation report" but does not specify the sample size of the test set or the data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the given text.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided in the given text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not provided in the given text. The study mentioned is a "standalone" algorithm validation, not a comparative effectiveness study involving human readers with and without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, a standalone algorithm validation was done. The document states: "The MoMe Arrhythmia detection algorithm has been tested..." and refers to an "Algorithm validation report." This implies testing the algorithm's performance independent of human intervention.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The document does not explicitly state the type of ground truth used for the algorithm validation. For arrhythmia detection algorithms, ground truth is typically established by expert cardiologists reviewing the ECG tracings.

8. The sample size for the training set:

The document does not specify the sample size for the training set.

9. How the ground truth for the training set was established:

The document does not specify how the ground truth for the training set was established.

Summary of available information regarding the study:

Study Type: Algorithm validation, software verification and validation, system verification and validation, transceiver verification and validation, usability testing.
Standards Followed: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-47, ANSI/AAMI/ISO EC 57:1998/R(2008), ANSI/AAMI EC53:1995/(R)2008, ISO 10993 (various parts for biological evaluation).
Compliance: The MoMe System complies with applicable clauses of IEC 60601 and was tested in accordance with the FDA Guidance "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" (October 2003).

Missing Information (not found in the provided text):

Specific quantitative acceptance criteria for arrhythmia detection (e.g., sensitivity, specificity, accuracy for different arrhythmia types).
Specific quantitative reported performance metrics of the MoMe system against these criteria.
Sample size of the test set.
Data provenance (country of origin, retrospective/prospective).
Number and qualifications of experts for ground truth establishment.
Adjudication method for ground truth.
Details of any MRMC comparative effectiveness study or human reader improvement data.
Type of ground truth explicitly defined (though likely expert review for ECGs).
Sample size of the training set.
Method for establishing ground truth for the training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 15, 2023

Infobionic, Inc. Carrie Neuberger Regulatory Consultant 600 Suffolk Street P.O. Box 9719 Lowell, Massachusetts 01853

Re: K133753

Trade/Device Name: Mome Ecg Continuous Detection And Arrhythmia Detector Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: QYX, DSI, MLO

Dear Carrie Neuberger:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 19, 2014. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jennifer Kozen, OHT2: Office of Cardiovascular Devices, 301-796-5813, jennifer.kozen@fda.hhs.gov.

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

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 19, 2014

Infobionic. Inc. % Carrie Neuberger Regulatory Consultant 600 Suffolk Street P.O. Box 9719 Lowell, Massachusetts 01853

Re: K133753

Trade/Device Name: Mome Ecg Continuous Detection And Arrhythmia Detector 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, MLO Dated: August 11, 2014 Received: August 13, 2014

Dear Carrie Neuberger,

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

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 vours.

Mude Jellman
for

Bram D. Zuckerman, M.D. 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): K133753

Device Name: MoMe™ Continuous ECG Monitor and Arrhythmia Detector System

Indications for Use:

The MoMe™ Continuous ECG Monitor and Arrhythmia Detector System (MoMe™ System) is indicated for:

1. Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia.
1. Patients with dizziness or lightheadedness.
1. Patients with palpitations.
1. Patients with syncope of unknown etiology.
1. Patients who require monitoring for non-life threatening arrhythmias, such as atrial fibrillation, other supraventricular arrhythmias, evaluation of various bradyarrhythmias and intermittent bundle branch block.
1. Patients recovering from coronary artery bypass graft (CABG) surgery who require monitoring for arrhythmias.
1. Patients requiring monitoring for arrhythmias inducing co-morbid conditions such as hyperthyroidism or chronic lung disease.
1. Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias.
1. Patients requiring arrhythmia evaluation for etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation.

The MoMe™ System is contraindicated for:

1. Patients with potentially life threatening arrhythmias who require in-patient monitoring.
1. Patients who the attending physician thinks should be hospitalized.
1. Patients with implanted pacemakers, ICDs, neurostimulators and/or body worn medical devices such as insulin pumps.

For Adult Use Only. The MoMe™ Continuous ECG Monitor and Intended Population: Arrhythmia Detector is intended for patients who are 22 years and older.

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Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 2 of 2_

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510(k) Summary

Submitter Name:	InfoBionic, Inc.
Submitter Address:	600 Suffolk Street, Lowell, MA 01854
Contact Person:	Carrie NeubergerRegulatory Affairs, InfoBionic
Phone Number:	800-532-4304
Date Prepared:	August 28, 2014
Device Trade Name:	MoMeTM Continuous ECG Monitor and ArrhythmiaDetector System
Device Common Name:	Continuous ECG monitor and Arrhythmia DetectionSystem
Product Code andRegulation:	DSI, 21 CFR 820.1025MLO, 21 CFR 820.2800
Predicate Device #1:	K072588, K093288 CardioNet ECG Monitoring andArrhythmia Detection System
Predicate Device #2:	K121197, Preventice Body Guardian
Device Description:	The MoMeTM Continuous ECG Monitor and ArrhythmiaDetector System (abbreviated to MoMe System in thissection) is a remote physiologic monitoring system thatdetects non-life threatening arrhythmias. The MoMeTMSystem incorporates a front end device worn by the patientthat collects and streams ECG, heart rate and motion(activity) to a dedicated smartphone that continuouslytransmits the data to remote server. The system then usesproprietary algorithms to continually analyze data andprovide reports of detected events. These reports can beaccessed anytime, anywhere by a physician using astandard browser or a MoMe iPad App.
Intended Population:	For Adult Use Only. The MoMeTM Continuous ECGMonitor and Arrhythmia Detector is intended for patientswho are 22 years and older.

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Indications for Use:

The MoMe™ System is indicated for use on:

1. Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or or sustained ventricular tachycardia.
1. Patients with dizziness or lightheadedness.
1. Patients with palpitations.
1. Patients with syncope of unknown etiology.
ર. Patients who require monitoring for non-life threatening arrhythmias, such as atrial fibrillation, other supraventricular arrhythmias, evaluation of various bradyarrhythmias and intermittent bundle branch block.
1. Patients recovering from coronary artery bypass graft (CABG) surgery who require monitoring for arrhythmias.
1. Patients requiring monitoring for arrhythmias inducing co-morbid conditions such as hyperthyroidism or chronic lung disease.
Patients with obstructive sleep apnea to evaluate 8. possible nocturnal arrhythmias.
1. Patients requiring arrhythmia evaluation for etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation.

MoMe™ System is contraindicated for:

. Patients with potentially life threatening arrhythmias who require in-patient monitoring.
. Patients who the attending physician thinks should be hospitalized.
. with implanted pacemakers, Patients ICDs. neurostimulators and/or body worn medical devices such as insulin pumps.

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Rationale for Substantial Equivalence:

Characteristics	InfoBionic MoMeSystem	CardioNetK072588, K093288	PreventiceK121197
ProductCode/ClassificationCode	DSI21CFR 870.1025	DSI21CFR 870.1025	DSI21CFR 870.1025
Two ECGleads/channels	Yes	Yes	Yes
Parameters	Arrhythmia detection+ ECG, Heart Rateand Activity	Arrhythmia detection	ECG, Heart Rate,Respiration Rate &Activity
Number of electrodes	Four electrodes	Three electrodes	Bandage-like bodysensor
Transmission	Bluetooth, cellular	Local wireless,cellular or PSTN	Bluetooth, cellular
Data storage &delivery of report toUsers	Remote server	Remote server	Remote server
iPad Display Option	Yes	No	Yes
Multiple monitoringmode options	Holter Event, MCT	Event, MCT	Event, MCT
Physician access topatient physiologicaland event information	Yes	Yes	Yes

Table 1 Comparison of MoMeTM to Predicate Devices

The MoMe System complies with applicable clauses of Performance Data: IEC 60601. The MoMe Arrhythmia detection algorithm has been tested using standard industry practices and in accordance with the FDA Guidance "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm", released October 2003. The Software Verification and Validation reports, MoMe System Verification and Validation report, Algorithm validation report, Transceiver Verification and Validation report, Usability test reports all demonstrate that the MoMe System meets its intended use and design input requirements.

Standards: This submission complies with the following standards:

IEC 60601-1 third edition 2005-12 - General requirements for basic safety and essential performance

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IEC 60601-1-2 edition 3 2007-03 General requirements for basic safety and essential performance - Collateral Standard: electromagnetic compatibility - requirements and tests

IEC 60601-1-11 edition1.0 2010-04 - 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

IEC 60601-2-47 edition 2.0 2012-02- Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of of ambulatory electrocardiographic systems (Revision of ANSI/AAMI EC 38:2007)

ANSI/AAMI/ISO EC 57:1998/R(2008) - Testing and reporting performance results of cardiac rhythm and STsegment measurement algorithms.

ANSI/AAMI EC53:1995/(R)2008 - ECG cables and lead wires (May 2010)

ISO 10993-1:2009 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

ISO 10993-5: 2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

ISO 10993-10:2010 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

Conclusion: The MoMe System Indications for use are aligned with both the CardioNet and Preventice indications. All three devices are monitoring devices and are classified under the same FDA classification code of 21 CFR 870.1025, DSI. The bench, standards, usability, algorithm and software testing in this submission demonstrate that the MoMe System meets the expected performance requirements for an ECG/Physiological monitor and Arrhythmia detection system, and is therefore equivalent to the predicate devices.

Regulation Number and Section

§ 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.