Patients who experience transient symptoms that may suggest cardiac arrhythmia.
Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)
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)
Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring.
ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports.

MoMe® Kardia is contraindicated for:

MoMe® Kardia is contraindicated for those patients requiring attended, in-hospital monitoring for life threatening arrhythmias.

Note: MoMe® Kardia does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician.

Device Description

MoMe® Kardia is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.

MoMe® Kardia includes the wearable MoMe® Kardia Device that acquires and stores ECG and motion (accelerometer) data and transmits that data via cellular technology to the MoMe® Software System (K152491), a web-based remote server software with proprietary algorithms for analysis, using the MoMe® Device Communications Protocol. MoMe® Software System analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. MoMe® Kardia requires no patient intervention to capture or analyze data however does provide a patient event trigger.

MoMe® Kardia supports three cardiac monitoring modes:

1 Holter
2 Event Monitoring
3 Mobile Cardiac Telemetry (MCT)

MoMe® Kardia:

Is non-invasive and poses no significant safety issues ●
Uses existing electrode and ECG technology ●
ls used in an adjunctive fashion, where physicians also use patient ● symptoms and other tests, in the diagnosis or monitoring of patients with cardiac arrhythmias.

MoMe Kardia 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.

AI/ML Overview

This document is a 510(k) summary for the MoMe® Kardia Wireless Ambulatory ECG Monitoring and Detection System, comparing it to a predicate device (TruVue™ Wireless Ambulatory ECG Monitoring System). It does not contain a detailed study proving the device meets specific acceptance criteria with reported performance metrics.

However, based on the information provided, we can infer some aspects relevant to your request.

Missing Information:

Specific acceptance criteria with numerical targets for device performance (e.g., sensitivity, specificity, accuracy for arrhythmia detection).
Reported device performance against these numerical acceptance criteria.
Details of the study that proves the device meets specific acceptance criteria. The document states "The test reports in the submission demonstrate the MoMe® Kardia meets its intended use and design requirements," but does not elaborate on these test reports or their results.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method for the test set.
Multi-reader multi-case (MRMC) comparative effectiveness study details.
Standalone (algorithm-only) performance details.
Sample size for the training set.
How ground truth for the training set was established.

Information that can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly provided in the document. The document states that "The MoMe® Kardia submission was written according to and in conformance with FDA Guidance "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" released on October 2003. The test reports in the submission demonstrate the MoMe® Kardia meets its intended use and design requirements." However, the specific acceptance criteria and the reported performance values that demonstrate this conformance are not listed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not explicitly provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not explicitly provided in the document.

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

This information is not explicitly provided in the document.

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 explicitly provided in the document. The device "flags for physician review" but there's no mention of a comparative effectiveness study with human readers.

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

The document mentions "proprietary algorithms for analysis" that flag data for physician review, suggesting a standalone algorithmic component. However, specific standalone performance metrics are not provided.

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

The document states, "Note: MoMe® Kardia does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician." This implies that the ultimate "ground truth" for clinical diagnosis would be physician interpretation. However, how the ground truth for the performance testing of the device's arrhythmia detection algorithm was established is not explicitly stated. It can be inferred that it would be based on expert review of ECG data, but the specifics are absent.

8. The sample size for the training set

This information is not explicitly provided in the document. The document mentions "proprietary algorithms for analysis" but does not detail their development or training.

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

This information is not explicitly provided in the document.

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 To Infobionic Inc. 600 Suffolk Street Lowell, Massachusetts 01854

Re: K160064

Trade/Device Name: MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection 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: QYX, DSI

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 March 11, 2016. 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

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

March 11, 2016

Infobionic, Inc. Ms. Carrie Neuberger Regulatory Consultant to Infobionic Inc. 600 Suffolk Street Lowell, Massachusetts 01854

Re: K160064 Trade/Device Name: MoMe Kardia Wireless Ambulatory ECG Monitoring And Detection 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: DSI Dated: January 12, 2016 Received: January 13, 2016

Dear Ms. 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 yours

FDA

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) K160064

Device Name

MoMe® Kardia Wireless Ambulatory ECG Monitoring and Detection System

Indications for Use (Describe) MoMe® Kardia is intended to be used for:

Patients who experience transient symptoms that may suggest cardiac arrhythmia.
Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)
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)
Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring.
ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports.

MoMe® Kardia is contraindicated for:

MoMe® Kardia is contraindicated for those patients requiring attended, in-hospital monitoring for life threatening arrhythmias.

Note: MoMe® Kardia 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.

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Image /page/4/Picture/0 description: The image shows the logo for Infobionic. The logo consists of the word "INFOBIONIC" in a combination of blue and green colors. The "INFO" part of the word is in blue, while the "BIONIC" part is in green. There is a blue heart symbol in the middle of the word. To the left of the word, there is a cluster of blue and green circles arranged in a semi-circular pattern.

MoMe® Kardia

K160064 Page 1 of 5

Section 5 510(K) SUMMARY COMPLYING WITH 21 CFR 807.92

Date Prepared:	January 12, 2015
Submitter Name:	InfoBionic, Inc.
Submitter Address:	600 Suffolk Street, Lowell, MA, 01854
Contact Person:	Carrie Neuberger, Regulatory Consultant
Phone Number:	415.640.3377
Device Trade Name:	MoMe® Kardia Wireless Ambulatory ECG Monitoringand Detection System
Device Common Name:	Continuous ECG monitor and Arrhythmia Detection
Classification Name:	Arrhythmia Detector and alarm, 21 CFR 870.1025,DSI
Predicate Device:	K100155, Biomedical Systems Corporation'sTruVue™ Wireless Ambulatory ECG MonitoringSystem

Device Description:

MoMe® Kardia is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.

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Image /page/5/Picture/0 description: The image shows the logo for Infobionic. The logo consists of the word "INFOBIONIC" in blue and green letters. The "INFO" part of the word is in blue, and the "BIONIC" part is in green. There is a blue heart in the middle of the word. To the left of the word is a cluster of blue and green dots.

MoMe® Kardia

K160064

Page 2 of 5

MoMe® Kardia supports three cardiac monitoring modes:

1	Holter
2	Event Monitoring
3	Mobile Cardiac Telemetry (MCT)

MoMe® Kardia:

Is non-invasive and poses no significant safety issues ●
Uses existing electrode and ECG technology ●
ls used in an adjunctive fashion, where physicians also use patient ● symptoms and other tests, in the diagnosis or monitoring of patients with cardiac arrhythmias.

MoMe Kardia 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® Kardia is indicated for:

1. Patients who experience transient symptoms that may suggest cardiac arrhythmia.
1. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)
1. 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)
Patients recovering from cardiac surgery or interventional procedures 4. who are indicated for outpatient arrhythmia monitoring.
ECG data recorded by the device can be analyzed by other processing 5. systems to provide Holter style reports.

MoMe® Kardia is contraindicated for:

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Image /page/6/Picture/0 description: The image shows the logo for Infobionic. The logo is made up of the word "INFOBIONIC" in blue and green letters. The letters "INFO" are in blue, and the letters "BIONIC" are in green. There is a blue heart in the middle of the word. To the left of the word is a cluster of blue and green dots.

MoMe® Kardia

K160064

Page 3 of 5

1. MoMe® Kardia is contraindicated for those patients requiring attended, inhospital monitoring for life threatening arrhythmias.
  Note: MoMe® Kardia does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician.

Performance Data and Standards Compliance:

The MoMe® Kardia submission was written according to and in conformance with FDA Guidance "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" released on October 2003. The test reports in the submission demonstrate the MoMe® Kardia meets its intended use and design requirements.

The MoMe® Kardia was tested and conforms to following voluntary FDA recognized standards,

IEC 60601-1:2005/R(2012) and A1:2012: Medical 1. electrical equipment - Part 1: General requirements for basic safety and essential performance
1. IEC 60601-1-2:2007/R(2012): Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests (Edition 3)
1. ANSI/AAMI/IEC 60601-2-47: 2012 Medical electrical equipment- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

Technological Characteristics:

MoMe® Kardia differs from the predicate device mainly in one area of the device technology and design. The MoMe® Kardia is a single unit body worn device used for acquisition and transmission of ECG data to the monitoring center while the predicate device is a two unit device comprising of a sensor unit to acquire ECG data and a handheld unit which transmits the data to the monitoring center. In predicate device, the sensor unit communicates with cellular modem using Bluetooth technology.

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Image /page/7/Picture/0 description: The image shows the logo for Infobionic. The logo is made up of the word "INFOBIONIC" in blue and green letters. The letters "INFO" are in blue, and the letters "BIONIC" are in green. There is a small blue heart in the middle of the "O" in "BIONIC". To the left of the word is a cluster of blue and green circles.

MoMe® Kardia

K160064

Page 4 of 5

Both the devices, MoMe® Kardia and the predicate device, transmit the recorded ECG data using cellular modem to remote Monitoring centers where the ECG data is analyzed using proprietary software algorithm.

Rationale for Substantial Equivalence:

Parameter	MoMe® Kardia	TruVue™ WirelessAmbulatory ECGMonitoring System
510(k) ReferenceNumber	Not applicable, this 510(k)submission	K100155
FDA Classification	Class II	Class II
Product Code/Classification Code/Common Name	DSI21 CFR 870.1025Arrhythmia detector andalarm	DSI21CFR 870.1025Arrhythmia detector andalarm
Indications for Use	Indications for use areidentical to predicate device.Please refer to Indications forUse in Section 12.2 below.	Refer to Indications for Use inSection 12.2 below
Intended Use	For ECG reporting andarrhythmia detection inpatients with non-lifethreatening arrhythmias	For ECG reporting andarrhythmia detection inpatients with non-lifethreatening arrhythmias
Number ofelectrodes	3	3
Number of ECGchannels	2 channels	2 channels
Ambulatory ECGPerformanceStandards	IEC60601-2-47	EC 38
ECG Acquisition	Single unit body worn (sensor+ cellular module)	Body worn sensor, handhelddevice with cellular module)
ECG Transmissionto Cellular	On board (single unit)	Bluetooth
ECG Transmissionto MonitoringCenter	Cellular	Cellular

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Image /page/8/Picture/0 description: The image shows the logo for Infobionic. The logo is made up of the word "INFOBIONIC" in blue and green letters. To the left of the word is a cluster of blue and green dots. The "O" in "BIONIC" is replaced with a blue heart.

MoMe® Kardia

Parameter	MoMe® Kardia	TruVue™ WirelessAmbulatory ECGMonitoring System
User Event Trigger	Device User Interface	Handheld User Interface
Battery Type	Li lon rechargeable	Sensor - 1 AAAMonitor - Li Ion rechargeable
Environmentswhere device maybe used	Physician practices, clinics,research institutions	Physician practices, clinics,research institutions
Environment wheredevice data storageand reports aregenerated	Remote (cloud-based) server	Remote (cloud-based) server
Prescription Use	Yes, intended to be used byphysicians and health careproviders only, not for use bypatients	Yes, intended to be used byphysicians and health careproviders only, not for use bypatients
Physician access topatientphysiological andevent information	Yes	Yes
Arrhythmiadetection algorithm	Proprietary/Server side	Proprietary/Server side

Conclusion:

The MoMe® Kardia Indications for Use are the same as the predicate device Indications for Use. The MoMe® Kardia utilizes equivalent operating principles and technology as compared to the predicate device. The descriptive information and performance testing in this submission demonstrate that the MoMe® Kardia meets the expected performance requirements, does not raise new issues of safety or effectiveness, and is therefore substantially equivalent to the predicate device.

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.