(284 days)
Unknown
The description mentions "proprietary algorithms" for data analysis and arrhythmia detection, but does not explicitly state whether these algorithms utilize AI or ML. The lack of information on training/test sets and performance metrics commonly associated with AI/ML models further contributes to the uncertainty.
No
The device is a diagnostic tool for cardiac monitoring and arrhythmia detection, not a therapeutic device. It helps identify and report medical conditions but does not provide treatment or therapy.
Yes
The MoMe System is used to detect and identify non-life threatening arrhythmias, providing reports of these detected events to a physician, which aligns with the definition of a diagnostic device.
No
The device description explicitly states that the system incorporates a "front end device worn by the patient that collects and streams ECG, heart rate and motion (activity)". This indicates the presence of hardware components beyond just software.
Based on the provided information, the MoMe™ Continuous ECG Monitor and Arrhythmia Detector System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- MoMe System Function: The MoMe System directly monitors physiological signals (ECG, heart rate, motion) from the patient's body while it is being worn. It analyzes this data in real-time or near real-time to detect arrhythmias. This is a form of in vivo monitoring, not in vitro testing of specimens.
The device description and intended use clearly indicate that the MoMe System is a remote physiological monitoring system that collects data directly from the patient's body.
N/A
Intended Use / Indications for Use
The MoMe™ Continuous ECG Monitor and Arrhythmia Detector System (MoMe™ System) is indicated for:
- 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.
The 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.
- Patients with implanted pacemakers, ICDs, neurostimulators and/or body worn medical devices such as insulin pumps.
Product codes
QYX, DSI, MLO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
For Adult Use Only. The MoMe™ Continuous ECG Monitor and Arrhythmia Detector is intended for patients who are 22 years and older.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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
3
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:
-
- 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.
The 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.
-
- 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.
4
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_
5
510(k) Summary
| Submitter Name: | InfoBionic, Inc. | ||
|---|---|---|---|
| Submitter Address: | 600 Suffolk Street, Lowell, MA 01854 | ||
| Contact Person: | Carrie Neuberger | ||
| Regulatory Affairs, InfoBionic | |||
| Phone Number: | 800-532-4304 | ||
| Date Prepared: | August 28, 2014 | ||
| Device Trade Name: | MoMeTM Continuous ECG Monitor and Arrhythmia | ||
| Detector System | |||
| Device Common Name: | Continuous ECG monitor and Arrhythmia Detection | ||
| System | |||
| Product Code and | |||
| Regulation: | DSI, 21 CFR 820.1025 | ||
| MLO, 21 CFR 820.2800 | |||
| Predicate Device #1: | K072588, K093288 CardioNet ECG Monitoring and | ||
| Arrhythmia Detection System | |||
| Predicate Device #2: | K121197, Preventice Body Guardian | ||
| 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. | |||
| Intended Population: | For Adult Use Only. The MoMeTM Continuous ECG | ||
| Monitor and Arrhythmia Detector is intended for patients | |||
| who are 22 years and older. |
6
Indications for Use:
The MoMe™ System is indicated for use on:
-
- Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or or sustained ventricular tachycardia.
-
- Patients with dizziness or lightheadedness.
-
- Patients with palpitations.
-
- 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.
-
- 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 8. possible nocturnal arrhythmias.
-
- 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.
7
Rationale for Substantial Equivalence:
| Characteristics | InfoBionic MoMe
System | CardioNet
K072588, K093288 | Preventice
K121197 |
|-----------------------------------------------------------------------|-----------------------------------------------------------|-------------------------------------|----------------------------------------------------|
| Product
Code/Classification
Code | DSI
21CFR 870.1025 | DSI
21CFR 870.1025 | DSI
21CFR 870.1025 |
| Two ECG
leads/channels | Yes | Yes | Yes |
| Parameters | Arrhythmia detection
- ECG, Heart Rate
and Activity | Arrhythmia detection | ECG, Heart Rate,
Respiration Rate &
Activity |
| Number of electrodes | Four electrodes | Three electrodes | Bandage-like body
sensor |
| Transmission | Bluetooth, cellular | Local wireless,
cellular or PSTN | Bluetooth, cellular |
| Data storage &
delivery of report to
Users | Remote server | Remote server | Remote server |
| iPad Display Option | Yes | No | Yes |
| Multiple monitoring
mode options | Holter Event, MCT | Event, MCT | Event, MCT |
| Physician access to
patient physiological
and 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
8
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.