(58 days)
Unknown
The device description mentions "proprietary algorithms for analysis" and that the "MoMe® Software System analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review." While this indicates algorithmic processing, the summary does not explicitly state whether these algorithms utilize AI or ML techniques. The lack of mention of training/test sets or specific AI/ML terms further contributes to the uncertainty.
B. No.
Explanation: The MoMe® Kardia is a diagnostic device used to aid physicians in the diagnosis of cardiac arrhythmias by monitoring and analyzing ECG data. It does not provide therapeutic interventions.
Yes
The intended use and device description clearly indicate that the MoMe® Kardia is designed to aid physicians in the diagnosis of cardiac arrhythmias by acquiring and analyzing ECG data.
No
The device description explicitly states that MoMe® Kardia includes a "wearable MoMe® Kardia Device that acquires and stores ECG and motion (accelerometer) data and transmits that data via cellular technology". This indicates the presence of hardware components beyond just software.
Based on the provided text, the MoMe® Kardia is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- MoMe® Kardia's Function: The MoMe® Kardia is a wearable device that acquires and transmits ECG (electrocardiogram) data and motion data. ECG data is a recording of the electrical activity of the heart, which is a physiological signal measured directly from the body, not a sample taken from the body.
- Intended Use: The intended use clearly states it's for monitoring cardiac arrhythmias and the effect of drugs on heart rate. This involves analyzing electrical signals from the heart, not performing tests on bodily fluids or tissues.
- Device Description: The description emphasizes acquiring and transmitting ECG and motion data, and analyzing this data via algorithms. There is no mention of collecting or analyzing biological samples.
Therefore, the MoMe® Kardia falls under the category of a medical device used for physiological monitoring, specifically cardiac monitoring, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
QYX, DSI
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:
- Holter
- Event Monitoring
- 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.
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
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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® 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 electrical equipment - Part 1: General requirements for basic safety and essential performance
- 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)
- 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
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 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
1
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
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 yours
FDA
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) 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) |
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4
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 Monitoring |
| and 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's |
| TruVue™ Wireless Ambulatory ECG Monitoring | |
| System |
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.
5
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
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:
-
- 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 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:
6
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
Page 3 of 5
-
- 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.
- MoMe® Kardia is contraindicated for those patients requiring attended, inhospital monitoring for life threatening arrhythmias.
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
-
- 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)
-
- 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.
7
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
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™ Wireless
Ambulatory ECG
Monitoring System |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| 510(k) Reference
Number | Not applicable, this 510(k)
submission | K100155 |
| FDA Classification | Class II | Class II |
| Product Code/
Classification Code/
Common Name | DSI
21 CFR 870.1025
Arrhythmia detector and
alarm | DSI
21CFR 870.1025
Arrhythmia detector and
alarm |
| Indications for Use | Indications for use are
identical to predicate device.
Please refer to Indications for
Use in Section 12.2 below. | Refer to Indications for Use in
Section 12.2 below |
| 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 |
| Number of
electrodes | 3 | 3 |
| Number of ECG
channels | 2 channels | 2 channels |
| Ambulatory ECG
Performance
Standards | IEC60601-2-47 | EC 38 |
| ECG Acquisition | Single unit body worn (sensor
- cellular module) | Body worn sensor, handheld
device with cellular module) |
| ECG Transmission
to Cellular | On board (single unit) | Bluetooth |
| ECG Transmission
to Monitoring
Center | Cellular | Cellular |
8
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™ Wireless
Ambulatory ECG
Monitoring System |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| User Event Trigger | Device User Interface | Handheld User Interface |
| Battery Type | Li lon rechargeable | Sensor - 1 AAA
Monitor - Li Ion rechargeable |
| Environments
where device may
be used | Physician practices, clinics,
research institutions | Physician practices, clinics,
research institutions |
| Environment where
device data storage
and reports are
generated | Remote (cloud-based) server | Remote (cloud-based) server |
| Prescription Use | Yes, intended to be used by
physicians and health care
providers only, not for use by
patients | Yes, intended to be used by
physicians and health care
providers only, not for use by
patients |
| Physician access to
patient
physiological and
event information | Yes | Yes |
| Arrhythmia
detection 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.