(175 days)
Not Found
No
The summary explicitly states that the detection of arrhythmias and other cardiac conditions is done on the ECG monitoring device, not on the EMMa server, and that no interpretation of data is performed by the server software. There are no mentions of AI, DNN, or ML in the document.
No
EMMa is a server part of a telemedical system intended for diagnostic evaluation and report generation to support physicians in adapting therapy, not for direct therapeutic intervention.
No
The device description clearly states, "The detection of arrhythmias and other cardiac conditions is done on the ECG monitoring device, not on the EMMA, and is not scope of this 510k." EMMa is a server that receives data and generates reports for physicians; it does not perform diagnostic evaluation itself.
Yes
The device description explicitly states that EMMa is the "server part of a telemedical system" and receives data from external ambulatory ECG monitors. It is software installed in a Telemonitoring Service Centre and does not include the hardware ECG monitors themselves. The 510(k) focuses on the software's function of receiving, storing, and forwarding data, and generating reports.
Based on the provided text, the EMMa system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The EMMa system receives physiological data (ECG) directly from ambulatory monitoring devices worn by the patient. It does not process or analyze biological samples like blood, urine, or tissue.
- The primary function of EMMa is data management and reporting. The text explicitly states that the arrhythmia detection is done on the ECG monitoring device, not on EMMa. EMMa's role is to receive, store, and forward this data to generate reports for physicians.
- The intended use is for diagnostic evaluation based on physiological data. The system supports the physician in evaluating cardiac arrhythmias based on the ECG data, not on the results of tests performed on biological specimens.
Therefore, the EMMa system falls under the category of a medical device that processes and manages physiological data, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EMMa system is intended for diagnostic evaluation of patients who experience transient symptomatic events that may suggest non-lethal cardiac arthythmia to support and possibly improve an ongoing treatment by the patient's physician. Data received from battery powered ambulatory monitoring devices, triggered by an arrhythmia detection algorithm or manually by the patient, are stored and forwarded to licensed physician for review.
For diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records the data, automatically records events triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded event activity associated with these symptoms for review by a licensed physician.
Product codes
DSI, DRG
Device Description
EMMa (Electronic Monitoring Management) is the server part of a telemedical system to receive data from the ambulatory ECG monitors Kate Loop (Event Monitor) and Kate MCT (Mobile Cardiac Telemetry; similar to Loop but with additional functions like trend data and streaming). Physiological data recorded by the ECG monitors are transmitted via their GSM module (cellular telephon network) to the server EMMa. The detection of arrhythmias and other cardiac conditions is done on the ECG monitoring device, not on the EMMA, and is not scope of this 510k.
EMMa is provided to be installed in a Telemonitoring Service Centre (TSC). ECG-technicians / Agents working there generate patient reports from physiological data with the aim to send the reports to the patients' physicians. No interpretation of data is performed by the server software. The generated reports support physicians in adapting the therapy. EMMa is not designed for and compatible with iOS and Android.
Data mapping is implemented by assignment of patient, physician and mobile ECG device in EMMa. The report technicians review ECG-strips and trend data and generate Daily Reports and End of Session Reports. These reports are sent to the assigned physician. A real time monitoring of patients is not feasible with this system.
Data transmissions are triggered by the mobile ECG monitors when abnormal events are detected. Declaration of remarkable events can be configured individually for each device via EMMa based on the patient's physician's recommendations.
Transmissions can also be triggered by a configured timer or manually by patients or agents. The system supports the following events:
- Pause: short Sinoatrial arrest
- Afib: atrial fibrillation
- VES: ventricular extrasystoles
- VES Couplet: pairs or VES
- VES Triplet: three VES in a row
- Bigenimy: heart arrhythmia in which there is a continuous alternation of long and short heart beats
- SVES Single: single supraventricular extrasystoles
- Bradycardia: slow heart rate (under 60 bpm)
- Tachycardia: heart rate that exceeds the normal resting rate (over 100bpm):
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
licensed physician
Telemonitoring Service Centre (TSC). ECG-technicians / Agents
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)
Software Verification and Validation Testing
IEC 62304;2006, Medical Device Software-Software life cycle processes
Software verification and validation testing was conducted and documentation provided as recommended by the FDA Guidance for Industry and FDA Staff. Guidance for the Content of Software Contained in Medical Devices. The software is determined as a "moderate" level of concern because a failure or latent flaw could lead to a minor injury to the patient through incorrect information or through the action of the care provider.
Other testing
IEC 62366-1;2015. Medical Devices Part 1—Application of usability engineering to medical devices
EMMa Electronic Monitoring Management meets all the stated requirements and passed all the testing noted above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K092947 Telesentry, Model TS01
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.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 25, 2016
Vitasystems Gmbh Michael Rothhaar Director Corporate Quality Markircher Str. 22 Mannheim, 68229 DE
Re: K153477
Trade/Device Name: Emma 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: April 11, 2016 Received: April 15, 2016
Dear Michael Rothhaar:
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 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
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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.
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153477
Device Name EMMa - Electronic Monitoring Management
Indications for Use (Describe)
The EMMa system is intended for diagnostic evaluation of patients who experience transient symptomatic events that may suggest non-lethal cardiac arthythmia to support and possibly improve an ongoing treatment by the patient's physician. Data received from battery powered ambulatory monitoring devices, triggered by an arrhythmia detection algorithm or manually by the patient, are stored and forwarded to licensed physician for review.
Contraindications of Use:
- Patients with potentially life-threatening arrhythmias who require inpatient monitoring. -
- -Patients who the attending physician thinks should be hospitalized.
The software is not intended to be used to trigger emergency treatment or alert chains.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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EMMa
Electronic Monitoring Management
| Submitter: | Vitasystems GmbH
Markircher Str. 22
D-68229 Mannheim, Germany
Phone: +49 621 178918 100
Fax: +49 621 178918 101 |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person:
Michael Rothhaar, Director Corporate Quality
Phone: +49 621 178918 174
Fax: +49 621 178918 101
Mail: michael.rothhaar@vitaphone.de |
| Establishment
Registration Number:
Trade Name: | 3005191294
EMMa |
| Common Name:
Classification Name: | Cardiac Event Recorder Data Server
Detector and alarm, arrhythmia (per 21 CFR Section 870.1025, Product
Code: DSI, DRG) |
| Date Prepared: | May 24, 2016 |
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1. Legally Marketed Predicate Devices
K092947 DSI/DRG Telesentry, Model TS01, Scottcare Corporation
2. Indications & Intended Use
The EMMa (Electronic Monitoring Management) is a standalone software medical device. Connected with battery powered ambulatory ECG monitor devices, it acts as an arrhythmia detector and alarm device. EMMa is designed to receive data, to send configuration parameters to the devices and to enable qualified persons to assess and forward the received data.
The EMMa system is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest non-lethal cardiac arrhythmia to support and possibly improve an ongoing treatment by the patient's physician. Data received from battery powered ambulatory monitoring devices, triggered by an arrhythmia detection algorithm or manually by the patient, are stored and forwarded to licensed physicians for review.
Contraindications of Use
-
Patients with potentially life-threatening arrhythmias who require inpatient monitoring. -
done on the ECG monitoring device, not on the EMMA, and is not scope of this 510k. -
Patients who the attending physician thinks should be hospitalized. -
3. Product Description
EMMa (Electronic Monitoring Management) is the server part of a telemedical system to receive data from the ambulatory ECG monitors Kate Loop (Event Monitor) and Kate MCT (Mobile Cardiac Telemetry; similar to Loop but with additional functions like trend data and streaming). Physiological data recorded by the ECG monitors are transmitted via their GSM module (cellular telephon network) to the server EMMa. The detection of arrhythmias and other cardiac conditions is
EMMa is provided to be installed in a Telemonitoring Service Centre (TSC). ECG-technicians / Agents working there generate patient reports from physiological data with the aim to send the reports to the patients' physicians. No interpretation of data is performed by the server software. The generated reports support physicians in adapting the therapy. EMMa is not designed for and compatible with iOS and Android.
Data mapping is implemented by assignment of patient, physician and mobile ECG device in EMMa. The report technicians review ECG-strips and trend data and generate Daily Reports and End of Session Reports. These reports are sent to the assigned physician. A real time monitoring of patients is not feasible with this system.
Data transmissions are triggered by the mobile ECG monitors when abnormal events are detected. Declaration of remarkable events can be configured individually for each device via EMMa based on the patient's physician's recommendations.
Transmissions can also be triggered by a configured timer or manually by patients or agents. The system supports the following events:
- Pause: short Sinoatrial arrest ●
- . Afib: atrial fibrillation
- VES: ventricular extrasystoles ●
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- VES Couplet: pairs or VES ●
- VES Triplet: three VES in a row .
- Bigenimy: heart arrhythmia in which there is a continuous alternation of long and short heart . beats
- SVES Single: single supraventricular extrasystoles
- Bradycardia: slow heart rate (under 60 bpm) ●
- . Tachycardia: heart rate that exceeds the normal resting rate (over 100bpm):
4. Substantial Equivalence Discussion
| EMMa (subject device) | TeleSentry Model TS01 | Comments | |
|---|---|---|---|
| Premarket | |||
| Notification | |||
| Number | K153477 | K092947 | N/A |
| Classification | Arrhythmia detector and | ||
| alarm | Arrhythmia detector and | ||
| alarm | same | ||
| Product Code | DSI | ||
| DRG | DSI | ||
| DRG | same | ||
| Requlation | |||
| Number | 870.1025 | 870.1025 | same |
| Class | II | II | same |
| Indication for | |||
| Use | For diagnostic evaluation of | ||
| patients who experience | |||
| transient symptoms or | |||
| asymptomatic events that | |||
| may suggest cardiac | |||
| arrhythmia. The device | |||
| continuously monitors and | |||
| records the data, | |||
| automatically records | |||
| events triggered by an | |||
| arrhythmia detection | |||
| algorithm or manually by | |||
| the patient, and | |||
| automatically transmits the | |||
| recorded event activity | |||
| associated with these | |||
| symptoms for review by a | |||
| licensed physician. | For diagnostic evaluation of | ||
| patients who experience | |||
| transient symptoms or | |||
| asymptomatic events that | |||
| may suggest cardiac | |||
| arrhythmia. The device | |||
| continuously monitors and | |||
| records the data, | |||
| automatically records | |||
| events triggered by an | |||
| arrhythmia detection | |||
| algorithm or manually by | |||
| the patient, and | |||
| automatically transmits the | |||
| recorded event activity | |||
| associated with these | |||
| symptoms for review by a | |||
| licensed physician. | Same | ||
| Supported | |||
| ECG devices | kate Loop + kate MCT | TeleSentry TS01 | Similar, difference |
| does not affect safety | |||
| or performance | |||
| Supported | |||
| ECG modes | Loop (Event Monitor) | ||
| MCT (Mobile Cardiac | |||
| Telemetry) | MCT | Difference does not | |
| affect safety or | |||
| performance | |||
| Transmission | |||
| method | GSM | Bluetooth/GSM/USB | Similar, difference |
| does not affect safety | |||
| or performance | |||
| EMMa (subject device) | TeleSentry Model TS01 | Comments | |
| Device | |||
| configuration | |||
| via | GSM | Bluetooth + GSM | Similar, difference |
| does not affect safety | |||
| or performance | |||
| Device | |||
| compatible to | |||
| IOS or | |||
| Android | NO | NO | same |
| WIFI | NO | NO | same |
| monitoring in | |||
| real time / | |||
| near real time | NO | NO | same |
| Patient | |||
| management | Yes | Yes | same |
| Device | |||
| management | Yes | Yes | same |
| Physician | |||
| Management | Yes | Yes | same |
| ECG Viewer | Yes | Yes | same |
| ECG Live | |||
| streaming | Yes | Yes | same |
| Trend-data | |||
| analysis | Yes | Yes | same |
| Reports | End of Session, Daily | ||
| Report, Event Report | End of Session, Daily | ||
| Report, Event Report | same | ||
| Device | |||
| configuration | |||
| over the air | Yes | Yes | same |
| Display device | |||
| status | |||
| (Battery,GSM) | Yes | Yes | same |
| Leads- | |||
| On/Leads-Off | |||
| Event | Yes | Yes | same |
| Events | Pause, Afib, VES, VES | ||
| Couplet, VES Triplet, | |||
| Bigenimy, SVES Single, | |||
| Bradycardia, Tachycardia | |||
| up to 3 | Tachycardia, Bradycardia, | ||
| Pause, Afip | same | ||
| ECG | |||
| Channels | up to 3 | 3 | same |
| Report | |||
| Management | Creation and Management | ||
| of reports inside the | |||
| software | Creation of reports, no | ||
| management | Similar, difference | ||
| does not affect safety | |||
| or performance | |||
| User Interface | Web Application | Windows Client | Similar, difference |
| does not affect safety | |||
| or performance | |||
| Audit trail | Yes | Yes | same |
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5. Non-Clinical Performance Data
Verification and validation activities established the safety and performance characteristics of the subject device with respect to the predicate device. The following performance data have been provided in support of the substantial equivalence determination.
Software Verification and Validation Testing
- IEC 62304;2006, Medical Device Software-Software life cycle processes ●
- Software verification and validation testing was conducted and documentation provided . as recommended by the FDA Guidance for Industry and FDA Staff. Guidance for the Content of Software Contained in Medical Devices. The software is determined as a "moderate" level of concern because a failure or latent flaw could lead to a minor injury to the patient through incorrect information or through the action of the care provider.
Other testing
- IEC 62366-1;2015. Medical Devices Part 1—Application of usability engineering to med-● ical devices
EMMa Electronic Monitoring Management meets all the stated requirements and passed all the testing noted above.
6. Clinical Performance Data
Clinical data were not required to support the safety and effectiveness of the device EMMa.
7. Statement of Substantial Equivalence
Through the data and information presented, Vitasystems GmbH considers EMMa as substantially equivalent to the previously mentioned predicate device. Any differences between the subject and predicate device have no significant influence on safety or effectiveness as established through performance testing. Therefore, EMMa raises no new issues of safety or effectiveness when compared to the predicate device.
Vitasvstems GmbH Michael Rothhaar Director Corporate Quality
Signature: ...................................................................................................................................................................