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.

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.

AI/ML Overview

The provided text does not contain detailed acceptance criteria for the EMMa device's performance, nor does it describe a study specifically designed to "prove" the device meets such criteria in terms of clinical accuracy or effectiveness.

The document is a 510(k) premarket notification letter and summary, primarily focusing on establishing substantial equivalence to a predicate device. It highlights software verification and validation activities and other non-clinical performance data, but clinical performance data was not required for the substantial equivalence determination.

Therefore, many of the requested details, such as specific performance metrics, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are not available in the provided text.

Here's what can be extracted and what information is missing:

Missing Information:

A table of acceptance criteria and reported device performance (specifically for clinical accuracy)
Sample size used for the test set
Data provenance for clinical testing
Number of experts used to establish ground truth
Qualifications of experts establishing ground truth
Adjudication method for the test set
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI assistance
Whether a standalone (algorithm only) performance study was done (the document states arrhythmia detection is done on the ECG monitoring device, not the EMMa software)
The type of ground truth used for clinical effectiveness (as clinical data was not required)
Sample size for the training set (no mention of a training set for clinical performance)
How ground truth for the training set was established (no mention of a training set for clinical performance)

Available Information (related to non-clinical performance and design):

A table of acceptance criteria and the reported device performance:

The document implies that the device "meets all the stated requirements and passed all the testing noted above." However, specific numerical performance metrics (e.g., sensitivity, specificity for arrhythmia detection) are not provided. The "acceptance criteria" appear to be compliance with relevant standards (IEC 62304, IEC 62366-1) and software verification/validation.

Acceptance Criterion (Implied)	Reported Device Performance
Compliance with IEC 62304 (Medical Device Software life cycle)	Passed; documentation provided
Compliance with FDA Guidance for Software Contained in Medical Devices	Software verification and validation conducted; documentation provided
Software Level of Concern (Moderate) satisfied	Yes
Compliance with IEC 62366-1 (Usability engineering)	Passed
Meeting "all stated requirements" (General design/functionality)	EMMa meets all stated requirements

Sample size used for the test set and the data provenance:
- Not provided for clinical performance. The "test set" mentioned refers to software verification and validation, not a clinical dataset for diagnostic accuracy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided for clinical performance. Clinical ground truth establishment was not part of the required testing for the 510(k) pathway for this device.
Adjudication method for the test set:
- Not applicable/Not provided for clinical performance.
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:
- No. The document explicitly states "Clinical data were not required to support the safety and effectiveness of the device EMMa." Furthermore, the EMMa is a server system designed to receive data and present it for human review by ECG-technicians and physicians; it does not perform final diagnostic interpretation or AI-driven assistance that would typically be evaluated in an MRMC study comparing human performance with and without AI. The arrhythmia detection algorithm itself resides on the ambulatory ECG monitoring devices (e.g., Kate Loop, Kate MCT), not on the EMMa server, and "is not scope of this 510k."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. The document clarifies that the arrhythmia detection is done on the ECG monitoring device, not on the EMMa software. EMMa is a server system for managing, storing, and forwarding data for human review.
The type of ground truth used:
- For the non-clinical software testing, the "ground truth" would be the expected functional behavior and output based on design specifications and regulatory standards. Clinical ground truth (e.g., pathology, outcomes data) was not used as clinical data was not required.
The sample size for the training set:
- Not provided. Clinical training data is not discussed as clinical studies were not performed for this 510(k).
How the ground truth for the training set was established:
- Not provided. (See point 8).

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K153477

Device Name EMMa - Electronic Monitoring Management

Indications for Use (Describe)

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Image /page/3/Picture/1 description: The image shows the logo for Vitasystems. The word "vita" is in a teal color, and the word "systems" is in black. There are three curved lines above the "a" in "vita".

EMMa

Electronic Monitoring Management

K153477

Submitter:	Vitasystems GmbHMarkircher Str. 22D-68229 Mannheim, GermanyPhone: +49 621 178918 100Fax: +49 621 178918 101
	Contact Person:Michael Rothhaar, Director Corporate QualityPhone: +49 621 178918 174Fax: +49 621 178918 101Mail: michael.rothhaar@vitaphone.de
EstablishmentRegistration Number:Trade Name:	3005191294EMMa
Common Name:Classification Name:	Cardiac Event Recorder Data ServerDetector and alarm, arrhythmia (per 21 CFR Section 870.1025, ProductCode: DSI, DRG)
Date Prepared:	May 24, 2016

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Image /page/4/Picture/1 description: The image shows the logo for Vitasystems. The word "vita" is in teal, and the word "systems" is in black. There are three curved lines above the "a" in "vita".

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 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
PremarketNotificationNumber	K153477	K092947	N/A
Classification	Arrhythmia detector andalarm	Arrhythmia detector andalarm	same
Product Code	DSIDRG	DSIDRG	same
RequlationNumber	870.1025	870.1025	same
Class	II	II	same
Indication forUse	For diagnostic evaluation ofpatients who experiencetransient symptoms orasymptomatic events thatmay suggest cardiacarrhythmia. The devicecontinuously monitors andrecords the data,automatically recordsevents triggered by anarrhythmia detectionalgorithm or manually bythe patient, andautomatically transmits therecorded event activityassociated with thesesymptoms for review by alicensed physician.	For diagnostic evaluation ofpatients who experiencetransient symptoms orasymptomatic events thatmay suggest cardiacarrhythmia. The devicecontinuously monitors andrecords the data,automatically recordsevents triggered by anarrhythmia detectionalgorithm or manually bythe patient, andautomatically transmits therecorded event activityassociated with thesesymptoms for review by alicensed physician.	Same
SupportedECG devices	kate Loop + kate MCT	TeleSentry TS01	Similar, differencedoes not affect safetyor performance
SupportedECG modes	Loop (Event Monitor)MCT (Mobile CardiacTelemetry)	MCT	Difference does notaffect safety orperformance
Transmissionmethod	GSM	Bluetooth/GSM/USB	Similar, differencedoes not affect safetyor performance
	EMMa (subject device)	TeleSentry Model TS01	Comments
Deviceconfigurationvia	GSM	Bluetooth + GSM	Similar, differencedoes not affect safetyor performance
Devicecompatible toIOS orAndroid	NO	NO	same
WIFI	NO	NO	same
monitoring inreal time /near real time	NO	NO	same
Patientmanagement	Yes	Yes	same
Devicemanagement	Yes	Yes	same
PhysicianManagement	Yes	Yes	same
ECG Viewer	Yes	Yes	same
ECG Livestreaming	Yes	Yes	same
Trend-dataanalysis	Yes	Yes	same
Reports	End of Session, DailyReport, Event Report	End of Session, DailyReport, Event Report	same
Deviceconfigurationover the air	Yes	Yes	same
Display devicestatus(Battery,GSM)	Yes	Yes	same
Leads-On/Leads-OffEvent	Yes	Yes	same
Events	Pause, Afib, VES, VESCouplet, VES Triplet,Bigenimy, SVES Single,Bradycardia, Tachycardiaup to 3	Tachycardia, Bradycardia,Pause, Afip	same
ECGChannels	up to 3	3	same
ReportManagement	Creation and Managementof reports inside thesoftware	Creation of reports, nomanagement	Similar, differencedoes not affect safetyor performance
User Interface	Web Application	Windows Client	Similar, differencedoes not affect safetyor 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: ...................................................................................................................................................................

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.