ScioCardio ECG transmitter is a physiological ECG acquisition module. It records and transmits the data acquired, to a compatible mobile phone via Bluetooth low energy link, for visualization without making any analysis or filtering to the data acquired.

ScioCardio ECG transmitter acquires Lead III ECG signals meeting the AAMI/ANSI/IEC standards for ambulatory ECG acquisition, via three electrodes attached to the patient's body.

ScioCardio ECG transmitter is a battery powered wearable device which allows the patient to be free to moving while wearing the device.

ScioCardio ECG transmitter transmits the acquired physiological signals in real-time to a compatible mobile phone where ScioCardio Mobile App is installed. ECG data is stored in the mobile phone verbatim without any sampling adjustment or any other modifications and also is displayed in the Mobile App.

ScioCardio ECG transmitter is a prescription only device which is intended for use under the supervision of a physician or those knowledgeable in all aspects of ECG morphology, rhythm and arrhythmia.

ScioCardio ECG transmitter and ScioCardio Mobile App are intended to be used on adult patients only.

Device Description

ScioCardio ECG transmitter is a battery powered wearable device, capable of continuously capturing a body surface ECG from the patient, storing and transmitting the data to an external device or a system wirelessly. ECG signals are captured from the conventional solid gel electrodes worn on the body using a 3 lead ECG system. Raw ECG data is stored and transmitted wirelessly to any compatible device with Bluetooth Low Energy capability. This allows visualization, analysis and interpretation which can be used for a variety of applications such as ECG monitoring, heart rate monitoring, arrhythmia detection and analysis, out-patient monitoring etc. Other than the ECG data, ScioCardio ECG transmitter also captures, stores and transmits patient's motion data from an IMU sensor providing information about the patient's activities which can also be used in above mentioned analysis and interpretations. ScioCardio ECG transmitter is an always-on device. Data acquisition, storing and transmission are all done automatically and require no patient intervention other than initializing the device. ScioCardio ECG transmitter is small in form factor and has a higher battery life, making it possible for the user to wear the device comfortably for longer durations as per specific requirements.

AI/ML Overview

The ScioCardio ECG Transmitter is a physiological ECG acquisition module that records and transmits ECG data to a compatible mobile phone via Bluetooth Low Energy. The device acquires Lead III ECG signals and is intended for use on adult patients under the supervision of a physician.

Here's an analysis of the acceptance criteria and the study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for performance in a tabular format. Instead, it demonstrates substantial equivalence through comparison to predicate devices and adherence to relevant standards. The performance aspects discussed indirectly serve as acceptable performance levels.

Performance Criterion	ScioCardio ECG Transmitter Reported Performance	Relevant Standard	SE Discussion/Equivalence
ECG Leads	3 leads	AAMI/ANSI/IEC standards for ambulatory ECG acquisition	Substantially equivalent to predicates. Analysis programs can utilize either 3 or 12 lead ECG formats.
Communications	Bluetooth Low Energy (BLE) Full ECG to Mobile Phone	Not explicitly listed as a standard, but a technological characteristic.	Same technology as predicate (Bluetooth, full ECG).
Analysis	3rd party program	N/A (Device transmits raw data)	Like predicates, analysis is done by a 3rd party program.
Power Source	Rechargeable 3.7V Li-ion battery	N/A	Battery operated: Substantially equivalent.
Battery Life	120 Hours	N/A	Has the longest battery life compared to predicates.
Device Powering	Always on, powered on when battery is inserted, no on/off button	N/A	Same as a predicate.
Compatible Operating System	Android (Future: iOS)	N/A	Functionally equivalent, same purposes as predicate's compatible OS (Windows).
CMRR (Common Mode Rejection Ratio)	100 dB	N/A (Compared to predicate's 115 dB)	Sufficient, no discussion of explicit acceptance criterion, but implicitly accepted via comparison.
Sampling Rate	250Hz with 17 bit ADC resolution	N/A (Compared to predicate's up to 1000 s/s)	Suitable for the intended use, substantially equivalent.
Bandwidth	0.05-40 Hz	Required by ambulatory ECG requirements (implicitly a standard)	Suitable for the intended use, substantially equivalent.
Input Range	10mV p-p over +/- 300mV DC offset	N/A (Compared to predicate's +/- 400mV offset)	Specified slightly differently but equivalent and suitable for the intended uses.
Standards Compliance	AAMI / ANSI ES60601-1:2005/(R)2012, IEC 60601-1-2 Ed. 4.0 2014-02, AAMI / ANSI / IEC 60601-2-47:2012	These are the standards the device claims compliance to.	Equivalent standards used. Tested to the more appropriate ambulatory standard (compared to predicate's multi-channel standard).

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical performance testing and states that clinical performance testing was not required to establish substantial equivalence. Therefore:

Sample size for the test set: Not applicable for clinical data. For non-clinical tests, specific sample sizes (e.g., number of devices tested for battery life) are not provided, but the tests were "successfully conducted" or "successfully performed."
Data provenance: Not applicable for clinical data. For non-clinical device performance, the testing was conducted by SYNERGEN Technology Labs LLC. The country of origin of the data is implicitly the USA (where the company is based), but not explicitly stated. The tests are prospective as they were performed to validate the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as clinical performance testing was not required or submitted for this 510(k) summary. The device transmits raw data and does not perform analysis itself.

4. Adjudication Method for the Test Set

Not applicable, as clinical performance testing was not required or submitted for this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No MRMC study was done. Clinical performance testing was not required. The device's function is to acquire and transmit raw ECG data; it does not include AI for interpretation or diagnosis that would typically warrant a comparative effectiveness study with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not applicable. The ScioCardio ECG Transmitter is a hardware device for acquiring and transmitting raw ECG signals. It explicitly states it transmits data "without making any analysis or filtering to the data acquired." Therefore, there is no embedded algorithm for diagnosis or interpretation that would require a standalone performance study.

7. The Type of Ground Truth Used

For non-clinical performance (e.g., battery life, transmitter range, operability): The ground truth was based on engineered specifications and successful operation against those specifications (e.g., battery lasted longer than 120 hours, transmitter range was "successfully conducted").
For standards compliance: The ground truth is the requirements outlined in the specified international and FDA recognized standards (e.g., AAMI / ANSI ES60601-1). The device was tested and found compliant with these standards, implying it met the specified performance metrics within those standards.
For clinical data / algorithm performance: Not applicable, as clinical performance testing was not required and there's no diagnostic algorithm in the device.

8. The Sample Size for the Training Set

Not applicable, as the device does not employ machine learning or AI algorithms requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as the device does not employ machine learning or AI algorithms requiring a training set.

Summary

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May 30, 2018

SYNERGEN Technology Labs LLC % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct Naples, Florida 34114

Re: K171019

Trade/Device Name: ScioCardio ECG Transmitter Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG Dated: April 30, 2018 Received: April 30, 2018

Dear Daniel Kamm:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Daniel Kamm

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

M.G. Hillemann

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) K171019

Device Name ScioCardio ECG Transmitter

Indications for Use (Describe)

ScioCardio ECG transmitter is a physiological ECG acquisition module. It records and transmits the a compatible mobile phone via Bluetooth low energy link, for visualization without making any analysis or filtering to the data acquired.

ScioCardio ECG transmitter acquires Lead III ECG signals meeting the AAMI/ANSI/IEC standards for ambulatory ECG acquisition, via three electrodes attached to the patient's body.

ScioCardio ECG transmitter is a battery powered wearable device which allows the patient to be free to moving while wearing the device.

ScioCardio ECG transmitter is a prescription only device which is intended for use under the supervision of a physician or those knowledgeable in all aspects of ECG morphology, rhythm and arrhythmia.

ScioCardio ECG transmitter and ScioCardio Mobile App are intended to be used on adult patients only.

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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Image /page/3/Picture/0 description: The image shows the logo for Synergen Technology Labs. The logo features the word "SYNERGEN" in large, bold, blue letters. Below that is the text "Technology Labs" in a smaller, gray font. To the left of the word "SYNERGEN" is a semi-circular design made up of blue and gray dots.

510(k) Summary, SYNERGEN TECHNOLOGY LABS LLC

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

Date Summary Prepared: January 26, 2017

Submitter's Identification:

SYNERGEN Technology Labs LLC 3131 McKinney Avenue, Suite 602 Dallas, Texas 75204

Summary Prepared by:

Sunil Konda, Vice President, Product Direct: 214-643-6002 Mobile: 214-435-0633 sunil.k@synergentl.com www.Synergentl.com

Device Name:

Trade /Proprietary Name: ScioCardio ECG Transmitter Regulation Number: 870.2910 Regulation Name: Transmitters and receivers, physiological signal, radiofrequency Regulatory Class: II Product Code: DRG

Legally Marketed Predicate Devices Information:

Trade/Device Name: Cardioline HD+ made by Cardioline S.p.A. Premarket Notification K150289 Regulation Number: 870.2910 Regulation Name: Transmitters and Receivers, Physiological Signal, Radiofrequency Regulatory Class: II Product Code: DRG

Trade/Device Name: PocketECG v2 made by Medicalgorithmics LLC Premarket Notification K112921 Regulation Number: 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: II Product Code: DSI

K171019

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Device Description:

Image /page/4/Figure/2 description: The image shows a diagram of a ScioCardio ECG Transmitter Device connected to a mobile phone, which is then connected to a remote system. The ScioCardio ECG Transmitter Device is on the left side of the image, and it is connected to the mobile phone by a blue arrow labeled "Data". The mobile phone is in the center of the image, and it is connected to the remote system by a blue arrow labeled "Data". The remote system is on the right side of the image, and it is represented by a cloud with a database icon.

Intended Use/Indications for use:

ScioCardio ECG transmitter is a physiological ECG acquisition module. It records and transmits the data acquired, to a

compatible mobile phone via Bluetooth low energy link, for visualization without making any analysis or filtering to the data acquired.

ScioCardio ECG transmitter acquires Lead III ECG signals meeting the AAMI/ANS/JEC standards for ambulatory ECG acquisition, via three electrodes attached to the patient's body.

ScioCardio ECG transmitter is a battery powered wearable device which allows the patient to be free to moving while wearing the device.

ScioCardio ECG transmitter is a prescription only device which is intended for use under the supervision of a physician or those knowledgeable in all aspects of ECG morphology, rhythm and arrhythmia.

ScioCardio ECG transmitter and ScioCardio Mobile App are intended to be used on adult patients only.

Safety and Effectiveness: As shown in the table below, the design presents no issues regarding safety and effectiveness as compared to the predicate devices. K171019 Page 2 of 7

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Table of comparison to Legally Marketed Devices:

ComparisonCriteria	K150289 Cardioline HD+Product Code DRG	Synergen ScioCardio ECGTransmitterProduct Code DRG	SE Discussion
Photo	Image: K150289 Cardioline HD+	Image: Synergen ScioCardio ECG Transmitter	Equivalent technology employed:Battery operated Bluetooth ECGrecorder/ transmitter
BasicComparison	12 lead ECG without arrhythmiadetection software, Bluetoothcommunication. Analysis program onthe host is a separate product notmarketed with the HD+.	3 Lead ECG without arrhythmiadetection software. Uses Bluetoothcommunication. Compatible with 3rdparty arrhythmia detection notmarketed with the ScioCardio.	Like K150289, i.e. without arrhythmiabut 3 leads instead of 12, sameproduct code.
MechanicalDesign	Portable plastic case with internalbatteries.	SAME	Substantially equivalent.
ComparisonCriteria	K150289 Cardioline HD+Product Code DRG	Synergen ScioCardio ECGTransmitterProduct Code DRG	SE Discussion
Indications forUse	HD+ is a physiological ECG acquisitionmodule. HD+ transmits wireless, viaBluetooth to a PC or Tablet, the dataacquired, without making any analysis orfiltering on the data acquired.HD+ acquires 12-lead ECG waveformsmeeting the standards for clinical anddiagnostic applications (AAMI, ANSI, AHA,ACC) and offers full ECG acquisition. HD+ isdesigned to acquire and transmit a highquality ECG data allowing the patient to befree to moving (without cable connected tothe processing unit). The HD+ transmits theacquired physiological signals in real-time toa computer/device where a compatibleapplication is installed. All data acquired aresent via Bluetooth to a receiver that it can bea PC, tablet or device capable of receiving BTdata. The ECG is transmitted verbatim to thereceiving system, without LSB or samplingadjustment. It is up to the receivingsystem/application to perform the necessaryprocessing such as (but not limited to) LSBscaling, signal filtering, Resting ECG analysisetc... The device HD+ is intended to be usedon adult and on all pediatric patients. Thedevice is intended for use by qualified,trained nurses and physicians operating inhospitals, clinics and medical practices.	ScioCardio ECG transmitter is a physiologicalECG acquisition module. It records andtransmits the data acquired, to acompatible mobile phone via Bluetooth lowenergy link, for visualization without makingany analysis or filtering to the data acquired.ScioCardio ECG transmitter acquires Lead IIand Lead III ECG signals meeting theAAMI/ANSI/IEC standards for ambulatoryECG acquisition, via three electrodesattached to the patient's body.ScioCardio ECG transmitter is a batterypowered wearable device which allows thepatient to be free to moving while wearingthe device.ScioCardio ECG transmitter transmits theacquired physiological signals in real-time toa compatible mobile phone whereScioCardio Mobile App is installed. ECG datais stored in the mobile phone verbatimwithout any sampling adjustment or anyother modifications and also is displayed inthe Mobile App.ScioCardio ECG transmitter is a prescriptiononly device which is intended for use underthe supervision of a physician or thoseknowledgeable in all aspects of ECGmorphology, rhythm and arrhythmia.ScioCardio ECG transmitter and ScioCardioMobile App are intended to be used on adultpatients only.	Like K112921 PocketECG v2 in that it records3 leads (but we don't perform the analysis,that is done by a 3rd party program.Like K150289 Cardioline HD+ in that it theanalysis is done by a 3rd party program, butwe record 3 leads instead of 12.The compatible 3rd party analysis program(Telemed, K142349) works with either 12 or3 leads.Substantially equivalent.
Comparison	K150289 Cardioline HD+	Synergen ScioCardio ECG	SE Discussion
Criteria	Product Code DRG	Transmitter
		Product Code DRG
ECG Leads	Up to 12 leads	3 leads	Substantially equivalent. Analysis
			programs can utilize either 3 or 12
			lead ECG formats.
Communications	Bluetooth, Full ECG	Bluetooth Low Energy (BLE) Full ECG	SAME technology
		to Mobile Phone
Analysis	3rd party program	3rd party program	Includes aspects of both predicates
Power Source	2x AAA Batteries	Rechargeable 3.7V Li-ion battery	Battery operated: Substantially
			equivalent
Battery Life	10 Hours	120 Hours	The subject device has the longest
			battery life.
Powering the	Device is always on	Device is always on	SAME
Device	Powered on when the battery is	Powered on when the battery is
	inserted to the device, no power	inserted to the device, no power
	on/off button is provided	on/off button is provided
Compatible	Windows 7 pro, Windows 8 pro,	Android. (Future: iOS.)	Functionally
Operating	32/64 bit		equivalent, same purposes.
System
CMRR	115 dB	100 dB
Sampling Rate	Up to 1000 s/s	Sampling rate 250Hz with 17 bit ADC	Suitable for the intended use,
		resolution	substantially equivalent.
Bandwidth	0.05 - 300 Hz, according to sampling	0.05-40 Hz (Required by ambulatory	Suitable for the intended use,
	frequency	ECG requirements.)	substantially equivalent.
Input Range	+/ -400mV offset	10mV p-p over +/- 300mV DC offset	Specified slightly differently but
			equivalent and suitable for the
			intended uses.
ComparisonCriteria	K150289 Cardioline HD+Product Code DRG	Synergen ScioCardio ECGTransmitterProduct Code DRG	SE Discussion
StandardsCompliance	IEC 60601-1 medical electrical equipment -part 1: general requirements for basic safetyand essential performanceIEC 60601-2-25 Particular requirements forthe basic safety and essential performanceof electrocardiographs.IEC 60601-2-51 Medical electricalequipment. Particular requirements forsafety, including essential performance, ofrecording and analysing single channel andmultichannel electrocardiographs.	AAMI / ANSI ES60601-1:2005/(R)2012 andA1:2012, c1:2009/(r)2012 anda2:2010/(r)2012 (consolidated text) medicalelectrical equipment - part 1: generalrequirements for basic safety and essential performanceIEC 60601-1-2 Edition 4.0 2014-02, medicalelectrical equipment - part 1-2: generalrequirements for basic safety and essentialperformance - collateral standard:electromagnetic disturbances - requirementsand tests.AAMI / ANSI / IEC 60601-2-47:2012, medicalelectrical equipment - part 2-47: particularrequirements for the basic safety andessential performance of ambulatoryelectrocardiographic systems.	Equivalent standards used.EC57 (Testing and reporting performanceresults of cardiac rhythm and ST segmentmeasurement algorithms) would apply to the3rd party analysis program we do not supply.Re K150289, testing was done to multi-channel ECG standard. We tested to themore appropriate ambulatory standard.

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The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness.

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Summary of non-clinical performance testing: Successful standards testing was performed in accordance with these International, FDA recognized Standards: AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance

IEC 60601-1-2 Edition 4.0 2014-02, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic disturbances requirements and tests.

AAMI / ANSI / IEC 60601-2-47:2012, medical electrical equipment -- part 2-47: particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.

Additional testing:

Battery life testing was performed to validate the claimed life of the rechargeable battery. The test results showed the battery lasted for longer than the specified time. (120 hours/5 days). Transmitter range testing was successfully conducted. Long term, and patient simulator operability testing was successfully performed. Software and firmware validation and risk analysis using ISO 14971:2007, 2009 and 2012 was successfully performed according to predetermined test protocols.

Summary of clinical performance testing: Not required to establish substantial equivalence.

Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Synergen Technology Labs concludes that the Synergen ScioCardio ECG Transmitter is substantially equivalent to the predicate device as described herein.

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).