(420 days)
No
The device description explicitly states that the device transmits data "without making any analysis or filtering to the data acquired" and that the data is stored "verbatim without any sampling adjustment or any other modifications." There is no mention of AI or ML in the text.
No
The device is described as an ECG acquisition module that records and transmits physiological data for visualization and analysis, with no mention of applying therapy.
No.
The device records and transmits ECG data without making any analysis or filtering or any modifications to the data. It is an acquisition module, not a diagnostic device. The documentation explicitly states that visualization, analysis, and interpretation can be used for applications like arrhythmia detection, but the device itself does not perform these diagnostic steps.
No
The device description explicitly states it is a "battery powered wearable device" that "continuously captur[es] a body surface ECG from the patient" using "conventional solid gel electrodes." This indicates the device includes hardware components for data acquisition, storage, and transmission, in addition to any software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: 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. These tests are performed outside of the body.
- Device Function: The ScioCardio ECG transmitter is described as a physiological ECG acquisition module. It records and transmits electrical signals from the patient's body surface (ECG) via electrodes attached to the skin. This is a measurement of a physiological process happening within the body.
- Intended Use: The intended use is to acquire and transmit ECG data for visualization and potential analysis by a physician. It does not involve testing samples taken from the body.
Therefore, the ScioCardio ECG transmitter falls under the category of a physiological monitoring device, not an In Vitro Diagnostic device.
N/A
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/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.
Product codes
DRG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's body (via three electrodes)
Indicated Patient Age Range
Adult patients only.
Intended User / Care Setting
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. Not specified if for hospital, clinic or home use although it's a wearable device that allows the patient to be moving.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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);
1
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
2
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 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.
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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3
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
4
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.
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 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.
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
5
Table of comparison to Legally Marketed Devices:
| Comparison
Criteria | K150289 Cardioline HD+
Product Code DRG | Synergen ScioCardio ECG
Transmitter
Product Code DRG | SE Discussion |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Photo | Image: K150289 Cardioline HD+ | Image: Synergen ScioCardio ECG Transmitter | Equivalent technology employed:
Battery operated Bluetooth ECG
recorder/ transmitter |
| Basic
Comparison | 12 lead ECG without arrhythmia
detection software, Bluetooth
communication. Analysis program on
the host is a separate product not
marketed with the HD+. | 3 Lead ECG without arrhythmia
detection software. Uses Bluetooth
communication. Compatible with 3rd
party arrhythmia detection not
marketed with the ScioCardio. | Like K150289, i.e. without arrhythmia
but 3 leads instead of 12, same
product code. |
| Mechanical
Design | Portable plastic case with internal
batteries. | SAME | Substantially equivalent. |
| Comparison
Criteria | K150289 Cardioline HD+
Product Code DRG | Synergen ScioCardio ECG
Transmitter
Product Code DRG | SE Discussion |
| Indications for
Use | HD+ is a physiological ECG acquisition
module. HD+ transmits wireless, via
Bluetooth to a PC or Tablet, the data
acquired, without making any analysis or
filtering on the data acquired.
HD+ acquires 12-lead ECG waveforms
meeting the standards for clinical and
diagnostic applications (AAMI, ANSI, AHA,
ACC) and offers full ECG acquisition. HD+ is
designed to acquire and transmit a high
quality ECG data allowing the patient to be
free to moving (without cable connected to
the processing unit). The HD+ transmits the
acquired physiological signals in real-time to
a computer/device where a compatible
application is installed. All data acquired are
sent via Bluetooth to a receiver that it can be
a PC, tablet or device capable of receiving BT
data. The ECG is transmitted verbatim to the
receiving system, without LSB or sampling
adjustment. It is up to the receiving
system/application to perform the necessary
processing such as (but not limited to) LSB
scaling, signal filtering, Resting ECG analysis
etc... The device HD+ is intended to be used
on adult and on all pediatric patients. The
device is intended for use by qualified,
trained nurses and physicians operating in
hospitals, clinics and medical practices. | 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 II
and 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. | Like K112921 PocketECG v2 in that it records
3 leads (but we don't perform the analysis,
that is done by a 3rd party program.
Like K150289 Cardioline HD+ in that it the
analysis is done by a 3rd party program, but
we record 3 leads instead of 12.
The compatible 3rd party analysis program
(Telemed, K142349) works with either 12 or
3 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. |
| Comparison
Criteria | K150289 Cardioline HD+
Product Code DRG | Synergen ScioCardio ECG
Transmitter
Product Code DRG | SE Discussion |
| Standards
Compliance | IEC 60601-1 medical electrical equipment -
part 1: general requirements for basic safety
and essential performance
IEC 60601-2-25 Particular requirements for
the basic safety and essential performance
of electrocardiographs.
IEC 60601-2-51 Medical electrical
equipment. Particular requirements for
safety, including essential performance, of
recording and analysing single channel and
multichannel electrocardiographs. | 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. | Equivalent standards used.
EC57 (Testing and reporting performance
results of cardiac rhythm and ST segment
measurement algorithms) would apply to the
3rd party analysis program we do not supply.
Re K150289, testing was done to multi-
channel ECG standard. We tested to the
more appropriate ambulatory standard. |
6
7
8
The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness.
9
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.