(90 days)
Not Found
No
The summary describes a standard electrophysiology recording system with hardware and software for signal acquisition, processing, display, and recording. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies sections.
No.
The device is used for acquiring, filtering, digitizing, amplifying, displaying, and recording clinical data for diagnosis and monitoring, and it is compatible with a third-party stimulator for diagnostic cardiac stimulation. It is not described as directly administering therapy or intended to treat a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart" and the "Device Description" also mentions it is used "as part of the diagnosis and treatment of cardiac arrhythmias."
No
The device description explicitly lists multiple hardware components as part of the system, including an amplifier, cables, a host computer, monitors, and a printer, in addition to the software.
Based on the provided information, the ECGenius™ System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the system is used to acquire, filter, digitize, amplify, display, and record clinical data obtained during electrophysiological studies and related procedures. This involves measuring electrical signals directly from the heart in vivo (within the living body).
- Device Description: The description details the components and how they process electrical signals from catheters and surface ECG leads connected to the patient. This is a system for in vivo physiological measurement.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease. This is the core definition of an IVD.
- Anatomical Site: The anatomical site is the heart, indicating direct interaction with the patient's organ.
In summary, the ECGenius™ System is an electrophysiology recording system used for in vivo diagnostic procedures related to cardiac arrhythmias, not for testing samples in vitro.
N/A
Intended Use / Indications for Use
The ECGenius™ System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record clinical data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
Product codes
DQK
Device Description
The ECGenius™ System consists of an electrophysiology amplifier (commercial name "Cube Amplifier" in the technical documentation also called "EP Amplifier" or "EPAMP"), recording system software (commercial name "ECGenius™ Software" in technical documentation also called "Recorder Software" or "Recorder SW" or abbreviated as "RecSW") running on a PC, and additional components including external cable assemblies, PC monitors, and a printer. Electrophysiological signals are filtered, amplified, digitized in the Cube Amplifier, and sent to the PC and recording system software for further processing, visualization, and recording. The ECGenius™ System works in an EP laboratory or operating room in hospitals in conjunction with several other devices from other manufacturers.
The ECGenius™ System is an electrophysiology (EP) recording system used in EP procedures as part of the diagnosis and treatment of cardiac arrhythmias. The ECGenius™ System includes the following items:
- Cube Amplifier
- Two IECG pin box cables for connection of catheters
- Surface ECG trunk cable and ECG leadwires
- Blood pressure cables
- Data cable to host computer
- Stimulator cable
- Analog-out and analog-in cables
- ECGenius™ Software
- Host computer (PC), monitors and printer
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
EP laboratory or operating room in hospitals
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
The following performance testing was conducted to demonstrate substantial equivalence to the predicate device: Software verification and validation, Operating environment verification, Biocompatibility, Packaging, Cleaning, Human factors/usability, Shelf life.
Performance testing for this submission has been limited to bench testing. There are no animal or clinical studies.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
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May 3, 2022
CathVision ApS % Sharon Bishop Director of Regulatory Affairs Graematter, Inc. 1324 Clarkson Clayton Ctr #332 Ballwin, Missouri 63011
Re: K220306
Trade/Device Name: ECGenius™ System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: January 31, 2022 Received: February 2, 2022
Dear Sharon Bishop:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220306
Device Name ECGenius™ System
Indications for Use (Describe)
The ECGenius™ System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record clinical data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
| 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
510(k) Summary
ECGenius™ Summary
Submitter's information CathVision ApS Titangade 11 2200 Copenhagen N Denmark
Contact: Sharon Bishop Graematter, Inc. 1324 Clarkson Clayton Ctr #332 Ballwin, MO 63011 Phone: 919-724-8978 Date: 31 January 2022
The classification for the new device is listed below. Classification
| 21 CFR
Reference | Product
Code | Class | Generic Device Name | Classification Description |
|---------------------|-----------------|-------|---------------------------------------|-------------------------------------|
| §870.1425 | DQK | II | Computer, Diagnostic,
Programmable | Programmable diagnostic
computer |
The new device's indications for use are listed in the table below. New device
| Device Name | Indications for Use |
|---|---|
| ECGenius™ | |
| System | The ECGenius™ System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record clinical data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart. |
4
Predicate The predicate device for the ECGenius™ System is shown in the table device below.
| K Number | Product
Code | Predicate Device
Name | Indications for Use |
|----------|-----------------|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K183266 | DQK | Schwarzer
CardioTek
EP-TRACER | The EP-TRACER System is an electrophysiology
measurement system used to acquire, filter,
digitize, amplify, display, and record signals
obtained during electrophysiological studies
and related procedures. The system allows the
user to monitor, display and record the signals.
The system incorporates a stimulator intended
to be used for diagnostic cardiac stimulation
during electrophysiological testing of the heart |
Device description
The ECGenius™ System consists of an electrophysiology amplifier (commercial name "Cube Amplifier" in the technical documentation also called "EP Amplifier" or "EPAMP"), recording system software (commercial name "ECGenius™ Software" in technical documentation also called "Recorder Software" or "Recorder SW" or abbreviated as "RecSW") running on a PC, and additional components including external cable assemblies, PC monitors, and a printer. Electrophysiological signals are filtered, amplified, digitized in the Cube Amplifier, and sent to the PC and recording system software for further processing, visualization, and recording. The ECGenius™ System works in an EP laboratory or operating room in hospitals in conjunction with several other devices from other manufacturers.
The ECGenius™ System is an electrophysiology (EP) recording system used in EP procedures as part of the diagnosis and treatment of cardiac arrhythmias. The ECGenius™ System includes the following items:
- Cube Amplifier ●
- Two IECG pin box cables for connection of catheters ●
- Surface ECG trunk cable and ECG leadwires ●
- Blood pressure cables ●
- Data cable to host computer
- Stimulator cable
- Analog-out and analog-in cables
- ECGenius™ Software
- Host computer (PC), monitors and printer
5
The table below lists the characteristics for both the new and predicate devices. Characteristics
| ATTRIBUTE | SUBJECT DEVICE
ECGeniusTM System K220306 | PREDICATE DEVICE
Schwarzer CardioTek GmbH EP-
TRACER K183266 | COMPARISON |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The ECGeniusTM System is an
electrophysiology measurement
system used to acquire, filter,
digitize, amplify, display, and
record clinical data obtained
during electrophysiological
studies and related procedures.
The system is compatible with
3rd-party stimulator, intended to
be used for diagnostic cardiac
stimulation during
electrophysiological testing of the
heart. | The EP-TRACER System is an
electrophysiology measurement
system used to acquire, filter,
digitize, amplify, display, and record
signals obtained during
electrophysiological studies and
related procedures.
The system allows the user to
monitor, display and record the
signals. The system incorporates a
stimulator intended to be used for
diagnostic cardiac stimulation during
electrophysiological testing of the
heart. | Similar except that the ECGeniusTM System
does not incorporate a stimulator |
| FDA Product code | DQK | DQK | Same |
| Classification | Programmable diagnostic
computer, 21 CFR §870.1425 | Programmable diagnostic computer,
21 CFR §870.1425 | Same |
| Amplifier Dimensions
WxDxH (cm) | 43x43x31 | 28x27x12 | Different but both can be installed and used in
an
EP lab |
| Temperature
Operating | +10°C to +30°C | +10°C to +30°C | Same |
| Temperature
Transport/Storage | -15°C to +50°C | -29°C to +66°C | As both systems are intended for use in air-
conditioned hospital EP labs and operating |
| ATTRIBUTE | SUBJECT DEVICE
ECGenius™ System K220306 | PREDICATE DEVICE
Schwarzer CardioTek GmbH EP-
TRACER K183266 | COMPARISON |
| Humidity Operating | 30 - 75 % rH (non-condensing) | 20 - 80 % rH (non-condensing) | rooms, the minor difference in environmental
humidity is insignificant. Similarly, both |
| Humidity
Transport/Storage | 10 - 95 % rH (non-condensing) | 120dB | > 100 dB | ratio (CMRR) of >120dB, where the EP-TRACER
CMRR is >100dB. |
| Input Impedance | >2.5MΩ | Typical 20 MΩ | The EP-TRACER claims that typical input
impedance is 20MΩ. CathVision has tested the
ECGenius™ System to verify that the input
impedance is >2.5MΩ, in accordance with IEC
60601-2-27 §201.12.1.101.3. Typical values
have not been established. |
| IECG Inputs | 128 channels + 2 references | 84 channels | The two systems are able to acquire multiple |
| IECG Switching | Each channel can be either
bipolar or unipolar with manual
switching | Each channel can be either bipolar or
unipolar with manual switching | intracardiac ECG signals, and all specifications
for the ECGenius™ System are at least as good
as for the EP-TRACER. |
| IECG High Pass Filter | None
0.01 Hz
0.05 Hz
0.1 Hz
0.5 Hz 1 Hz 10 Hz 30 Hz 100 Hz | 0.05 Hz
0.2 Hz 40 Hz 80 Hz | Specifically, the ECGenius™ System has a
greater range of high-pass and low-pass filter
choice, a larger input range and offset, plus a
greater maximum gain. |
| IECG Low Pass Filter | 50 Hz | 350 Hz | |
| ATTRIBUTE | SUBJECT DEVICE
ECGenius™ System K220306 | PREDICATE DEVICE
Schwarzer CardioTek GmbH EP-
TRACER K183266 | COMPARISON |
| | 100 Hz | | |
| | 250 Hz | | |
| | 500 Hz | | |
| | None | | |
| IECG RF Filtering | All inputs | All inputs | |
| IECG Gain | Between 0.01 and 5120 mm/mV
– discrete intervals | Between 0 and 255 mm/mV
– continuous | |
| IECG Saturation
Recovery |