ECGenius System

K223787 · Cath Vision Aps · DQK · Aug 4, 2023 · Cardiovascular

Device Facts

• Record ID: K223787
• Device Name: ECGenius System
• Applicant: Cath Vision Aps
• Product Code: DQK · Cardiovascular
• Decision Date: Aug 4, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The ECGenius™ System is an electrophysiology measurement system and analysis tool used to acquire, filter, digitize, amplify, display, record, and analyze 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. The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation.

Device Story

Electrophysiology (EP) recording system; acquires, filters, digitizes, and amplifies intracardiac and surface ECG signals; processes data via ECGenius™ Software V3.0. Includes PVI Analyzer™ module for automated real-time analysis of electrograms from circular mapping catheters to aid in evaluating pulmonary vein isolation status; Signal Complexity™ module for visualizing signal properties and fractionation index on colormaps. Used in EP labs/operating rooms by physicians. Output displayed on PC monitors; provides supplementary information to support clinical decision-making during cardiac arrhythmia procedures. PVI Analyzer™ serves as a secondary measure; does not replace traditional isolation confirmation methods.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included software verification and validation, cybersecurity, operating environment verification, biocompatibility, packaging, cleaning, human factors/usability, and shelf-life testing.

Technological Characteristics

Programmable diagnostic computer (21 CFR 870.1425). Components: Cube Amplifier, PC, monitors, printer, cable assemblies. Inputs: 128 IECG channels, 10 ECG leads, 4 pressure, 2 auxiliary. Sampling rate: 2kHz. Connectivity: Standalone system for EP lab. Software: ECGenius™ V3.0 (includes PVI Analyzer and Signal Complexity modules). Standards: IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366-1, ISO 10993-1.

Indications for Use

Indicated for adults in sinus rhythm undergoing their first pulmonary vein isolation (PVI) treatment, and for use during electrophysiological studies and related procedures.

Regulatory Classification

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.

Predicate Devices

• ECGenius™ System (K220306)

Reference Devices

• Carto 3 (K180238)
• Bard LabSystem PRO (K101331)

Submission Summary (Full Text)

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August 4, 2023

Cath Vision ApS % Sharon Bishop Director of Regulatory Affairs Graematter, Inc. 1324 Clarkson Clayton Ctr #332 St. Louis, Missouri 63011

Re: K223787

Trade/Device Name: ECGenius™ System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: July 4, 2023 Received: July 6, 2023

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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Aneesh S. Deoras -S

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

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#### Indications for Use

510(k) Number (if known) K223787

Device Name ECGenius™ System

#### Indications for Use (Describe)

The ECGenius™ System is an electrophysiology measurement system and analysis tool used to acquire, filter, digitize, amplify, display, record, and analyze 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.

The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation.

| Type of Use (Select one or both, as applicable) | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| <table border="0"><tr><td><div> <span> <span style="font-size: 14px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div></td><td><div> <span> <span style="font-size: 14px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div></td></tr></table> | <div> <span> <span style="font-size: 14px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 14px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
| <div> <span> <span style="font-size: 14px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 14px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |

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## 510(k) Summary K223787

### ECGenius™ System Summary

| Submitter's<br>information | CathVision ApS | Contact: Sharon Bishop |
|----------------------------|-------------------|--------------------------------|
| | Titangade 11 | Graematter, Inc. |
| | 2200 Copenhagen N | 1324 Clarkson Clayton Ctr #332 |
| | Denmark | Ballwin, MO 63011 |
| | | Phone: [phone] |
| | | Date: August 4, 2023 |

The classification for the new device is listed below. Classification

| 21 CFR<br>Reference | Product<br>Code | Class | Generic Device Name | Classification Description |
|---------------------|-----------------|-------|---------------------------------------|-------------------------------------|
| §870.1425 | DQK | II | Computer, Diagnostic,<br>Programmable | Programmable diagnostic<br>computer |

New device The new device's indications for use are listed in the table below.

| Device Name | Indications for Use |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ECGenius™<br>System | The ECGenius™ System is an electrophysiology measurement system and analysis tool used to acquire, filter, digitize, amplify, display, record, and analyze 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.<br>The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation. |

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Predicate device

The predicate device for the ECGenius™ System is shown in the table below.

| K Number | Product<br>Code | Predicate Device<br>Name | Indications for Use |
|----------|-----------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K220306 | DQK | ECGenius™ System | The ECGenius™ System is an electrophysiology<br>measurement system used to acquire, filter, digitize,<br>amplify, display, and record clinical data obtained<br>during electrophysiological studies and related<br>procedures. The system is compatible with a 3rd-party<br>stimulator, intended to be used for diagnostic cardiac<br>stimulation during electrophysiological testing of the<br>heart. |

Reference The reference devices for the ECGenius™ System are shown in the table devices below.

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| K Number | Product<br>Code | Predicate Device<br>Name | Indications for Use |
|----------|-----------------|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K180238 | DQK | Carto 3 | The intended use of the CARTO® 3 System is catheter-<br>based cardiac electrophysiological (EP) procedures. The<br>CARTO 3 System provides information about the<br>electrical activity of the heart and about catheter<br>location during the procedure. The system can be used<br>on patients who are eligible for a conventional<br>electrophysiological procedure. The system has no<br>special contraindications. |
| K101331 | DQK | Bard LabSystem<br>PRO | The Bard LabSystem ER Laboratory is a computer and<br>software driven data acquisition and analysis tool<br>designed to facilitate the gathering, display, analysis by<br>a physician, pace mapping and storage of cardiac<br>electrophysiologic data. When integrated with the<br>Philips EP navigator system, the BARD® LabSystem™<br>PRO EP Recording System is designed to acquire,<br>analyze, and display 3D electro- anatomical maps of the<br>human heart. The maps are constructed using<br>intracardiac electrograms with their respective cardiac<br>locations taken from live x-ray overlay on a patient's 3D<br>cardiac anatomy. Maps may be displayed as electrical<br>activation maps, voltage maps, dominant frequency<br>maps and location maps with user defined<br>measurement values. |

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Device The ECGenius™ System is an electrophysiology (EP) recording system used description in EP procedures as part of the diagnosis and treatment of cardiac arrhythmias. ECGenius™ System (with ECGenius™ Software V3.0) is similar to ECGenius™ System (with ECGenius™ Software V2.0) but has two additional software modules.

> The Signal Complexity™ software module analyzes various properties of the signals from a connected 10-pole catheter and visualizes them on a colormap. No clinical claims are made for Signal Complexity™.

> The PVI Analyzer™ software module aids the user in evaluating the isolation status of a pulmonary vein. The module performs automated real time analysis of electrograms (EGM) from compatible connected 8- or 10-pole circular mapping catheters during a PVI procedure. The result of the analysis (Isolated vs Non-isolated) is presented in a visual plot to the user. The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation.

The ECGenius™ System consists of an electrophysiology amplifier (Cube Amplifier), recording system software (ECGenius™ Software) running on a PC, and additional components including external cable assemblies, PC monitors, and a printer. Electrophysiological signals are filtered, amplified, and digitized in the Cube Amplifier, and sent to the PC and recording system software for further processing, analysis, 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 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 with the PVI Analyzer™ and Signal Complexity™ software modules
- · Host computer (PC), monitors and printer
- Isolation transformers

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Characteristics - The table below lists the characteristics for both the new and predicate devices. comparison with predicate device

| ATTRIBUTE | SUBJECT DEVICE<br>ECGenius™ System<br>(with ECGenius™ Software V3.0) | PREDICATE DEVICE<br>ECGenius™ System<br>(with ECGenius™ Software V2.0)<br>K220306 | COMPARISON |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The ECGenius™ System is an<br>electrophysiology measurement<br>system and analysis tool used to<br>acquire, filter, digitize, amplify,<br>display, record, and analyze data<br>obtained during electrophysiological<br>studies and related procedures. The<br>system is compatible with a 3rd-<br>party stimulator, intended to be used<br>for diagnostic cardiac stimulation<br>during electrophysiological testing of<br>the heart.<br>The PVI Analyzer™ feature is a<br>secondary measure of pulmonary<br>vein isolation and should not replace<br>traditional methods of confirming<br>isolation. | The ECGenius™ System is an<br>electrophysiology measurement<br>system used to acquire, filter,<br>digitize, amplify, display, and record<br>clinical data obtained during<br>electrophysiological studies and<br>related procedures.<br>The system is compatible with 3rd-<br>party stimulator, intended to be used<br>for diagnostic cardiac stimulation<br>during electrophysiological testing of<br>the heart. | Subject device includes<br>additional analysis tools, and<br>the term "analyze" is added to<br>the indications for use.<br>The change does not impact<br>intended use or safety and<br>effectiveness. |
| FDA Product code | DQK | DQK | Same |
| ATTRIBUTE | SUBJECT DEVICE<br>ECGenius™ System<br>(with ECGenius™ Software V3.0) | PREDICATE DEVICE<br>ECGenius™ System<br>(with ECGenius™ Software V2.0)<br>K220306 | COMPARISON |
| Classification | Programmable diagnostic computer,<br>21 CFR §870.1425 | Programmable diagnostic computer,<br>21 CFR §870.1425 | Same |
| Population | Adults<br>PVI Analyzer™ is indicated for adults<br>in sinus rythmn undergoing their first<br>PVI treatment | Adults | Comparable - PVI Analyzer™<br>(analysis tool) is indicated for<br>adults in sinus rythmn<br>undergoing their first PVI<br>treatment. Does not impact<br>safety and effectiveness. |
| Recorder Software | ECGenius™ Software V3.0 | ECGenius™ Software V2.0 | The recorder software in the<br>subject device is an evolution<br>of the recorder software in the<br>predicate device. |
| CARDIALYTICS™<br>software plug-ins | Signal Complexity™<br>PVI Analyzer™ | None | The recorder software for the<br>subject device includes two<br>new software modules<br>(analysis tools). Does not<br>impact safety and<br>effectiveness. |
| Amplifier<br>Dimensions<br>WxDxH (cm) | 43x43x31 | 43x43x31 | Same |
| Temperature<br>Operating | +10°C to +30°C | +10°C to +30°C | Same |
| Temperature<br>Transport/Storage | -15°C to +50°C | -15°C to +50°C | Same |
| Humidity Operating | 30 - 75 % rH (non-condensing) | 30 - 75 % rH (non-condensing) | Same |
| ATTRIBUTE | SUBJECT DEVICE<br>ECGenius™ System<br>(with ECGenius™ Software V3.0) | PREDICATE DEVICE<br>ECGenius™ System<br>(with ECGenius™ Software V2.0)<br>K220306 | COMPARISON |
| Humidity<br>Transport/Storage | 10 - 95 % rH (non-condensing) | 10 - 95 % rH (non-condensing) | Same |
| Power<br>Requirements | 100 - 240 V AC, 50 - 60 Hz | 100 - 240 V AC, 50 - 60 Hz | Same |
| Current Draw | 0.7A @ 110VAC, 0.35A @ 240VAC | 0.7A @ 110VAC, 0.35A @ 240VAC | Same |
| Sampling Rate | 2kHz | 2kHz | Same |
| CMRR | > 120dB | > 120dB | Same |
| Input Impedance | >2.5MΩ | >2.5MΩ | Same |
| IECG Inputs | 128 channels + 2 references | 128 channels + 2 references | Same |
| IECG Switching | Each channel can be either bipolar or<br>unipolar with manual switching | Each channel can be either bipolar or<br>unipolar with manual switching | Same |
| IECG High Pass Filter | None | None | Same |
| | 0.01 Hz | 0.01 Hz | |
| | 0.05 Hz | 0.05 Hz | |
| | 0.1 Hz | 0.1 Hz | |
| | 0.5 Hz | 0.5 Hz | |
| | 1 Hz | 1 Hz | |
| | 10 Hz | 10 Hz | |
| | 30 Hz | 30 Hz | |
| | 100 Hz | 100 Hz | |
| IECG Low Pass Filter | 50 Hz | 50 Hz | Same |
| | 100 Hz | 100 Hz | |
| | 250 Hz | 250 Hz | |
| | 500 Hz | 500 Hz | |
| | None | None | |
| IECG RF Filtering | All inputs | All inputs | Same |
| ATTRIBUTE | SUBJECT DEVICE<br>ECGenius™ System<br>(with ECGenius™ Software V3.0) | PREDICATE DEVICE<br>ECGenius™ System<br>(with ECGenius™ Software V2.0)<br>K220306 | COMPARISON |
| IECG Scale | Between 1.25 and 5120 mm/mV<br>– discrete intervals | Between 1.125 and 5120 mm/mV<br>– discrete intervals | Same |
| IECG Saturation<br>Recovery | < 1 s (auto reset) | < 1 s (auto reset) | Same |
| IECG Power-line<br>Filter | Notch 50/60Hz<br>Adaptive Notch<br>None | Notch 50/60Hz<br>None | Similar. Subject device has in<br>additional a (software based)<br>Adaptive Notch filter. Does<br>not impact safety and<br>effectiveness. |
| IECG Dynamic Range | ±100 mV | ±100 mV | Same |
| IECG Baseline<br>Correction | ±1000 mV | ±1000 mV | Same |
| ECG Inputs | 10 ECG inputs (= 12 leads) | 10 ECG inputs (= 12 leads) | Same |
| ECG High Pass Filter | None<br>0.01 Hz<br>0.05 Hz<br>0.1 Hz<br>0.5 Hz<br>1 Hz<br>10 Hz | None<br>0.01 Hz<br>0.05 Hz<br>0.1 Hz<br>0.5 Hz<br>1 Hz<br>10 Hz | Same |
| ECG Low Pass Filter | 100 Hz<br>150 Hz<br>250 Hz<br>500 Hz<br>None | 100 Hz<br>150 Hz<br>250 Hz<br>500 Hz<br>None | Same |
| ECG RF Filtering | All inputs | All inputs | Same |
| ATTRIBUTE | SUBJECT DEVICE<br>ECGenius™ System<br>(with ECGenius™ Software V3.0) | PREDICATE DEVICE<br>ECGenius™ System<br>(with ECGenius™ Software V2.0)<br>K220306 | COMPARISON |
| ECG Scale | Between 1.25 and 5120 mm/mV<br>– discrete intervals | Between 1.25 and 5120 mm/mV<br>– discrete intervals | Same |
| ECG Saturation<br>Recovery | < 1 s (auto reset)…