Who is the manufacturer of ECGenius System?

Cath Vision Aps filed the 510(k) submission for ECGenius System (K220306).

What is the FDA product code for ECGenius System?

DQK. It is classified under 21 CFR 870.1425 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for ECGenius System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ECGenius System?

Schwarzer CardioTek EP-TRACER (K183266).

Who can help prepare an FDA 510(k) submission like ECGenius System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ECGenius System

K220306 · Cath Vision Aps · DQK · May 3, 2022 · Cardiovascular

Device Facts

Record ID	K220306
Device Name	ECGenius System
Applicant	Cath Vision Aps
Product Code	DQK · Cardiovascular
Decision Date	May 3, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1425
Device Class	Class 2

Intended 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.

Device Story

ECGenius™ System is an electrophysiology (EP) recording system for use in EP labs or operating rooms by clinicians. It acquires, filters, amplifies, and digitizes intracardiac and surface ECG signals via catheters and leadwires connected to a 'Cube Amplifier'. Data is transmitted to a host PC running 'ECGenius™ Software' for visualization, processing, and recording. The system integrates with 3rd-party stimulators for diagnostic cardiac stimulation and RF ablation generators. It provides real-time signal monitoring to assist physicians in the diagnosis and treatment of cardiac arrhythmias. The system includes a stimulator bypass feature for safety. It does not perform automated diagnostic analysis; it serves as a measurement and recording platform.

Clinical Evidence

No clinical or animal studies were conducted. Substantial equivalence is supported by bench testing, including software verification and validation, operating environment verification, biocompatibility, packaging, cleaning, human factors/usability, and shelf-life testing.

Technological Characteristics

Electrophysiology measurement system; 128 intracardiac channels, 12-lead surface ECG, 4 pressure/2 auxiliary inputs. Sampling rate 2kHz; CMRR >120dB; Input impedance >2.5MΩ. Connectivity: PC-based, wired catheter/ECG inputs. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-27, IEC 60601-2-34, IEC 62366-1, IEC 62304, ISO 10993-1.

Indications for Use

Indicated for use in electrophysiology measurement and recording during electrophysiological studies and related cardiac procedures, including diagnostic cardiac stimulation when used with a compatible 3rd-party stimulator.

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

Schwarzer CardioTek EP-TRACER (K183266)

Related Devices

K161245 — EP-TRACER System · Cardio Tek, BV · Aug 5, 2016
K180805 — Pure EP · Biosig Technologies · Aug 8, 2018
K994011 — EP MEDSYSTEMS, EP-WORKMATE · Ep Medsystems, Inc. · Mar 23, 2000
K092810 — EP-WORKMATE SYSTEM, VERSION 4.2 · St Jude Medical · Oct 9, 2009
K071348 — EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM · Mennen Medical , Ltd. · Sep 7, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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) | | |----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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) | < 95 % rH (non-condensing) | humidity is insignificant. Similarly, both systems are able to withstand the expected temperature and humidity variations to be experienced during transport/storage. | | Power Requirements | 100 - 240 V AC, 50 - 60 Hz | 100 - 240 V AC, 50 - 60 Hz | Same | | Current Draw | 0.7A @ 110VAC, 0.35A @ 240VAC | 15A @ 115V, 7A @ 230V | ECGenius™ System consumes less power | | Sampling Rate | 2kHz | 1 kHz | The ECGenius™ System is capable of acquiring data at 2kHz, with a common mode rejection | | CMRR | > 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 | < 1 s (auto reset) | < 1 s (manual reset) | | | IECG Notch Filter | 50/60Hz None | 50/60 Hz None | | | IECG Dynamic Range | ±100 mV | ±5 mV | | | IECG Baseline Correction | ±1000 mV | ±300 mV | | | ECG Inputs | 10 ECG inputs (= 12 leads) | 10 ECG inputs (=12 leads) | Same | | ECG High Pass Filter | None 0.01 Hz 0.05 Hz 0.1 Hz 0.5 Hz 1 Hz 10 Hz | 0.05 Hz 0.2 Hz | The two systems are able to acquire multiple surface ECG signals, and all specifications for the ECGenius™ System are at least as good as for the EP- TRACER. | | ECG Low Pass Filter | 100 Hz 150 Hz 250 Hz 500 Hz None | 150 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. | | ECG RF Filtering | All inputs | All inputs | Note: the EP-TRACER claims to support 12 ECG 'channels', but the number corresponds to the | | ECG Gain | Between 0.01 and 5120 mm/mV – discrete intervals | Between 0 and 255 mm/mV - continuous | | | ATTRIBUTE | SUBJECT DEVICE ECGenius™ System K220306 | PREDICATE DEVICE Schwarzer CardioTek GmbH EP- TRACER K183266 | COMPARISON | | ECG Saturation Recovery | < 1 s (auto reset) | < 1 sec (manual reset) | ECG leads (derived from the standard 10 electrodes). | | ECG Notch Filter | 50/60Hz None | 50/60 Hz None | | | ECG Dynamic Range | ±10mV | ±5 mV | | | Baseline Correction | ±300mV | ±300 mV | | | Auxiliary Inputs Channels | 4 pressure 2 auxiliary (analog in) | 6 auxiliary (pressure) | Both systems offer 6 input channels. In the case of the EP-TRACER, these are all pressure inputs. For the ECGenius™ System, 4 channels are dedicated to pressure signals, but the remaining two can be utilized for any type of analog signal. | | Output channels | 12 lead ECG produced | 12 lead ECG produced | The EP-TRACER provides the user with analog output signals representing the 12 ECG leads. In comparison, the ECGenius™ System allows the user to output 12 ECG signals and 1 bipolar intracardiac ECG signal. The ECGenius™ System also has a single channel analog output dedicated to the ECG lead II. Although the systems differ in the signals made available, this feature is not part of the core functionality of an EP recording system and the differences are not significant. | | Isolated Stimulus Channels, Stimulator | 2 (external stimulator) | 2 | The EP-TRACER contains an internal cardiac stimulator, with 2 independent channels, each of which can be assigned, under software control, to any of the intracardiac channels. ECGenius™ System is compatible with an | | ATTRIBUTE | SUBJECT DEVICE ECGenius™ System K220306 | PREDICATE DEVICE Schwarzer CardioTek GmbH EP- TRACER K183266 | COMPARISON | | | | | external 2-channel stimulator, whereby each stimulator signal can be independently routed under software control, to any of the intracardiac channels. | | Backup | Connect catheters to stimulator bypass connections | Use external backup stimulator | For the EP-TRACER, the user is expected to use an external backup stimulator in the event of the system failing. | | |…