(90 days)
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.
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
The provided document is a 510(k) Summary for the ECGenius™ System. It discusses the device's substantial equivalence to a predicate device, the EP-TRACER. However, it does NOT contain the specific details required to fulfill all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.
Here's what can be extracted from the document based on your request:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide specific quantitative "acceptance criteria" for performance that the device was tested against and then reports the performance against those criteria in a table format as you've requested. Instead, it offers a "Characteristics" table comparing the ECGenius™ System to its predicate device, the EP-TRACER, to demonstrate substantial equivalence. This comparison implies that meeting or exceeding the predicate device's performance would be a form of acceptance.
Table: Comparison of ECGenius™ System (Subject Device) vs. Predicate Device (EP-TRACER)
| ATTRIBUTE | SUBJECT DEVICE ECGenius™ System K220306 | PREDICATE DEVICE Schwarzer CardioTek GmbH EP-TRACER K183266 | COMPARISON |
|---|---|---|---|
| Indications for use | As described in the summary. | As described in the summary. | Similar except that the ECGenius™ 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 rooms, the minor difference in environmental humidity is insignificant. Similarly, both systems are able to withstand the expected temperature and humidity variations to be experienced during transport/storage. |
| Humidity Operating | 30 - 75 % rH (non-condensing) | 20 - 80 % rH (non-condensing) | (See above for combined humidity comparison, stating "minor difference in environmental humidity is insignificant.") |
| Humidity Transport/Storage | 10 - 95 % rH (non-condensing) | < 95 % rH (non-condensing) | (See above for combined humidity comparison, stating "minor difference in environmental humidity is insignificant." and "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 ratio (CMRR) of >120dB, where the EP-TRACER CMRR is >100dB. (Implies better performance for ECGenius) |
| CMRR | > 120dB | > 100 dB | (See above for combined Sampling Rate/CMRR comparison, stating that ECGenius™ CMRR is >120dB compared to EP-TRACER's >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 intracardiac ECG signals, and all specifications for the ECGenius™ System are at least as good as for the EP-TRACER. (Implies better/equivalent performance for ECGenius) |
| IECG Switching | Each channel can be either bipolar or unipolar with manual switching | Each channel can be either bipolar or unipolar with manual switching | (Combined with IECG Inputs comparison, stating "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. (Implies better range/flexibility for ECGenius) |
| IECG Low Pass Filter | 50 Hz, 100 Hz, 250 Hz, 500 Hz, None | 350 Hz | (Combined with IECG High Pass Filter comparison, stating "greater range of high-pass and low-pass filter choice.") |
| IECG RF Filtering | All inputs | All inputs | (Within the context of IECG signals, implying equivalence.) |
| IECG Gain | Between 0.01 and 5120 mm/mV – discrete intervals | Between 0 and 255 mm/mV – continuous | (Combined with IECG High Pass Filter comparison, stating "greater maximum gain.") |
| IECG Saturation Recovery | < 1 s (auto reset) | < 1 s (manual reset) | (Within the context of IECG signals, implying equivalence in recovery time, but ECGenius™ has "auto reset" which is an improvement.) |
| IECG Notch Filter | 50/60Hz, None | 50/60 Hz, None | (Within the context of IECG signals, implying equivalence.) |
| IECG Dynamic Range | ±100 mV | ±5 mV | (Combined with IECG High Pass Filter comparison, stating "larger input range and offset.") |
| IECG Baseline Correction | ±1000 mV | ±300 mV | (Combined with IECG High Pass Filter comparison, stating "larger input range and offset.") |
| 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. 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. (Implies better range/flexibility for ECGenius) |
| ECG Low Pass Filter | 100 Hz, 150 Hz, 250 Hz, 500 Hz, None | 150 Hz | (Combined with ECG High Pass Filter comparison, stating "greater range of high-pass and low-pass filter choice.") |
| ECG RF Filtering | All inputs | All inputs | Note: the EP-TRACER claims to support 12 ECG 'channels', but the number corresponds to the ECG leads (derived from the standard 10 electrodes). (Within the context of ECG signals, implying equivalence in RF filtering.) |
| ECG Gain | Between 0.01 and 5120 mm/mV – discrete intervals | Between 0 and 255 mm/mV - continuous | (Combined with ECG High Pass Filter comparison, stating "greater maximum gain.") |
| ECG Saturation Recovery | < 1 s (auto reset) | < 1 sec (manual reset) | (Within the context of ECG signals, implying equivalence in recovery time, but ECGenius™ has "auto reset" which is an improvement.) |
| ECG Notch Filter | 50/60Hz, None | 50/60 Hz, None | (Within the context of ECG signals, implying equivalence.) |
| ECG Dynamic Range | ±10mV | ±5 mV | (Combined with ECG High Pass Filter comparison, stating "larger input range and offset.") |
| Baseline Correction | ±300mV | ±300 mV | (Within the context of ECG signals, implying equivalence.) |
| 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. (Implies greater flexibility for ECGenius) |
| 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. (Implies slightly different but not clinically significant output capabilities) |
| 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 external 2-channel stimulator, whereby each stimulator signal can be independently routed under software control, to any of the intracardiac channels. (Difference in stimulator integration, but both support 2 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. For the ECGenius™ System, a system failure could result in the user not being able to select the correct routing for the stimulation signal. In this case, the user is expected to connect the appropriate electrodes to the ECGenius™ System's dedicated stimulator bypass connections (which are hardwired to the external stimulator). (Different backup methods for stimulator, but both have a plan) |
| Display Ablation Parameters | Connection to RF ablation generator(s) | Connection to RF ablation generator(s) | Same |
| Standards | IEC 60601-1: 2005+A1:2012, IEC 60601-1-2: 2014, etc. | IEC 60601-1: 2005+A1:2012, IEC 60601-1-2: 2014, etc. | The same standards are used; however, some have been updated for the ECGenius™ System. |
| Leakage Current Patient | < 10 μΑ | < 10 μΑ | Same |
| Leakage Current Patient (single fault conditions) | < 50 μΑ | < 50 μΑ | Same |
| Leakage Current Touch current | < 100 μΑ | < 100 μΑ | Same |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Performance testing for this submission has been limited to bench testing. There are no animal or clinical studies."
Therefore, there is no clinical "test set" in the context of patient data, sample size, or data provenance to report. The testing was laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since there were no clinical or animal studies, there was no "test set" requiring expert ground truth establishment for diagnostic accuracy or similar performance metrics. The testing was focused on engineering performance and compliance with standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there was no clinical "test set" and no diagnostic performance evaluation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The ECGenius™ System is an electrophysiology measurement system, not described as an AI-powered diagnostic tool that assists human readers/clinicians in interpreting findings for improved effectiveness through an MRMC study. The document states "Performance testing ... has been limited to bench testing."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable in the context of an algorithm's diagnostic performance. The device is a "Programmable Diagnostic Computer" for acquiring, filtering, digitizing, amplifying, displaying, and recording clinical data. Its performance was assessed through bench testing against engineering specifications and standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since the testing was limited to bench testing against engineering specifications and international standards, the "ground truth" would be the expected performance values based on those specifications and standards. For example, a "ground truth" for CMRR performance would be ">100 dB" (predicate) or ">120 dB" (subject device), as derived from design specifications and standard requirements, and verified through laboratory measurements.
8. The sample size for the training set
Not applicable. The document states "Performance testing ... has been limited to bench testing. There are no animal or clinical studies." There is no mention of a "training set" for an algorithm or AI model.
9. How the ground truth for the training set was established
Not applicable, as there was no training set for an AI model.
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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.
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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 (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
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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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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 CFRReference | ProductCode | Class | Generic Device Name | Classification Description |
|---|---|---|---|---|
| §870.1425 | DQK | II | Computer, Diagnostic,Programmable | Programmable diagnosticcomputer |
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. |
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Predicate The predicate device for the ECGenius™ System is shown in the table device below.
| K Number | ProductCode | Predicate DeviceName | Indications for Use |
|---|---|---|---|
| K183266 | DQK | SchwarzerCardioTekEP-TRACER | The EP-TRACER System is an electrophysiologymeasurement system used to acquire, filter,digitize, amplify, display, and record signalsobtained during electrophysiological studiesand related procedures. The system allows theuser to monitor, display and record the signals.The system incorporates a stimulator intendedto be used for diagnostic cardiac stimulationduring 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
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The table below lists the characteristics for both the new and predicate devices. Characteristics
| ATTRIBUTE | SUBJECT DEVICEECGeniusTM System K220306 | PREDICATE DEVICESchwarzer CardioTek GmbH EP-TRACER K183266 | COMPARISON |
|---|---|---|---|
| Indications for use | The ECGeniusTM System is anelectrophysiology measurementsystem used to acquire, filter,digitize, amplify, display, andrecord clinical data obtainedduring electrophysiologicalstudies and related procedures.The system is compatible with3rd-party stimulator, intended tobe used for diagnostic cardiacstimulation duringelectrophysiological testing of theheart. | The EP-TRACER System is anelectrophysiology measurementsystem used to acquire, filter,digitize, amplify, display, and recordsignals obtained duringelectrophysiological studies andrelated procedures.The system allows the user tomonitor, display and record thesignals. The system incorporates astimulator intended to be used fordiagnostic cardiac stimulation duringelectrophysiological testing of theheart. | Similar except that the ECGeniusTM Systemdoes not incorporate a stimulator |
| FDA Product code | DQK | DQK | Same |
| Classification | Programmable diagnosticcomputer, 21 CFR §870.1425 | Programmable diagnostic computer,21 CFR §870.1425 | Same |
| Amplifier DimensionsWxDxH (cm) | 43x43x31 | 28x27x12 | Different but both can be installed and used inanEP lab |
| TemperatureOperating | +10°C to +30°C | +10°C to +30°C | Same |
| TemperatureTransport/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 DEVICEECGenius™ System K220306 | PREDICATE DEVICESchwarzer CardioTek GmbH EP-TRACER K183266 | COMPARISON |
| Humidity Operating | 30 - 75 % rH (non-condensing) | 20 - 80 % rH (non-condensing) | rooms, the minor difference in environmentalhumidity is insignificant. Similarly, both |
| HumidityTransport/Storage | 10 - 95 % rH (non-condensing) | < 95 % rH (non-condensing) | humidity is insignificant. Similarly, bothsystems are able to withstand the expectedtemperature and humidity variations to beexperienced 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 acquiringdata at 2kHz, with a common mode rejection |
| CMRR | > 120dB | > 100 dB | ratio (CMRR) of >120dB, where the EP-TRACERCMRR is >100dB. |
| Input Impedance | >2.5MΩ | Typical 20 MΩ | The EP-TRACER claims that typical inputimpedance is 20MΩ. CathVision has tested theECGenius™ System to verify that the inputimpedance is >2.5MΩ, in accordance with IEC60601-2-27 §201.12.1.101.3. Typical valueshave 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 eitherbipolar or unipolar with manualswitching | Each channel can be either bipolar orunipolar with manual switching | intracardiac ECG signals, and all specificationsfor the ECGenius™ System are at least as goodas for the EP-TRACER. |
| IECG High Pass Filter | None0.01 Hz0.05 Hz0.1 Hz0.5 Hz 1 Hz 10 Hz 30 Hz 100 Hz | 0.05 Hz0.2 Hz 40 Hz 80 Hz | Specifically, the ECGenius™ System has agreater range of high-pass and low-pass filterchoice, a larger input range and offset, plus agreater maximum gain. |
| IECG Low Pass Filter | 50 Hz | 350 Hz | |
| ATTRIBUTE | SUBJECT DEVICEECGenius™ System K220306 | PREDICATE DEVICESchwarzer 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 SaturationRecovery | < 1 s (auto reset) | < 1 s (manual reset) | |
| IECG Notch Filter | 50/60HzNone | 50/60 HzNone | |
| IECG Dynamic Range | ±100 mV | ±5 mV | |
| IECG BaselineCorrection | ±1000 mV | ±300 mV | |
| ECG Inputs | 10 ECG inputs (= 12 leads) | 10 ECG inputs (=12 leads) | Same |
| ECG High Pass Filter | None0.01 Hz0.05 Hz0.1 Hz0.5 Hz 1 Hz 10 Hz | 0.05 Hz0.2 Hz | The two systems are able to acquire multiplesurface ECG signals, and all specifications forthe ECGenius™ System are at least as good asfor the EP- TRACER. |
| ECG Low Pass Filter | 100 Hz150 Hz250 Hz500 HzNone | 150 Hz | Specifically, the ECGenius™ System has agreater range of high-pass and low-pass filterchoice, a larger input range and offset, plus agreater 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 DEVICEECGenius™ System K220306 | PREDICATE DEVICESchwarzer CardioTek GmbH EP-TRACER K183266 | COMPARISON |
| ECG SaturationRecovery | < 1 s (auto reset) | < 1 sec (manual reset) | ECG leads (derived from the standard 10electrodes). |
| ECG Notch Filter | 50/60HzNone | 50/60 HzNone | |
| ECG Dynamic Range | ±10mV | ±5 mV | |
| Baseline Correction | ±300mV | ±300 mV | |
| Auxiliary InputsChannels | 4 pressure2 auxiliary (analog in) | 6 auxiliary (pressure) | Both systems offer 6 input channels. In thecase of the EP-TRACER, these are all pressureinputs. For the ECGenius™ System, 4 channelsare dedicated to pressure signals, but theremaining two can be utilized for any type ofanalog signal. |
| Output channels | 12 lead ECG produced | 12 lead ECG produced | The EP-TRACER provides the user with analogoutput signals representing the 12 ECG leads.In comparison, the ECGenius™ System allowsthe user to output 12 ECG signals and 1 bipolarintracardiac ECG signal. The ECGenius™System also has a single channel analog outputdedicated to the ECG lead II.Although the systems differ in the signalsmade available, this feature is not part of thecore functionality of an EP recording systemand the differences are not significant. |
| Isolated StimulusChannels, Stimulator | 2 (external stimulator) | 2 | The EP-TRACER contains an internal cardiacstimulator, with 2 independent channels, eachof which can be assigned, under softwarecontrol, to any of the intracardiac channels.ECGenius™ System is compatible with an |
| ATTRIBUTE | SUBJECT DEVICEECGenius™ System K220306 | PREDICATE DEVICESchwarzer CardioTek GmbH EP-TRACER K183266 | COMPARISON |
| external 2-channel stimulator, whereby eachstimulator signal can be independently routedunder software control, toany of the intracardiac channels. | |||
| Backup | Connect catheters to stimulatorbypass connections | Use external backup stimulator | For the EP-TRACER, the user is expected to usean external backup stimulator in the event ofthe system failing. |
| For the ECGenius™ System, a system failurecould result in the user not being able to selectthe correct routing for the stimulation signal.In this case, the user is expected to connectthe appropriate electrodes to the ECGenius™System's dedicated stimulator bypassconnections (which are hardwired to theexternal stimulator). | |||
| Display AblationParameters | Connection to RF ablationgenerator(s) | Connection to RF ablationgenerator(s) | Same |
| Standards | IEC 60601-1: 2005+A1:2012IEC 60601-1-2: 2014IEC 60601-1-6:2010+A1:2013IEC 60601-2-27: 2011IEC 60601-2-34: 2011IEC 62366-1: 2015IEC 62304: 2006+A1:2015 | IEC 60601-1: 2005+A1:2012IEC 60601-1-2: 2014IEC 60601-1-6:2010+A1:2013IEC 60601-2-27: 2011IEC 60601-2-34: 2011IEC 62366: 2007+A1:2014IEC 62304: 2006 | The same standards are used; however, somehave been updated for the ECGenius™ System |
| Leakage Current | < 10 μΑ | < 10 μΑ | Same |
| Patient | |||
| ATTRIBUTE | SUBJECT DEVICEECGenius™ System K220306 | PREDICATE DEVICESchwarzer CardioTek GmbH EP-TRACER K183266 | COMPARISON |
| Leakage CurrentPatient (single faultconditions) | < 50 μΑ | < 50 μΑ | Same |
| Leakage CurrentTouch current | < 100 μΑ | < 100 μΑ | Same |
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| Performancetesting | The following performance testing was conducted to demonstratesubstantial equivalence to the predicate device: Software verification and validation Operating environment verification Biocompatibility Packaging Cleaning Human factors/usability Shelf life |
|---|---|
| Guidancedocumentsreferenced fortesting | The following guidance documents were referenced for testing: Content of Premarket Submissions for Management ofCybersecurity in Medical Device – Draft Guidance for Industry andFDA staff Content of Premarket Submissions for Management ofCybersecurity in Medical Device Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices Information to Support a Claim of Electromagnetic Compatibility(EMC) of Electrically-Powered Medical Devices Off-The-Shelf Software Use in Medical Devices Applying Human Factors and Usability Engineering to MedicalDevices Use of International Standard ISO 10993-1, "Biological evaluation ofmedical devices - Part 1: Evaluation and testing within a riskmanagement process |
| Consensusstandards usedfor testing | The following consensus standards were referenced for testing. All exceptIEC 60601-1:2005+A1:2012 are FDA-recognized consensus standards. IEC 60601-1:2005+A1:2012 (not FDA-recognized but similar to FDA-recognized ANSI AAMI ES60601-1) IEC 60601-1-2:2014 4th Edition IEC 60601-2-27 Edition 3.0 2011-03 (see note) IEC 60601-2-34 Edition 3.0 2011-05 (see note) IEC 62366 Edition 1.0 2015-02 IEC 62304 Edition 1.1 2015-06 ISO 10993-1 5th edition 2018-8 |
system, clauses relating to alarm systems do not apply.
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Summary and Performance testing for this submission has been limited to bench testing. conclusion There are no animal or clinical studies.
In summary:
- Verification and validation of the design of the ECGenius™ System has been conducted in accordance with ISO 13485:2016 and the Quality System Regulations (21CFR820) section 820.30.
- The ECGenius™ System has been tested against and complies with the multiple international standards listed herein.
The EP-TRACER and the ECGenius™ System share the same intended use as a cardiology electrophysiology recording system. The most important characteristics for fulfilling this use are those related to the acquisition of intracardiac and surface ECG signals. The ECGenius™ System exhibits performance characteristics that are substantially equivalent to the EP-TRACER.
For the majority of other characteristics, the ECGenius™ System is the same or similar in specification to the EP-TRACER as documented in its 510(k) summary. The ECGenius™ System, like the EP-TRACER, is compliant with all applicable standards.
Based on the above, it is considered that the ECGenius™ System is substantially equivalent to the EP-TRACER System from Schwarzer Cardiotek (K183266).
§ 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).