(228 days)
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.
The ECGenius™ System is an electrophysiology (EP) recording system used 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
The provided document is a 510(k) Summary for the CathVision ApS ECGenius™ System. Section 510(k) summaries disclose information to FDA about how a specific device is substantially equivalent to other devices already legally marketed in the U.S. This document outlines the device description, indications for use, comparison to a predicate device, and various performance testing conducted. However, it does not contain details about specific acceptance criteria or a study design that quantitatively evaluates the device's performance against pre-defined metrics.
The document states that the ECGenius™ System with ECGenius™ Software V3.0 introduces two new software modules: PVI Analyzer™ and Signal Complexity™.
- The PVI Analyzer™ is described as a "secondary measure of pulmonary vein isolation" and explicitly states it "should not replace traditional methods of confirming isolation."
- The Signal Complexity™ module "analyzes various properties of the signals" and "No clinical claims are made for Signal Complexity™."
Given this, the document asserts that these new modules "do not present different questions of safety or effectiveness because they are only intended to provide the physician with additional information that supplements common clinical practice and do not alter the Intended Use."
Therefore, based solely on the provided text, a detailed table of acceptance criteria and a study proving the device meets these criteria cannot be constructed as the necessary information is not present in this 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device and outlines general performance testing (e.g., software verification, cybersecurity, biocompatibility), but not a specific clinical performance study with acceptance criteria for the new features.
The document does not contain the following information typically found in a clinical performance study write-up:
- A table of acceptance criteria and reported device performance for the new features.
- Sample sizes used for a test set.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication methods.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
The document details the device's technological characteristics and compares them to those of its predicate and reference devices, focusing on demonstrating equivalence rather than proving clinical performance against specific quantitative metrics for the new features.
{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.
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.
{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 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
{2}------------------------------------------------
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) | ||
|---|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ 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.qov
"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 K223787
ECGenius™ System Summary
| Submitter'sinformation | CathVision ApS | Contact: Sharon Bishop |
|---|---|---|
| Titangade 11 | Graematter, Inc. | |
| 2200 Copenhagen N | 1324 Clarkson Clayton Ctr #332 | |
| Denmark | Ballwin, MO 63011 | |
| Phone: 919-724-8978 | ||
| Date: August 4, 2023 |
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 |
New device The new device's indications for use are listed in the table below.
| Device Name | Indications for Use |
|---|---|
| ECGenius™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.The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation. |
{4}------------------------------------------------
Predicate device
The predicate device for the ECGenius™ System is shown in the table below.
| K Number | ProductCode | Predicate DeviceName | Indications for Use |
|---|---|---|---|
| K220306 | DQK | ECGenius™ System | The ECGenius™ System is an electrophysiologymeasurement system used to acquire, filter, digitize,amplify, display, and record clinical data obtainedduring electrophysiological studies and relatedprocedures. The system is compatible with a 3rd-partystimulator, intended to be used for diagnostic cardiacstimulation during electrophysiological testing of theheart. |
Reference The reference devices for the ECGenius™ System are shown in the table devices below.
{5}------------------------------------------------
| K Number | ProductCode | Predicate DeviceName | Indications for Use |
|---|---|---|---|
| K180238 | DQK | Carto 3 | The intended use of the CARTO® 3 System is catheter-based cardiac electrophysiological (EP) procedures. TheCARTO 3 System provides information about theelectrical activity of the heart and about catheterlocation during the procedure. The system can be usedon patients who are eligible for a conventionalelectrophysiological procedure. The system has nospecial contraindications. |
| K101331 | DQK | Bard LabSystemPRO | The Bard LabSystem ER Laboratory is a computer andsoftware driven data acquisition and analysis tooldesigned to facilitate the gathering, display, analysis bya physician, pace mapping and storage of cardiacelectrophysiologic data. When integrated with thePhilips EP navigator system, the BARD® LabSystem™PRO EP Recording System is designed to acquire,analyze, and display 3D electro- anatomical maps of thehuman heart. The maps are constructed usingintracardiac electrograms with their respective cardiaclocations taken from live x-ray overlay on a patient's 3Dcardiac anatomy. Maps may be displayed as electricalactivation maps, voltage maps, dominant frequencymaps and location maps with user definedmeasurement values. |
{6}------------------------------------------------
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
{7}------------------------------------------------
Characteristics - The table below lists the characteristics for both the new and predicate devices. comparison with predicate device
| ATTRIBUTE | SUBJECT DEVICEECGenius™ System(with ECGenius™ Software V3.0) | PREDICATE DEVICEECGenius™ System(with ECGenius™ Software V2.0)K220306 | COMPARISON |
|---|---|---|---|
| Indications for use | The ECGenius™ System is anelectrophysiology measurementsystem and analysis tool used toacquire, filter, digitize, amplify,display, record, and analyze dataobtained during electrophysiologicalstudies and related procedures. Thesystem is compatible with a 3rd-party stimulator, intended to be usedfor diagnostic cardiac stimulationduring electrophysiological testing ofthe heart.The PVI Analyzer™ feature is asecondary measure of pulmonaryvein isolation and should not replacetraditional methods of confirmingisolation. | The ECGenius™ System is anelectrophysiology measurementsystem used to acquire, filter,digitize, amplify, display, and recordclinical data obtained duringelectrophysiological studies andrelated procedures.The system is compatible with 3rd-party stimulator, intended to be usedfor diagnostic cardiac stimulationduring electrophysiological testing ofthe heart. | Subject device includesadditional analysis tools, andthe term "analyze" is added tothe indications for use.The change does not impactintended use or safety andeffectiveness. |
| FDA Product code | DQK | DQK | Same |
| ATTRIBUTE | SUBJECT DEVICEECGenius™ System(with ECGenius™ Software V3.0) | PREDICATE DEVICEECGenius™ System(with ECGenius™ Software V2.0)K220306 | COMPARISON |
| Classification | Programmable diagnostic computer,21 CFR §870.1425 | Programmable diagnostic computer,21 CFR §870.1425 | Same |
| Population | AdultsPVI Analyzer™ is indicated for adultsin sinus rythmn undergoing their firstPVI treatment | Adults | Comparable - PVI Analyzer™(analysis tool) is indicated foradults in sinus rythmnundergoing their first PVItreatment. Does not impactsafety and effectiveness. |
| Recorder Software | ECGenius™ Software V3.0 | ECGenius™ Software V2.0 | The recorder software in thesubject device is an evolutionof the recorder software in thepredicate device. |
| CARDIALYTICS™software plug-ins | Signal Complexity™PVI Analyzer™ | None | The recorder software for thesubject device includes twonew software modules(analysis tools). Does notimpact safety andeffectiveness. |
| AmplifierDimensionsWxDxH (cm) | 43x43x31 | 43x43x31 | Same |
| TemperatureOperating | +10°C to +30°C | +10°C to +30°C | Same |
| TemperatureTransport/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 DEVICEECGenius™ System(with ECGenius™ Software V3.0) | PREDICATE DEVICEECGenius™ System(with ECGenius™ Software V2.0)K220306 | COMPARISON |
| HumidityTransport/Storage | 10 - 95 % rH (non-condensing) | 10 - 95 % rH (non-condensing) | Same |
| PowerRequirements | 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 orunipolar with manual switching | Each channel can be either bipolar orunipolar 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 DEVICEECGenius™ System(with ECGenius™ Software V3.0) | PREDICATE DEVICEECGenius™ System(with ECGenius™ Software V2.0)K220306 | COMPARISON |
| IECG Scale | Between 1.25 and 5120 mm/mV– discrete intervals | Between 1.125 and 5120 mm/mV– discrete intervals | Same |
| IECG SaturationRecovery | < 1 s (auto reset) | < 1 s (auto reset) | Same |
| IECG Power-lineFilter | Notch 50/60HzAdaptive NotchNone | Notch 50/60HzNone | Similar. Subject device has inadditional a (software based)Adaptive Notch filter. Doesnot impact safety andeffectiveness. |
| IECG Dynamic Range | ±100 mV | ±100 mV | Same |
| IECG BaselineCorrection | ±1000 mV | ±1000 mV | Same |
| 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 Hz1 Hz10 Hz | None0.01 Hz0.05 Hz0.1 Hz0.5 Hz1 Hz10 Hz | Same |
| ECG Low Pass Filter | 100 Hz150 Hz250 Hz500 HzNone | 100 Hz150 Hz250 Hz500 HzNone | Same |
| ECG RF Filtering | All inputs | All inputs | Same |
| ATTRIBUTE | SUBJECT DEVICEECGenius™ System(with ECGenius™ Software V3.0) | PREDICATE DEVICEECGenius™ System(with ECGenius™ Software V2.0)K220306 | COMPARISON |
| ECG Scale | Between 1.25 and 5120 mm/mV– discrete intervals | Between 1.25 and 5120 mm/mV– discrete intervals | Same |
| ECG SaturationRecovery | < 1 s (auto reset) | < 1 s (auto reset) | Same |
| ECG Power-lineFilter | Notch 50/60HzNone | Notch 50/60HzNone | Same |
| ECG Dynamic Range | ±10mV | ±10mV | Same |
| Baseline Correction | ±300mV | ±300mV | Same |
| Auxiliary InputsChannels | 4 pressure2 auxiliary (analog in) | 4 pressure2 auxiliary (analog in) | Same |
| Output channels | 12 lead ECG produced | 12 lead ECG produced | Same |
| Isolated StimulusChannels, Stimulator | 2 (external stimulator) | 2 (external stimulator) | Same |
| Backup | Connect catheters to stimulatorbypass connections | Connect catheters to stimulatorbypass connections | Same |
| Display AblationParameters | Connection to RF ablationgenerator(s) | Connection to RF ablationgenerator(s) | Same |
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
| ATTRIBUTE | SUBJECT DEVICEECGenius™ System(with ECGenius™ Software V3.0) | PREDICATE DEVICEECGenius™ System(with ECGenius™ Software V2.0)K220306 | COMPARISON |
|---|---|---|---|
| Standards | IEC 60601-1: 2005+A2:2020 (*) | IEC 60601-1: 2005+A1:2012 | Same. However, subjectdevice complies with newerversions (*) |
| IEC 60601-1-2: 2014+ A1:2020 (*) | IEC 60601-1-2: 2014 | ||
| IEC 60601-1-6:2010+A1:2014 | IEC 60601-1-6:2010+A1:2014 | ||
| IEC 60601-2-27: 2014 | IEC 60601-2-27: 2014 | ||
| IEC 60601-2-34: 2014 | IEC 60601-2-34: 2014 | ||
| IEC 62366-1: 2015 | IEC 62366-1: 2015 | ||
| IEC 62304: 2006+ A1:2015 | IEC 62304: 2006+ A1:2015 | ||
| Leakage CurrentPatient | < 10 μΑ | < 10 μΑ | Same |
| Leakage CurrentPatient (single faultconditions) | < 50 μΑ | < 50 μΑ | Same |
| Leakage CurrentTouch current | < 100 μΑ | < 100 μΑ | Same |
{13}------------------------------------------------
PVI Analyzer comparison with reference device
The table below lists the characteristics for the PVI Analyzer module and reference device.
| ReferenceDevices | PVI Analyzer | ReferenceDescription | Comparison |
|---|---|---|---|
| K180238 Carto 3 | PVI AnalyzerTManalyses the signalsfrom intracardiacmapping catheter toproduce a value thatis related through adecision threshold toa binaryclassification of theIsolation Status.The PVI AnalyzerTMfeature is asecondary measureof pulmonary veinisolation and shouldnot replacetraditional methodsof confirmingisolation. | Carto VISITAGModule calculates atag index value usingelectrophysiologicalparameters toindicate when highand low indexthresholds are metduring RF application. | Both devices use as inputmeasurements from intracardiaccatheters, combining thosemeasurements in a singlevalue/index and applies athreshold to output aclassification of themeasurements to the user.The user uses the value/indexand the classification assupplementaryinformation/secondary measureto support an ablation strategyduring a pulmonary vein isolationprocedure. |
{14}------------------------------------------------
The table below lists the characteristics for the Signal Complexity module Signal and reference devices. Complexity comparison with reference devices
| ReferenceDevices | Signal Complexity | Reference Description | Comparison |
|---|---|---|---|
| K180238 Carto 3 | The SignalComplexity™module generates afractionation index. | The Carto CFAE modulegenerates color-codedmaps displaying areasof CFAEs according tothe degree of signalfractionation. | Both devices are creating ameasurement of fractionation. |
| K101331 BardLabSystem PRO | Signal Complexity™module - analyseselectrical activationsand dominantfrequency from anintracardiaccatheter anddisplays them in acolormap. | Acquires, analyzes, anddisplays electricalactivation maps,voltage maps,dominant frequencymaps, and locationmaps with user definedmeasurement values. | Both devices makemeasurements of electricalactivations and dominantfrequency and displays them in acolormap.The Signal Complexity™ modulefurther calculates a dominantfrequency gradient measurementwhereas the reference devicedisplays measurements ofdominant frequencies ofdifferent locations in a map. |
| The SignalComplexity™module calculatescycle length. | Cycle lengthinformation associatedwith each location. | Both devices measure anddisplay cycle length. |
{15}------------------------------------------------
| Performancetesting | The following performance testing was conducted to demonstratesubstantial equivalence to the predicate device:Software verification and validation Cybersecurity testing Operating environment verification Biocompatibility Packaging Cleaning Human factors/usability Shelf life |
|---|---|
| Guidancedocumentsreferenced fortesting | The following guidance documents were referenced for testing:Cybersecurity in Medical Devices: Quality System Considerations andContent of Premarket Submissions Content of Premarket Submissions for Management of Cybersecurity inMedical Device (2014 and 2018) 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 Medical Devices Use of International Standard ISO 10993-1, "Biological evaluation ofmedical devices – Part 1: Evaluation and testing within a riskmanagement process" |
{16}------------------------------------------------
| Consensusstandards usedfor testing | The following consensus standards were referenced for testing.• IEC 60601-1:2005+A2:2020 Edition 3.2• IEC 60601-1-2:2014+A1:2020 Edition 4.1• 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 2018-8Note: As the ECGenius™ System is not intended as a patient monitorsystem, clauses relating to alarm systems do not apply. |
|---|---|
| Conclusion | A comparison has been conducted of the intended use/indications for use,technological characteristics (including fundamental operating principle,functional characteristics, design features and performance characteristics)and labelling for the ECGenius™ System with ECGenius™ Software V3.0 andthe ECGenius™ System with ECGenius™ Software V2.0. The technologicaldifferences between the subject and predicate devices are the PVIAnalyzer™ and Signal Complexity™ modules. These modules do not presentdifferent questions of safety or effectiveness because they are onlyintended to provide the physician with additional information thatsupplements common clinical practice and do not alter the Intended Use.Thus, the ECGenius™ System with ECGenius™ Software V3.0 is substantiallyequivalent to the ECGenius™ System with ECGenius™ Software V2.0predicate device (K220306). |
§ 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).