(94 days)
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.
The EP-TRACER System is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.
The EP-TRACER System is comprised of these major components,
- EP-TRACER hardware – Amplifier/stimulator
- EP-TRACER Software – Software pre-installed
The EP-TRACER System is an electrophysiology measurement system. The acceptance criteria and supporting study are described below.
Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Performance |
|---|---|---|
| Radiated emission, Conducted emission, Radiated immunity, Conducted immunity | Pass | Pass |
| Conducted emission (harmonics), Radiated immunity (PMF), Conducted immunity | Pass | Pass |
| IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 | Pass | Pass |
| Amendment - IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 | Pass | Pass |
| IEC 60601-1-6:2010 (Third Edition) + A1:2013 | Pass | Pass |
| IEC 62366:2007 (First Edition) + A1: 2014 for use in conjunction with IEC 60601-1-6: 2010 | Pass | Pass |
| IEC 60601-1-27:2011 (Third Edition) for use in conjunction with IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) | Pass | Pass |
| IEC 60601-2-34 (Third Edition): 2011 | Pass | Pass |
Study Information
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Sample size used for the test set and data provenance: Not explicitly stated. The document indicates that "Testing has been conducted through software and/or user verification/validation protocols" and electrical safety and electromagnetic compatibility testing was performed. The data provenance (e.g., country of origin, retrospective/prospective) is not provided.
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Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. The testing primarily focuses on the device's adherence to electrical safety and electromagnetic compatibility standards, and software functionality, rather than diagnostic performance against a medical ground truth established by experts.
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Adjudication method for the test set: Not applicable. The testing involves standardized engineering and software validation protocols with pass/fail criteria.
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Multi-reader multi-case (MRMC) comparative effectiveness study: No, a MRMC comparative effectiveness study was not done. The device is an electrophysiology measurement system, not an AI-assisted diagnostic tool.
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Standalone (algorithm only without human-in-the-loop performance) study: Yes, the performance testing described appears to be a standalone evaluation of the device's compliance with safety and performance standards. The "results" provided in the table indicate whether the device "Passed" tests against specific IEC standards for electrical safety and electromagnetic compatibility.
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Type of ground truth used: The ground truth for the performance testing is based on the requirements and standards set forth by the listed IEC and other electrical safety and EMC standards (e.g., IEC 60601-1, IEC 60601-1-2, etc.).
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Sample size for the training set: Not applicable. This device is an electrophysiology measurement system with software (V2.0) that "maintains the capabilities in the previous version, adding user interface enhancements." It's not described as a machine learning or AI-driven system that would typically require a training set in the sense of predictive modeling.
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How the ground truth for the training set was established: Not applicable, as there is no mention of a training set for machine learning.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2016
CardioTek, B.V. % Melissa Walker President & CTO Graematter, Inc. 1324 Clarkson Clayton Center #332 St Louis. Missouri 63011
Re: K161245
Trade/Device Name: EP-Tracer System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: June 13, 2016 Received: June 22, 2016
Dear Melissa Walker:
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. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Muda Jellman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161245
Device Name EP TRACER System
Indications for Use (Describe)
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
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5: 510(k) Summary per 21CFR §807.92
EP TRACER System Summary
| Submitter'sinformation | Contact: Oliver RothSchwarzer Cardiotek GmbHIm Zukunftspark 374076 Heilbronn / Germany | Contact: Melissa WalkerGraematter, Inc.1324 Clarkson Clayton Ctr #332Ballwin, MO 63011Phone: 636-405-7498Date: 02/14/2016 |
|---|---|---|
| Device/classificationname | Device Name:The EP-TRACER System is a Class 2 device (product code DQK).Classification/Common name:• Programmable diagnostic computer, 21 CFR §870.1425,The marketed device(s) to which substantial equivalence is claimed:• EP-TRACER System, K134044 | |
| Devicedescription | The EP-TRACER System is a computerized electrophysiology measurementsystem designed for both regular and experimental EP studies.The EP-TRACER System is comprised of these major components,1. EP-TRACER hardware – Amplifier/stimulator2. EP-TRACER Software – Software pre-installed | |
| Indications foruse | "The EP-TRACER System is an electrophysiology measurement system usedto acquire, filter, digitize, amplify, display, and record signals obtainedduring electrophysiological studies and related procedures."The system allows the user to monitor, display and record the signals. Thesystem incorporates a stimulator intended to be used for diagnostic cardiacstimulation during electrophysiological testing of the heart".Continued on next page |
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EP TRACER System Summary, Continued
Technological The table below lists the technological characteristics for both the new and characteristics predicate devices.
| Device Characteristic | Predicate Device EP-TRACER V1.05K134044 | New Device EP-TRACER V2K161245 |
|---|---|---|
| Amplifier Dimensions (withintegrated stimulator) WxDxH | 38 channels: 28x27x7 in cm70/102 channels: 28x27x12 in cm | Same |
| Environmental Specifications | ||
| Temperature Operating | +10°C to +30°C | Same |
| Temperature Transport/Storage | -29°C to +66°C | Same |
| Humidity Operating | 20 - 80 % rH (non-condensing) | Same |
| Humidity Transport/Storage | < 95 % rH (non-condensing) | Same |
| Power Specifications | ||
| Power Requirements | 100 - 240 V AC,50 - 60 Hz | Same |
| Power Input | 38 channels:+5 V, 0.3 A & +12 V, 0.9 A70 channels:+5 V, 0.3 A & +12 V, 1.5 A102 channels:+5 V, 0.3 A & +12 V, 2 A | Same |
| Design | ||
| Sampling and Hold | Each channel sampled prior theacquisition | Same |
| Sampling Rate | 1 kHz | Same |
| CMRR | > 100 dB | Same |
| Input Impedance | Typical 20 MΩ | Same |
| Leakage Current | ||
| Patient Source | < 10 μA | Same |
| Patient Sink | < 10 μA | Same |
| Patient Sink (measured at patientleads under single fault conditions) | < 50 μA | Same |
| Chassis Leakage | < 100 μA | Same |
| ECG Input | ||
| Outputs | 12 lead ECG produced | Same |
| High Pass Filter | 0.05 Hz, 0.2 Hz | Same |
| Low Pass Filter | 150 Hz | Same |
| RF Filtering | All inputs | Same |
| Gain | Between 0 and 255 mm/mV -continuous | Same |
| Saturation Recovery | < 1 sec (manual reset) | Same |
| Notch Filter | Power line (50/60 Hz) | Same |
| Dynamic Range | ±5 mV | Same |
| Baseline Correction | +300 mV | Same |
| Device Characteristic | Predicate Device EP-TRACER V1.05K134044 | New Device EP-TRACER V2K161245 |
| Input/ Output | ||
| Inputs 32/38 channels | 20 intracardiac channels, 6 auxiliarychannels, 12 ECG channels | Same |
| Inputs 64/70 channels | 52 intracardiac channels, 6 auxiliarychannels, 12 ECG channels | Same |
| Inputs 102 channels | 84 intracardiac channels, 6 auxiliary(pressure) channels, 12 ECG channels | Same |
| Outputs | No outputs | Same |
| Switching | Each channel can be either bipolar orunipolar with manual switching | Same |
| High Pass Filter | 0.05 Hz, 0.2 Hz, 40 Hz, 80 Hz | Same |
| Low Pass Filter | 350 Hz | Same |
| RF Filtering | All inputs | Same |
| Gain | Between 0 and 255 mm/mV –continuous | Same |
| Saturation Recovery | < 1 s (manual reset) | Same |
| Notch Filter | Power line (50/60 Hz) | Same |
| Dynamic Range | ±5 mV | Same |
| Baseline Correction | ±300 mV | Same |
| Stimulator (integrated into device) | ||
| Isolated Stimulus Channels | 2 | Same |
| Pulse Amplitude | ||
| Range | 0 - 25.5 mA into 1000 Ω load | Same |
| Increment | 0.1 ms | Same |
| Accuracy | ±0.15 ms | Same |
| Pulse Duration | ||
| Range | 0.1 - 9.9 ms | Same |
| Increment | 0.1 ms | Same |
| Accuracy | ±0.15 ms | Same |
| Inter-Stimulus Interval (ISI) | ||
| Range | 10 - 9999 ms | Same |
| Range (Burst) | 10 - 9999 ms | Same |
| Increment | 10 ms | Same |
| Sequential Delay (AV) | ||
| Range | 11 - 250 ms | Same |
| Increment | 1 ms | Same |
| Programmed Protocols | Preprogrammed protocols:BASIC 1 (induction)BASIC 2 (termination)BASIC 3 (backup)ACUTEMulti-Sx | Same |
| Programmed Protocols | PaceAutomatic modeWenkebach mode | Same |
| Device Characteristic | Predicate Device EP-TRACER V1.05K134044 | New Device EP-TRACER V2K161245 |
| Programmable Protocol Key | 10 | Same |
| Number of Extra-Stimuli | 5 (S2 - S6) | Same |
| Sensing (ECG Synchronization) | ||
| Automatic or Manual TriggerSetting - Sensitivity | Internal from any surface or intra-cardiac channel | Same |
| Automatic or Manual TriggerSetting - Trigger lockup(refractory time) | 5 - 5000 ms | Same |
| Automatic or Manual TriggerSetting - ECG Delay | 5 - 5000 ms | Same |
| Additional Outputs | No | Same |
| Power Source | Integrated with amplifier38 channels:+5 V, 0.3 A & +12 V, 0.9 A70 channels:+5 V, 0.3 A & +12 V, 1.5 A102 channels:+5 V, 0.3 A & +12 V, 2 A | Same |
| Pacing Channels | ||
| Isolated Channels | (i) atrial and(ii) ventricular and(iii) emergency fixed pace output to atrium and ventricle | Same |
| Circuit Isolation | Compliant with IEC 60601-1, Class CF,5 kV, common & differential mode | Same |
| Computer Controlled Stimulus Pulses | ||
| Current | 0 - 25.5 mA into 1000 Ω load | Same |
| Current Steps | 0.1 mA | Same |
| Accuracy | ±0.1 mA | Same |
| Pulse duration | Pulse width 0.1 - 9.9 ms, steps of 0.1 ms | Same |
| Accuracy | ±0.1 mA | Same |
| Load Impedance | 1000 Ω | Same |
| Max. Output Voltage | 25 V | Same |
| Inter-Stimulus Intervals | ||
| S1 Range | 10 - 9999 ms | Same |
| Stability | Quartz computer clock, ±30 parts permillion at +25°C | Same |
| Extra-Stimuli | 5 (S2 - S6) | Same |
| Coupling Interval | 30 - 9990 ms | Same |
| Accuracy | ±10 ms | Same |
| Protocol Automation | ||
| Auto decrement/increment | Yes | Same |
| Backup Manually ControlledStimulation | Use external backup stimulator | Same |
| Device Characteristic | Predicate Device EP-TRACER V1.05K134044 | New Device EP-TRACER V2K161245 |
| Compliance with Standards | ||
| Standards | EN 60601-1EN 60601-1-2 | Same |
| Device Directive | European Union Medical DeviceDirective (CE Marked) | Same |
| Environmental/ Electrical Specifications | ||
| Operating Temperature | +10°C to +30°C | Same |
| Storage Temperature | -29°C to +66°C | Same |
| Operating Humidity | 20 - 80 % rH (non-condensing) | Same |
| Storage Humidity | < 95 % rH (non-condensing) | Same |
| Max. Current Draw | 15 A/115 V, 7 A/230 V | Same |
| Chassis Leakage Current | < 100 μΑ | Same |
| Advanced Features | ||
| Display Ablation Parameters | Connection to RF ablation generator(s) | Same |
| Certification | ||
| MDD Device Class | Class IIb | Same |
| IEC 60601-1 | Certified | Same |
| EMC Compliance | Certified | Same |
| CE Marking | Certified CE 0197 | Same |
| US Regulations | K134044 | Current submission |
| System Dimensions | ||
| W x D x H | Customer OptionMobile Cart: 100x80x170 cmMobile Desk: 125x80x150 cmControl Desk: customer definedLaptop: customer defined | Same |
| Software | ||
| Programming language | Borland Delphi 5 | Visual C# |
| Component library | VCL Framework (Visual ComponentLibrary) | .NET |
| Software architecture | Single Threaded | Multi Threaded |
| Drawing method | 2D | 3D |
| License concept | Text file | Dongle |
| Context sensitive help texts | No | Mouse over context help |
| Operating concept | Menus and short-cuts | Menus, short-cuts and displayelements (i.e. buttons) |
| Language support | English (full), partial support for otherlanguages | Full multi language support |
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Continued on next page
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EP TRACER System Summary, Continued
Performance The updated version of the EP-TRACER system and software (V2.0) testing maintains the capabilities in the previous version, adding user interface enhancements.
Testing has been conducted through software and/or user verification/validation protocols to ensure the EP TRACER System meets its intended use and user needs.
Electrical safety and electromagnetic compatibility testing shown in the table below was performed. All tests passed.
| Test | Results |
|---|---|
| Radiated emission: Conducted emission: Radiated immunity:Conducted immunity | Pass |
| Conducted emission (harmonics); Radiated immunity (PMF);Conducted immunity | Pass |
| IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 +AM1:2012 | Pass |
| Amendment - IEC 60601-1:2005 (Third Edition) + CORR.1:2006 + CORR. 2:2007 + A1:2012 | Pass |
| IEC 60601-1-6:2010 (Third Edition) + A1:2013 | Pass |
| IEC 62366:2007 (First Edition) + A1: 2014 for use in conjunctionwith IEC 60601-1-6: 2010 | Pass |
| IEC 60601-1-27:2011 (Third Edition) for use in conjunction withIEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) | Pass |
| IEC 60601-2-34 (Third Edition): 2011 | Pass |
Based on the technical characteristics and the results of the performance Conclusion testing, the EP TRACER V2.0 is substantially equivalent to V1.05.
§ 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).