EP-TRACER System

K183266 · Schwarzer Cardiotek GmbH · DQK · Mar 1, 2019 · Cardiovascular

Device Facts

• Record ID: K183266
• Device Name: EP-TRACER System
• Applicant: Schwarzer Cardiotek GmbH
• Product Code: DQK · Cardiovascular
• Decision Date: Mar 1, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

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 Story

EP-TRACER System is a computerized electrophysiology measurement system; used in clinical settings for electrophysiological studies. Inputs include intracardiac, auxiliary, and ECG signals. Device hardware (amplifier/stimulator) acquires, filters, digitizes, and amplifies these signals. Integrated stimulator provides diagnostic cardiac stimulation via isolated channels. System displays and records signals; allows user-controlled pacing protocols (e.g., induction, termination, backup, acute). Clinicians use the system to monitor cardiac electrical activity and perform diagnostic stimulation. Output aids clinical decision-making during cardiac procedures. Software V2.2 adds user interface convenience features (minimized pressure mode, vertical/horizontal calipers, customizable report generation, procedure clock, and icon-based controls).

Clinical Evidence

Bench testing only. Verification and validation activities confirmed the device meets design and performance specifications. Conformance to harmonized standards demonstrated, including EN 60601-1, EN 60601-1-2, EN 62304, and EN 14971.

Technological Characteristics

Programmable diagnostic computer; 38/70/102 channel configurations. Amplifier/stimulator hardware; 1 kHz sampling rate; >100 dB CMRR; 20 MΩ input impedance. Isolated stimulus channels (2); 0-25.5 mA current range; 0.1-9.9 ms pulse duration. Connectivity: Windows 7 (32/64-bit). Compliant with IEC 60601-1 (Type CF), EN 60601-1-2, and EN 62304. Sterilization not applicable (non-invasive).

Indications for Use

Indicated for use in electrophysiological studies and related procedures for the acquisition, filtering, digitization, amplification, display, and recording of cardiac signals, and for diagnostic cardiac stimulation.

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

• EP-TRACER System (K161245)

Submission Summary (Full Text)

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#### March 1, 2019

Schwarzer CardioTek GmbH % Melissa Walker President and Chief Technology Officer Graematter, Inc. 1324 Clarkson Clayton Ctr., #332 Ballwin, Missouri 63011

Re: K183266

Trade/Device Name: EP-TRACER System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: February 4, 2019 Received: February 4, 2019

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. 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.

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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mude 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) K183266

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)

| <div> <span>☑</span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> |
|---------------------------------------------------------------------------------------|
| <div> <span>☐</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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## EP TRACER Summary

| Submitter's<br>information | Contact: Tatjana Nuber<br>Schwarzer CardioTek GmbH<br>Im Zukunftspark 3<br>74076 Heilbronn / Germany | Contact: Melissa Walker<br>Graematter, Inc.<br>1324 Clarkson Clayton Ctr #332<br>Ballwin, MO 63011<br>Phone: [phone]<br>Date: 28 Feb 2019 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Device/<br>classification<br>name | Device Name:<br>The EP-TRACER is a Class 2 device (product code DQK). | |
| | Classification/Common name:<br>• Programmable diagnostic computer, 21 CFR §870.1425. | |
| | The marketed device(s) to which substantial equivalence is claimed:<br>• EP-TRACER System, K161245. | |
| Device<br>description | The EP-TRACER system is a computerized electrophysiology measurement<br>system designed for both regular and experimental EP studies.<br><br>The EP-TRACER is comprised of these major components:<br>EP-TRACER hardware – Amplifier/stimulator EP-TRACER Software – Software pre-installed | |
| Indications for<br>use | "The EP-TRACER System is an electrophysiology measurement system used to<br>acquire, filter, digitize, amplify, display, and record signals obtained during<br>electrophysiological studies and related procedures.<br><br>"The system allows the user to monitor, display and record the signals. The<br>system incorporates a stimulator intended to be used for diagnostic cardiac<br>stimulation during electrophysiological testing of the heart". | |
| | | Continued on next page |

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# 510(k) Summary per 21CFR §807.92, Continued

Technological The table below lists the technological characteristics for both the new and characteristics predicate devices. Modifications to the EP TRACER for V2.2 are limited to user interface modifications.

| Device Characteristic | Predicate Device EP-TRACER V2.0 | New Device EP-TRACER V2.2 |
|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Amplifier Dimensions (with<br>integrated stimulator) WxDxH | 38 channels: 28x27x7 in cm<br>70/102 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,<br>50 - 60 Hz | Same |
| | | |
| | | |
| Power Input | 38 channels:<br>+5 V, 0.3 A & +12 V, 0.9 A | Same |
| | 70 channels:<br>+5 V, 0.3 A & +12 V, 1.5 A | |
| | 102 channels:<br>+5 V, 0.3 A & +12 V, 2 A | |
| | | |
| Design | | |
| Sampling and Hold | Each channel sampled prior the<br>acquisition | Same |
| | | |
| Sampling Rate | 1 kHz | Same |
| CMRR | > 100 dB | Same |
| Input Impedance | Typical 20 ΜΩ | Same |
| Leakage Current | | |
| Patient Source | < 10 μΑ | Same |
| Patient Sink | < 10 μΑ | Same |
| Patient Sink (measured at patient<br>leads under single fault<br>conditions) | < 50 μΑ | Same |
| | | |
| Chassis Leakage | < 100 μΑ | 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 -<br>continuous | Same |
| Saturation Recovery | < 1 sec (manual reset) | Same |
| Notch Filter | Power line (50/60 Hz) | Same |
| Device Characteristic | Predicate Device EP-TRACER V2.0 | New Device EP-TRACER V2.2 |
| Dynamic Range | ±5 mV | Same |
| Baseline Correction | ±300 mV | Same |
| Input/ Output | | |
| Inputs 32/38 channels | 20 intracardiac channels, 6 auxiliary<br>channels, 12 ECG channels | Same |
| Inputs 64/70 channels | 52 intracardiac channels, 6 auxiliary<br>channels, 12 ECG channels | Same |
| Inputs 102 channels | 84 intracardiac channels, 6 auxiliary<br>(pressure) channels, 12 ECG channels | Same |
| Outputs | No outputs | Same |
| Switching | Each channel can be either bipolar or<br>unipolar 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 -<br>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:<br>BASIC 1 (induction)<br>BASIC 2 (termination)<br>BASIC 3 (backup)<br>ACUTE<br>Multi-Sx | Same |
| Device Characteristic | Predicate Device EP-TRACER V2.0 | New Device EP-TRACER V2.2 |
| Programmed Protocols | Pace<br>Automatic mode<br>Wenkebach mode<br>User defined protocols | Same |
| Programmable Protocol Key | 10 | Same |
| Number of Extra-Stimuli | 5 (S2 - S6) | Same |
| Sensing (ECG Synchronization) | | |
| Automatic or Manual Trigger<br>Setting - Sensitivity | Internal from any surface or intra-<br>cardiac channel | Same |
| Automatic or Manual Trigger<br>Setting - Trigger lockup<br>(refractory time) | 5 - 5000 ms | Same |
| Automatic or Manual Trigger<br>Setting - ECG Delay | 5 - 5000 ms | Same |
| Additional Outputs | No | Same |
| Power Source | Integrated with amplifier<br>38 channels:<br>+5 V, 0.3 A & +12 V, 0.9 A<br>70 channels:<br>+5 V, 0.3 A & +12 V, 1.5 A<br>102 channels:<br>+5 V, 0.3 A & +12 V, 2 A | Same |
| Pacing Channels | | |
| Isolated Channels | (i) atrial and<br>(ii) ventricular and<br>(iii) emergency fixed pace output to<br>atrium and ventricle | Same |
| Circuit Isolation | Compliant with IEC 60601-1, Type CF,<br>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<br>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 per<br>million 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 |
| Device Characteristic | Predicate Device EP-TRACER V2.0 | New Device EP-TRACER V2.2 |
| Backup Manually Controlled<br>Stimulation | Use external backup stimulator | Same |
| Emergency Backup Pacing | Use external backup stimulator | Same |
| Compliance with Standards | | |
| Standards | EN 60601-1<br>EN 60601-1-2 | Same |
| Device Directive | European Union Medical Device<br>Directive (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<br>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 | K161245 | Current submission |
| System Dimensions | | |
| W x D x H | Customer Option<br>Mobile Cart: 100x80x170 cm<br>Mobile Desk: 125x80x150 cm<br>Control Desk: customer defined<br>Laptop: customer defined | Same |

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Continued on next page

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## 510(k) Summary per 21CFR §807.92, Continued

Software – user The EP TRACER V2.2 included software modifications affecting the user interface interface including improvements in the display and organization of the convenience system's outputs. There were no modifications to the hardware of the new features added device.

> The table below shows the software differences between the EP-TRACER V2.2 vs. the predicate device EP-TRACER V2.0.

| Device Characteristic | Predicate Device<br>EP-TRACER V2.0 | New Device<br>EP-TRACER V2.2 |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User Interface Convenience Features | | |
| Pressure mode display | Pressure data is displayed in a<br>full-screen window which is<br>separate from the main trace<br>display window. | In addition to the full-screen<br>pressure mode available in V2.0,<br>pressure channels can be<br>displayed in a “minimized”<br>pressure mode display within<br>the main trace display window. |
| Calipers | Horizontal calipers can be<br>displayed | Both horizontal and vertical<br>calipers can be displayed |
| One-click report generation | Enables transfer of procedural<br>data in a limited format | Enables transfer of procedural<br>data to a customizable,<br>preconfigured template. |
| Clock | Real-time clock | Added a procedure clock,<br>displaying procedure time. |
| New Icons | | |
| Split-screens | Executed with keystrokes | Icon added for existing feature |
| Pressure mode | Only one pressure mode display | Toggles between full-screen and<br>minimized pressure mode<br>display |
| Stimulator power settings | Executed with keystrokes | Icon added for existing feature |
| Add comment | Executed with keystrokes | Icon added for existing feature |
| Add mark | Executed with keystrokes | Icon added for existing feature |
| Take screenshot | Executed with keystrokes | Icon added for existing feature |
| Toggle stimulator protocol/parameters windows | Executed with keystrokes | Icon added for existing feature |
| Software compatibility | | |
| Operating system | Windows 7 (32 bit) | Windows 7 (64 bit) and<br>Windows 7 (32 bit) |

Continued on next page

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## 510(k) Summary per 21CFR §807.92, Continued

| Performance<br>testing | Completion of all verification and validation activities demonstrated that the<br>subject devices meet their predetermined design and performance<br>specifications. Verification activities performed confirmed that the<br>modifications to the predicate device did not adversely affect the safety and<br>effectiveness of the modified device. |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Testing for the EP-Tracer V 2.2 shows conformance to the following<br>harmonized standards:<br>• EN ISO 13485:2012<br>• EN ISO 14971:2012<br>• EN 60601-1:2006+A1: 2013<br>• EN 60601-1-2:2007+ AC: 2010<br>• EN 60601-1-6:2010<br>• EN 60601-2-27:2006<br>• EN 60601-2-34:2011<br>• EN 10993-1:2009<br>• EN 980:2008<br>• EN 1041:2008<br>• EN 62366: 2008<br>• EN 62304: 2006 |
| Conclusion | Both the subject and predicate devices have the same intended use,<br>indications for use, and operate using the same fundamental scientific<br>technology. |

Based on the technical characteristics and the results of the performance testing, the EP TRACER V2.2 is substantially equivalent to V2.0.