(90 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 is comprised of these major components, 1. EP-Tracer hardware - Amplifier/stimulator 2. EP-Tracer Software - Software pre-installed
The provided text focuses on the 510(k) summary for the EP-Tracer system, primarily comparing its technological characteristics to a predicate device (Mennen Medical EMS-XL Cardiac Electrophysiology System) to demonstrate substantial equivalence.
From the provided text, there is no detailed experimental study proving the device meets specific performance acceptance criteria beyond demonstrating substantial equivalence to a predicate device. The document outlines the technological characteristics of the new device and the predicate device, indicating that the EP-Tracer system aligns with the predicate's specifications or improves upon them.
Therefore, many of the requested items (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and training set ground truth establishment) are not explicitly described for this specific 510(k) submission. This is common for 510(k) clearances that rely heavily on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical performance data from scratch.
However, I can extract the available information about the device's technical specifications, which are implicitly its acceptance criteria based on its predicate.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the EP-Tracer system are inferred from its technological characteristics being "Same" or improved compared to the predicate device, Mennen Medical EMS-XL. No specific quantitative "acceptance criteria" are explicitly stated with corresponding "reported performance" against those criteria in a tabular format as if it were a direct test. Instead, the comparison demonstrates equivalency.
Below is a table summarizing the technological characteristics that were compared between the EP-Tracer and its predicate, acting as the de facto "acceptance criteria" for substantial equivalence. The "Reported Device Performance" for the EP-Tracer is simply its measured characteristic as stated in the document.
| Device Characteristic | Acceptance Criteria (Predicate: Mennen EMS-XL) | Reported Device Performance (EP-Tracer™) |
|---|---|---|
| Environmental Specifications | ||
| Temperature Operating | 0°C to +35°C | +10°C to +30°C |
| Temperature Transport/Storage | -15°C to +50°C | -29°C to -66°C |
| Humidity Operating | < 95 % rH at -35°C (non-condensing) | 20 - 80 % rH (non-condensing) |
| Humidity Transport/Storage | < 95 % rH at -35°C (non-condensing) | < 95 % rH (non-condensing) |
| Power Specifications | ||
| Power Requirements | 100 - 240 V AC, 50 - 60 Hz | Same |
| Power Input | -5 V, 0.0 - 0.2 A; +12 V, 0.0 - 0.3 A; -12V, 0.0 - 0.3 A | (38 ch) ±5 V, 0.3 A & +12 V, 0.9 A; (70 ch) +5 V, 0.3 A & -12 V, 1.5 A; (102 ch) +5 V, 0.3 A & -12 V, 2 A |
| Design | ||
| Sampling and Hold | Each channel sampled prior acquisition | Same |
| Sampling Rate | 1 kHz | Same |
| CMRR | > 100 dB | Same |
| Input Impedance | Typical 20 MΩ | Same |
| Leakage Current Patient Source | < 10 µA | Same |
| Leakage Current Patient Sink | < 10 µA | Same |
| Leakage Current Patient Sink (single fault) | < 50 µA | Same |
| Chassis Leakage Current | < 100 µA | Same |
| ECG Input | ||
| Outputs | 12 lead ECG produced | Same |
| High Pass Filter | 0.05 Hz, 0.2 Hz, 40 Hz, 80 Hz | 0.05 Hz, 0.2 Hz (for ECG); Same (for other inputs) |
| Low Pass Filter | 100 Hz (ECG) / 500 Hz (Inputs) | 150 Hz (ECG) / 350 Hz (Inputs) |
| RF Filtering | All inputs | Same |
| Gain | Between 0 and 255 mm/mV - continuous | Same |
| Saturation Recovery | < 1 sec | < 1 sec (manual reset) |
| Notch Filter | Power line (50/60 Hz) | Same |
| Dynamic Range | ±5 mV | Same |
| Baseline Correction | ±300 mV | Same |
| Input/Output (Channels) | ||
| 32/38 channels | 18 intracardiac, 2 pressure, 12 ECG | 20 intracardiac, 6 auxiliary, 12 ECG |
| 64/70 channels | 50 intracardiac, 2 pressure, 12 ECG | 52 intracardiac, 6 auxiliary, 12 ECG |
| 102 channels | N/A | 84 intracardiac, 6 auxiliary (pressure), 12 ECG |
| Outputs | No outputs | Same |
| Switching | Bipolar or unipolar with manual switching | Same |
| Stimulator | ||
| Isolated Stimulus Channels | 2 | Same |
| Pulse Amplitude Range | 0.1 - 25 mA into 1500 Ω load | 0 - 25.5 mA into 1000 Ω load |
| Increment (Pulse Amplitude) | 0.1 ms | Same |
| Accuracy (Pulse Amplitude) | ±0.15 ms | Same |
| Pulse Duration Range | 0.1 - 9.9 ms | Same |
| Increment (Pulse Duration) | 0.1 ms | Same |
| Accuracy (Pulse Duration) | ±0.15 ms | Same |
| Inter-Stimulus Interval (ISI) Range | 180 ms to 9990 ms +1ms or ±0.1% (whichever is larger) | 10 - 9999 ms |
| ISI Range (Burst) | 30 ms to 9900 ms ±1ms or ±0.1% (whichever is larger) | 10 - 9999 ms |
| Increment (ISI) | 10 ms | Same |
| Sequential Delay (AV) Range | 11 - 250 ms | Same |
| Increment (Sequential Delay) | 1 ms | Same |
| Programmed Protocols | Threshold, SNRT, Vent./Atrial Burst/Overdrive, Multi-Sx, Pace, User defined | BASIC 1/2/3, ACUTE, Multi-Sx, Pace, Automatic mode, Wenkebach mode, User defined protocols |
| Prog. Protocol Key | 5 | 10 |
| Number of Extra-Stimuli | 4 (S2 - S5) | 5 (S2 - S6) |
| Trigger Lockup (Refractory Time) | 5 - 5000 ms | Same |
| ECG Delay | 5 - 5000 ms | Same |
| Pacing Channels Isolated | (i) atrial, (ii) ventricular, (iii) emergency fixed pace output to ventricle | (i) atrial, (ii) ventricular, (iii) emergency fixed pace output to atrium and ventricle |
| Circuit Isolation | IEC 60601-1, Class CF, 5 kV | Same |
| Current Output (Computer Controlled) | 0.1 - 25.5 mA into 1500 Ω load 40 V | 0 - 25.5 mA into 1000 Ω load |
| Current Steps | 0.1 mA | Same |
| Accuracy (Current) | ±0.1 mA | Same |
| Accuracy (Pulse Duration) | ±0.1 mA (likely error, should be time unit) | Same |
| Load Impedance | 1500 Ω | 1000 Ω |
| Max. Output Voltage | 40 V | 25 V |
| Si Range | 180 - 9990 ms (pace); 30 - 9990 ms (Burst pace) | 10 - 9999 ms |
| Stability | Quartz clock, ±30 ppm at --25°C | Same |
| Coupling Interval Accuracy | ±10 ms | Same |
| Auto decrement/increment | Yes | Same |
| Backup Stimulation/Pacing | Use external backup stimulator | Same |
| Compliance with Standards | ||
| Standards | CL 2601-1, IEC 60601-1-2 | EN 60601-1, EN 60601-1-2 (and others listed in Section 5, implying compliance as "performance data") |
| Device Directive | EU Medical Device Directive (CE Marked) | Same |
| MDD Device Class | Class IIb | Same |
| IEC 60601-1 | Certified | Same |
| EMC Compliance | Certified | Same |
| CE Marking | Certified CE 0473 | Certified CE 0459 |
| US Regulations | 510(k) cleared | Current submission |
Regarding the specific study details:
- Sample size used for the test set and the data provenance: Not provided. The submission relies on technological comparison to a predicate device. Performance data is stated as "Based upon the documentation presented in this 510(k) it has been demonstrated that the EP-Tracer System is safe and effective for its intended use." This implies that the demonstration of compliance with harmonized standards and comparison to the predicate serve as the "study" for safety and effectiveness, rather than a clinical trial with a specific test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. The ground truth for this type of submission is typically based on established engineering standards and the performance of the predicate device.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
- 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. This device is an electrophysiology measurement system and stimulator, not an AI-based diagnostic image interpretation tool. No "human readers" or "AI assistance" are mentioned in the context of improving interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an AI algorithm. The device itself is a "standalone" system in that it measures and stimulates, but its "performance" is about accurate signal acquisition and stimulation, not algorithm output.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" implicitly relies on established engineering principles, international harmonized standards (e.g., IEC 60601 series, EN ISO 14971), and the performance characteristics of the legally marketed predicate device.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the 510(k) submission for the EP-Tracer system uses substantial equivalence to a predicate device as its primary method for demonstrating safety and effectiveness. The "study" for this submission consists of a detailed comparison of technological characteristics to show that the new device is as safe and effective as the predicate, along with compliance with relevant international and national harmonized standards.
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January 20, 2014
ﻨ
EP-Tracer 510(k) Summary per 21CFR §807.92
| Submitter'sinformation | Contact: Leon DohmenCardioTek, B.V.Amerikalaan 706199 AE Maastricht-AirportThe Netherlands | Contact: Melissa WalkerGraematter, Inc.1324 Clarkson Clayton Ctr#332Ballwin, MO 63011Phone: 636-405-7498Date: 12/27/2013 |
|---|---|---|
| Device/classificationname | Device Name:The EP-Tracer 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:• Mennen Medical EMS-XL Cardiac Electrophysiology System, K071348 | |
| Devicedescription | The EP-Tracer system is a computerized electrophysiology measurementsystem designed for both regular and experimental EP studies. | |
| The EP-Tracer 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 used toacquire, filter, digitize, amplify, display, and record signals obtained duringelectrophysiological 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". |
・
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Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
The table below lists the technological characteristics for both the new and Technological characteristics predicate devices
| Device Characteristic | Predicate Device Mennen EMS-XL | New Device EP-Tracer™ |
|---|---|---|
| Amplifier Dimensions (withintegrated stimulator) WxDxH | 32 channels: 29x22x11 in cm64 channels: 29x22x22 in cm | 38 channels: 28x27x7 in cm70/102 channels: 28x27x12 in cm |
| Environmental Specifications | ||
| Temperature Operating | 0°C to +35°C | +10°C to +30°C |
| Temperature Transport/Storage | -15°C to +50°C | -29°C to -66°C |
| Humidity Operating | < 95 % rH at -35°C (non-condensing) | 20 - 80 % rH (non-condensing) |
| Humidity Transport/Storage | < 95 % rH at -35°C (non-condensing) | < 95 % rH (non-condensing) |
| Power Specifications | ||
| Power Requirements | 100 - 240 V AC, 50 - 60 Hz | Same |
| Power Input | -5 V, 0.0 - 0.2 A+12 V, 0.0 - 0.3 A-12V, 0.0 - 0.3 A | 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 |
| Design | ||
| Sampling and Hold | Each channel sampled prior acquisition | 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, 40 Hz, 80 Hz | 0.05 Hz, 0.2 Hz |
| Low Pass Filter | 100 Hz | 150 Hz |
| RF Filtering | All inputs | Same |
| Gain | Between 0 and 255 mm/mV -continuous | Same |
| Saturation Recovery | < 1 sec | < 1 sec (manual reset) |
| Notch Filter | Power line (50/60 Hz) | Same |
| Dynamic Range | ±5 mV | Same |
| Baseline Correction | ±300 mV | Same |
{2}------------------------------------------------
EP-Tracer 510(k) Summary per 21CFR §807.92, Continued
Technological characteristics (continued)
| Device Characteristic | Predicate Device Mennen EMS-XL | New Device F.P-TracerTM |
|---|---|---|
| Input/ Output | ||
| Inputs 32/38 channels | 18 intracardiac channels, 2 pressurechannels, 12 ECG channels | 20 intracardiac channels, 6auxiliary channels. 12 ECGchannels |
| Inputs 64/70 channels | 50 intracardiac channels, 2 pressurechannels, 12 ECG channels | 52 intracardiac channels, 6auxiliary channels, 12 ECGchannels |
| Inputs 102 channels | N/A | 84 intracardiac channels, 6auxiliary (pressure) channels, 12ECG channels |
| 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 | 500 Hz | 350 Hz |
| RF Filtering | All inputs | Same |
| Gain | Between 0 and 255 mm/mV –continuous | Same |
| Saturation Recovery | < 1 s | < 1 s (manual reset) |
| 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 | 0.1 - 25 mA into 1500 Ω load | 0 - 25.5 mA into 1000 Ω load |
| 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 | 180 ms to 9990 ms +1 ms or ±0.1 %(whichever is larger) | 10 - 9999 ms |
| Range (Burst) | 30 ms to 9900 ms ±1 ms or ±0.1 %(whichever is larger) | 10 - 9999 ms |
| Increment | 10 ms | Same |
{3}------------------------------------------------
EP-Tracer 510(k) Summary per 21CFR §807.92, Continued
Technological characteristics (continued)
| Device Characteristic . | Predicate Device Mennen EMS-XL | New Device EP-Tracer™ |
|---|---|---|
| Sequential Delay (AV) | ||
| Range | 11 - 250 ms | Same |
| Increment | 1 ms | Same |
| Programmed Protocols | Threshold panel keySNRT panel keyVent. Burst keyAtrial burst keyVent. Overdrive keyAtrial overdrive keyMulti-Sx | Preprogrammed protocols:BASIC 1 (induction)BASIC 2 (termination)BASIC 3 (backup)ACUTEMulti-Sx |
| Programmed Protocols | PaceUser defined protocolUser defined protocol | PaceAutomatic modeWenkebach modeUser defined protocols |
| Programmable Protocol Key | 5 | 10 |
| Number of Extra-Stimuli | 4 (S2 - S5) | 5 (S2 - S6) |
| 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 amplifier-5 V, 0.0 - 0.2 A+12 V, 0.0 - 0.3 A-12 V. 0.0 - 0.3 A | 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 |
| Pacing Channels | ||
| Isolated Channels | (i) atrial and(ii) ventricular and(iii) emergency fixed pace output toventricle | (i) atrial and(ii) ventricular and(iii) emergency fixed pace outputto atrium and ventricle |
| Circuit Isolation | Compliant with IEC 60601-1, ClassCF, 5 kV, common & differential mode | Same |
{4}------------------------------------------------
EP-Tracer 510(k) Summary per 21CFR §807.92, Continued
Technological characteristics (continued)
| Device Characteristic | Predicate Device Mennen EMS-XL | New Device EP-Tracer™ | |
|---|---|---|---|
| Computer Controlled Stimulus Pulses | |||
| Current | 0.1 - 25.5 mA into 1500 (2 load 40 V | 0 - 25.5 mA into 1000 £2 load | |
| Current Steps | 0.1 mA | Same | |
| Accuracy | 10.1 mA | Same | |
| Pulse duration | Pulse width 0.1 - 9.9 ms, steps of 0.1חוק | Same | |
| Accuracy | =0.1 mA | Same | |
| Load Impedance | 1500 ಬ | 1000 ರ | |
| Max. Output Voltage | 40 V | 25 V | |
| Inter-Stimulus Intervals | |||
| Si Range | 180 - 9990 ms (pace)30 - 9990 ms (Burst pace) | 10 - 9999 ms | |
| Stability | Quartz computer clock, = 30 parts permillion at -- 25°C | Same | |
| Extra-Stimuli | 4 (S2 - S5), independent | 5 (S2 - S6) | |
| Coupling Interval | 30 - 999() ms | Same | |
| Accuracy | ±10 ms | Same | |
| Protocol Automation | |||
| Auto decrement/increment | Yes | Same | |
| Backup Manually ControlledStimulation | Use external backup stimulator | Same | |
| Emergency Backup Pacing | Use external backup stimulator | Same | |
| Compliance with Standards | |||
| Standards | CL 2601-1IEC 60601-1-2 | EN 60601-1EN 60601-1-2 | |
| Device Directive | European Union Medical DeviceDirective (CE Marked) | Same | |
| Environmental/ Electrical Specifications | |||
| Operating Temperature | 0°C to +35°C | +10°C to +30°C | |
| Storage Temperature | -200C to +65℃ | -29°C to +66°C | |
| Operating Humidity | 30 - 75 % rH (non-condensing) | 20 - 80 % rH (non-condensing) | |
| Storage Humidity | 5 - 95 % rH (non-condensing) | < 95 % rH (non-condensing) | |
| Max. Current Draw | 15 A/115 V. 7 A/230 V | Same | |
| Chassis Leakage Current | < 100 μ.Α | Same |
{5}------------------------------------------------
EP-Tracer 510(k) Summary per 21CFR §807.92, Continued
Technological characteristics (continued)
| Device Characteristic | Predicate Device Mennen EMS-XL | New Device EP-Tracer™ |
|---|---|---|
| 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 0473 | Certified CE 0459 |
| US Regulations | 510(k) cleared | Current submission |
| System Dimensions | ||
| WxDxH | Cart with display: 61x61x162 cmConsole with display: 90x85x125 cm | Customer OptionMobile Cart: 100x80x170 cmMobile Desk: 125x80x150 cmControl Desk: customer defined |
Performance data
Based upon the documentation presented in this 510(k) it has been demonstrated that the EP-Tracer System is safe and effective for its intended use.
The following lists the harmonized standards currently applicable to the EP-Tracer product:
- · EN ISO 14971: 2012
- · EN 980 : 2008
- · EN 1041: 2008
- · EN 60601-1 : 1998 + A1 : 1991 + A2 : 1995
- · EN 60601-1-1 : 2000
- · EN 60601-1-2 : 2001 + A1 : 2006
- · EN 60601-1-4: 1996 + AI : 1999
- · IEC 60601-1-6: 2004
- · EN 60601-2-34 : 2000
- IEC 62304 : 2006
- IEC 62366 : 2008
- · ISO 13485: 2003 + CI : 2009
- · EN 60601-2-27
{6}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Image /page/6/Picture/3 description: The image shows a partial view of a circular emblem or logo. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle. To the right of the text is a stylized symbol consisting of three curved shapes, possibly representing a person or abstract form.
March 31, 2014
.. .
Cardiotek, B.V. c/o Melissa Walker Graematter, Inc. 1324 Clarkson Clayton Center #332 Ballwin, MO 63011
K134044 Re:
Trade/Device Name: EP-Tracer system 38, EP-Tracer system 70, EP-Tracer system 102 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: January 20, 2014 Received: January 22, 2014
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
{7}------------------------------------------------
Page 2 - Melissa Walker
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 the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
for
Sincerely yours,
LindaJ.RICCI-S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{8}------------------------------------------------
Traditional Premarket Notification CardioTek B.V.
. .
K134044 1/1 12/27/2013
Appendix 2: Indications for Use Statement
Statement
The Indications for Use Statement:
510(k) Number: K______________________________________________________________________________________________________________________________________________________________
Device Name: EP-Tracer System
"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".
AND/OR x Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of of ___________________________________________________________________________________________________________________________________________________________________
Image /page/8/Picture/14 description: The image shows a logo with the text "Linda J. Ricca S". The text is stylized and appears to be part of a larger design. The logo has a geometric and somewhat abstract appearance, with the letters integrated into a pattern of lines and shapes.
The information berein is considered CONFIDENTIAL to CardioTek B.V. per the provisions and expectations of 21 CFR §20.61, 21 CFR §812.38, and 21 CFR §814.9.
Page 73
§ 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).