(90 days)
Not Found
No
The summary describes a standard electrophysiology measurement system with hardware and software for signal acquisition and display, without mentioning any AI or ML capabilities.
No
The EP-Tracer System is stated to be a diagnostic tool used to acquire, filter, digitize, amplify, display, and record signals during electrophysiological studies and for diagnostic cardiac stimulation. It is not described as providing treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is used to "acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies" and "incorporates a stimulator intended to be used for diagnostic cardiac stimulation". These functions are characteristic of a diagnostic device.
No
The device description explicitly states that the EP-Tracer system is comprised of both hardware (Amplifier/stimulator) and software components.
Based on the provided information, the EP-Tracer System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the system is used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. This involves measuring electrical activity directly from the heart within the patient's body (in vivo).
- Device Description: The description confirms it's a computerized electrophysiology measurement system with hardware (amplifier/stimulator) and software. This aligns with a system used for in-vivo physiological measurements.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological or pathological state. The EP-Tracer System does not process such specimens.
Therefore, the EP-Tracer System falls under the category of a physiological measurement system used for in-vivo diagnostic procedures, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for 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".
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
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,
- EP-Tracer hardware - Amplifier/stimulator
- EP-Tracer Software - Software pre-installed
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
January 20, 2014
ﻨ
EP-Tracer 510(k) Summary per 21CFR §807.92
| Submitter's
information | Contact: Leon Dohmen
CardioTek, B.V.
Amerikalaan 70
6199 AE Maastricht-Airport
The Netherlands | Contact: Melissa Walker
Graematter, Inc.
1324 Clarkson Clayton Ctr
#332Ballwin, MO 63011
Phone: 636-405-7498
Date: 12/27/2013 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Device/
classification
name | 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 | |
| Device
description | 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 | |
| Indications for
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". | |
・
1
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 (with | ||
integrated stimulator) WxDxH | 32 channels: 29x22x11 in cm | |
64 channels: 29x22x22 in cm | 38 channels: 28x27x7 in cm | |
70/102 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 | 100 dB | Same |
Input Impedance | Typical 20 MΩ | Same |
Leakage Current. | ||
Patient Source | 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.
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