(94 days)
Not Found
No
The summary describes a standard electrophysiology measurement system with hardware and software for signal acquisition, display, and recording, and a stimulator. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies summary. The "Mentions AI, DNN, or ML" field explicitly states "Not Found".
No.
The system is used for acquiring, filtering, displaying, and recording signals during electrophysiological studies and related procedures, and includes a stimulator for diagnostic cardiac stimulation. These functions are diagnostic and monitoring, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system incorporates a stimulator "intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart."
No
The device description explicitly states that the system is comprised of both "EP-TRACER hardware – Amplifier/stimulator" and "EP-TRACER Software". This indicates the presence of physical hardware components in addition to the software.
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 directly interacting with the patient's body (measuring electrical signals from the heart) and performing diagnostic cardiac stimulation.
- Device Description: The description reinforces this by stating it's a computerized electrophysiology measurement system for EP studies.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. The EP-TRACER System does not process or analyze biological specimens in this manner.
- Anatomical Site: The indicated anatomical site is the Heart, which is consistent with a device used for in-vivo procedures.
Therefore, the EP-TRACER System is a medical device used for in-vivo diagnostic procedures related to cardiac electrophysiology, 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 System 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
Heart
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)
Performance 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 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 conjunction with IEC 60601-1-6: 2010 | Pass |
| IEC 60601-1-27:2011 (Third Edition) for use in conjunction with IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) | Pass |
| IEC 60601-2-34 (Third Edition): 2011 | Pass |
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines above them, possibly representing hair or movement.
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
1
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
2
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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3
Section 5: 510(k) Summary per 21CFR §807.92
EP TRACER System Summary
| Submitter's
information | Contact: Oliver Roth
Schwarzer Cardiotek GmbH
Im Zukunftspark 3
74076 Heilbronn / Germany | Contact: Melissa Walker
Graematter, Inc.
1324 Clarkson Clayton Ctr #332
Ballwin, MO 63011
Phone: 636-405-7498
Date: 02/14/2016 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Device/
classification
name | 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 | |
| Device
description | 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 | |
| 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".
Continued on next page | |
4
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 V1.05
K134044 | New Device EP-TRACER V2
K161245 |
|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Amplifier Dimensions (with
integrated stimulator) WxDxH | 38 channels: 28x27x7 in cm
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 | 100 dB | Same |
| Input Impedance | Typical 20 MΩ | Same |
| Leakage Current | | |
| Patient Source | 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 conjunction | |
| with IEC 60601-1-6: 2010 | Pass |
| IEC 60601-1-27:2011 (Third Edition) for use in conjunction with | |
| IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) | Pass |
| IEC 60601-2-34 (Third Edition): 2011 | Pass |