(98 days)
Not Found
No
The summary describes a standard electrophysiology measurement system and does not mention AI, ML, or related concepts.
Yes
The device incorporates a stimulator used for diagnostic cardiac stimulation during electrophysiological testing, which involves applying energy to the heart for diagnostic purposes, classifying it as a therapeutic device.
Yes
The "Intended Use / Indications for Use" section states: "The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart." This explicitly indicates a diagnostic purpose.
No
The device description explicitly states that the EP-TRACER system is comprised of both "EP-TRACER hardware – Amplifier/stimulator" and "EP-TRACER Software".
Based on the provided information, the EP-TRACER System is not an In Vitro Diagnostic (IVD) device.
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. It also incorporates a stimulator for diagnostic cardiac stimulation during testing. This describes a system used for in vivo (within a living organism) measurements and interventions, not in vitro (outside of a living organism, typically on biological samples).
- Device Description: The description reinforces that it's a computerized electrophysiology measurement system for EP studies, which are performed on patients.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (like blood, urine, tissue), reagents, or any other components typically associated with in vitro testing.
Therefore, the EP-TRACER System is a medical device used for in vivo electrophysiological procedures, not an IVD.
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
DOK
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
Heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications. Verification activities performed confirmed that the modifications to the predicate device did not adversely affect the safety and effectiveness of the modified device.
Testing for the EP-Tracer V 2.2 shows conformance to the following harmonized standards:
• EN ISO 13485:2012
• EN ISO 14971:2012
• EN 60601-1:2006+A1: 2013
• EN 60601-1-2:2007+ AC: 2010
• EN 60601-1-6:2010
• EN 60601-2-27:2006
• EN 60601-2-34:2011
• EN 10993-1:2009
• EN 980:2008
• EN 1041:2008
• EN 62366: 2008
• EN 62304: 2006
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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EP TRACER Summary
| Submitter's
information | Contact: Tatjana Nuber
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: 28 Feb 2019 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| 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:
• EP-TRACER System, K161245. | |
| 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 | |
| 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
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 | ||
| 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 ΜΩ | Same |
| Leakage Current | ||
| Patient Source | 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
EP-TRACER V2.0 | New Device
EP-TRACER V2.2 |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User Interface Convenience Features | | |
| Pressure mode display | Pressure data is displayed in a
full-screen window which is
separate from the main trace
display window. | In addition to the full-screen
pressure mode available in V2.0,
pressure channels can be
displayed in a “minimized”
pressure mode display within
the main trace display window. |
| Calipers | Horizontal calipers can be
displayed | Both horizontal and vertical
calipers can be displayed |
| One-click report generation | Enables transfer of procedural
data in a limited format | Enables transfer of procedural
data to a customizable,
preconfigured template. |
| Clock | Real-time clock | Added a procedure clock,
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
minimized pressure mode
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
Windows 7 (32 bit) |
Continued on next page
9
510(k) Summary per 21CFR §807.92, Continued
| Performance
testing | Completion of all verification and validation activities demonstrated that the
subject devices meet their predetermined design and performance
specifications. Verification activities performed confirmed that the
modifications to the predicate device did not adversely affect the safety and
effectiveness of the modified device. |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Testing for the EP-Tracer V 2.2 shows conformance to the following
harmonized standards:
• EN ISO 13485:2012
• EN ISO 14971:2012
• EN 60601-1:2006+A1: 2013
• EN 60601-1-2:2007+ AC: 2010
• EN 60601-1-6:2010
• EN 60601-2-27:2006
• EN 60601-2-34:2011
• EN 10993-1:2009
• EN 980:2008
• EN 1041:2008
• EN 62366: 2008
• EN 62304: 2006 |
| Conclusion | Both the subject and predicate devices have the same intended use,
indications for use, and operate using the same fundamental scientific
technology. |
Based on the technical characteristics and the results of the performance testing, the EP TRACER V2.2 is substantially equivalent to V2.0.