(228 days)
No
The document describes automated analysis of electrograms but does not mention AI, ML, or any related technologies like neural networks or deep learning. The analysis appears to be based on traditional signal processing techniques.
No.
The "Intended Use / Indications for Use" section explicitly states that the system is "intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart," and its purpose is to "acquire, filter, digitize, amplify, display, record, and analyze data obtained during electrophysiological studies." This describes a diagnostic and analysis tool, not a device used to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states that the system is "intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart." Additionally, the "Device Description" mentions that it is used "as part of the diagnosis and treatment of cardiac arrhythmias."
No
The device description explicitly states that the ECGenius™ System consists of hardware components such as the Cube Amplifier, cables, PC, monitors, and a printer, in addition to the software.
Based on the provided information, the ECGenius™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, in order to provide information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.
- ECGenius™ System's Function: The ECGenius™ System is described as an electrophysiology measurement system and analysis tool that acquires, filters, digitizes, amplifies, displays, records, and analyzes data obtained during electrophysiological studies and related procedures. It works in conjunction with catheters and a stimulator to measure electrical activity directly from the heart.
- Lack of Specimen Analysis: The system does not analyze specimens (like blood, tissue, or urine) that have been removed from the body. It is directly interacting with the patient's heart during a procedure.
Therefore, the ECGenius™ System falls under the category of a medical device used in vivo (within the living body) for diagnostic and procedural support, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ECGenius™ System is an electrophysiology measurement system and analysis tool used to acquire, filter, digitize, amplify, display, record, and analyze data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
The ECGenius™ System is an electrophysiology (EP) recording system used in EP procedures as part of the diagnosis and treatment of cardiac arrhythmias. ECGenius™ System (with ECGenius™ Software V3.0) is similar to ECGenius™ System (with ECGenius™ Software V2.0) but has two additional software modules.
The Signal Complexity™ software module analyzes various properties of the signals from a connected 10-pole catheter and visualizes them on a colormap. No clinical claims are made for Signal Complexity™.
The PVI Analyzer™ software module aids the user in evaluating the isolation status of a pulmonary vein. The module performs automated real time analysis of electrograms (EGM) from compatible connected 8- or 10-pole circular mapping catheters during a PVI procedure. The result of the analysis (Isolated vs Non-isolated) is presented in a visual plot to the user. The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation.
The ECGenius™ System consists of an electrophysiology amplifier (Cube Amplifier), recording system software (ECGenius™ Software) running on a PC, and additional components including external cable assemblies, PC monitors, and a printer. Electrophysiological signals are filtered, amplified, and digitized in the Cube Amplifier, and sent to the PC and recording system software for further processing, analysis, visualization, and recording. The ECGenius™ System works in an EP laboratory or operating room in hospitals in conjunction with several other devices from other manufacturers.
The ECGenius™ System includes the following items:
- Cube Amplifier
- Two IECG pin box cables for connection of catheters
- Surface ECG trunk cable and ECG leadwires
- Blood pressure cables
- Data cable to host computer
- Stimulator cable
- Analog-out and analog-in cables
- ECGenius™ Software with the PVI Analyzer™ and Signal Complexity™ software modules
- Host computer (PC), monitors and printer
- Isolation transformers
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
Adults
PVI Analyzer™ is indicated for adults in sinus rythmn undergoing their first PVI treatment
Intended User / Care Setting
EP laboratory or operating room in hospitals.
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)
Software verification and validation
Cybersecurity testing
Operating environment verification
Biocompatibility
Packaging
Cleaning
Human factors/usability
Shelf life
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.
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
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August 4, 2023
Cath Vision ApS % Sharon Bishop Director of Regulatory Affairs Graematter, Inc. 1324 Clarkson Clayton Ctr #332 St. Louis, Missouri 63011
Re: K223787
Trade/Device Name: ECGenius™ System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: July 4, 2023 Received: July 6, 2023
Dear Sharon Bishop:
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.
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223787
Device Name ECGenius™ System
Indications for Use (Describe)
The ECGenius™ System is an electrophysiology measurement system and analysis tool used to acquire, filter, digitize, amplify, display, record, and analyze data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation.
| 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary K223787
ECGenius™ System Summary
| Submitter's
| information | CathVision ApS | Contact: Sharon Bishop |
|---|---|---|
| Titangade 11 | Graematter, Inc. | |
| 2200 Copenhagen N | 1324 Clarkson Clayton Ctr #332 | |
| Denmark | Ballwin, MO 63011 | |
| Phone: 919-724-8978 | ||
| Date: August 4, 2023 |
The classification for the new device is listed below. Classification
| 21 CFR
Reference | Product
Code | Class | Generic Device Name | Classification Description |
|---------------------|-----------------|-------|---------------------------------------|-------------------------------------|
| §870.1425 | DQK | II | Computer, Diagnostic,
Programmable | Programmable diagnostic
computer |
New device The new device's indications for use are listed in the table below.
| Device Name | Indications for Use |
|---|---|
| ECGenius™ | |
| System | The ECGenius™ System is an electrophysiology measurement system and analysis tool used to acquire, filter, digitize, amplify, display, record, and analyze data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart. |
| The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation. |
4
Predicate device
The predicate device for the ECGenius™ System is shown in the table below.
| K Number | Product
Code | Predicate Device
Name | Indications for Use |
|----------|-----------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K220306 | DQK | ECGenius™ System | The ECGenius™ System is an electrophysiology
measurement system used to acquire, filter, digitize,
amplify, display, and record clinical data obtained
during electrophysiological studies and related
procedures. The system is compatible with a 3rd-party
stimulator, intended to be used for diagnostic cardiac
stimulation during electrophysiological testing of the
heart. |
Reference The reference devices for the ECGenius™ System are shown in the table devices below.
5
| K Number | Product
Code | Predicate Device
Name | Indications for Use |
|----------|-----------------|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K180238 | DQK | Carto 3 | The intended use of the CARTO® 3 System is catheter-
based cardiac electrophysiological (EP) procedures. The
CARTO 3 System provides information about the
electrical activity of the heart and about catheter
location during the procedure. The system can be used
on patients who are eligible for a conventional
electrophysiological procedure. The system has no
special contraindications. |
| K101331 | DQK | Bard LabSystem
PRO | The Bard LabSystem ER Laboratory is a computer and
software driven data acquisition and analysis tool
designed to facilitate the gathering, display, analysis by
a physician, pace mapping and storage of cardiac
electrophysiologic data. When integrated with the
Philips EP navigator system, the BARD® LabSystem™
PRO EP Recording System is designed to acquire,
analyze, and display 3D electro- anatomical maps of the
human heart. The maps are constructed using
intracardiac electrograms with their respective cardiac
locations taken from live x-ray overlay on a patient's 3D
cardiac anatomy. Maps may be displayed as electrical
activation maps, voltage maps, dominant frequency
maps and location maps with user defined
measurement values. |
6
Device The ECGenius™ System is an electrophysiology (EP) recording system used description in EP procedures as part of the diagnosis and treatment of cardiac arrhythmias. ECGenius™ System (with ECGenius™ Software V3.0) is similar to ECGenius™ System (with ECGenius™ Software V2.0) but has two additional software modules.
The Signal Complexity™ software module analyzes various properties of the signals from a connected 10-pole catheter and visualizes them on a colormap. No clinical claims are made for Signal Complexity™.
The PVI Analyzer™ software module aids the user in evaluating the isolation status of a pulmonary vein. The module performs automated real time analysis of electrograms (EGM) from compatible connected 8- or 10-pole circular mapping catheters during a PVI procedure. The result of the analysis (Isolated vs Non-isolated) is presented in a visual plot to the user. The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation.
The ECGenius™ System consists of an electrophysiology amplifier (Cube Amplifier), recording system software (ECGenius™ Software) running on a PC, and additional components including external cable assemblies, PC monitors, and a printer. Electrophysiological signals are filtered, amplified, and digitized in the Cube Amplifier, and sent to the PC and recording system software for further processing, analysis, visualization, and recording. The ECGenius™ System works in an EP laboratory or operating room in hospitals in conjunction with several other devices from other manufacturers.
The ECGenius™ System includes the following items:
- · Cube Amplifier
- Two IECG pin box cables for connection of catheters
- Surface ECG trunk cable and ECG leadwires
- Blood pressure cables
- Data cable to host computer
- · Stimulator cable
- Analog-out and analog-in cables
- ECGenius™ Software with the PVI Analyzer™ and Signal Complexity™ software modules
- · Host computer (PC), monitors and printer
- Isolation transformers
7
Characteristics - The table below lists the characteristics for both the new and predicate devices. comparison with predicate device
| ATTRIBUTE | SUBJECT DEVICE
ECGenius™ System
(with ECGenius™ Software V3.0) | PREDICATE DEVICE
ECGenius™ System
(with ECGenius™ Software V2.0)
K220306 | COMPARISON |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The ECGenius™ System is an
electrophysiology measurement
system and analysis tool used to
acquire, filter, digitize, amplify,
display, record, and analyze data
obtained during electrophysiological
studies and related procedures. The
system is compatible with a 3rd-
party stimulator, intended to be used
for diagnostic cardiac stimulation
during electrophysiological testing of
the heart.
The PVI Analyzer™ feature is a
secondary measure of pulmonary
vein isolation and should not replace
traditional methods of confirming
isolation. | The ECGenius™ System is an
electrophysiology measurement
system used to acquire, filter,
digitize, amplify, display, and record
clinical data obtained during
electrophysiological studies and
related procedures.
The system is compatible with 3rd-
party stimulator, intended to be used
for diagnostic cardiac stimulation
during electrophysiological testing of
the heart. | Subject device includes
additional analysis tools, and
the term "analyze" is added to
the indications for use.
The change does not impact
intended use or safety and
effectiveness. |
| FDA Product code | DQK | DQK | Same |
| ATTRIBUTE | SUBJECT DEVICE
ECGenius™ System
(with ECGenius™ Software V3.0) | PREDICATE DEVICE
ECGenius™ System
(with ECGenius™ Software V2.0)
K220306 | COMPARISON |
| Classification | Programmable diagnostic computer,
21 CFR §870.1425 | Programmable diagnostic computer,
21 CFR §870.1425 | Same |
| Population | Adults
PVI Analyzer™ is indicated for adults
in sinus rythmn undergoing their first
PVI treatment | Adults | Comparable - PVI Analyzer™
(analysis tool) is indicated for
adults in sinus rythmn
undergoing their first PVI
treatment. Does not impact
safety and effectiveness. |
| Recorder Software | ECGenius™ Software V3.0 | ECGenius™ Software V2.0 | The recorder software in the
subject device is an evolution
of the recorder software in the
predicate device. |
| CARDIALYTICS™
software plug-ins | Signal Complexity™
PVI Analyzer™ | None | The recorder software for the
subject device includes two
new software modules
(analysis tools). Does not
impact safety and
effectiveness. |
| Amplifier
Dimensions
WxDxH (cm) | 43x43x31 | 43x43x31 | Same |
| Temperature
Operating | +10°C to +30°C | +10°C to +30°C | Same |
| Temperature
Transport/Storage | -15°C to +50°C | -15°C to +50°C | Same |
| Humidity Operating | 30 - 75 % rH (non-condensing) | 30 - 75 % rH (non-condensing) | Same |
| ATTRIBUTE | SUBJECT DEVICE
ECGenius™ System
(with ECGenius™ Software V3.0) | PREDICATE DEVICE
ECGenius™ System
(with ECGenius™ Software V2.0)
K220306 | COMPARISON |
| Humidity
Transport/Storage | 10 - 95 % rH (non-condensing) | 10 - 95 % rH (non-condensing) | Same |
| Power
Requirements | 100 - 240 V AC, 50 - 60 Hz | 100 - 240 V AC, 50 - 60 Hz | Same |
| Current Draw | 0.7A @ 110VAC, 0.35A @ 240VAC | 0.7A @ 110VAC, 0.35A @ 240VAC | Same |
| Sampling Rate | 2kHz | 2kHz | Same |
| CMRR | > 120dB | > 120dB | Same |
| Input Impedance | >2.5MΩ | >2.5MΩ | Same |
| IECG Inputs | 128 channels + 2 references | 128 channels + 2 references | Same |
| IECG Switching | Each channel can be either bipolar or
unipolar with manual switching | Each channel can be either bipolar or
unipolar with manual switching | Same |
| IECG High Pass Filter | None | None | Same |
| | 0.01 Hz | 0.01 Hz | |
| | 0.05 Hz | 0.05 Hz | |
| | 0.1 Hz | 0.1 Hz | |
| | 0.5 Hz | 0.5 Hz | |
| | 1 Hz | 1 Hz | |
| | 10 Hz | 10 Hz | |
| | 30 Hz | 30 Hz | |
| | 100 Hz | 100 Hz | |
| IECG Low Pass Filter | 50 Hz | 50 Hz | Same |
| | 100 Hz | 100 Hz | |
| | 250 Hz | 250 Hz | |
| | 500 Hz | 500 Hz | |
| | None | None | |
| IECG RF Filtering | All inputs | All inputs | Same |
| ATTRIBUTE | SUBJECT DEVICE
ECGenius™ System
(with ECGenius™ Software V3.0) | PREDICATE DEVICE
ECGenius™ System
(with ECGenius™ Software V2.0)
K220306 | COMPARISON |
| IECG Scale | Between 1.25 and 5120 mm/mV
– discrete intervals | Between 1.125 and 5120 mm/mV
– discrete intervals | Same |
| IECG Saturation
Recovery |