(265 days)
Not Found
No
The summary describes a system for acquiring, storing, and displaying cardiac electrophysiological data and maps. It mentions signal analysis and 3D mapping based on ECG and CT data. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The focus is on data acquisition, processing, and visualization, not on automated interpretation or prediction using AI/ML.
No.
The system is solely intended for the acquisition, storage, and analysis of cardiac electrophysiological data and maps for diagnostic purposes, not for providing therapy.
Yes
The device acquires, stores, and analyzes cardiac electrophysiological data and maps for physicians, and displays cardiac maps and virtual electrograms to identify the origin and pattern of various rhythms. This clearly indicates its use in diagnosing cardiac conditions.
No
The device description explicitly mentions a "Sensor Array placed on the torso" and the performance studies include "hardware verification and validation," indicating the system includes hardware components beyond just software.
Based on the provided information, the CardioInsight ECVUE Mapping System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- ECVUE's Function: The ECVUE system works by acquiring and analyzing electrical signals from the patient's body (ECG signals from a sensor array on the torso) and combining them with imaging data (CT scans). It does not analyze specimens taken from the body.
- Intended Use: The intended use is for "acquisition, and storage of cardiac electrophysiological data and maps for analysis by a physician." This is focused on analyzing electrical activity within the heart, not on analyzing biological samples.
The device is a non-invasive system that uses external measurements and imaging data to create maps of the heart's electrical activity. This falls under the category of medical devices used for diagnosis and monitoring, but not specifically as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CardioInsight ECVUE Mapping System is intended for acquisition, and storage of cardiac electrophysiological data and maps for analysis by a physician.
Product codes (comma separated list FDA assigned to the subject device)
DOK
Device Description
ECVUE is a non-invasive mapping system for beat-by-beat, multi-chamber, 3D mapping of the heart. The system displays cardiac maps and virtual electrograms from real-time chest ECG signals (measured by a Sensor Array placed on the torso) and CT scan data. The ECVUE software provides various cardiac signal analyses and displays interactive 3D color maps including potential, activation, voltage, propagation, and phase maps. The system is mobile and can be used for mapping at the patient's bedside or in the EP lab.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
real-time chest ECG signals, CT scan data
Anatomical Site
heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / patient's bedside or in the EP lab.
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: Bench
To assure reliable design and performance, the Company performed in vitro testing including software and hardware verification and validation, electrical safety testing, and electromagnetic compatibility testing. The test results demonstrate that the ECVUE mapping system meets the applicable standards and specifications.
Performance Testing: Animal
A GLP study was conducted to demonstrate the performance of the ECVUE system in identifying origin and pattern of various rhythms as compared to a standard electrophysiology (EP) study in a controlled porcine model. The ability of the ECVUE system to acquire ECG signals, perform signal analyses, and display 3D maps to localize various rhythms and characterize cycle length and activation times was established in this study. There were no adverse events. The study clearly demonstrated the substantial equivalence of the ECVUE system to the legally marketed predicate devices.
Performance Testing: Clinical Experience with commercially available device
Clinical experience from 60 patients, representing the use of the ECVUE system in routine EP clinical practice from two European centers were included to complement the results of the GLP animal study. There have been no adverse events reported with the use of ECVUE. These clinical data provide strong supporting information indicating that in routine EP clinical practice, the non-invasive ECVUE system is safe and performs as intended.
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.
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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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are black and are oriented to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 19, 2014
CardioInsight Technologies, Inc. Ms. Christina V. Vacca Vice President Quality, Regulatory Affairs and Operations 11000 Cedar Ave., Suite 210 Cleveland, OH 44106
Re: K140497
Trade/Device Names: CardioInsight ECVUE Mapping System Regulatory Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (Two) Product Code: DOK Dated: October 21, 2014 Received: October 22, 2014
Dear Ms. Vacca:
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.
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Page 2 - Ms. Christina V. Vacca
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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Melissa A. Torres -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement on last page. |
510(k) Number (if known)
Device Name ECVUE
Indications for Use (Describe)
The CardioInsight ECVUE Mapping System is intended for acquisition, and storage of cardiac electrophysiological data and maps for analysis by a physician.
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)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740
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| Submitter: | CardioInsight Technologies, Inc.
11000 Cedar Ave, Suite 210
Cleveland, OH 44106
chris@cardioinsight.com
Office: 216-453-5950 ext 105
Mobile: 440-315-6973 | |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Contact Person: | Christina V. Vacca
Vice President Quality, Regulatory Affairs and Operations | |
| Date Prepared: | October 21, 2014 | |
| Name and
Classification | ECVUE™ | |
| | Electrophysiological cardiac mapping system:
Programmable diagnostic computer | 21 CFR
870.1425, DQK |
| Predicate Device(s): | The legally marketed device to which we are claiming equivalence is
Bard LabSystem PRO EP Recording System (K113811) | |
| Summary | ECVUE is a non-invasive mapping system for beat-by-beat, multi-
chamber, 3D mapping of the heart. The system displays cardiac maps
and virtual electrograms from real-time chest ECG signals (measured
by a Sensor Array placed on the torso) and CT scan data. The
ECVUE software provides various cardiac signal analyses and
displays interactive 3D color maps including potential, activation,
voltage, propagation, and phase maps. The system is mobile and can
be used for mapping at the patient's bedside or in the EP lab. | |
| Intended/Indication for
Use: | The CardioInsight ECVUE Mapping System is intended for
acquisition, analysis, display and storage of cardiac
electrophysiological data and maps for analysis by a physician. | |
| Device Characteristics
Compared to the
Predicate | Performance Testing: Bench
To assure reliable design and performance, the Company performed
in vitro testing including software and hardware verification and
validation, electrical safety testing, and electromagnetic compatibility
testing. The test results demonstrate that the ECVUE mapping system
meets the applicable standards and specifications. | |
| | Performance Testing: Animal
A GLP study was conducted to demonstrate the performance of the
ECVUE system in identifying origin and pattern of various rhythms
as compared to a standard electrophysiology (EP) study in a
controlled porcine model. The ability of the ECVUE system to
acquire ECG signals, perform signal analyses, and display 3D maps
to localize various rhythms and characterize cycle length and | |
| | activation times was established in this study. There were no adverse
events. The study clearly demonstrated the substantial equivalence of
the ECVUE system to the legally marketed predicate devices. | |
| | Performance Testing: Clinical Experience with commercially
available device
Clinical experience from 60 patients, representing the use of the
ECVUE system in routine EP clinical practice from two European
centers were included to complement the results of the GLP animal
study. There have been no adverse events reported with the use of
ECVUE. These clinical data provide strong supporting information
indicating that in routine EP clinical practice, the non-invasive
ECVUE system is safe and performs as intended. | |
| Conclusion: | CardioInsight believes the ECVUE mapping system is substantially
equivalent to the predicate devices. | |
| | The conclusions drawn from in-vitro testing, GLP animal testing and
clinical experience (discussed above) demonstrate that the device is
equivalent and is as safe and effective as the predicate devices. | |
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