ECVUE MAPPING SYSTEM

K140497 · Cardioinsight Technologies, Inc. · DQK · Nov 19, 2014 · Cardiovascular

Device Facts

• Record ID: K140497
• Device Name: ECVUE MAPPING SYSTEM
• Applicant: Cardioinsight Technologies, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Nov 19, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended 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 Story

ECVUE is a non-invasive 3D cardiac mapping system. It acquires real-time chest ECG signals via a torso-mounted sensor array and integrates them with patient CT scan data. The system processes these inputs to generate virtual electrograms and interactive 3D color maps, including potential, activation, voltage, propagation, and phase maps. Used in clinical settings like the EP lab or at the patient's bedside, the system is operated by healthcare professionals. Physicians use the displayed maps and signal analyses to characterize cardiac rhythms, localize origins, and determine activation times. This information assists in clinical decision-making during electrophysiological studies, potentially benefiting patients by providing non-invasive diagnostic insights into cardiac rhythm patterns.

Clinical Evidence

Evidence includes bench testing (verification/validation, electrical safety, EMC), a GLP porcine animal study, and clinical experience from 60 patients across two European centers. The animal study validated the system's ability to acquire ECG signals, perform signal analysis, and display 3D maps to localize rhythms and characterize cycle lengths/activation times compared to standard EP study methods. Clinical data from routine practice supported the safety and intended performance of the system. No adverse events were reported in either the animal or clinical studies.

Technological Characteristics

Non-invasive 3D cardiac mapping system. Components include a torso-mounted sensor array for ECG signal acquisition and a programmable diagnostic computer. Integrates external CT scan data for anatomical mapping. Software provides signal analysis and 3D visualization (potential, activation, voltage, propagation, phase maps). Mobile form factor for bedside or EP lab use. Verification testing confirms compliance with electrical safety and electromagnetic compatibility standards.

Indications for Use

Indicated for use by physicians for the acquisition, analysis, display, and storage of cardiac electrophysiological data and maps in patients undergoing cardiac electrophysiological evaluation.

Regulatory Classification

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.

Predicate Devices

• Bard LabSystem PRO EP Recording System (K113811)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone]

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| Submitter: | CardioInsight Technologies, Inc.<br>11000 Cedar Ave, Suite 210<br>Cleveland, OH 44106<br>[e-mail]<br>Office: 216-453-5950 ext 105<br>Mobile: [phone] | |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Contact Person: | Christina V. Vacca<br>Vice President Quality, Regulatory Affairs and Operations | |
| Date Prepared: | October 21, 2014 | |
| Name and<br>Classification | ECVUE™ | |
| | Electrophysiological cardiac mapping system:<br>Programmable diagnostic computer | 21 CFR<br>870.1425, DQK |
| Predicate Device(s): | The legally marketed device to which we are claiming equivalence is<br>Bard LabSystem PRO EP Recording System (K113811) | |
| Summary | ECVUE is a non-invasive mapping system for beat-by-beat, multi-<br>chamber, 3D mapping of the heart. The system displays cardiac maps<br>and virtual electrograms from real-time chest ECG signals (measured<br>by a Sensor Array placed on the torso) and CT scan data. The<br>ECVUE software provides various cardiac signal analyses and<br>displays interactive 3D color maps including potential, activation,<br>voltage, propagation, and phase maps. The system is mobile and can<br>be used for mapping at the patient's bedside or in the EP lab. | |
| Intended/Indication for<br>Use: | The CardioInsight ECVUE Mapping System is intended for<br>acquisition, analysis, display and storage of cardiac<br>electrophysiological data and maps for analysis by a physician. | |
| Device Characteristics<br>Compared to the<br>Predicate | Performance Testing: Bench<br>To assure reliable design and performance, the Company performed<br>in vitro testing including software and hardware verification and<br>validation, electrical safety testing, and electromagnetic compatibility<br>testing. The test results demonstrate that the ECVUE mapping system<br>meets the applicable standards and specifications. | |
| | Performance Testing: Animal<br>A GLP study was conducted to demonstrate the performance of the<br>ECVUE system in identifying origin and pattern of various rhythms<br>as compared to a standard electrophysiology (EP) study in a<br>controlled porcine model. The ability of the ECVUE system to<br>acquire ECG signals, perform signal analyses, and display 3D maps<br>to localize various rhythms and characterize cycle length and | |
| | activation times was established in this study. There were no adverse<br>events. The study clearly demonstrated the substantial equivalence of<br>the ECVUE system to the legally marketed predicate devices. | |
| | Performance Testing: Clinical Experience with commercially<br>available device<br>Clinical experience from 60 patients, representing the use of the<br>ECVUE system in routine EP clinical practice from two European<br>centers were included to complement the results of the GLP animal<br>study. There have been no adverse events reported with the use of<br>ECVUE. These clinical data provide strong supporting information<br>indicating that in routine EP clinical practice, the non-invasive<br>ECVUE system is safe and performs as intended. | |
| Conclusion: | CardioInsight believes the ECVUE mapping system is substantially<br>equivalent to the predicate devices. | |
| | The conclusions drawn from in-vitro testing, GLP animal testing and<br>clinical experience (discussed above) demonstrate that the device is<br>equivalent and is as safe and effective as the predicate devices. | |

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