(265 days)
The CardioInsight ECVUE Mapping System is intended for acquisition, and storage of cardiac electrophysiological data and maps for analysis by a physician.
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.
The CardioInsight ECVUE Mapping System's acceptance criteria and studies are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ability to acquire ECG signals | Established in GLP animal study and clinical experience |
| Ability to perform signal analyses | Established in GLP animal study and clinical experience |
| Ability to display 3D maps | Established in GLP animal study and clinical experience |
| Ability to localize various rhythms | Established in GLP animal study |
| Ability to characterize cycle length and activation times | Established in GLP animal study |
| Absence of adverse events | Demonstrated in GLP animal study and clinical experience |
| Meets applicable standards and specifications (software, hardware, electrical safety, EMC) | Demonstrated through in-vitro testing |
| Performance as intended in routine EP clinical practice | Demonstrated through clinical experience from two European centers |
| Substantial equivalence to legally marketed predicate devices | Concluded based on in-vitro, animal, and clinical studies |
2. Sample Size and Data Provenance for Test Set
- Sample Size (Clinical Experience): 60 patients.
- Data Provenance: From two European centers (retrospective, given the phrase "Clinical experience with commercially available device").
- Sample Size (Animal Study): Not explicitly stated, but described as a "controlled porcine model" in a GLP study.
- Data Provenance (Animal Study): Not explicitly stated but assumed to be prospective due to the nature of a GLP "study."
3. Number of Experts and Qualifications for Ground Truth (Test Set)
The document does not explicitly state the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience").
- For the animal study, the comparison was made "as compared to a standard electrophysiology (EP) study," implying that the ground truth was established by standard EP procedures and potentially interpreted by associated EP specialists.
- For the clinical experience, the data represents "routine EP clinical practice," suggesting that the interpretation and ground truth were established by the treating physicians in those EP centers.
4. Adjudication Method for the Test Set
The document does not explicitly mention an adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth in either the animal study or the clinical experience. The ground truth seems to be derived from the "standard electrophysiology (EP) study" in the animal model and from "routine EP clinical practice" in the clinical experience.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is described where the effect size of human readers improving with AI vs. without AI assistance is quantified. The focus is on the device's performance compared to standard EP studies or its performance in clinical practice, not on the improvement of human readers specifically with AI assistance.
6. Standalone Performance Study
Yes, a standalone (algorithm only without human-in-the-loop performance) study was effectively done. The GLP animal study aimed to "demonstrate the performance of the ECVUE system in identifying origin and pattern of various rhythms as compared to a standard electrophysiology (EP) study." This suggests an assessment of the device's capability to localize rhythms and characterize timings on its own, without explicit interaction with a human reader for real-time decision-making in the performance evaluation. The clinical experience section also states that the device "performs as intended," implying its standalone functionality.
7. Type of Ground Truth Used
- Animal Study: The ground truth was established by "a standard electrophysiology (EP) study." This typically involves invasive mapping techniques that are considered the gold standard for cardiac electrophysiology.
- Clinical Experience: The ground truth was derived from "routine EP clinical practice," which would involve standard diagnostic and treatment procedures by physicians, using a range of available tools and expert interpretation.
8. Sample Size for the Training Set
The document does not explicitly state the sample size used for the training set.
9. How Ground Truth for the Training Set was Established
The document does not explicitly describe how the ground truth for any potential training set was established. The studies mentioned focus on verification and validation (for performance testing and clinical experience) rather than the development or training of the system.
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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 210Cleveland, OH 44106chris@cardioinsight.comOffice: 216-453-5950 ext 105Mobile: 440-315-6973 | |
|---|---|---|
| Contact Person: | Christina V. VaccaVice President Quality, Regulatory Affairs and Operations | |
| Date Prepared: | October 21, 2014 | |
| Name andClassification | ECVUE™ | |
| Electrophysiological cardiac mapping system:Programmable diagnostic computer | 21 CFR870.1425, DQK | |
| Predicate Device(s): | The legally marketed device to which we are claiming equivalence isBard 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 mapsand virtual electrograms from real-time chest ECG signals (measuredby a Sensor Array placed on the torso) and CT scan data. TheECVUE software provides various cardiac signal analyses anddisplays interactive 3D color maps including potential, activation,voltage, propagation, and phase maps. The system is mobile and canbe used for mapping at the patient's bedside or in the EP lab. | |
| Intended/Indication forUse: | The CardioInsight ECVUE Mapping System is intended foracquisition, analysis, display and storage of cardiacelectrophysiological data and maps for analysis by a physician. | |
| Device CharacteristicsCompared to thePredicate | Performance Testing: BenchTo assure reliable design and performance, the Company performedin vitro testing including software and hardware verification andvalidation, electrical safety testing, and electromagnetic compatibilitytesting. The test results demonstrate that the ECVUE mapping systemmeets the applicable standards and specifications. | |
| Performance Testing: AnimalA GLP study was conducted to demonstrate the performance of theECVUE system in identifying origin and pattern of various rhythmsas compared to a standard electrophysiology (EP) study in acontrolled porcine model. The ability of the ECVUE system toacquire ECG signals, perform signal analyses, and display 3D mapsto localize various rhythms and characterize cycle length and | ||
| activation times was established in this study. There were no adverseevents. The study clearly demonstrated the substantial equivalence ofthe ECVUE system to the legally marketed predicate devices. | ||
| Performance Testing: Clinical Experience with commerciallyavailable deviceClinical experience from 60 patients, representing the use of theECVUE system in routine EP clinical practice from two Europeancenters were included to complement the results of the GLP animalstudy. There have been no adverse events reported with the use ofECVUE. These clinical data provide strong supporting informationindicating that in routine EP clinical practice, the non-invasiveECVUE system is safe and performs as intended. | ||
| Conclusion: | CardioInsight believes the ECVUE mapping system is substantiallyequivalent to the predicate devices. | |
| The conclusions drawn from in-vitro testing, GLP animal testing andclinical experience (discussed above) demonstrate that the device isequivalent and is as safe and effective as the predicate devices. |
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§ 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).