(78 days)
The CardioInsight ECVUE Mapping System is intended for acquisition, analysis, display 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.
This document does not contain the detailed information necessary to answer all parts of your request. It is a 510(k) summary for a medical device and primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive study report with acceptance criteria and performance metrics in the way you've outlined.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
This information is not present in the provided document. The 510(k) summary states "Testing demonstrated that the modified ECVUE Mapping System is substantially equivalent to the original (predicate) system." and "Full system, integration, unit regression testing was performed." However, it does not specify what the acceptance criteria for these tests were or report specific performance metrics against those criteria.
2. Sample sized used for the test set and the data provenance:
This information is not present in the provided document. The document states "No clinical testing was conducted." The non-clinical testing ("Full system, integration, unit regression testing") does not specify a test set size or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not present in the provided document, as no clinical testing with a "test set" and "ground truth" established by experts is mentioned.
4. Adjudication method for the test set:
This information is not present in the provided document, as no clinical testing with adjudication is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not present in the provided document. The device is a "mapping system" that "displays cardiac maps and virtual electrograms from real-time chest ECG signals... for analysis by a physician." It's not described as an AI-powered diagnostic tool that assists human readers in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not present in the provided document, as no explicit performance study (standalone or otherwise) is detailed. The device is intended for "analysis by a physician," implying a human-in-the-loop system.
7. The type of ground truth used:
This information is not present in the provided document, as no clinical testing with a defined ground truth is mentioned.
8. The sample size for the training set:
This information is not present in the provided document. The document refers to "updates to the software based on internal/user feedback and maintenance updates to the OTS," but does not describe a training set for an algorithm.
9. How the ground truth for the training set was established:
This information is not present in the provided document, as no training set or its ground truth establishment is mentioned.
Summary of what is available from the document:
- Device Name: ECVUE Mapping System, Model AT200
- Intended Use: Acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
- Regulatory Status: Class II, Product Code DOK (Programmable Diagnostic Computer).
- Predicate Device: ECVUE Mapping System (K140497) - implying the current device is an updated version of an already cleared device.
- Changes from Predicate: Software updates based on internal/user feedback and maintenance updates to OTS (Off-The-Shelf) components. These changes are described as "very small and do not change the functionality or technological characteristics of the device. The Intended Use of the device is not affected."
- Testing Performed: "Full system, integration, unit regression testing was performed."
- Clinical Testing: "No clinical testing was conducted."
- Conclusion: The modified system is "substantially equivalent to the original (predicate) system and the changes did not affect the safety and effectiveness of the device when it is used as labeled."
The document focuses on demonstrating that the changes made to the device (mostly software updates) do not affect its safety and effectiveness, thus maintaining substantial equivalence to its predicate. It does not provide performance data or acceptance criteria for an initial clearance study of the device's efficacy in the way a new, de novo device might.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a row, with the first profile being the most prominent and the others slightly overlapping behind it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the upper portion of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 2, 2015
Ms. Christina V. Vacca Vice President Quality, Regulatory Affairs and Operations CardioInsight Technologies, Inc. 11000 Cedar Ave., Suite 210 Cleveland, OH 44106
Re: K150990
Trade/Device Name: ECVUE Mapping System, Model AT200 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DOK Dated: June 9, 2015 Received: June 12, 2015
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. Isting 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 (reporting of medical
{1}------------------------------------------------
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,
Mitchell Stein
forBram 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) K150990
Device Name ECVUE Mapping System
Indications for Use (Describe)
The CardioInsight ECVUE Mapping System is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
K150990 510(k) Summary
| Submitter | CardioInsight Technologies, Inc.11000 Cedar Ave, Suite 210Cleveland, OH 44106 |
|---|---|
| Contact Person | Christina V. VaccaVice President Quality, Regulatory Affairs and OperationsCardioInsight Technologies, Inc.11000 Cedar Ave, Suite 210Cleveland, OH 44106chris@cardioinsight.comOffice: 216-453-5950 ext. 105Mobile: 440-315-6973 |
| Date Prepared | June 9, 2015 |
| Trade Name | ECVUETM Mapping System |
| Classification | 21 CFR 870.1425, Electrophysiological cardiac mapping system:Programmable diagnostic computer, Class II |
| Product Code | DQK |
| Predicate Device | ECVUE Mapping System (K140497) |
| 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. |
| 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. |
| Comparison of Technological Characteristics | The modified ECVUE Mapping System is as follows:• Similarities to the unmodified device:• Identical intended use/indications for use• Identical operating principle• Incorporate same basic design• Same hardware components• Identical fundamental technology• Identical manufacturing and quality control procedures• Differences compared to unmodified device:The original ECVUE Mapping System has been modified by updates to the software based on internal/user feedback and maintenance updates to the OTS. These changes to the software are very small and do not change the functionality or technological characteristics of the device. The Intended Use of the device is not affected. Testing demonstrated that the modified ECVUE Mapping |
| System is substantially equivalent to the original (predicate) system. | |
| system. | |
| Non-Clinical Testing | Full system, integration, unit regression testing was performed. |
| Clinical Testing | No clinical testing was conducted. |
| Conclusion | Testing showed that the modified ECVUE Mapping System issubstantially equivalent to the original (predicate) system and thechanges did not affect the safety and effectiveness of the devicewhen it is used as labeled |
{4}------------------------------------------------
§ 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).