(78 days)
Not Found
No
The document describes a system for acquiring, analyzing, and displaying cardiac electrophysiological data and maps using ECG signals and CT scan data. It mentions various signal analyses and 3D map displays but does not mention AI, ML, or related terms, nor does it describe any training or test sets typically associated with AI/ML development.
No
The device is described as a non-invasive mapping system for acquiring, analyzing, displaying, and storing cardiac electrophysiological data and maps for analysis by a physician. Its function is to provide diagnostic information and not to treat or therapeutically intervene.
Yes
The device is described as "acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician," and it "displays cardiac maps and virtual electrograms from real-time chest ECG signals." This suggests it is used to analyze heart function to identify potential issues, which is a diagnostic purpose.
No
The device description explicitly states that the system uses a "Sensor Array placed on the torso" to measure ECG signals, indicating a hardware component beyond just software.
Based on the provided information, the CardioInsight ECVUE Mapping System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This typically includes blood, urine, tissue, etc.
- The ECVUE system analyzes signals from the human body (ECG) and imaging data (CT scan). It does not analyze samples taken from the body.
- The intended use is for acquiring, analyzing, displaying, and storing cardiac electrophysiological data and maps. This is a diagnostic tool that works on the patient, not on a sample from the patient.
Therefore, the ECVUE Mapping System falls under the category of a medical device that is used in vivo (on the living body) for diagnostic purposes, but it is not an IVD.
N/A
Intended Use / Indications 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.
Product codes
DOK, DQK
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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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
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 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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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
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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
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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)
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K150990 510(k) Summary
| Submitter | CardioInsight Technologies, Inc.
11000 Cedar Ave, Suite 210
Cleveland, OH 44106 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Christina V. Vacca
Vice President Quality, Regulatory Affairs and Operations
CardioInsight Technologies, Inc.
11000 Cedar Ave, Suite 210
Cleveland, OH 44106
chris@cardioinsight.com
Office: 216-453-5950 ext. 105
Mobile: 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 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 |
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