CardioInsight Cardiac Mapping System

K162440 · Cardioinsight Technologies, Inc. · DQK · Nov 4, 2016 · Cardiovascular

Device Facts

• Record ID: K162440
• Device Name: CardioInsight Cardiac Mapping System
• Applicant: Cardioinsight Technologies, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Nov 4, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The Medtronic CardioInsight Cardiac Mapping System is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.

Device Story

Non-invasive system for beat-by-beat, multichamber, 3D cardiac mapping; inputs include real-time chest ECG signals from torso-worn sensor array and patient CT scan data; system uses mathematical algorithms to solve cardiac inverse problem, transforming body surface signals into epicardial signals; outputs include interactive 3D color maps (potential, activation, voltage, propagation, phase) and virtual electrograms; used in clinical settings (bedside or EP lab) by physicians; output assists in cardiac electrophysiological analysis and clinical decision-making; benefits include non-invasive visualization of cardiac electrical activity.

Clinical Evidence

Bench testing only. No clinical data required. Verification included hardware (dimensions, mechanical/electrical safety), software/firmware integration, and usability testing in a simulated environment. Compliance with ANSI/AAMI ES 60601-1, IEC 60601-1, and AAMI/ANSI/IEC 60601-1-2 verified.

Technological Characteristics

System includes cart, monitor, core processor, sensor array (vest), amplifier, and cabling. Sensing principle: body surface ECG potentials combined with CT-derived anatomical geometry. Software: moderate level of concern, includes OTS components (Fellow Oak DICOM, Boost C++, DevExpress, WPF, Parallel Studio XE). Connectivity: standalone workstation. Sterilization: N/A (non-invasive).

Indications for Use

Indicated for individuals undergoing an EP study requiring acquisition, analysis, display, and storage of cardiac electrophysiological data and maps.

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

• ECVUE MAPPING SYSTEM (K150990)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 4, 2016

Medtronic Inc. Laurie Lewandowski Regulatory Associate 8200 Coral Sea St NE Mounds View, MN 55112

Re: K162440

Trade/Device Name: Medtronic CardioInsight® Cardiac Mapping System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: October 6, 2016 Received: October 7, 2016

Dear Laurie Lewandowski:

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.

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 devicerelated 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.

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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

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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## Indications for Use

510(k) Number (if known) K162440

Device Name

Medtronic CardioInsight® Cardiac Mapping System

Indications for Use (Describe)

The Medtronic CardioInsight Cardiac 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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# 510(k) Summary per 21 CFR §807.92

| Date Summary<br>Prepared: | October 4, 2016 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Medtronic (Owner/Operator)<br>CardioInsight Technologies<br>11000 Cedar Avenue Suite 210<br>Cleveland, OH 44106<br>Establishment Registration No.: 3006526833 |
| Primary Contact: | Laurie Lewandowski<br>Regulatory Affairs Specialist (consultant)<br>Telephone: [phone]<br>Email: [e-mail] |
| Alternate Contact: | Kristyn Benson<br>Director, Regulatory Affairs<br>Telephone [phone]<br>Email: [e-mail] |
| | Medtronic Inc./AF Solutions<br>8200 Coral Sea Street NE<br>Mounds View, MN 55112<br>Fax: [phone] |
| Trade Name: | Medtronic CardioInsight® Cardiac Mapping System |
| Common Name: | Electrophysiological cardiac mapping system |
| Classification Name: | Programmable diagnostic computer, |
| Classification &<br>Panel: | Class II<br>Cardiovascular |
| Product Code: | DQK |
| Regulation: | 21 CFR 870.1425 |
| Predicate Device(s): | ECVUE MAPPING SYSTEM. (K150990) |

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### Device Description:

The Medtronic CardioInsight® Cardiac Mapping System is a non-invasive mapping system for beat-by-beat, multichamber, 3D mapping of the heart. The CardioInsight Cardiac Mapping 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 ECG signals in concert with the CT scan information (geometrical information) are used in mathematical algorithms to transform the measured body surface signals into epicardial signals via solving the cardiac inverse problem. The CardioInsight Cardiac Mapping System software uses this data to provide various cardiac signal analyses and displays interactive 3D color maps including potential, activation, voltage, propagation, and phase maps. The CardioInsight Cardiac Mapping System system is mobile and can be used for mapping at the patient's bedside or in the EP lab.

| System<br>Component | or<br>Model Number |
|-----------------------------------------|--------------------------------------------|
| CardioInsight Cardiac<br>Mapping System | CIT 200 |
| Work Station<br>Computer | CIT 200-PC-0001 (w/SW) |
| Sensor Array (Vest) | CIT200-SA-0001 (S) |
| | CIT 200-SA-0002 (M) |
| | CIT 200-SA-0003 (L) |
| | CIT 200-SA-0004 (XL) |
| Cart | 200-WC-0001 |
| Amplifier | CIT 200-AMP-0001 |
| Connector Cables | CIT 200-AMP-0002 Signal Cable (Right) |
| | CIT 200-AMP-0003 Signal Cable (Left) |
| | CIT 200-AMP-0004 Signal Cable (Back Left) |
| | CIT 200-AMP-0005 Signal Cable (Back Right) |
| Patient/Ground<br>Reference Cable | CIT 200-AMP-0021 |

Model numbers of the system components are as follows:

Indications for Use: The Medtronic CardioInsight Cardiac Mapping System is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.

The Indications for Use statement is identical to the predicate device.

The CardioInsight Cardiac Mapping System uses the same technology, and Comparison of has the same intended use, fundamental technology, principal of operation and Technological Characteristics performance as the predicate device. Modifications were made for processing capacity and usability.

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| Characteristic | Medtronic<br>CardioInsight Cardiac<br>Mapping System<br>(Proposed System) | CardioInsight<br>ECVUE Mapping<br>System<br>(Predicate System) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Identical | For individuals<br>undergoing an EP Study |
| Indications for Use | Identical | The CardioInsight<br>ECVUE Mapping<br>System is intended for<br>acquisition, analysis,<br>display and storage of<br>cardiac<br>electrophysiological data<br>and maps for analysis by<br>a physician |
| System | Cart,<br>Monitor,<br>Core Processor,<br>Keyboard,<br>Mouse,<br>Isolation Transformer,<br>Cabling,<br>Sensor Array,<br>Second Monitor connection | Cart,<br>Monitor,<br>Core Processor,<br>Keyboard,<br>Mouse,<br>Isolation Transformer,<br>Cabling,<br>Sensor Array,<br>Printer,<br>UPS |
| Principal of Operation | Identical | Electrocardiographic<br>potentials are<br>measured from the<br>torso sensors on the<br>surface of the body. A<br>CT scan is segmented<br>to obtain the 3-<br>dimensional location<br>of each sensor and the<br>detailed anatomy of the<br>epicardial surface of<br>the heart. From these<br>data, the system uses<br>mathematical<br>algorithms to use the<br>geometrical<br>information to<br>transform the<br>measured body surface<br>signals into<br>epicardial signals via<br>solving the cardiac<br>inverse problem |
| Characteristic | Medtronic<br>CardioInsight Cardiac<br>Mapping System<br>(Proposed System) | CardioInsight<br>ECVUE Mapping<br>System<br>(Predicate System) |
| Software / Firmware /<br>Algorithm | Equivalent functionality –<br>improved usability,<br>reducing manual input<br>required and fixing bugs<br>OTS software | Create patient records<br>Segment heart and vest<br>electrodes<br>Acquire sensor array<br>signals<br>Create and review maps |
| Off the Shelf Software | Updated to latest versions.<br>Added additional Off the<br>Shelf Software to support<br>functionality<br>• Fellow Oak DICOM<br>• Boost C++ Libraries<br>• DevExpress<br>• WPF Components<br>Library<br>• Parallel Studio XE<br>Composer | Entity Framework<br>SQL Server Express<br>OpenInventor 64-bit<br>.NET Framework |
| Performance testing was completed on the CardioInsight Cardiac Mapping<br>System which verified that the System complies with the safety and<br>specifications and performs as designed; it is suitable for its intended use. | | |
| Performance testing for the proposed system included the following: | | |
| Hardware Verification compliance with dimensions, cart functionality and<br>mechanical safety as well as the amplifier mechanical and electrical<br>functionality and electrical safety.<br>Labeling Verification to applicable requirements<br>Electrical Safety compliance per<br>ANSI/AAMI ES 60601-1:2005/A1:2012<br>IEC 60601-1:2005/A1:2012<br>EN 60601 1:2006/A1:2013<br>All excluding: excluding biocompatibility (cl. 11.7), usability (cl. 1<br>and 15.1), and EMC (cl. 17)<br>EMC/EMI compliance per<br>AAMI / ANSI / IEC 60601-1-2:2007/(R)2012 | | |
| Mechanical Safety compliance per<br>ANSI/AAMI ES 60601-1:2005/A1:2012<br>IEC 60601-1:2005/A1:2012<br>EN 60601 1:2006/A1:2013<br>All excluding: excluding biocompatibility (cl. 11.7), usability (cl. 1<br>and 15.1), and EMC (cl. 17) | | |
| | with FDA's Guidance for the Content of Premarket Submissions for Software<br>Contained in Medical Devices" and AAMI / ANSI / IEC 62304:2006, Medical<br>Device Software - Software Life Cycle Processes. The software in this system<br>is considered moderate level of concern as failure could contribute to a hazard<br>leading to non-serious injury.<br>Algorithm Testing and Integration – verified the algorithms met requirements<br>and functioned as intended and when integrated performed as expected. | |
| | Firmware Verification – demonstrated that the firmware met requirements<br>Packaging Validation was performed and demonstrated that the packaging and<br>the system met the environmental conditioning and simulated shipping per the<br>applicable sections of ASTM D4332-14 and ASTM D4169.<br>Usability Testing<br>System Verification and Validation testing for functionality and performance<br>in a simulated environment. | |
| | Preclinical and clinical testing were not required for the CardioInsight Cardiac<br>Mapping System.<br>Testing demonstrated that the CardioInsight Cardiac Mapping System met the | |
| | requirements and functioned as intended. | |
| Discussion | Minor differences in technology, update of hardware due to obsolescence,<br>removal of the printer that was not used, removal of the UPS for portability<br>and not necessary for function of current system and the addition of an<br>optional second monitor do not change the fundamental technology.<br>Modifications to the software, firmware and algorithms were made for<br>usability, reducing the manual interaction required. Updates were made to<br>firmware for bug fixes, off the shelf software to update to the latest versions<br>and additions to support functionality. Indications for use, principals of<br>operations and fundamental technology do not change with these<br>modifications. | |
| Conclusion | The data presented in this submission demonstrate that the Medtronic<br>CardioInsight Cardiac Mapping System is substantially equivalent to the<br>predicate device identified in intended use, device design, fundamental<br>technology and performance. | |

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Performance Data

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Image /page/7/Picture/0 description: The image contains the Medtronic logo. The logo features a circular graphic with three stylized human figures in different poses, suggesting movement or transformation. Below the graphic is the word "Medtronic" in a bold, blue sans-serif font. The overall design is clean and corporate, reflecting the company's presence in the medical technology industry.