CardioInsight Cardiac Mapping System

K181918 · Medtronic, Inc. · DQK · Nov 8, 2018 · Cardiovascular

Device Facts

• Record ID: K181918
• Device Name: CardioInsight Cardiac Mapping System
• Applicant: Medtronic, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Nov 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The 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

CardioInsight Cardiac Mapping System is a non-invasive, mobile system for beat-by-beat, multi-chamber, 3D cardiac mapping. It operates by acquiring real-time chest ECG signals via a torso-worn Sensor Array and integrating them with patient-specific CT scan data. Mathematical algorithms solve the cardiac inverse problem to transform body surface ECG signals into virtual epicardial electrograms. The system generates interactive 3D color maps—including potential, activation, voltage, propagation, and phase maps—displayed on a workstation. Used in clinical settings like the EP lab or at the bedside, the system is operated by physicians to analyze cardiac electrophysiology. The output assists clinicians in visualizing cardiac electrical activity, supporting clinical decision-making during electrophysiological procedures. Benefits include non-invasive mapping of cardiac rhythms.

Clinical Evidence

Bench testing only. No clinical data. Testing included software verification and integration testing per AAMI/ANSI/IEC 62304, algorithm testing, and simulated use testing. Usability testing was conducted per IEC 62366-1, including formative evaluations, use error analysis, and mockup reviews. Testing verified that the system meets design input requirements and performs as intended.

Technological Characteristics

Non-invasive 3D mapping system comprising a workstation, amplifier, isolation transformer, and torso Sensor Array. Uses mathematical algorithms to solve the cardiac inverse problem. Connectivity includes standard workstation peripherals and USB tools. Software is moderate level of concern. Security features include hard drive encryption and database permissions. Sterilization not applicable (non-invasive).

Indications for Use

Indicated for individuals undergoing an EP study for the 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

• CardioInsight Cardiac Mapping System (K162440)

Submission Summary (Full Text)

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November 8, 2018

Medtronic, Inc. Janell Colley Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112

# Re: K181918

Trade/Device Name: CardioInsight Cardiac Mapping System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: October 9, 2018 Received: October 10, 2018

# Dear Janell Colley:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely

Mude Jellman
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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#### K181918

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K181918

### Device Name

CardioInsight® Cardiac Mapping System

#### Indications for Use (Describe)

The 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)

> 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 9, 2018 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Medtronic, Inc.<br>8200 Coral Sea Street NE<br>Mounds View, MN 55112<br>Establishment Registration Number 2012208 |
| Contact Persons<br>Primary Contact: | Janell Colley<br>Principal Regulatory Affairs Specialist<br>Telephone: [phone]<br>Email: [e-mail] |
| Alternate Contact: | Heather Taylor<br>Regulatory Affairs Manager<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: | CardioInsight Cardiac Mapping System |
| Common Name: | Electrophysiological cardiac mapping system |
| Classification: | Class II |
| Panel: | Cardiovascular |
| Product Code: | DQK |
| Regulation: | 21 CFR 870.1425 |
| Predicate Device: | CardioInsight Cardiac Mapping System, K162440, Cleared November 4, 2016 |

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Image /page/4/Picture/1 description: The image contains the Medtronic logo. The logo consists of a circular graphic above the word "Medtronic" in blue. The graphic shows a human figure in motion, with three overlapping silhouettes suggesting movement. The word "Medtronic" is written in a bold, sans-serif font.

| Device Description | The CardioInsight Cardiac Mapping System is a non-invasive mapping system for<br>beat-by-beat, multi-chamber, 3D mapping of the heart. The CardioInsight Cardiac<br>Mapping System displays cardiac maps and virtual electrograms from real-time chest<br>ECG signals (measured by a Sensor Array placed on the torso) and CT scan data.<br>The ECG signals in concert with the CT scan information (geometrical information)<br>are used in mathematical algorithms to transform the measured body surface signals<br>into epicardial signals via solving the cardiac inverse problem. The CardioInsight<br>Cardiac Mapping System software uses this data to provide various cardiac signal<br>analyses and displays interactive 3D color maps including potential, activation,<br>voltage, propagation, and phase maps. The CardioInsight Cardiac Mapping System is<br>mobile and can be used for mapping at the patient's bedside or in the EP lab. |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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| Model Numbers | |
|--------------------------------------|-------------------------------------|
| CardioInsight Cardiac Mapping System | CIT200 |
| Sensor Array (Vest) | CITVST0001S (size small) |
| | CITVST0002M (size medium) |
| | CITVST0003L (size large) |
| | CITVST0004XL (size x-large) |
| Workstation Computer with Software | PN-0008-0001-0000 |
| Amplifier | PN-0006-0001-0000 |
| Signal Cables | PN-AT200-AMP-0002 (right side) |
| | PN-AT200-AMP-0003 (left side) |
| | PN-AT200-AMP-0004 (back left side) |
| | PN-AT200-AMP-0005 (back right side) |
| Patient Ground Reference Cable | PN-AT200-AMP-0021 |
| Isolation Transformer | PN-0004-0008-0003 |
| Monitor | PN-0004-0008-0007 |
| USB Tool | CITUSB |

| <b>Indications for Use:</b> | The 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. |

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#### Medtronic Comparison of The CardioInsight Cardiac Mapping System uses the same technology, and has the Technological same intended use, fundamental technology, principal of operation and performance as Characteristics the predicate device. Modifications to software were made to enhance map processing/analysis capabilities and usability. Multiple anomalies were addressed, and

| Characteristic | CardioInsight Cardiac Mapping System<br>v3.0<br>(Predicate System) | CardioInsight Cardiac Mapping System<br>v3.5<br>(Proposed System) |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Intended Use | Individuals undergoing an EP Study | Identical |
| Indications for Use | The CardioInsight Cardiac Mapping System is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician. | Identical |
| System components | Cart, Monitor, Core processor, Keyboard, Mouse, Isolation Transformer, Cabling, Sensor Array, Second monitor connections | Identical |
| Principles of Operation | Electrocardiographic potentials are measured from the torso sensors on the surface of the body. A CT scan is segmented to obtain the 3-dimensional location of each sensor and the detailed anatomy of the epicardial surface of the heart. From these data, the system uses mathematical algorithms to use the geometrical information to transform the measured body surface signals into epicardial signals via solving the cardiac inverse problem. | Identical |
| Software/<br>Firmware/<br>Algorithm | Creates patient records<br>Segments heart and vest electrodes<br>Acquires sensor array signals<br>Creates and reviews maps | Identical workflows; software enhancements throughout. |

off-the-shelf software updates and additions were made. Security features were added.

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| Off the Shelf<br>Software | In addition to other unchanged OTS/SOUP software, device uses the following OTS/SOUP software: | In addition to other unchanged OTS/SOUP software, |
|---------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | BBV Common 7.4 SQL Server Express 12.0.2000.8 SnagIt 9.1.3 .NET 4.5.2 DevExpress 14.2.4 MVVM Light 3.0.0.29166 | Appccelerate State 2.12.0 (formerly BBV Common) SQL Server Express 12.0.5000.8 SnagIt 12.4.1 .NET 4.5.2 with Language Packs DevExpress 14.2.4 with Language Packs libFLAC 1.3.2 Libogg 1.3.1 FlacDotNet 1.5.0.0 NASM 2.13.01 Json.NET 10.0.3 Ndesk.Options 0.2.1 McAfee Endpoint Security for OEM 10.5.3 McAfee Medical Devices Solution 7.2.4 |

| Performance<br>Data | Performance testing was completed on the CardioInsight Cardiac Mapping System<br>which verified that the System complies with the safety and specifications and<br>performs as designed; it is suitable for its intended use. Performance testing for the<br>proposed system included the following: |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Software verification and integration testing was performed and complied with<br>FDA's Guidance for the Content of Premarket Submissions for Software<br>Contained in Medical Devices" and AAMI / ANSI / IEC<br>62304:2006/AMD1:2015, Medical Device Software - Software Life Cycle<br>Processes. The software in this system is considered moderate level of<br>concern as failure could contribute to a hazard leading to non-serious injury. Testing evaluated the following: Integration testing to conclude that the product design output meets the<br>design input requirements of the integration of algorithm code. Verification testing to conclude the product design output meets the design<br>input requirements Algorithm Testing and Integration – verified the algorithms met requirements<br>and functioned as intended, and when integrated, performed as expected. Bench testing and simulated use testing evaluated the following: Max -dV/dt vs. Mid-Point Activation Algorithm Detection via new IBCD Algorithm Remove bad channels from inverse calculation |

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| System Verification and Validation testing for functionality and performance in a simulated environment.<br>Testing evaluated the following: Verification testing to conclude the product design output meets the design input requirements Validation testing to conclude the design validation for the incremental changes made to the system performs as intended from the user perspective Usability Testing per IEC 62366-1 Edition 1.0 2015-02<br>Usability testing consisted of Human Factors testing for the incremental changes made to the system, including formative evaluation activities, use error analysis, user interface design, mockup reviews, labeling review, and formal/informal simulated use evaluations. | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Discussion | Modifications to the software and algorithms were made for usability and mapping enhancements. Updates were made to address anomalies. Off-the-shelf software changes were made to utilize latest versions and additions to support functionality. Security features including hard drive encryption and database permissions refinement have been added. Indications for use, principals of operations and fundamental technology do not change with these modifications. |
| Conclusion | The data presented in this submission demonstrate that the CardioInsight Cardiac Mapping System v3.5 is substantially equivalent to the predicate device identified in intended use, device design, fundamental technology and performance. |