VIVO

K183195 · Catheter Precision, Inc. · DQK · Jun 14, 2019 · Cardiovascular

Device Facts

• Record ID: K183195
• Device Name: VIVO
• Applicant: Catheter Precision, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Jun 14, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

VIVO is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician. VIVO is intended to be used as a pre-procedure planning tool for patients with structurally normal hearts undergoing ablation treatment for idiopathic ventricular arrhythmias.

Device Story

VIVO is a noninvasive pre-procedure planning tool for focal ventricular arrhythmias. Inputs include patient-specific CT or MR DICOM images, standard 12-lead ECG recordings, and a 3D photograph of the patient's chest (captured via handheld 3D camera) to record electrode positions. The system segments DICOM images to create a 3D model of the heart and torso; it then merges this model with the 3D photograph to determine the spatial relationship between ECG electrodes and cardiac anatomy. A mathematical algorithm solves the cardiac inverse problem to transform body surface potentials into myocardial potentials. The system outputs a 3D rendering of the heart with color-coded activation maps indicating the earliest activation site. Used in clinical settings by physicians to identify arrhythmia foci prior to ablation procedures. Benefits include improved pre-procedure planning and localization accuracy, potentially streamlining ablation treatment.

Clinical Evidence

Prospective, non-randomized study (N=45) in patients with structurally normal hearts and <10% scar undergoing PVC/VT ablation. Primary endpoint: accuracy of VIVO in identifying PVC/VT foci compared to CARTO localization. Results showed 100% agreement (95% CI: 93.6%, 100%). No adverse events reported.

Technological Characteristics

System includes laptop computer and handheld 3D camera (Kinect). Uses DICOM (CT/MR) for anatomical modeling. Employs mathematical algorithms to solve the cardiac inverse problem, transforming body surface potentials to myocardial potentials. Software-based analysis. No specific material standards cited.

Indications for Use

Indicated for patients with structurally normal hearts undergoing ablation treatment for idiopathic ventricular arrhythmias.

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

• Medtronic CardioInsight Cardiac Mapping System (K162440)

Submission Summary (Full Text)

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June 14, 2019

Catheter Precision, Inc. Karen Bannick Regulatory Affairs Consultant 500 International Drive Suite 333 Mt. Olive, New Jersey 07828

Re: K183195

Trade/Device Name: VIVO Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: May 9, 2019 Received: May 15, 2019

Dear Karen Bannick:

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

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K183195

Device Name VIVO

#### Indications for Use (Describe)

VIVO is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.

VIVO is intended to be used as a pre-procedure planning tool for patients with structurally normal hearts undergoing ablation treatment for idiopathic ventricular arrhythmias.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">☑</span> |
|----------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |

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Image /page/3/Picture/1 description: The image shows the logo for Catheter Precision. The logo consists of a blue graphic on the left and the words "Catheter Precision" on the right. The graphic is made up of three curved lines that are stacked on top of each other. The words "Catheter Precision" are written in a sans-serif font.

| Applicant's Name | Catheter Precision, Inc. (Owner/Operator)<br>500 International Drive<br>Suite 333<br>Mt. Olive, NJ 07828<br>Telephone: [phone]<br>Establishment Registration No: 3010728615 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Mr. Steve Adler<br>Chief Executive Officer<br>Telephone: [phone]<br>Email: [e-mail] |
| Alternate Contact: | Ms. Karen Bannick<br>Regulatory Affairs Consultant<br>Bannick Consulting, LLC<br>Telephone: [phone]<br>Email: [e-mail] |
| Trade Name: | VIVO™ |
| Common Name: | Electrophysiological cardiac mapping system |
| Classification Name: | Programmable diagnostic computer |
| Date Revised: | June 13, 2019 |
| Classification/Panel: | Class II, Cardiovascular |
| Product Code: | DQK |

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### Regulation Number: 21 CFR 870.1425

Predicate Device: Medtronic CardioInsight® Cardiac Mapping System (K162440)

#### Device Description:

The VIVO system is a noninvasive pre-procedure planning tool that provides a 3D mapping of the heart to aid in the identification of the general location of the origin of focal ventricular arrhythmias prior to electrophysiology procedures. VIVO requires acquisition of MRI or CT images and standard ECG recordings and lead (electrode) placement. Electrocardiographic potentials are measured from the torso using standard 12 lead electrocardiogram (ECG) sensors placed on the surface of the body. A DICOM image (CT or MR scan) of the thorax and heart is acquired and then segmented to provide a detailed, three-dimensional (3D) anatomy of the endocardial and epicardial surface of the heart. A 3D photograph of the patient's chest with the precise ECG lead positions used to acquire the 12 lead ECG is merged with the torso and heart model to determine the spatial relationship between the electrodes and the heart. From these data, the system uses a mathematical algorithm to use the geometrical information to transform the measured body surface potentials into myocardial potentials via solving the cardiac inverse problem. The VIVO system uses an off the shelf laptop computer and a handheld 3D camera. The VIVO software creates, displays, and stores a cardiac model that displays the site of earliest activation of ventricular arrhythmias.

To develop the cardiac model, VIVO requires the following inputs:

- · MR or CT scan images in the DICOM file format are imported and combined with preloaded reference models in the VIVO software
- · Standard 12-lead ECG recordings acquired during the arrhythmia are imported to VIVO software
- A 3D photograph of the placement of the ECG leads is created using the VIVO 3D camera

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VIVO software is comprised of two software applications, VIVO Anatomy and VIVO Analysis.

VIVO Anatomy merges the imported cardiac MR/CT image data with a model to create a heart and torso model representative of a patient's specific anatomy. The MR/CT image data must be imported via a DVD containing the images in DICOM format (Note: VIVO does not have a web interface). The DICOM image is then overlayed on top of one of a number of preloaded anatomical models to fine tune the preloaded model. The model that best matches the patient's anatomical profile is chosen. Specific cardiac structures and tissues are identified by the User within the images to better match the patient anatomy. An outline of the chambers and tissue walls is automatically created by VIVO which is then finetuned by the User for a precise match to the patient's anatomy.

VIVO Analysis combines the heart and torso model generated from VIVO Anatomy with ECG data, and a 3D photograph of the ECG lead placement to identify the location of the arrhythmia foci. After ECG leads are placed on the patient, a 3D photograph of the patient's chest is captured to accurately record lead locations. Arrhythmic ECG signals are recorded from these electrodes and imported into the VIVO software. This data is combined and a mathematical algorithm is used create a 3D rendering of the patient's heart with superimposed color coding to indicate the area of earliest activation.

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Model Number of VIVO System: 9001.

### Comparison of Technical Characteristics with Predicate Device

This submission is seeking the clearance of the VIVO system which, like the predicate device, provides a 3D mapping of the heart to aid in the identification of the general location of the origin of focal cardiac arrhythmias prior to electrophysiology procedures.

The predicate device and the VIVO system have the same intended use, fundamental technology, principal of operation and performance. Both VIVO and the predicate require a DICOM image and location data of the electrodes to create a patient specific model.

VIVO users review and adjust a merged 3D image of the 12 lead ECG electrode locations and the torso. Users of the predicate add and delete electrodes after the algorithm merges ECG location with the torso using a segmentation process.

Where there are technological differences, they do not affect the safety and effectiveness of the device when used as labeled. Table 1 provides a comparison of the technological characteristics for the VIVO system against the predicate device.

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| Characteristic | VIVO™<br>Subject Device | Medtronic<br>CardioInsight™<br>K162440 | Rationale for Difference<br>(if applicable) | |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DQK | DQK | Same | |
| Regulation | 21 CFR 870.1425 | 21 CFR 870.1425 | Same | |
| Intended Use | For individuals undergoing<br>an EP study for focal<br>ventricular arrhythmias. | For individuals undergoing<br>an EP study. | VIVO software has not<br>been validated for atrial<br>use. | |
| Indications for Use | VIVO is intended for<br>acquisition, analysis, display<br>and storage of cardiac<br>electrophysiological data<br>and maps for analysis by a<br>physician.<br><br>VIVO is intended to be used<br>as a pre-procedure planning<br>tool for patients with<br>structurally normal hearts<br>undergoing ablation<br>treatment for idiopathic<br>ventricular arrhythmias. | The Medtronic<br>CardioInsight 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 a<br>physician. | | |
| System | Monitor, Core Processor,<br>Keyboard, and Mouse (all<br>part of the laptop<br>computer), 3D Camera<br>(Kinect™). | Cart, Monitor, Core<br>Processor, Keyboard,<br>Mouse, Isolation<br>Transformer, Cabling,<br>Sensor Array, Second<br>Monitor connection. | | |
| DICOM Compliance | Yes | Yes | Same | |
| Image Scan<br>Modalities Accepted | CT, MR | CT | | |
| Principles of<br>Operation | Electrocardiographic<br>potentials are measured<br>from standard 12-lead ECG.<br>VIVO establishes patient<br>torso geometry via<br>segmented DICOM images<br>and ECG electrode<br>placement via a 3D<br>photograph. From these<br>data, the system uses<br>mathematical algorithms to<br>use the geometrical<br>information to transform the<br>measured body surface<br>signals into epicardial signals<br>via solving the cardiac<br>inverse problem. | Electrocardiographic<br>potentials are measured<br>from the torso sensors on<br>the surface of the body. A CT<br>scan is segmented to obtain<br>the 3- dimensional location<br>of each sensor and the<br>detailed anatomy of the<br>epicardial surface of the<br>heart. From these data, the<br>system uses mathematical<br>algorithms to use the<br>geometrical information to<br>transform the measured<br>body surface signals into<br>epicardial signals via solving<br>the cardiac inverse problem. | | |
| Functional Overview | Basic Steps to Mapping:<br>1. MR/CT images are<br>imported and used to<br>build 3D model of the<br>patient's heart and<br>torso<br>2. Overlay ECG<br>location via 3D<br>camera<br>3. Align torso/heart model<br>4. Load ECG Data<br>5. Analyze | Basic Steps to Mapping:<br>1. CT images are<br>imported and used<br>to build 3D model of<br>the patient's heart<br>2. Capture 3D<br>geometry of<br>patient's torso<br>(from vest)<br>3. Overlay ECG<br>location during CT<br>image acquisition | The method of generating<br>the map does not impact<br>the final results. | |
| | | | 4. Align torso/heart<br>model | |
| | | | 5. Load ECG data | |
| | | | 6. Analyze | |
| | | | 7. Produce map | |
| ECG Acquisition | | Standard 12-lead surface<br>ECG output imported into<br>VIVO device | Proprietary vest with 252<br>electrodes for surface ECG<br>and recorded through<br>proprietary ECG<br>acquisition<br>hardware/firmware | VIVO uses a standard 12-<br>lead ECG and standard<br>lead placement. VIVO<br>captures the lead<br>locations relative<br>to the patient's torso<br>geometry using the Kinect |
| ECG Electrode<br>Identification/<br>Localization | | Standard 12 lead ECG<br>electrode locations acquired<br>with 3D imaging camera.<br><br>Algorithm merges the 3D<br>image of the 12 lead ECG<br>electrode locations with<br>torso. User manually<br>adjusts the electrode<br>position to the 3D image<br>for accuracy. | Custom 252 electrode<br>images acquired during CT<br>imaging.<br><br>Algorithm merges ECG<br>location with torso with a<br>segmentation process. User<br>manually adds and deletes<br>electrodes after merge. | 3D camera to obtain a 3D<br>photograph. The<br>predicate, CardioInsight<br>utilizes a 252 electrode<br>sensor-array vest to gather<br>the ECG and determine<br>the patient's torso<br>geometry. |
| Cardiac Maps<br>Provided | | Color coded map of earliest<br>activation point and<br>propagation of cardiac beat | Activation map, directional<br>activation map, phase map,<br>potential map, voltage<br>map, slew rate map,<br>propagation map | VIVO's color coded<br>activation map is provided<br>for illustrative purposes<br>only during pre-procedure<br>mapping. |

# Table 1: Technological Characteristics Comparison

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K183195

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## Indications for Use:

VIVO is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.

VIVO is intended to be used as a pre-procedure planning tool for patients with structurally normal hearts undergoing ablation treatment for idiopathic ventricular arrhythmias.

### Performance Data

Performance testing was completed on the VIVO system which verified that the device complies with the safety and specifications and performs as designed. VIVO is suitable for its intended use. Performance Testing included hardware testing, software verification and integration testing performed in compliance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and AAMI / ANSI / IEC 62304:2006, Medical Device Software -Software Life Cycle Processes, clinical testing, system verification and validation testing for functionality and performance in a simulated environment.

## Clinical Study

A prospective, non-randomized study ("VIVO Accuracy Study") was completed at 6 US centers. This clinical evaluation was developed primarily to assess VIVO's ability to accurately determine the anatomical location of a particular ventricular origin. The VIVO Accuracy Study enrolled 51 patients and analyzed data from 45 patients presenting for PVC or VT ablation with structurally normal hearts and less than 10% scar.

Approximately 47% of subjects were male, and the average age was 56.4 years. Of the 45 subjects, 44 underwent an ablation procedure for PVCs and 1 underwent an ablation procedure for ventricular tachycardia (determined day of procedure). There was no subgroup analysis conducted.

Of the 45 subjects, 20% (N=9) had previous ablations and no subjects

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had a previous myocardial infarction (MI). Other arrhythmias were noted at baseline in 53.33% (24), and 15.56% (N=7) reported having no symptoms associated with their PVC or VT. The most common symptom was palpitations which was reported in 57.78% (N=26) of subjects.

The study results demonstrated acceptable clinical accuracy performance of VIVO. There were no adverse events. The primary endpoint assessed the accuracy of VIVO to properly identify a PVC or VT foci in the right, left, or septal region of the heart. It was determined that the VIVO localization of the PVC/VT foci agreed (was a match) with the CARTO localization in 45 of the 45 subjects. Thus, the primary endpoint had an accuracy rate of 100% (95% Cl: 93.6%, 100%), which met the pre-specified performance goal.

#### Conclusion

The data presented in this submission demonstrate that the VIVO system is substantially equivalent to the predicate device identified in intended use, device design, fundamental technology and performance.