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 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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Accuracy to properly identify a PVC or VT foci in the right, left, or septal region of the heart	100% agreement with CARTO localization (45 out of 45 subjects)

Study Details

2. Sample size used for the test set and the data provenance:

Sample Size: 45 patients
Data Provenance: Prospective, non-randomized study conducted at 6 US centers.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. However, it indicates that the VIVO localization was compared with "CARTO localization", implying that CARTO mapping results were used as the reference standard (ground truth), which would typically be interpreted by electrophysiologists.

4. Adjudication method for the test set:

The document does not explicitly describe an adjudication method. The comparison states "VIVO localization... agreed (was a match) with the CARTO localization," suggesting a direct comparison without a complex adjudication process between multiple readers.

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:

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted. This study focused on the standalone accuracy of the VIVO system compared to CARTO localization.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Yes, a standalone assessment of the VIVO system's performance was done. The study "assessed VIVO's ability to accurately determine the anatomical location of a particular ventricular origin," and its localization was directly compared to CARTO results. While physicians analyze the VIVO output, the study evaluates the accuracy of the system itself in producing the localization.

7. The type of ground truth used:

The ground truth used was CARTO localization. CARTO is an established electroanatomical mapping system used to create 3D maps of the heart and identify arrhythmia origins.

8. The sample size for the training set:

The document does not provide information regarding the sample size for the training set. The clinical study described is for validation/performance assessment.

9. How the ground truth for the training set was established:

The document does not provide information on how the ground truth for any training set was established. The clinical study described focuses on the performance of the finished device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)	☑
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)500 International DriveSuite 333Mt. Olive, NJ 07828Telephone: (973) 691-2000Establishment Registration No: 3010728615
Primary Contact:	Mr. Steve AdlerChief Executive OfficerTelephone: (973) 691-2000Email: steve.adler@catheterprecision.com
Alternate Contact:	Ms. Karen BannickRegulatory Affairs ConsultantBannick Consulting, LLCTelephone: (320) 630-5171Email: Karen@bannickconsulting.com
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:

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.

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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™Subject Device	MedtronicCardioInsight™K162440	Rationale for Difference(if applicable)
Product Code	DQK	DQK	Same
Regulation	21 CFR 870.1425	21 CFR 870.1425	Same
Intended Use	For individuals undergoingan EP study for focalventricular arrhythmias.	For individuals undergoingan EP study.	VIVO software has notbeen validated for atrialuse.
Indications for Use	VIVO is intended foracquisition, analysis, displayand storage of cardiacelectrophysiological dataand maps for analysis by aphysician.VIVO is intended to be usedas a pre-procedure planningtool for patients withstructurally normal heartsundergoing ablationtreatment for idiopathicventricular arrhythmias.	The MedtronicCardioInsight MappingSystem is intended foracquisition, analysis,display and storage ofcardiacelectrophysiological dataand maps for analysis by aphysician.
System	Monitor, Core Processor,Keyboard, and Mouse (allpart of the laptopcomputer), 3D Camera(Kinect™).	Cart, Monitor, CoreProcessor, Keyboard,Mouse, IsolationTransformer, Cabling,Sensor Array, SecondMonitor connection.
DICOM Compliance	Yes	Yes	Same
Image ScanModalities Accepted	CT, MR	CT
Principles ofOperation	Electrocardiographicpotentials are measuredfrom standard 12-lead ECG.VIVO establishes patienttorso geometry viasegmented DICOM imagesand ECG electrodeplacement via a 3Dphotograph. From thesedata, the system usesmathematical algorithms touse the geometricalinformation to transform themeasured body surfacesignals into epicardial signalsvia solving the cardiacinverse problem.	Electrocardiographicpotentials are measuredfrom the torso sensors onthe surface of the body. A CTscan is segmented to obtainthe 3- dimensional locationof each sensor and thedetailed anatomy of theepicardial surface of theheart. From these data, thesystem uses mathematicalalgorithms to use thegeometrical information totransform the measuredbody surface signals intoepicardial signals via solvingthe cardiac inverse problem.
Functional Overview	Basic Steps to Mapping:1. MR/CT images areimported and used tobuild 3D model of thepatient's heart andtorso2. Overlay ECGlocation via 3Dcamera3. Align torso/heart model4. Load ECG Data5. Analyze	Basic Steps to Mapping:1. CT images areimported and usedto build 3D model ofthe patient's heart2. Capture 3Dgeometry ofpatient's torso(from vest)3. Overlay ECGlocation during CTimage acquisition	The method of generatingthe map does not impactthe final results.
			4. Align torso/heartmodel
			5. Load ECG data
			6. Analyze
			7. Produce map
ECG Acquisition		Standard 12-lead surfaceECG output imported intoVIVO device	Proprietary vest with 252electrodes for surface ECGand recorded throughproprietary ECGacquisitionhardware/firmware	VIVO uses a standard 12-lead ECG and standardlead placement. VIVOcaptures the leadlocations relativeto the patient's torsogeometry using the Kinect
ECG ElectrodeIdentification/Localization		Standard 12 lead ECGelectrode locations acquiredwith 3D imaging camera.Algorithm merges the 3Dimage of the 12 lead ECGelectrode locations withtorso. User manuallyadjusts the electrodeposition to the 3D imagefor accuracy.	Custom 252 electrodeimages acquired during CTimaging.Algorithm merges ECGlocation with torso with asegmentation process. Usermanually adds and deleteselectrodes after merge.	3D camera to obtain a 3Dphotograph. Thepredicate, CardioInsightutilizes a 252 electrodesensor-array vest to gatherthe ECG and determinethe patient's torsogeometry.
Cardiac MapsProvided		Color coded map of earliestactivation point andpropagation of cardiac beat	Activation map, directionalactivation map, phase map,potential map, voltagemap, slew rate map,propagation map	VIVO's color codedactivation map is providedfor illustrative purposesonly during pre-proceduremapping.

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.

Regulation Number and Section

§ 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).