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 identifying the origin of cardiac arrhythmias prior to electrophysiology procedures. VIVO requires acquisition of MRI or CT images combined with standard ECG recordings and electrode placement. Electrocardiographic potentials are measured from the torso using standard 12 lead electrocardiogram (ECG) electrodes 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 patient specific, three-dimensional (3D) anatomy of the endocardial and epicardial surfaces of the heart. A 3D photograph of the patient's chest with the precise ECG lead locations and positioning patches that were used to acquire the ECG is merged with the torso and heart model to determine the spatial relationship between them. From these data, the system uses a mathematical algorithm to assimilate the geometrical information and transform the measured body surface signals into epicardial signals by solving the cardiac inverse problem. VIVO software creates, displays, and stores a cardiac activation map that displays the site of earliest activation of ventricular arrhythmias.

The VIVO system includes an off the shelf laptop computer and a handheld 3D camera. The preloaded software takes data from previously acquired cardiac and thoracic images, standard 12-lead ECG recording made during an arrhythmia and 3D picture of the ECG leads and positioning patches. This information, obtained prior to the procedure, can be used during pre-procedure planning by a qualified physician.

AI/ML Overview

The provided text details the 510(k) premarket notification for the VIVO™ Model 9002 system (K200313), which is a pre-procedure planning tool for identifying the origin of cardiac arrhythmias. However, the document does not contain explicit acceptance criteria or detailed results of a study proving the device meets specific performance criteria related to its accuracy in identifying arrhythmia origins.

Instead, the performance data section focuses on verification and validation (V&V) testing to confirm that the VIVO Model 9002 system operates as intended and is substantially equivalent to its predicate device (VIVO Model 9001). The "Performance Data" section primarily describes:

System Testing: Verification that the assembled VIVO Model 9002 device met specified requirements, including VIVO software access, laptop PC function, and 3D camera function (with positioning patches).
Bench Testing: Confirmation of the system's ability to collect the position of patches and electrodes.
User Validation Testing: Evaluation of the usability of the new software workflow and the user's ability to generate a 3D model. This included identifying critical tasks and collecting pass/fail data.
Biocompatibility Testing: For positioning patches, conforming to ISO 10993-1.
Shelf Life Testing: For positioning patches (one-year shelf life).

The document explicitly states: "Clinical Testing Not required to demonstrate substantial equivalence to the predicate device." This implies that the FDA determined that extensive clinical performance data for arrhythmia localization was not necessary for the 510(k) clearance, likely due to the device's classification and its claimed substantial equivalence to a previously cleared device.

Therefore, many of the requested details about acceptance criteria for device performance (e.g., accuracy in identifying arrhythmia origin), sample sizes for test sets, ground truth establishment, expert adjudication, and comparative effectiveness studies are not present in the provided 510(k) summary. The study described is primarily a non-clinical performance study focusing on system functionality, usability, and equivalence to the predicate, rather than a clinical accuracy or comparative effectiveness study for the core diagnostic claim.

Given the limitations of the provided text, I will answer the questions based on the information available and explicitly state when information is not present.

Acceptance Criteria and Device Performance Study (Based on Provided Document)

1. A table of acceptance criteria and the reported device performance

As explicitly stated, the performance testing focused on system verification and validation, demonstrating that the device met system requirements, component operation, and performance, and that the usability was acceptable. There are no quantitative acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity for arrhythmia origin localization) provided in this specific document.

Acceptance Criteria Category	Specific Criteria (Implied from text)	Reported Device Performance
System Functionality	Device meets system requirements; component operation and performance as specified. Access to VIVO software, Laptop PC function, and 3D camera function (with positioning patches) are as intended. Ability to collect the position of patches and electrodes.	"System performance specifications were successfully verified to meet design outputs at the end of the bench testing." "Bench testing was performed to confirm the ability of the system to collect the position of the patches and electrodes."
Usability / Workflow	New software workflow is usable; user can successfully generate a 3D model; design mitigates user error to an acceptable level for critical and essential tasks.	"The user validation testing supporting the accuracy of the user to generate a 3D model by the simplified workflow, and that the design has mitigated user error to an acceptable level." Task performance (pass, fail, close call/serious difficulty) data was collected, with clear pass/fail criteria. (Specific quantitative results not provided).
Biocompatibility of Positioning Patches	Conforms to ISO 10993-1.	"The results demonstrate that the device is biocompatible."
Shelf Life of Positioning Patches	Demonstrates a one-year shelf life.	"Shelf life testing was performed to demonstrate a one-year shelf life for the positioning patches."
Compliance with Software Standards (IEC 62304)	Software verification and integration testing performed in compliance with "FDA's Guidance for the Content of Premarket Submissions for Software in Medical Devices" and AAMI / ANSI / IEC 62304:2006.	"Performance testing... included product system testing, software verification and integration testing performed in compliance with 'FDA's Guidance for the Content of Premarket Submissions for Software in Medical Devices' and AAMI / ANSI / IEC 62304:2006..."
Substantial Equivalence (Overall Conclusion)	Device is substantially equivalent to the predicate device in intended use, device design, fundamental technology, and performance.	"The VIVO Model 9002 system has the same intended use, fundamental technology, principles of operation and performance as the predicate device." "Performance testing verified that the VIVO system complies with the safety and specifications and performs as designed. Therefore, VIVO is suitable for its intended use."

Note: The document does not provide performance data or acceptance criteria related to accuracy of arrhythmia localization, as this was not a required part of the substantial equivalence determination according to the stated "Clinical Testing Not required" clause.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated for performance testing. The text refers to "System Testing," "Bench testing," and "User Validation Testing" but does not quantify the number of cases or users involved in these tests.
Data Provenance: Not specified. The testing described appears to be internal verification and validation, possibly synthetic data for bench tests or internal users for usability tests, rather than clinical patient data. The clinical testing was explicitly stated as "Not required."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable as the described "Performance Data" section focuses on system functionality and usability, not diagnostic accuracy requiring expert-established ground truth for a clinical test set. The document states "Clinical Testing Not required".

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as the described "Performance Data" section focuses on system functionality and usability, not diagnostic accuracy requiring adjudication for a clinical test set.

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 performed or submitted for this 510(k). The document explicitly states, "Clinical Testing Not required to demonstrate substantial equivalence to the predicate device." The VIVO system is described as a "pre-procedure planning tool" and not an AI-assisted diagnostic tool that would typically warrant such a study for this type of clearance.

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

The document describes the VIVO system as a "pre-procedure planning tool that provides a 3D mapping of the heart to aid in identifying the origin of cardiac arrhythmias prior to electrophysiology procedures." The "Analysis algorithm is identical to VIVO Model 9001." However, the performance data section focuses on system and software functionality and usability, not the standalone algorithmic accuracy of "identifying the origin of cardiac arrhythmias." While the algorithm is a core component, a specific standalone performance study measuring its diagnostic accuracy (e.g., against some defined ground truth) is not detailed. The clearance relies on substantial equivalence primarily due to the functional and technical similarities to the predicate, and usability enhancements.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the reported performance testing (system and user validation), the "ground truth" was internal design specifications and defined usability task completion criteria. For the purpose of "identifying the origin of cardiac arrhythmias," the document implies that this is a physician's analysis, and no external ground truth (e.g., confirmed ablation success, invasive mapping, pathology) was used as part of this 510(k)'s "Performance Data."

8. The sample size for the training set

The document does not discuss a training set or the development of an AI/machine learning model. While the system uses "mathematical algorithms to assimilate the geometrical information and transform the measured body surface signals into epicardial signals," there is no indication that this involves trainable components requiring a distinct "training set" in the machine learning sense. The "Analysis algorithm is identical to VIVO Model 9001," implying it's a fixed, established algorithm rather than a newly trained one.

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

Not applicable, as a training set for an AI/machine learning model is not discussed in the document.

Summary

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September 14, 2020

Catheter Precision, Inc. Steve Adler CEO 500 International Drive, Suite 255 Mt. Olive, New Jersey 07828

Re: K200313

Trade/Device Name: VIVO™M Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: July 30, 2020 Received: August 5, 2020

Dear Steve Adler:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 mediation-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 Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200313

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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Catheter Precision, Inc. 510(k): K200313

510(k) Summary

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((Catheter

Applicant's Name	Catheter Precision, Inc. (Owner/Operator)500 International Drive, Suite 255Mt Olive, NJ 07828 USATelephone: (973) 691-2000Establishment Registration No: 3010728615
Primary Contact:	Mr. Steve AdlerChief Executive OfficerTelephone: (973) 691-2000Email: steve.adler@catheterprecision.com
Alternate Contact:	Ms. Karen Bannick McQuoidRegulatory Affairs ConsultantBannick, LLCTelephone: (612) 310-4529Email: karen@bannickprimary.com
Trade Name:	VIVO™
Common Name:	Electrophysiological cardiac mapping system
Classification Name:	Programmable diagnostic computer
Date Prepared:
Classification/Panel:	Class II, Cardiovascular
Product Code:	DQK
Regulation Number:	21 CFR 870.1425
Predicate Device:	Catheter Precision VIVO™(K183195)

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Device Description:

Model Number of VIVO System: 9002.

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.

Comparison of Technical Characteristics with Predicate Device

This submission is seeking the clearance of the VIVO Model 9002 system which, like the predicate device the VIVO Model 9001, 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 VIVO Model 9002 system has the same intended use, fundamental technology, principles of operation and performance as the predicate device. Where there are minor technological differences, they do not affect procedure, how the device is used, performance, function or safety compared to the predicate. Two changes include a smaller camera and the inclusion of positioning patches. VIVO Model 9002 includes an improved Graphical Use Interface (GUI) workflow during the Anatomy, 3D Image and

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ECG functions; however, the Analysis algorithm is identical to VIVO Model 9001. The fundamental Analysis algorithm creates, displays and stores a cardiac activation map that identifies the localization of the earliest activation of an arrhythmic heartbeat.

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™ Model 9002	VIVO™ Model 9001	Rationale for Differences (ifapplicable)
Subject Device	K183195
Product Code	DQK	DQK	Identical
Regulation	21 CFR 870.1425	21 CFR 870.1425	Identical
Intended Use	For individuals undergoing an EPstudy for ventricular arrhythmias.	For individuals undergoing an EPstudy for ventricular arrhythmias.	Identical
Indications for Use	VIVO is intended for the acquisition,analysis, display and storage ofcardiac electrophysiological data andmaps for analysis by a physician.	VIVO is intended for the acquisition,analysis, display and storage ofcardiac electrophysiological data andmaps for analysis by a physician.	Identical
System Components	Monitor, Core Processor, Keyboard,and Mouse (all part of the laptopcomputer), positioning patches.	Monitor, Core Processor, Keyboard,and Mouse (all part of the laptopcomputer).	Minor Technical Difference:Positioning patches are included inthe 3D Image.
3D Camera	3D Camera (Intel® RealSense™),	3D Camera (Kinect™).	Minor Technical Difference:The 3D camera has been replacedwith a smaller camera. Outputimages used by VIVO are equivalent.
Manufacturer	Intel	Microsoft
RGB Camera resolution(pixels)	1920 x 1080	1920 x 1080
Frame rate (fps)	30	30
Depth Cameraresolution (pixels)	1280 x 720	512 x 424
Frame rate (fps)	90	30
Color field of view:horiz/vert (degrees)	74 x 62	70 x 60
Characteristic	VIVO™ Model 9002	VIVO™ Model 9001	Rationale for Differences (ifapplicable)
Connector	USB 3.1 type C	USB 2.0 type A
Size (mm)	90 x 25 x 25	249 x 66 x 67
Weight	0.6 oz	3.1 lbs.
Graphical User Interface	Functions are on display, dialog boxesand pop-up messages, sliders, menusstructure for simplification andimproved workflow	Many functions require use ofmouse/key shortcuts	Minor Technical Differences:Changes with VIVO Model 9002simplify the user interface.
DICOM Compliance	Yes	Yes	Identical
Image Scan ModalitiesAccepted	CT, MR	CT, MR	Identical
Principles of Operation	Electrocardiographic potentials aremeasured from the torso electrodeson the surface of the body. A CT orMRI scan is segmented to obtain thedetailed anatomy of the epicardialand endocardial surface of the heartand torso geometry. The exactlocation of the ECG leads to the heartare then identified within thesoftware. From these data, thesystem uses mathematical algorithmsto use the geometrical information totransform the measured bodysurface signals into epicardial signalsvia solving the cardiac inverseproblem.	Electrocardiographic potentials aremeasured from the torso electrodeson the surface of the body. A CT orMRI scan is segmented to obtain thedetailed anatomy of the epicardialand endocardial surface of the heartand torso geometry. The exactlocation of the ECG leads to the heartare then identified within thesoftware. From these data, thesystem uses mathematical algorithmsto use the geometrical information totransform the measured bodysurface signals into epicardial signalsvia solving the cardiac inverseproblem.	Minor Technical Differences:VIVO Model 9002 establishes patienttorso geometry via semi-automatedsegmentation or manual DICOMimages compared to manual withVIVO Model 9001.VIVO Model 9002 has eight 3-Dmodels compared to 2 with VIVOModel 9001
Functional Overview	Steps to Mapping:1. MR/CT images are importedand used to build 3D model	Steps to Mapping:1. MR/CT images are importedand used to build 3D model	Minor Technical Difference:Positioning patches facilitatemerging of the 3D image andheart/torso model.
Characteristic	VIVO™ Model 9002	VIVO™ Model 9001	Rationale for Differences (if applicable)
	of the patient's heart and torso2. Overlay ECG and positioning patch location via 3D camera3. Align torso/heart model4. Load ECG Data5. Analyze6. Produce map	of the patient's heart and torso2. Overlay ECG location via 3D camera3. Align torso/heart model4. Load ECG Data5. Analyze6. Produce map
Software / Firmware / Algorithm	Create patient recordsSegment heart and electrodesAcquire ECG dataCreate and review maps	Create patient recordsSegment heart and electrodesAcquire ECG dataCreate and review maps	Minor Technical Differences:Simplified clinical workflow, combined two software applications into one, and improved user interface.
ECG Compatible Formats	Expanded ECG formats: mat, UNI, XML, inf, zip, csv, txt	inf, and mat (Bard conversion)	Minor Technical Difference:VIVO Model 9002 allows additional ECG formats.
Report Generation	PNG image as screen shot, and VTK export	None	Minor Technical Difference:VIVO Model 9002 has added a report generation function which can be created and exported.

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Performance Data

Performance testing was completed on the VIVO Model 9002 system in the same manner as the predicate device. Performance testing, adapted where necessary to evaluate minor technical changes, included product system testing, software verification and integration testing performed in compliance with "FDA's Guidance for the Content of Premarket Submissions for Software in Medical Devices" and AAMI / ANSI / IEC 62304:2006, Medical Device Software - Software Life Cycle Processes, system verification and validation testing for functionality and performance in a simulated environment.

Testing included:

Performance Testing

System Testing to verify that the device met system requirements and the component operation and performance. The testing included the assembled VIVO Model 9002 device met the specified requirements. This included the accessing the VIVO software, Laptop PC function and 3D camera function (with positioning patches). Conclusion: System performance specifications were successfully verified to meet design outputs at the end of the bench testing.

Bench testing was performed to confirm the ability of the system to collect the position of the patches and electrodes.

User Validation Testing was conducted to address the use related with using/navigating the software and successful rendering of an accurate image; in particular to evaluate the usability of the new software workflow and the User's ability to generate a 3D model. Critical and essential tasks were identified and data collected included task performance (pass, fail, close call/serious difficulty), with pass/fail criteria clearly defined. Conclusion: The user validation testing supporting the accuracy of the user to generate a 3D model by the simplified workflow, and that the design has mitigated user error to an acceptable level.

Biocompatibility Testing

Biocompatibility testing was performed to demonstrate that the positioning patches conform to ISO 10993-1. The results demonstrate that the device is biocompatible.

Shelf Life Testing Shelf life testing was performed to demonstrate a one-year shelf life for the positioning patches.

Clinical Testing Not required to demonstrate substantial equivalence to the predicate device.

Conclusion of Performance Testing:

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Performance testing verified that the VIVO system complies with the safety and specifications and performs as designed. Therefore, VIVO is suitable for its intended use.

Conclusion

The data presented 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).