The VX1 assists operators in the real-time manual annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia.

The clinical significance of utilizing the VX1 software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

Device Description

The VX1 "" is a machine and deep learning based-algorithm designed to assist operators in the real-time manual annotation of 3D anatomical and electrical maps of the human atria for the presence of electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia", i.e., dispersed intra-cardiac atrial electrograms (DEs). The device works with all existing 510(k) cleared catheters that meet specific dimension requirements and with two data acquisition systems: the LabSystem Pro Acquisition System (Boston Scientific) (K141185) and the MacLab CardioLab Acquisition System (General Electric) (K130626). A connection cable is used to connect the data acquisition system with an Advantech PCI-1713U analog-to-digital converter, which transmits the acquired information to a nearby computer that hosts the VX1 software. The computer and its attached display are located outside the sterile operating room area. The VX1 software analyzes the patient's electrograms to cue operators in real-time to intra-cardiac electrograms of interest for atrial regions harboring DEs as well as a cycle length estimation from electrograms recorded with the mapping and the coronary sinus catheters. The results of the analysis are graphically presented on the attached computer display.

AI/ML Overview

Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance values in the way typically seen in a formal statistical analysis plan. However, the outcomes of the "Reader Study" and the "Limited Time Annotation Testing" serve as a form of acceptance criteria, where the device's agreement with expert consensus is evaluated.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Inter-operator agreement	Strong agreement among expert readers	Confirmed. Experts strongly agreed with one another.
VX1 correlation with expert annotation (Reader Study)	Acceptable correlation with physician annotation	VX1 adjudication acceptably correlates with physician annotation.
Period estimation performance	Outperform or be comparable to alternative algorithms	VX1 period estimation algorithm outperformed both FFT-based and AC-based algorithms for noisy/non-periodic electrograms.
VX1 algorithm accuracy (k-fold cross-validation)	High accuracy	Over 89% accuracy.
VX1 performance vs. unassisted electrophysiologists	Superior agreement to annotating experts than unassisted humans	VX1 algorithm demonstrated superior performance (agreement to annotating experts) to cardiac electrophysiologists.
Clinical risk and procedure time	No additional risk or procedure time	Not associated with additional risk or procedure time.
Comparable performance to predicate's CFAE module	Comparable performance	VX1 device demonstrated comparable performance in locating electrical signal transmission pattern disruptions as the predicate's CFAE module.

Sample sizes used for the test set and data provenance:
- Reader Study: 14,370 electrograms.
- Period Estimation Algorithm Testing: 2,550 electrograms.
- Limited Time Annotation Testing: 1,020 electrograms.
- Clinical Study: 300 patients across 8 centers.
- Data Provenance: The document states "An OUS clinical study was performed..." indicating that at least some clinical data is from outside the US. The "training database of 275,020 1.5 second annotated electrograms" drew on "anonymized information from a very large database". The nature (retrospective/prospective) is not explicitly stated for all datasets, but the clinical study was likely prospective to evaluate usability and efficacy.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Reader Study and Limited Time Annotation Testing: 3 independent experts were used to adjudicate the 14,370 electrograms for the Reader Study. For the Limited Time Annotation Testing, 2 annotating experts were used (who reached a consensus). Their specific qualifications beyond "independent experts" and "annotating experts" are not detailed (e.g., years of experience or board certification).
- "Unassisted" Human Readers in Limited Time Annotation Testing: 28 cardiac electrophysiologists who underwent a "full-day seminar on spatiotemporal dispersion."
Adjudication method for the test set:
- Reader Study: "adjudicated by three independent experts". It doesn't specify if this was a 2+1, 3+1, or simple majority.
- Limited Time Annotation Testing: "two annotating experts who were allowed unlimited time to make a classification determination and reach a consensus". This suggests a consensus-based adjudication between two experts.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- A comparative study was done during the "Limited Time Annotation Testing" comparing the VX1 algorithm's performance to that of 28 cardiac electrophysiologists. This fits the description of a multi-reader (28 electrophysiologists) multi-case (1,020 electrograms) study.
- Effect Size: The document states the "VX1 algorithm demonstrated superior performance (agreement to the annotating experts) to the cardiac electrophysiologists in identifying dispersed and non-dispersed intra-cardiac atrial electrograms." However, a specific effect size (e.g., AUC difference, sensitivity/specificity improvement, or statistical significance value) is not provided.
If a standalone performance (algorithm only without human-in-the-loop performance) was done:
- Yes, the "Reader Study" directly compared the VX1's classification to expert annotation, implying a standalone performance evaluation.
- The "Period estimation algorithm testing" also evaluated the algorithm's performance independently.
- The k-fold cross-validation is a standalone algorithm performance test.
The type of ground truth used:
- Expert Consensus: The primary ground truth for the Reader Study and Limited Time Annotation Testing was established by "independent experts" or "annotating experts" reaching a consensus on the presence or absence of dispersed intra-cardiac atrial electrograms.
The sample size for the training set:
- The k-fold cross-validation was performed on a "training database of 275,020 1.5 second annotated electrograms."
How the ground truth for the training set was established:
- The training database drew on "anonymized information from a very large database... of 1.5 second snippets of multipolar intra-cardiac atrial electrograms located on a dedicated data server". The document does not explicitly state how these 275,020 electrograms were annotated (e.g., by experts, or through a different automated process). However, the context of comparing the algorithm to expert annotations in the validation suggests that expert annotation would be the most robust method for establishing ground truth for training as well. Without explicit mention, it's inferred to be expert-annotated.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 16, 2020

Volta Medical % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103

Re: K201298

Trade/Device Name: VX1 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DOK Dated: August 17, 2020 Received: August 17, 2020

Dear Janice Hogan:

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 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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510(k) Number (if known)

K201298

Device Name

VX1

Indications for Use (Describe)

The clinical significance of utilizing the VX1 software to help identify areas with intra-cardial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY VOLTA MEDICAL's VX1 K201298

Submitter

Volta Medical 29 Boulevard de Louvain 13008 Marseille France Phone: (+33) 6 52 57 96 94

Contact Person: Théophile Mohr Durdez Date Prepared: September 15, 2020

Name of Device:	VX1
Common or Usual Name:	Cardiac mapping system
Classification Name:	Programmable Diagnostic Computer
Regulatory Class:	21 C.F.R. § 870.1425
Product Code:	DQK
Predicate Devices:	Biosense Webster, Inc.'s CARTO® XP V10 System(K093566)

Device Description:

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Intended Use / Indications for Use:

Summary of Technological Characteristics Compared to the Predicate Device:

The VX1 device and its predicate (the CARTO® XP V10 System; K093566) both work with standard electrophysiology catheters to aid in mapping the atria. The predicate device contains several functional modules that are not included in the VX1 device; however, as described in the table below. these functions can generally be performed by another (compatible) device that can be used during the same procedure that includes the VX1 device. Whether these functions are bundled in one device (as with the predicate device) or performed by separate devices during the same procedure does not affect the subject device performance nor raise different questions of safety or effectiveness. Because mapping can be used independently, the provision of a separate functionality in the VX1 versus an integrated functionality in the predicate does not raise new types of questions or otherwise adversely impact performance, as confirmed in the submitted testing.

In particular, the VX1 performs an equivalent function to the CFAE Module of the predicate device. Both devices aid operators by assisting in annotating complex electrical maps of the atria, and both devices process and output information via a computer and display that are operated by use of a keyboard / mouse. Additionally, the signals identified by the VX1 device are of the same nature (multipolar atrial electrograms) as those identified by the CFAE module of CARTO, as demonstrated in the definition of dispersion which partly relies on the definition of CFAE. Both devices also have the same input (intra-cardiac signals) and output (associated dispersion / fractionation).

The CARTO CFAE module: however, performs analysis of individual per-procedural data sets, whereas VX1 includes analytical parameters that pertain to previous similar procedures. Specifically, VX1 methods rely on conceptualizing a discriminant algorithm, which, during training, drew on anonymized information from a very large database of 1.5 second snippets of multipolar intra-cardiac atrial electrograms located on a dedicated data server. In actual commercial use, however, the trained machine and deep learning models are incorporated into the stand alone local software application which is not connected to a network.

Like the predicate device, the VX1 assists in the real-time annotation of complex 3D anatomical and electrical maps of the human atria, including the presence of multipolar electrograms. Thus, both the subject and predicate device have the same intended use,

The indications for use of the CARTO® XP V10 System, while broader, specify that it "displays Complex Fractionated Atrial Electrograms (CFAE)." Spatiotemporal dispersed Intra-cardiac atrial electrograms are a non-exclusive subset of CFAEs in which the

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fractionation occurs in a non-simultaneous fashion at neighboring electrode locations (temporal dispersion) and are organized in well-defined clusters (spatial dispersion). Thus, the predicate CFAE technology relates to the same cardiac phenomena for which the VX1 is indicated for use.

Neither device is intended for directing treatment or affecting the outcome of any particular heart arrhythmia.

The difference in indications therefore does not alter the intended diagnostic effect, and therefore the first criterion for a finding of substantial equivalence is satisfied.

	Volta MedicalVX1	CARTO® XP System withCARTOXPRESS™ Module(V10)K093566	Comments
Regulation	21 C.F.R. § 870.1425ProgrammableDiagnostic ComputerProduct Code: DQK	21 C.F.R. § 870.1425Programmable DiagnosticComputerProduct Code: DQK	Same
Indicationsfor Use	The VX1 assistsoperators in the real-time manualannotation of 3Danatomical andelectrical maps ofhuman atria for thepresence of multipolarintra-cardiac atrialelectrograms exhibitingspatiotemporaldispersion during atrialfibrillation or atrialtachycardia.The clinicalsignificance of utilizingthe VX1 software tohelp identify areas withintra-cardiac atrialelectrograms exhibitingspatiotemporaldispersion for catheterablation of atrialarrhythmias, such asatrial fibrillation, hasnot been establishedby clinicalinvestigations.	The intended use of theCARTO® XP System withCARTOXPRESS™ Module(V10) is catheter-basedatrial and ventricularmapping.The CARTO® XP Systemwith CARTOXPRESS™Module (V10) allows real-time display of cardiacmaps in a number ofdifferent formats. Mapsmay be displayed ascardiac electrical activationmaps, cardiac electricalpropagation maps, cardiacelectrical potential maps,impedance maps, andcardiac chamber geometrymaps. The acquired patientsignals, including bodysurface EGG and intra-cardiac electrograms mayalso be displayed in real-time on the system displayscreen.CARTO® XP System withCARTOXPRESS™ Module(V10) includes theCARTOMERGE® capabilityto import, register, and	Like the predicate device,the VX1 assists in the real-time annotation of complex3D anatomical andelectrical maps of thehuman atria, including thepresence of multipolarelectrograms. Thus, boththe subject and predicatedevice have the sameintended use.The indications for use ofthe CARTO® XP V10System, while broader,specify that it "displaysComplex FractionatedAtrial Electrograms(CFAE)." Spatiotemporaldispersed intra-cardiacatrial electrograms are anon-exclusive subset ofCFAEs in which thefractionation occurs in anon-simultaneous fashionat neighboring electrodelocations (temporaldispersion) and areorganized in well-definedclusters (spatialdispersion). Thus, thepredicate CFAE technologyrelates to the same cardiac
	Volta MedicalVX1	CARTO® XP System withCARTOXPRESSTM Module(V10)K093566	Comments
		merge CT or MRI structuralimages with CARTO Mapsphysiological informationand real-time catheternavigation. CARTO® XPSystem withCARTOXPRESSTM Module(V10) also allows theintegration of intra-cardiacecho (ICE) 2D images toprovide 3D combined maps.CARTO® XP System withCARTOXPRESSTM Module(V10) includes FastAnatomical Mapping (FAM)that is a method for quickcreation of cardiacanatomical volumes usingcatheters with magneticlocation sensors, supportsthe LASSO® NAV Catheterwith location sensors,displays ComplexFractionated AtrialElectrograms (CFAE), andadds Pace-MappingSoftware (PaSo) ECGsignal correlation tool.	phenomena for which theVX1 is indicated for use.Neither device is intendedfor directing treatment oraffecting the outcome ofany particular heartarrhythmia.Additional CARTO® XPSystem withCARTOXPRESSTM Module(V10) functions can beaccomplished by other(compatible) devices usedin the same procedure asthe VX1.Thus, the difference inindications does not alterthe intended diagnosticeffect.
System Type	Signal processing-based atrial mappingsystem.	Electromagnetic andcatheter-based atrial andventricular mapping system.	Similar catheter-basedsystems. The lack ofventricular mapping in thesubject device does notaffect its performancerelative to its atrial mappingfunctionality. Further, useof the VX1 does notpreclude the use of othermapping systems duringthe same procedure whichcan perform broadmapping features (e.g.,ventricular mapping). TheVX1 simply providescomplementary additionalinformation regardingdispersed intra-cardiacatrial electrograms to theuser in addition to the
	Volta MedicalVX1	CARTO® XP System withCARTOXPRESS™ Module(V10)K093566	Comments
			information provided bytraditional mappingsystems. Thus, there areno different questions ofsafety or effectivenessraised by the VX1 system.
Display(s)Control	Color monitorStandard keyboard /mouse	Color monitorStandard keyboard / mouse	SameSame
InputsRequired	Intra-cardiac atrialelectrograms that arerecorded withcatheters, amplifiedand redirected to anacquisition system onwhich they aredisplayed.	ECG and electrogram datafrom the patient capturedwith proprietary and non-proprietary catheters andpatches.	Comparable inputs tothose captured by theCARTO XP System (e.g.,ECG and EGM data) canbe captured by compatibledevices used during thesame procedure thatincludes VX1.Whether these functionsare bundled in one device(as with the predicatedevice) or performed byseparate devices duringthe same procedure doesnot affect the subjectdevice performance norraise different questions ofsafety or effectiveness.Use of the VX1 does notpreclude the use of othermapping systems duringthe same procedure whichcan provide appropriateinput (ECG and patches).
PrincipalMappingOutput	Displays adjudicationsas visual cues afteranalyzing intra-cardiacatrial electrograms inreal-time using signalprocessing techniques.	Displays anatomical andelectrical maps such asactivation and voltage mapsof the human heart in real-time using magneticnavigation techniques andECG-EGM analysis.	Use of the VX1 does notpreclude the use of othermapping systems duringthe same procedure whichcan perform theseadditional mappingfeatures. Thus, there is noeffect on safety oreffectiveness.
Map TypesGenerated	Real-time DispersedElectrogram (DE)subtype of multipolarelectrogram map- Theoperator is providedwith display of the	Real-time 3D cardiacmaps including: cardiacelectrical activation maps,cardiac electricalpropagation maps,impedance maps, and	VX1 provides real-timeadjudications of dispersionwithout providingcorresponding 3D mappinginformation. The use of theVX1 does not preclude the
	Volta MedicalVX1	CARTO® XP System withCARTOXPRESS™ Module(V10)K093566	Comments
	electrode locationswhere dispersed ornon-dispersedelectrograms havebeen recorded duringatrial fibrillation or atrialtachycardia.	cardiac chamber geometrymaps.Complex Fractionated AtrialElectrograms (CFAE) aredisplayed on maps that arecolored according to theduration and repetitions offragmented electrograms.	use of other mappingsystems during the sameprocedure which canperform 3D cardiacmaps including: cardiacelectrical activation maps,cardiac electricalpropagation maps,impedance maps, andcardiac chamber geometrymaps.
CompatibleCatheters	Any compatiblecatheter meeting therequirements listedbelow:CompatibilityRequirements:Mapping catheter:- Electrode size : 1 mm- Inter-electrodeSpacing : 2 - 3 mm- Number of selecteddipoles : 10Coronary sinuscatheter:- Electrode size: 1 mm- Inter-electrode Spacing : 2 -3 mm- Number of selecteddipoles : 5	Supports the BiosenseWebster NAVISTAR® familyof catheters with built-inmagnetic sensor for real-time navigation, includingthe LASSO® NAV Catheter(K093376) with locationsensors and the ability todisplay the catheter'scircular loop based on theposition of magnetic singleaxial sensors (SAS) andprovide selective pacingthrough the loop electrodes.Supports the CARTOSOUNDSTAR 3Dultrasound catheter; alocation sensingIntracardiac Echo (ICE)catheter with an acousticarray embedded in thecatheter tip that allows theacquisition of real timeultrasound images. Thelocation sensor enables theaccurate location of theU/S-observed intracardiacanatomies in the CARTOXP EP Navigation Systemspatial coordinates.	The CARTO proprietaryand non-proprietarycatheters perform identicalelectromagnetic sensingfunctions to the cathetersthat are compatible for usewith VX1.Other systems' cathetersmay be used to providereal time navigation and/orcatheter loop display,selective pacing throughthe loop electrodes, orultrasound integration.The difference in specificcatheters does not affectthe device performance orraise different questions ofsafety or effectiveness.
HardwareDesign andMaterials	Off-the-shelf analog /digital converter,computer and monitor,connection cable,acquisition system,proprietary software	Off-the-shelf informationtechnology (IT) hardware:computer and monitor,proprietary catheters,patient interface unit andaccessories.	Equivalent, but with certaincompatible vs. proprietaryequipment (e.g.,catheters).

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Performance Data - Nonclinical Tests:

The Volta Medical VX1 was subjected to extensive non-clinical testing including rigorous verification and validation testing. The Company additionally conducted the following studies:

(1) A Reader Study to evaluate the level of inter-operator agreement after unlimited-time physician visual intra-cardiac atrial DE annotation and determine whether algorithm-enabled classification acceptably correlates with physician annotation. A dataset of 14,370 electrograms were adjudicated by three independent experts and VX1 for the presence or absence of dispersed intra-cardiac atrial electrograms. The study demonstrated that the expert readers both strongly agreed with one another as to the presence or absence of dispersed intra-cardiac atrial electrograms in the evaluated electrogram recordings and that they, similarly, independently agreed with the VX1 adjudication of the presence or absence of intra-cardiac atrial DEs.

(2) A period estimation algorithm testing to assess the performance of the VX1 software against two alternative period estimation approaches: a sophisticated auto-correlation (AC) algorithm and a Fast Fourier Transform (FFT) with Blackman window processing across a dataset of 2,550 electrograms. Overall, the VX1 period estimation algorithm outperformed both the FFT-based and the AC-based algorithms for evaluating noisy and non-periodic electrograms and for estimating the period on the period estimation dataset.

(3) A k-fold cross-validation of VX1 algorithm was performed on the training database of 275,020 1.5 second annotated electrograms. 5-fold cross validation was performed on the model with a resulting accuracy of over 89%.

(4) Limited time annotation testing in which 1,020 electrograms were classified by two annotating experts who were allowed unlimited time to make a classification determination and reach a consensus as to the presence or absence of intra-cardiac atrial dispersion. VX1 performance was compared to the performance of 28 cardiac electrophysiologists who underwent a full-day seminar on spatiotemporal dispersion. The cardiac electrophysiologists each classified 1,020 electrograms as either dispersed or non-dispersed with 17 seconds allotted for each classification. The VX1 algorithm demonstrated superior performance (agreement to the annotating experts) to the cardiac electrophysiologists in identifying dispersed and non-dispersed intra-cardiac atrial electrograms.

Performance Data - Clinical Tests:

An OUS clinical study was performed to evaluate the performance of the VX1 in the detection of intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during a catheter ablation procedure for atrial fibrillation or atrial tachycardia. The study was aimed at evaluating the usability and efficacy of VX1 for detecting DEs and involved 8 centers. 18 operators, and 300 patients. The results indicate that the implementation of VX1 in a cardiac electrophysiology laboratory is not associated with additional risk or procedure time. Also,

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the VX1 device demonstrated comparable performance in locating electrical signal transmission pattern disruptions as the predicate's CFAE module.

Conclusions:

The VX1 device and its predicate both work with standard electrophysiology catheters to aid in mapping the human atria. The predicate device contains several functional modules that are not included in the VX1 device; however, these functions can generally be performed by another device that can be used during the same procedure as the VX1 device. Because mapping can be used independently, the provision of a separate functionality in the VX1 versus an integrated functionality in the predicate does not raise new types of questions or otherwise adversely impact performance, as confirmed in the submitted testing.

Specifically, the VX1 device is substantially equivalent to the CARTO® XP System with CARTOXPRESS™ Module. In particular, the VX1 performs an equivalent function to the CFAE Module of the predicate device, and works with mapping systems and compatible catheters to form a system which is equivalent to the predicate system. The VX1 and CFAE module have similar technological characteristics and principles of operation. The signals identified by the VX1 device are of the same nature (multipolar electrograms), and have the same input (intra-cardiac atrial signals) and output (associated dispersion / fractionation). The VX1 has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended use of the device as an electrophysiological evaluation tool and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the VX1 and its predicate device raise no new issues of safety or effectiveness. Performance data, as described above, demonstrate that the VX1 device is as safe and effective as the predicate. Thus, the VX1 device is substantially equivalent.

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).