The VX1+ assists operators in the real-time manual or automatic 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 or automatic annotation of 3D anatomical and electrical maps of the human heart for the presence of electrograms exhibiting spatio-temporal dispersion, i.e., dispersed electrograms (DEs).

The VX1+ device is a non-sterile reusable medical device, composed of a computing platform and a software application. VX1+ works with all existing 510(k)-cleared catheters that meet specific dimension requirements and with one of the three specific data acquisition systems:

two compatible EP recording systems (identical to VX1 (Volta Medical (K201298)): the LabSystem Pro EP Recording System (Boston Scientific) (K141185) or the MacLab CardioLab EP Recording System (General Electric) (K130626),
a 3D mapping system (novelty compared to VX1): EnSite X 3D mapping system (Abbott) (K221213).

A connection cable is used to connect the corresponding data acquisition system to the VX1+ system, depending on the type of communication used:

Unidirectional analog communication with the EP recording systems via a custom-made cable (two different variants: DSUB, Octopus) and an Advantech PCI-1713U analog-todigital converter, which acquires analog data, digitizes it, and transmits the digital signals to the computer that hosts the VX1+ software.
-Bidirectional digital communication with the EnSite 3D mapping system via an ethernet cable (four different lengths: 20,10, 5 or 2m) which transmits the digital signals directly to the computer.

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 intracardiac 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 and/or on a secondary medical screen or on an operating room widescreen. The identified regions of interest are either manually (all configurations) or automatically (only available in digital bidirectional communication with the EnSite X 3D mapping system) tagged in the corresponding 3D mapping system.

AI/ML Overview

The provided text describes the acceptance criteria and a study for the Volta Medical VX1+ device. However, it does not contain a detailed table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy, F1-score) and corresponding reported device performance, nor does it detail a multi-reader multi-case (MRMC) comparative effectiveness study.

Based on the available information, here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Device Performance

The document describes non-clinical and clinical tests performed, implying certain underlying acceptance criteria were met for substantial equivalence to the predicate device (VX1). However, explicit quantitative acceptance criteria (e.g., "sensitivity > 90%") are not provided in the text. The reported device performance is described generally as "acceptably correlate" and "reliably assists."

Table of Acceptance Criteria and Reported Device Performance (as inferred and with missing specifics):

Criterion Description (Inferred)	Acceptance Criteria (Explicitly Stated? Not in document)	Reported Device Performance (from document)
Non-Clinical – Algorithm Performance (Dispersion Adjudication Correlation)	Not explicitly stated (e.g., a specific correlation coefficient or concordance rate).	VX1+ dispersion algorithm "acceptably correlate[s] with unlimited-time expert visual analysis" (replayed from VX1's 510(k) study).
Non-Clinical – Usability	Not explicitly stated (e.g., number of critical usability errors < X).	Usability evaluation "did not raise any safety issues and confirmed the relevance of the related risks identified."
Clinical – Reliability of Dispersion Detection & Auto-Tagging	Not explicitly stated (e.g., a specific agreement rate with human operators or ground truth).	"The results indicate that VX1+ reliably assists operators in the detection and auto-tagging of regions harboring dispersed electrograms during AF/AT."
Clinical – Safety Profile	Not explicitly stated (e.g., absence of critical adverse events).	"[with] no associated additional risks or procedure time."

Study Details

Sample sizes used for the test set and the data provenance:
- Clinical Study (OUS):
  - Sample Size: 22 patients.
  - Data Provenance: OUS (Outside US) clinical study. The text does not specify the country beyond "OUS." It is a prospective clinical study as it "involved 1 center, 4 operators, and 22 patients" and was "aimed at evaluating the reliability of VX1+ detection of dispersed electrograms and automatic tagging function."
- Non-Clinical (Algorithm Performance):
  - The text alludes to a "Reader Study described in VX1's 510(k) (K201298) and intended to show that the algorithm's adjudications acceptably correlate with unlimited-time expert visual analysis, was replayed with VX1+ dispersion algorithm." The specific sample size for this "replayed" test set is not provided in the current document, nor is its provenance explicitly stated, other than being "replayed" data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the non-clinical algorithm performance, it refers to "unlimited-time expert visual analysis" for ground truth. The number and qualifications of these experts are not detailed in this document; they would presumably be in the predicate VX1's 510(k) (K201298).
- For the clinical study, the text states "4 operators" were involved. It's unclear if these operators are considered the "experts" for ground truth or if an independent "expert" review was performed. Their qualifications are not stated.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not specify the adjudication method used for either the non-clinical re-analysis or the clinical study.
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:
- A formal MRMC comparative effectiveness study demonstrating human reader improvement with AI assistance vs. without AI assistance is not explicitly described in this document. The clinical study aimed at evaluating the reliability of VX1+ detection and auto-tagging, and its assistance to operators, rather than directly measuring an improvement in human reader performance (e.g., diagnostic accuracy or speed).
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the "Reader Study described in VX1's 510(k) (K201298) and intended to show that the algorithm's adjudications acceptably correlate with unlimited-time expert visual analysis, was replayed with VX1+ dispersion algorithm." This suggests a standalone evaluation of the algorithm's output against an expert-derived ground truth.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the non-clinical algorithm evaluation was based on "unlimited-time expert visual analysis." This implies expert review/consensus.
- For the clinical study, the ground truth is implicitly tied to the "reliable assistance" to operators in identifying dispersed electrograms, suggesting it was established through the clinical workflow and potentially by the operating physicians themselves. The method of establishing definitive ground truth (e.g., independent adjudication, follow-up outcomes) is not explicitly stated.
The sample size for the training set:
- The document does not provide the sample size for the training set used for the VX1+ machine and deep learning-based algorithm.
How the ground truth for the training set was established:
- The document does not provide details on how the ground truth for the training set was established.

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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.

January 21, 2023

Volta Medical % Kristin Zielinski Duggan Partner Hogan Lovells US LLP 555 13 Street NW Washington, District of Columbia 20004

Re: K223516

Trade/Device Name: VX1+ Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: November 22, 2022 Received: November 22, 2022

Dear Kristin Zielinski Duggan:

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.

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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 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.

Aneesh S. Deoras -S

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices 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) K223516

Device Name VX1+

Indications for Use (Describe)

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

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)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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+

Submitter

Volta Medical

65 Avenue Jules Cantini 13006 Marseille France

Phone: +33 7 68 02 54 99

Contact Person: Paola MILPIED

Date Prepared: November 22, 2022

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

Volta Medical, VX1 (K201298)

Device Description

two compatible EP recording systems (identical to VX1 (Volta Medical (K201298)): the LabSystem Pro EP Recording System (Boston Scientific) (K141185) or the MacLab CardioLab EP Recording System (General Electric) (K130626),
a 3D mapping system (novelty compared to VX1): EnSite X 3D mapping system (Abbott) (K221213).

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A connection cable is used to connect the corresponding data acquisition system to the VX1+ system, depending on the type of communication used:

Unidirectional analog communication with the EP recording systems via a custom-made cable (two different variants: DSUB, Octopus) and an Advantech PCI-1713U analog-todigital converter, which acquires analog data, digitizes it, and transmits the digital signals to the computer that hosts the VX1+ software.
-Bidirectional digital communication with the EnSite 3D mapping system via an ethernet cable (four different lengths: 20,10, 5 or 2m) which transmits the digital signals directly to the computer.

Intended Use / Indications for Use

Summary of Technological Characteristics

The VX1+ device is a new device manufactured by Volta Medical, based on the same concept (identification of electrograms dispersion) than predicate VX1.

VX1 and VX1+ are both software programs that work with standard electrophysiology catheters to aid in mapping the heart. Both devices aid operators by assisting in annotating complex electrical maps of the heart, and both devices process and output information via a computer and display that are operated by use of a keyboard / mouse. VX1 and VX1+ have the same input (intra-cardiac multipolar signals) and the same output (associated dispersion), with the addition of the 3D position of the corresponding electrodes available in VX1+.

VX1 and VX1+ support Electrophysiologists in the manual annotation of dispersed areas using a unidirectional analog communication. In addition, VX1+ brings the ability to connect to a

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specific 3D mapping system through a bidirectional digital communication, which enables the operator to use the automatic tagging function.

The VX1+ indications for use are the same as for the VX1, with the addition of automatic annotation. The VX1+ displays an analysis of dispersed electrograms, just as VX1 and therefore, the intended use of the VX1+ and the VX1 are essentially the same.

RegulationClassificationNameProductCodeIndicationsfor UseSystem TypePrimaryFeature	Volta MedicalVX1+	Volta MedicalVX1(K201298)
Regulation	21 C.F.R. § 870.1425	21 C.F.R. § 870.1425
ClassificationName	Programmable DiagnosticComputer	Programmable DiagnosticComputer
ProductCode	DQK	DQK
Indicationsfor Use	The VX1+ assists operators in thereal-time manual or automaticannotation of 3D anatomical andelectrical maps of human atria forthe presence of multipolar intra-cardiac atrial electrogramsexhibiting spatiotemporal dispersionduring atrial fibrillation or atrialtachycardia.The clinical significance of utilizingthe VX1+ software to help identifyareas with intra-cardiac atrialelectrograms exhibitingspatiotemporal dispersion forcatheter ablation of atrialarrhythmias, such as atrialfibrillation, has not been establishedby clinical investigations.	The VX1 assists operators in thereal-time manual annotation of 3Danatomical and electrical maps ofhuman atria for the presence ofmultipolar intra-cardiac atrialelectrograms exhibitingspatiotemporal dispersion duringatrial fibrillation or atrial tachycardia.The clinical significance of utilizingthe VX1 software to help identifyareas with intra-cardiac atrialelectrograms exhibitingspatiotemporal dispersion forcatheter ablation of atrialarrhythmias, such as atrialfibrillation, has not been establishedby clinical investigations.
System Type	Signal processing based atrialmapping system	Signal processing based atrialmapping system
PrimaryFeature	Displays and analyzes electricalmaps such as intra-cardiacelectrograms in real-time usingmachine learning and signalprocessing techniques	Displays and analyzes electricalmaps such as intra-cardiacelectrograms in real-time usingmachine learning and signalprocessing techniques
	Volta MedicalVX1+	Volta MedicalVX1(K201298)
3D LocationTechnology	Electroanatomic location isperformed by another commerciallyavailable navigation system.In bidirectional digitalcommunication, 3D Location isshared by the 3D Mapping Systemwith VX1+.	Electroanatomic location isperformed by another commerciallyavailable navigation system.
CompatibleAcquisitionSystems	LabSystem Pro EP Recording System (Boston Scientific) CardioLab EP Recording System (GE) EnSite X 3D Mapping System (Abbott)	LabSystem Pro EP Recording System (Boston Scientific) CardioLab EP Recording System (GE)
CompatibleCathetersDisplay(s)	Any compatible mapping andablation catheterColor monitor	Any compatible mapping andablation catheterColor monitor
Multi-DisplaySupport	Yes, duplicate display on asecondary medical screen or on anoperating room widescreen	Yes, duplicate display on asecondary medical screen or on anoperating room widescreen
Control	Standard keyboard / mouse	Standard keyboard / mouse
DisplayTiming	Real-time	Real-time
InputsRequired	Analog or digital Intra-cardiacsignalsIn digital mode, 3D locations ofcorresponding electrodes bipoles	Analog Intra-cardiac signals
Output	Presence or absence ofelectrogram dispersion at eachelectrode bipole underconsiderationIn digital mode, 3D locations ofcorresponding electrodes bipolesComputed values of mapping andreference cycle length	Presence or absence ofelectrogram dispersion at eachelectrode bipole underconsiderationComputed values of mapping andreference cycle length
Duration ofElectrogramRecordings	1.5 Seconds	1.5 Seconds
OuputDisplay	The system generates color codedsymbol(s) that indicates to theoperator that the area under	The system generates color codedsymbol(s) that indicates to theoperator that the area under
	Volta MedicalVX1+	Volta MedicalVX1(K201298)
	investigation is one exhibitingdispersionIn bidirectional digitalcommunication, validateddispersion area can also beautomatically displayed in the 3Dmapping system as tags in the 3Datrial shell	investigation is one exhibitingdispersion
SignalInformationDisplayed	Acquired patient signals, includingbody surface ECG and intra-cardiacEGMs.	Acquired patient signals, includingbody surface ECG and intra-cardiacEGMs.
ComputingPlatform	Computer with Intel Core i7-7700CPU (8MB Cache, up to 4.20 GHz,RAM 32 GB),with integrated analog/digitalconverter PCI card and TPM(Trusted Platform Module)Debian-based Linux OS	Computer with Intel Core i5-6500CPU (6MB Cache, up to 3.60 GHz,RAM 32 GB),with integrated analog/digitalconverter PCI cardWindows 10 or higher OS
HardwareDesign andMaterials	Computing platform, proprietarysoftware algorithm, monitor,mouse/keyboard, custom-madeanalog connection cable, ethernetcable, acquisition system	Computing platform, proprietarysoftware algorithm, monitor,mouse/keyboard, custom-madeanalog connection cable,acquisition system

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Performance Data - Nonclinical Tests:

The Volta Medical VX1+ was subjected to non-clinical testing including electromagnetic compatibility and electrical safety tests, rigorous software verification and validation testing including unitary testing of the main algorithm modules of VX1+ application. Specifically the Reader Study described in VX1's 510(k) (K201298) and intended to show that the algorithm's adjudications acceptably correlate with unlimited-time expert visual analysis, was replayed with VX1+ dispersion algorithm.

A usability verification and validation study was launched in a simulated environment at Volta Medical headquarters and in a clinical environment in the scope of the AMPERE study. Usability evaluation did not raise any safety issues and confirmed the relevance of the related risks identified.

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Performance Data - Clinical Tests:

Since a full set of tests was performed, including a non-regression analysis of VX1+ versus VX1 with respect to dispersion adjudication, additional clinical data is not required to demonstrate substantial equivalence of the VX1+. However; for completeness, the Company supplied data from an OUS clinical study of the VX1+. The study was aimed at evaluating the reliability of VX1+ detection of dispersed electrograms and automatic tagging function, and involved 1 center, 4 operators, and 22 patients. The results indicate that VX1+ reliably assists operators in the detection and auto-tagging of regions harboring dispersed electrograms during AF/AT, with no associated additional risks or procedure time.

Conclusions

The VX1+ is as safe and effective as the VX1. The VX1+ has the same intended uses and same indications, and substantially similar technological characteristics, and principles of operation as its predicate device. The introduction of the automatic tagging feature does 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 (i.e., bidirectional communication with the acquisition system) 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 VX1. 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).