The Volta AF-Xplorer 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.

Device Description

The Volta AF-Xplorer 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 (EGMs) exhibiting spatio-temporal dispersion, i.e., dispersed EGMs.

The Volta AF-Xplorer device is a non-sterile reusable medical device, composed of a computing platform and a software application. Volta AF-Xplorer 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: the LabSystem Pro EP Recording System (Boston Scientific) (K141185) or the MacLab CardioLab EP Recording System (General Electric) (K130626),
a 3D mapping system: EnSite X 3D mapping system (Abbott) (K221213).

A connection cable is used to connect the corresponding data acquisition system to the Volta AF-Xplorer 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-to-digital converter, which acquires analog data, digitizes it, and transmits the digital signals to the computer that hosts the Volta AF-Xplorer 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 Volta AF-Xplorer software analyzes the patient's electrograms to cue operators in real-time to intra-cardiac electrograms of interest for atrial regions harboring dispersed electrograms 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

Based on the provided FDA 510(k) clearance letter for the Volta AF-Xplorer, here's a breakdown of the acceptance criteria and the study used to demonstrate device performance. It's important to note that the document primarily focuses on demonstrating substantial equivalence to a predicate device, and the "acceptance criteria" discussed here are implicitly related to clinical effectiveness and safety, rather than specific performance metrics (like sensitivity/specificity) for the algorithm itself.

The core of the "study that proves the device meets acceptance criteria" is the Tailored-AF study, which the manufacturer uses to support an updated Indications for Use statement for the Volta AF-Xplorer. The acceptance criteria are essentially the favorable clinical outcomes demonstrated by this study, which allowed for the removal of cautionary language in the indications for use.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) clearance for an update based on clinical evidence, the "acceptance criteria" are interpreted as the clinical outcomes required to justify the change in the Indications for Use. The device performance is represented by the outcomes of the Tailored-AF study.

Acceptance Criteria (Implied)	Reported Device Performance (Tailored-AF Study - VX1 device)
Primary Effectiveness: Demonstrated superiority in freedom from AF	88% of patients in the "Tailored" group (AI-assisted ablation + PVI) achieved freedom from AF (lasting > 30 seconds after 3-month blanking, through 12 months post-ablation, with or without AADs). 70% of patients in the "Anatomical" group (PVI-only) achieved this outcome. 18% difference, statistically significant (log-rank p<0.0001).
Secondary Effectiveness (Any Atrial Arrhythmia): Non-inferiority or superiority in freedom from any atrial arrhythmia	76% in Tailored arm vs. 71% in Anatomical arm for freedom from any atrial arrhythmia (AF + AT) at 12 months after one or two ablation procedures, with or without AADs. (Difference not statistically significant.) 60% vs. 60% for freedom from any atrial arrhythmia at 12 months after one procedure, with or without AADs. (No difference.)
Safety: Acceptable complication rates	Serious adverse events (death, cerebrovascular events, serious treatment-related AE): 4.3% in Tailored arm vs. 2.7% in Anatomical arm (no statistically significant difference).Major procedure-related complications: 2.7% in Tailored arm vs. 2.7% in Anatomical arm (no difference).Minor procedure-related complications: 8.0% in Tailored arm (driven by fluid overload and pericardial complications) vs. 3.2% in Anatomical arm (numerically higher in Tailored).
Operational Impact: Acceptable procedure and ablation times	Procedure time: 178 ± 60 minutes (Tailored) vs. 92 ± 36 minutes (Anatomical) - nearly twice as long in Tailored arm.Ablation time: 42 ± 17 minutes (Tailored) vs. 20 ± 11 minutes (Anatomical) - twice as long in Tailored arm.
(Implied) Justification for updated Indications for Use: Sufficient evidence to remove clinical significance disclaimer	The study results are presented as the basis for removing the previous qualifying language regarding the clinical significance of the device.

2. Sample Size and Data Provenance

Test Set (Trial Population): The Tailored-AF study included a total of 370 patients randomized (1:1 ratio) to two arms:
- "Tailored" group: 187 patients
- "Anatomical" group: 183 patients
- Modified Intention-To-Treat (mITT) Population: 180 patients in the Tailored arm and 177 patients in the Anatomical arm were included in the primary analysis after excluding early dropouts.
Data Provenance: The Tailored-AF study was an international, multicenter, randomized, controlled, single-blind, superiority trial. It was conducted at 26 centers across 5 countries in Europe and the United States. This indicates prospective data collection.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used to establish "ground truth" in the context of the study's endpoints. However, the study involved:

51 operators performing the catheter ablation procedures. These would be electrophysiologists with experience in performing AF ablations.
The primary and secondary endpoints (freedom from AF/atrial arrhythmia, complications, etc.) were assessed based on clinical data, including 12-lead ECGs, 24-hour Holter monitoring, and recordings from Kardia portable monitors. The analysis and interpretation of these clinical endpoints would typically involve trained medical personnel (e.g., cardiologists, electrophysiologists) following specific protocols, but the exact number or individual qualifications of those adjudicating the final outcomes are not detailed.

4. Adjudication Method for the Test Set

The document does not specify a separate adjudication method (e.g., 2+1, 3+1 consensus) for the clinical endpoints. The study design (randomized, single-blind trial) implies that patient outcomes were assessed according to predefined criteria and standard clinical practice, with data collection through scheduled visits, ECGs, and Holter monitoring. An independent Clinical Events Committee or similar body often adjudicates endpoints in such trials, but this is not explicitly stated in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a traditional MRMC comparative effectiveness study was not conducted in the context of human readers improving with AI vs. without AI assistance for the specific task of annotating electrograms.

Instead, the Tailored-AF study was a clinical trial evaluating the effectiveness of an AI-assisted ablation strategy (using VX1, the predecessor to Volta AF-Xplorer) compared to a standard PVI-only ablation strategy. It compared patient outcomes between a group where physicians used the AI device to guide ablation (along with PVI) and a group where physicians performed PVI without the AI guidance.

Therefore, it's not about "how much human readers improve with AI vs. without AI assistance" in terms of measurement accuracy, but rather how much patient outcomes improve when physicians use the AI-guided strategy.

Effect Size of AI-assisted strategy on patient outcomes:
- Primary Effectiveness Endpoint: The AI-assisted "Tailored" group demonstrated an 18% absolute difference in freedom from AF compared to the "Anatomical" (PVI-only) group (88% vs. 70%), which was statistically significant (log-rank p<0.0001). This indicates a substantial positive effect on the primary clinical outcome when the AI-guided strategy was employed.

6. Standalone (Algorithm Only) Performance Study

The document does not describe a standalone performance study for the Volta AF-Xplorer algorithm (or its predecessor VX1) in terms of its diagnostic accuracy (e.g., sensitivity, specificity, or AUC) for identifying dispersed electrograms compared to an expert ground truth.

The Tailored-AF study focused on the clinical efficacy and safety of an AI-guided intervention, not on the standalone accuracy of the algorithm's identification of dispersed electrograms itself. The algorithm's output (identification of dispersed EGMs) was then used by human operators for intervention, integrating the AI into a human-in-the-loop workflow.

7. Type of Ground Truth Used

The ground truth for the Tailored-AF study (clinical outcomes) was based on clinical follow-up data, including:

Documented atrial fibrillation lasting more than 30 seconds (from 12-lead ECGs, 24-hour Holter monitoring, and Kardia portable monitor recordings).
Freedom from any atrial arrhythmia (including atrial fibrillation and atrial tachycardia).
Death, cerebrovascular events, or serious treatment-related adverse events.
Procedure-related complications.
Quality of life questionnaires (AFEQT and SF-36).

This is best categorized as outcomes data and expert-interpreted clinical findings.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for training the Volta AF-Xplorer (or VX1) algorithm. The focus of this 510(k) submission is on demonstrating substantial equivalence based on the clinical study, not on detailing the algorithm's development or internal validation.

9. How Ground Truth for the Training Set Was Established

The document does not provide any information on how the ground truth for the training set (if any was used for algorithm development) was established.

Summary

FDA 510(k) Clearance Letter - Volta AF-Xplorer

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

May 9, 2025

Volta Medical
℅ Kristin Duggan
Partner
Hogan Lovells US LLP
555 Thirteenth Street, NW
Washington, District of Columbia 20004

Re: K243812
Trade/Device Name: Volta AF-Xplorer
Regulation Number: 21 CFR 870.1425
Regulation Name: Programmable Diagnostic Computer
Regulatory Class: Class II
Product Code: DQK
Dated: December 11, 2024
Received: April 10, 2025

Dear Kristin 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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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assistance/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,

MARCO CANNELLA -S

for
Aneesh Deoras
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K243812

Device Name
Volta AF-Xplorer

Indications for Use (Describe)
The Volta AF-Xplorer 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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF

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K243812 510(k) SUMMARY

VOLTA MEDICAL's Volta AF-Xplorer

Submitter

Volta Medical
65 Avenue Jules Cantini
13006 Marseille
France

Phone: +33 7 68 02 54 99
Contact Person: Paola MILPIED
Date Prepared: December 11, 2024

Name of Device: Volta AF-Xplorer
Common or Usual Name: Cardiac Mapping System
Classification Name: Programmable Diagnostic Computer
Regulatory Class: 21 C.F.R § 870.1425
Product Code: DQK

Predicate Device

Volta Medical, Volta AF-Xplorer (K232616)

Reference Device

Volta Medical, VX1 (K201298)

Device Description

Two compatible EP recording systems: the LabSystem Pro EP Recording System (Boston Scientific) (K141185) or the MacLab CardioLab EP Recording System (General Electric) (K130626),
a 3D mapping system: 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 Volta AF-Xplorer 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-to-digital converter, which acquires analog data, digitizes it, and transmits the digital signals to the computer that hosts the Volta AF-Xplorer 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

Differences between subject and predicate intended use:
The intended use / indications for use of the subject and predicate devices are identical with the exception that the qualifying language related to the clinical significance of the device has been removed based upon the results of the Tailored-AF clinical study which provide new clinical evidence related to the device safety, effectiveness and performance.

The updated indications for use statement and additions to the product labeling do not alter the intended use of the device as an electrophysiological evaluation tool and do not affect, or raise different questions of, the device safety and effectiveness.

Summary of Technological Characteristics

The Volta AF-Xplorer device is technologically identical to its Volta AF-Xplorer predicate (K232616). Volta AF-Xplorer and predicate are software programs that work with standard electrophysiology catheters to aid in mapping the heart. Volta AF-Xplorer and its predicate aid operators by assisting in annotating complex electrical maps of the heart, and process and output information via a computer and display that are operated by use of a keyboard / mouse. Volta AF-Xplorer and its predicate have the same input (intra-cardiac multipolar signals) and the same output (associated dispersion).

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Volta AF-Xplorer and its predicate support electrophysiologists in the manual annotation of dispersed areas using an unidirectional analog communication. Volta AF-Xplorer and its predicate provide the ability to connect to a specific 3D mapping system through a bidirectional digital communication, which enables the operator to use the device's function for automatically tagging regions of interest.

A table comparing the key features of the subject and predicate devices is provided below.

Feature	Volta Medical Volta AF-Xplorer (Subject)	Volta Medical Volta AF-Xplorer (K232616)
Regulation	21 C.F.R. § 870.1425	SAME
Classification Name	Programmable Diagnostic Computer	SAME
Product Code	DQK	SAME
Indications for Use	The Volta AF-Xplorer 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 Volta AF-Xplorer 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 Volta AF-Xplorer 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.
System Type	Signal processing based atrial mapping system	SAME
Primary Feature	Displays and analyzes electrical maps such as intra-cardiac electrograms in real-time using machine learning and signal processing techniques	SAME
3D Location Technology	Electroanatomic location is performed by another commercially available navigation system. In bidirectional digital communication, 3D Location is shared by the 3D Mapping System with Volta AF-Xplorer	SAME
Compatible Acquisition Systems	• LabSystem Pro EP Recording System (Boston Scientific)• CardioLab EP Recording System (GE)• EnSite X 3D Mapping System (Abbott)	SAME

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Feature	Volta Medical Volta AF-Xplorer (Subject)	Volta Medical Volta AF-Xplorer (K232616)
Compatible Catheters	Any compatible mapping and ablation catheter	SAME
Display(s)	Color monitor	SAME
Multi-Display Support	Yes, duplicate display on a secondary medical screen or on an operating room widescreen	SAME
Control	Standard keyboard / mouse	SAME
Display Timing	Real-time	SAME
Inputs Required	Analog or digital Intra-cardiac signals In digital mode, 3D locations of corresponding electrodes bipoles	SAME
Output	Presence or absence of electrogram dispersion at each electrode bipole under consideration In digital mode, 3D locations of corresponding electrodes bipolesComputed values of mapping and reference cycle length	SAME
Duration of Electrogram Recordings	1.5 Seconds	SAME
Output Display	The system generates color coded symbol(s) that indicates to the operator that the area under investigation is one exhibiting dispersion In bidirectional digital communication, validated dispersion area can also be automatically displayed in the 3D mapping system as tags in the 3D atrial shell	SAME
Signal Information Displayed	Acquired patient signals, including body surface ECG and intra-cardiac EGMs	SAME
Computing Platform	Computer with Intel Core i7-7700 CPU (8MB Cache, up to 4.20 GHz, RAM 32 GB), with integrated analog/digital converter PCI card and TPM (Trusted Platform Module)Debian-based Linux OS	SAME
Hardware Design and Materials	Computing platform, proprietary software algorithm, monitor, mouse/keyboard, custom-made analog connection cable, ethernet cable, acquisition system	SAME

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Performance Data

No bench or animal testing was conducted in support of this submission.

The company also provided the Tailored-AF study results published in Nature Medicine Journal (Deisenhofer et al) and performed on VX1, the substantially equivalent predicate device to Volta AF-Xplorer, to support the updated indications for use and product labeling.

The Tailored-AF Trial (NCT04702451) was an international, multicenter, randomized, controlled, single-blind, superiority trial in which patients with drug-refractory persistent atrial fibrillation were randomly assigned in a 1:1 ratio to either (1) a tailored ablation procedure targeting areas of spatiotemporal dispersion detected by VX1 artificial intelligence software (predecessor to Volta AF-Xplorer) in addition to pulmonary vein isolation (PVI) (the "Tailored" group; n=187), or (2) to a conventional pulmonary vein isolation-only procedure (the "Anatomical" group; n=183). The trial was conducted at 26 centers across 5 countries in Europe and the United States. A total of 51 operators performed the catheter ablation procedures.

The primary effectiveness endpoint was freedom from documented atrial fibrillation lasting more than 30 seconds after a 3-month blanking period through 12 months after one ablation procedure with or without anti-arrhythmic drugs (AADs). Freedom from any atrial arrhythmia was addressed in secondary effectiveness endpoints. The use of anti-arrhythmic medications was allowed during the first 3 months after the initial ablation (the post-ablation "blanking period"), after which their use was discouraged. All study subjects were followed for 12 months with scheduled visits at 3, 6, and 12 months. Clinical assessments, 12-lead electrocardiograms and 24-hour Holter monitoring recordings were obtained at each visit. All patients received a 6-lead Kardia portable monitor and were asked to perform and transmit rhythm recordings weekly and any time they had symptoms for the complete study duration. Patients with recurrent atrial fibrillation after the blanking period were allowed to start or resume the use of anti-arrhythmic medications; they were also allowed to undergo a repeat ablation using the same procedure to which they were initially randomly assigned. A total of 13 patients dropped out of the study before the end of the blanking period (7 in the Tailored arm and 6 in the Anatomical arm) and were not included in the analyzed modified Intention-To-Treat ("mITT") population.

The proportion of subjects who were on a Class 1 or 3 AAD at study enrollment, hospital discharge, and the 3-month visit was similar between the two study arms. However, a greater proportion of subjects in the Tailored arm were on a Class 1 or 3 AAD at the 6-month visit (24% in Tailored arm vs. 20% in Anatomical arm) and the 12-month visit (25% in Tailored arm vs. 23% in Anatomical arm), due at least in part to the need for managing atrial tachycardia that occurred more often in the Tailored arm after the blanking period.

Regarding the primary effectiveness endpoint, of the 180 mITT patients in the Tailored arm who underwent the Tailored procedure and remained in the study, 158 (88%) demonstrated treatment success with respect to the primary effectiveness endpoint as compared to 124 (70%) patients who demonstrated treatment success in the Anatomical mITT population (n=177). The 18% difference in primary effectiveness success between the two study arms was statistically significant (log-rank p<0.0001). The proportion of primary effectiveness successes who were completely off Class 1/3 AADs throughout the effectiveness evaluation period (i.e., after the 3-month blanking period through the 12-month visit) was lower in the Tailored arm than in the Anatomical arm (91/158 or 58% in Tailored

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arm vs. 82/124 or 66% in Anatomical arm) due at least in part to the use of AADs for managing atrial tachycardia that occurred more often in the Tailored arm after the blanking period. The proportion of primary effectiveness successes who were on a Class 1 or 3 AAD throughout the effectiveness evaluation period was similar between the two study arms (30/158 or 19% in Tailored arm vs. 21/124 or 17% in Anatomical arm).

Regarding secondary effectiveness endpoints, in the mITT population, more patients in the Tailored arm experienced freedom from any atrial arrhythmia (including atrial fibrillation and atrial tachycardia) at 12 months after one or two ablation procedures, with or without the use of anti-arrhythmic medications after a 3-month blanking period, although this difference was not statistically significant (76% in Tailored arm vs. 71% in Anatomical arm). There was no difference between the two study arms in the proportion of subjects free of any atrial arrhythmia recurrence at 12 months after one procedure, with or without the use of antiarrhythmic medications after a 3-month blanking period (60% vs. 60%).

The number of repeat procedures considered in the multiple-procedure endpoint was greater in the Tailored arm than in the Anatomical arm (47 vs. 34 in the Tailored and Anatomical arms, respectively). Patient's quality of life assessed by using the AFEQT and SF-36 questionnaires improved significantly at 12 months post-index procedure from baseline, independent of the ablation strategy. The differences in the improvement in the AFEQT and SF-36 scores from baseline to 12 months post-index procedure were not statistically significant between the Tailored and Anatomical arms.

The rate of death, cerebrovascular events, or serious treatment-related adverse event at 12 months post procedure, which was a secondary endpoint of the study did not differ statistically between the two study arms (8/187 or 4.3% in the Tailored arm vs. 5/183 or 2.7% in the Anatomical arm). There was no difference between the two study arms in the proportion of subjects with at least one major procedure-related complications (5/187 or 2.7% in Tailored arm vs. 5/183 or 2.7% in Anatomical arm). However, the rate of subjects with at least one minor procedure-related complication is numerically higher in the Tailored arm (8.0%) (driven by more events of fluid overload and pericardial complications) compared to the Anatomical arm (3.2%) due presumably to the longer procedure and radiofrequency (RF) ablation times in the Tailored arm. Indeed, the procedure and ablation time were twice as long in the Tailored arm (178 ± 60 minutes vs. 92 ± 36 minutes for procedure time and 42 ± 17 minutes vs. 20 ± 11 minutes for ablation time).

In summary, the results of the Tailored-AF study showed that ablation of areas with dispersed EGMs detected by the VX1 device, a previous version of the Volta AF-Xplorer that uses the same primary algorithm, in addition to PVI was superior to PVI alone in terms of freedom from AF at one-year follow-up in patients with drug-refractory symptomatic persistent AF, while additional ablation of areas with dispersed EGMs did not result in greater treatment success in terms of freedom from any atrial arrhythmia at one-year follow-up in this population. The latter was due to more occurrences of atrial tachycardia following the tailored ablation procedure targeting areas with dispersed EGMs in addition to PVI. Moreover, compared to PVI alone, the tailored ablation procedure was associated with more minor procedure-related complications (fluid overload and pericardial complications), and longer procedure and ablation times due to additional ablation of areas with dispersed EGMs.

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Conclusions

The subject Volta AF-Xplorer device is as safe and effective as the previously cleared Volta AF-Xplorer device (K232616). The Volta AF-Xplorer has the same intended uses and similar indications, and identical technological characteristics, and principles of operation as its predicate device.

Performance data demonstrate the appropriateness of updating the indications for use and product labeling. The updated indications for use statement and additions to the product labeling do not alter the intended use of the device as an electrophysiological evaluation tool and do not affect, or raise different questions of, the device safety and effectiveness.

Thus, the Volta AF-Xplorer is substantially equivalent to its predicate device.

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).