Volta AF-Xplorer II

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 12, 2025 Volta Medical % Kristin Duggan Partner Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, District of Columbia 20004 Re: K251518 Trade/Device Name: Volta AF-Xplorer II Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: May 16, 2025 Received: August 15, 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K251518 - Kristin Duggan Page 2 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- {2} K251518 - Kristin Duggan Page 3 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, # 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 Quality Center for Devices and Radiological Health Enclosure {3} Volta AF-Xplorer II Page 10 of 65 | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K251518 | ? | | Please provide the device trade name(s). | | ? | | Volta AF-Xplorer II | | | | Please provide your Indications for Use below. | | ? | | The Volta AF-Xplorer II 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. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} K251518 Page 1 of 7 510(K) SUMMARY VOLTA MEDICAL's Volta AF-Xplorer II K251518 Submitter Volta Medical 65 Avenue Jules Cantini 13006 Marseille France Phone: +33 7 68 02 54 09 Contact Person: Paola MILPIED Date Prepared: September 11, 2025 Name of Device: Volta AF-Xplorer II 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 (K243812) Device Description The Volta AF-Xplorer II 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 Volta AF-Xplorer II device is a non-sterile reusable medical device, composed of a computing platform and a software application. Volta AF-Xplorer II 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 II 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 {5} converter, which acquires analog data, digitizes it, and transmits the digital signals to the computer that hosts the Volta AF-Xplorer II software. - Bidirectional digital communication with the EnSite 3D mapping system (K221213) and MacLab CardioLab EP Recording System (General Electric) (K130626), 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 II 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 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. ## Intended Use / Indications for Use The Volta AF-Xplorer II 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. ## Summary of Technological Characteristics Volta AF-Xplorer II and the Volta AF-Xplorer predicate (K243812) 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 process and output information via a computer and display that are operated by use of a keyboard / mouse. Both devices have the same input (intra-cardiac multipolar signals) and similar outputs (associated dispersion). Volta AF-Xplorer II and its predicate support electrophysiologists in the manual annotation of dispersed areas using an unidirectional analog communication. Volta AF-Xplorer II 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. The following technological differences exist between the subject and predicate devices: ### Catheters Compatibility: Volta AF-Xplorer II supports Advisor HD Grid X catheter which replaces the Advisor HD Grid catheter. Catheter characteristics remain identical, name compatibility was addressed. Reflexion HD catheter and "any circular 20 poles catheter" that were supported by predicate device Volta AF-Xplorer, are not supported anymore by Volta AF-Xplorer II. The Lasso 20 is the only 20 poles catheter that remains compatible with Volta AF-Xplorer II. These limited changes in compatible catheters do not affect the safety or performance of the device and do not raise different questions than those evaluated by FDA in the prior predicate clearance. K251518 {6} K251518 Page 3 of 7 ## Output The output provided by predicate Volta AF-Xplorer and the subject device Volta AF-Xplorer II are similar. The subject device now groups the previous output categories of high and very high likelihood of dispersion as a single "high likelihood". This change does not change the use of the device because, previously, whether a "high" or "very high" likelihood, the operator mapped a dispersion at that location and so combining the output merely simplified the information without modifying device usage. Additionally, the post-processing "extra analysis" that has been added to the output of the subject Volta AF-Xplorer II device related to dispersion stability does not alter the mapping function of the device, it merely provides the electrophysiologist with additional display data to better visualize the areas of interest. Accordingly, this minor change in output does not impact the manner in which the device is used or raise different questions of safety or effectiveness than those that were considered for the predicate device. ## Algorithm For both predicate device (Volta AF-Xplorer) and the subject device (Volta AF-Xplorer II), the way in which the various algorithm steps are assembled follows the same principles of combining signal processing and machine-generated features into a single output, only the architecture / implementation has been updated to include more state of the art classifiers. Consequently, this change does not raise different questions of safety or effectiveness than were addressed in for the predicate device. The dataset used to train the algorithm has been extended for subject device Volta AF-Xplorer II compared to predicate device Volta AF-Xplorer by adding intracardiac electrograms samples, number of ablation procedures and experts. Only the volume of the dataset was changed, the type of data and the manner in which the data was captured or utilized did not change, therefore this change does not raise questions regarding subject device safety and effectiveness. ## Operating System Subject device (Volta AF-Xplorer II) operating system has been upgraded to a new version compared to its predicate Volta AF-Xplorer. ## Connection with EP Recording System In addition, Volta AF-Xplorer II brings the ability to connect to a specific EP recording through a unidirectional digital communication. The connection with this EP recording system was available on predicate device Volta AF-Xplorer through an analog communication. A table comparing the key features of the subject and predicate devices is provided below. | | Subject Device: VOLTA MEDICAL Volta AF-Xplorer II | Predicate: VOLTA MEDICAL Volta AF-Xplorer (K243812) | Analysis | | --- | --- | --- | --- | | Regulation | 21 CFR §870.1425 | 21 CFR §870.1425 | Same | | Classification Name | Programmable Diagnostic Computer | Programmable Diagnostic Computer | Same | | Product Code | DQK | DQK | Same | {7} K251518 Page 4 of 7 | | Subject Device: VOLTA MEDICAL Volta AF-Xplorer II | Predicate: VOLTA MEDICAL Volta AF-Xplorer (K243812) | Analysis | | --- | --- | --- | --- | | **Intended Use / Indications for use** | The Volta AF-Xplorer II 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. | Same | | **User Population** | • Electrophysiologists • Medical personnel (e.g. biomedical engineer or nurses) • Hospital administrator | • Electrophysiologists • Medical personnel (e.g. biomedical engineer or nurses) • Hospital administrator | Same | | **Intended Population** | Adults only | Adults only | Same | | **System Type** | Signal processing based atrial mapping system | 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 | 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 II | 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 HealthCare) • EnSite X 3D Mapping System (Abbott) | • LabSystem Pro EP Recording System (Boston Scientific) • CardioLab EP Recording System (GE HealthCare) • EnSite X 3D Mapping System (Abbott) | Same | | **Compatible Catheters** | Pentaray Nav (Biosense Webster), Advisor HD Grid (Abbott), **Advisor HD Grid X (Abbott)**, Intellamap Orion (Boston Scientific), Octaray 2-2-2, Octaray 2-5-2, Octaray 3-3-3 (Biosense Webster), **Lasso 20 (Biosense Webster)** | Pentaray Nav (Biosense Webster), Advisor HD Grid (Abbott), **Reflexion HD (Abbott)**, Intellamap Orion (Boston Scientific), Octaray 2-2-2, Octaray 2-5-2, Octaray 3-3-3 (Biosense Webster), **any circular 20 poles catheter** | Similar; substantially equivalent. These limited changes in compatible catheters do not affect the safety or performance of the device (as confirmed | {8} K251518 Page 5 of 7 | | Subject Device: VOLTA MEDICAL Volta AF-Xplorer II | Predicate: VOLTA MEDICAL Volta AF-Xplorer (K243812) | Analysis | | --- | --- | --- | --- | | | | | via testing) and do not raise different questions than those evaluated by FDA in the prior predicate clearance. | | **Inputs Required** | Analog or digital Intra-cardiac signals at a sampling rate of 1000Hz. In digital mode, 3D locations of corresponding electrodes bipoles | Analog or digital Intra-cardiac signals at a sampling rate of 1000Hz. In digital mode, 3D locations of corresponding electrodes bipoles | Same | | **Output** | Presence or absence of electrogram dispersion at each electrode bipole under consideration. Two levels of dispersion: • Red for a high likelihood of dispersion (includes previous orange and red colors – high and very high likelihood and very high likelihood of dispersion, respectively) and • An extra analysis (subgroup of red) towards a two-level hierarchy of regions of interest based on consistency of the dispersion in time and intensity for each bipole, and visually displayed as a gauge that slowly gets filled up. In digital mode, 3D locations of corresponding electrodes bipoles are displayed. Computed values of mapping and reference cycle length. | Presence or absence of electrogram dispersion at each electrode bipole under consideration. Two levels of dispersion corresponding to the likelihood of dispersion: • Orange for a high likelihood of dispersion and • Red for a very high likelihood of dispersion) In digital mode, 3D locations of corresponding electrodes bipoles are displayed. Computed values of mapping and reference cycle length. | Similar, substantially equivalent. The subject device now groups the previous output categories of high (orange) and very high (red) likelihood of dispersion as a single “high likelihood” (red only). This minor change in output does not impact the manner in which the device is used or raise different questions of safety or effectiveness than those that were considered for the predicate device. | | **Dispersion main algorithm** | Machine learning and deep learning classifiers. | Machine learning and deep learning classifiers. | Same | | **Duration of Electrogram Recordings** | 1.5 Seconds | 1.5 Seconds | Same | {9} | | Subject Device: VOLTA MEDICAL Volta AF-Xplorer II | Predicate: VOLTA MEDICAL Volta AF-Xplorer (K243812) | Analysis | | --- | --- | --- | --- | | 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 | 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 | Similar; substantially equivalent. The color coding of signals of interest has been modified between predicate Volta AF-Xplorer and subject device Volta AF-Xplorer II. This modification does not alter the mapping function of the device since the 2-level is just a visualization tool to better understand the dispersion maps. There is no impact on the clinical decision making. | | Signal Information Displayed | Acquired patient signals, including body surface ECG and intra-cardiac EGMs | 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 (Ubuntu version 22.04LTS) | 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 (Ubuntu version 20.04LTS) | Similar; substantially equivalent. OS was upgraded to newer version. | | Hardware Design and Materials | Computing platform, proprietary software algorithm, monitor, mouse/keyboard, custom-made analog connection cable, ethernet cable, acquisition system | Computing platform, proprietary software algorithm, monitor, mouse/keyboard, custom-made analog connection cable, ethernet cable, acquisition system | Same | # Performance Data Unitary tests performed on each algorithm unit are satisfactory with a conformity rate of $100\%$ . This confirms that expected performances of algorithm units are reached. Further, bench testing has been performed on subject device Volta AF-Xplorer II system and includes dispersion detection validation by expert assessment in comparison with the predicate device Volta AF Xplorer: K251518 {10} - The dispersion maps from Volta AF-Xplorer II using the autotagging functionality were demonstrated to be satisfactory for the clinician without significantly deviating from the dispersion maps generated manually from Volta AF-Xplorer II as confirmed by the qualitative analysis of the 2D maps. - Highly stable dispersion tags of Volta AF-Xplorer II as a subset of dispersion for a simple or smart de-densification of dispersion were validated by experts through quantitative and qualitative analysis of 2D dispersion maps generated by Volta AF-Xplorer II during ablation procedures in a simulated environment. Taken together, the subject device Volta AF-Xplorer II reaches the same level of performance as its predicate Volta AF-Xplorer. ## Conclusions The subject device Volta AF-Xplorer II is as safe and effective as the predicate device Volta AF-Xplorer (K243812). The Volta AF-Xplorer II has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. In addition, the minor technological differences between the Volta AF-Xplorer II device and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Volta AF-Xplorer II is as safe and effective as the Volta AF-Xplorer. Thus, the Volta AF-Xplorer II is substantially equivalent to its predicate. K251518 Page 7 of 7