(149 days)
Yes.
The "Device Description" states that "The Volta AF-Xplorer is a machine and deep learning based-algorithm". It also mentions "artificial intelligence software" and "machine learning" in the "Mentions AI, DNN, or ML" section.
No
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 exhibiting spatio-temporal dispersion. It does not directly provide therapy.
Yes
The device is designed to "assist 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." This indicates its role in identifying and characterizing a medical condition (atrial fibrillation or tachycardia based on electrogram patterns), which is a diagnostic function.
No
The device is not a software-only medical device because it requires specific hardware components for operation, including a computing platform, connection cables (custom-made or ethernet), and an analog-to-digital converter for unidirectional communication. It also integrates with existing 510(k)-cleared catheters and data acquisition systems like EP recording systems and 3D mapping systems. While the core algorithm is software-based, it explicitly relies on and interacts with various hardware components to function as intended.
No.
The device analyzes electrograms, which are electrical signals from the human heart. It does not analyze specimens derived from the human body.
No
The input document does not contain any explicit statements indicating that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. While the device is of the type that could utilize a PCCP due to its AI/ML components, the necessary approval language is absent.
Intended Use / 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.
Product codes
DQK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
machine and deep learning based-algorithm
artificial intelligence software
Input Imaging Modality
Not Found
Anatomical Site
human atria
human heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operators
The computer and its attached display are located outside the sterile operating room area.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
§ 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).
FDA 510(k) Clearance Letter - Volta AF-Xplorer
Page 1
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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K243812 - Kristin Duggan
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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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K243812 - Kristin Duggan
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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
Page 4
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.
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
Page 5
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
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).
1 of 7
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K243812
2 of 7
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.
Intended Use / 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.
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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K243812
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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 bipoles |
Computed 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