Volta AF-Xplorer

K243812

Volta Medical · cleared 2025-05-09 · product code DQK · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“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.”
Algorithmmachine and deep learning based-algorithm; artificial intelligence software
source quote (p.5)
“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 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).”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=370 patients · 26 site(s)

endpoints: 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; patient's quality of life; rate of death, cerebrovascular events, or serious treatment-related adverse event; proportion of subjects with at least one major procedure-related complications; rate of subjects with at least one minor procedure-related complication

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

28
recalls in product code, 24mo
423
MAUDE reports in code, 12mo
-1%
vs code's own 3-yr baseline
3
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K251518 (decision 2025-09-12) from Volta Medical for a matching device line ("Volta AF-Xplorer II") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251518

  • recall_reason_pattern

    Software/algorithm-related recall in product code DQK (Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom, initiated 2025-09-16): "Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97686

  • recall_reason_pattern

    Software/algorithm-related recall in product code DQK (Boston Scientific Corporation, initiated 2024-09-05): "Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95331

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K243812