Volta AF-Xplorer II

K251518

Volta Medical · cleared 2025-09-12 · product code DQK · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“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 and the Volta AF-Xplorer predicate (K243812) are both software programs that work with standard electrophysiology catheters to aid in mapping the heart.”
Algorithmmachine and deep learning based-algorithm; signal processing and machine-generated features into a single output, with state of the art classifiers
source quote (p.5)
“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). 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. Machine learning and deep learning classifiers.”
Adaptive (vs locked)No
source quote (p.7)
“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.”
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

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
2
drift signals on this device
  • 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/K251518