VX1

K201298

Volta Medical · cleared 2020-09-16 · product code DQK · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“The VX1T™ is a machine and deep learning based-algorithm designed to assist operators in the real-time manual annotation of 3D anatomical and electrical maps of the human atria for the presence of electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia””
Algorithmmachine and deep learning based-algorithm
source quote (p.4)
“The VX1T™ is a machine and deep learning based-algorithm designed to assist operators in the real-time manual annotation of 3D anatomical and electrical maps of the human atria for the presence of electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia””
Adaptive (vs locked)No
source quote (p.5)
“In actual commercial use, however, the trained machine and deep learning models are incorporated into the stand alone local software application which is not connected to a network.”
PCCPNo
Cybersecurity addressedNo

Validation studies (5)

Reader study (MRMC)

n=14,370 cases

endpoints: inter-operator agreement; algorithm-enabled classification acceptably correlates with physician annotation

Bench

n=2,550 cases

endpoints: performance of the VX1 software against two alternative period estimation approaches; evaluating noisy and non-periodic electrograms and for estimating the period on the period estimation dataset

Bench

n=275,020 cases

endpoints: accuracy of over 89%

Reader study (MRMC)

n=1,020 cases

endpoints: VX1 algorithm demonstrated superior performance (agreement to the annotating experts) to the cardiac electrophysiologists in identifying dispersed and non-dispersed intra-cardiac atrial electrograms

Retrospective clinical

n=300 patients · 8 site(s)

endpoints: evaluate the performance of the VX1 in the detection of intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during a catheter ablation procedure for atrial fibrillation or atrial tachycardia; evaluating the usability and efficacy of VX1 for detecting DEs; implementation of VX1 in a cardiac electrophysiology laboratory is not associated with additional risk or procedure time

Reported performance (1 observation)

accuracyas written: “Accuracy”0.89
source quote (p.10)
“A k-fold cross-validation of VX1 algorithm was performed on the training database of 275,020 1.5 second annotated electrograms. 5-fold cross validation was performed on the model with a resulting accuracy of over 89%.”

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) K223516 (decision 2023-01-21) from Volta Medical for a matching device line ("VX1+") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K223516

  • 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/K201298