STAR Apollo Mapping System

K220786

Rhythm Al, Ltd · cleared 2022-12-01 · product code DQK · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“The STAR ApolloTM Mapping System is a software driven system designed to assist operators in identifying Early Site of Activations (ESA) and Repetitive Patterns of Activation (RPA) in patients undergoing a cardiac mapping procedure for Atrial Fibrillation (AF).”
Algorithmfixed algorithms and equations
source quote (p.6)
“VX1 is a software that utilizes deep learning based algorithms to analyze data sets, whereas the STAR Apollo Mapping System software uses fixed algorithms and equations to analyze the data sets.”
Adaptive (vs locked)No
source quote (p.6)
“VX1 is a software that utilizes deep learning based algorithms to analyze data sets, whereas the STAR Apollo Mapping System software uses fixed algorithms and equations to analyze the data sets.”
PCCPNo
Cybersecurity addressedNo

Validation studies (4)

Bench

sample size not stated

endpoints: mathematical calculations performed by the software match that of the correct, predetermined output

Bench

sample size not stated

endpoints: software performance met the acceptance criteria for each of the test cases; numerical and graphical output was correct

Reader study (MRMC)

sample size not stated

endpoints: manual annotation yielded similar results to the STAR Apollo Mapping System output

Reader study (MRMC)

sample size not stated

endpoints: overall use of the STAR Apollo Mapping System software was appropriate for use

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/K220786