Caption Interpretation Automated Ejection Fraction Software

K200621

Caption Health · cleared 2020-07-22 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“The Caption Interpretation Automated Ejection Fraction Software applies machine learning algorithms to process echocardiography images in order to calculate left ventricular ejection fraction.”
Algorithmmachine learning algorithms
source quote (p.4)
“The Caption Interpretation Automated Ejection Fraction Software applies machine learning algorithms to process echocardiography images in order to calculate left ventricular ejection fraction.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Reader study (MRMC)

sample size not stated

endpoints: PPV point estimates for the Clip Annotator were greater than 97% for identification of the imaging mode and the view; observed sensitivity point estimates were greater than 90% across views and imaging mode

Retrospective clinical

sample size not stated

endpoints: relationship (RMSD) between AutoEF derived values based on the best available view combination and the reference method; Secondary hypothesis testing evaluating combinations of views (i.e., EF estimation based on two or more views of AP2, AP4 or PLAX)

Reported performance (2 observations)

sensitivity90
source quote (p.6)
“observed sensitivity point estimates were greater than 90% across views and imaging mode.”
ppvas written: “PPV”97
source quote (p.6)
“observed PPV point estimates for the Clip Annotator were greater than 97% for identification of the imaging mode and the view.”

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K210747 (decision 2022-01-19) from Caption Health for a matching device line ("Caption Interpretation Automated Ejection Fraction Software") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K210747

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Caption Health) — same firm and product code, not necessarily this device · initiated 2021-05-19

    The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoEF) and image quality score (IQS) estimates.

    recall event 88101 (openFDA)

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 Radiology 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/K200621