IRNF App

K212516

Apple Inc. · cleared 2021-10-22 · product code QDB · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote
“The Irregular Rhythm Notification Feature is a software-only mobile medical application that is intended to be used with the Apple Watch.”
Algorithmnew rhythm classification algorithm that leverages machine learning techniques to differentiate between AFib and non-AFib rhythms. The new rhythm classification algorithm uses a convolutional neural network based architecture
source quote (p.9)
“IRNF 2.0 includes a new rhythm classification algorithm that leverages machine learning techniques to differentiate between AFib and non-AFib rhythms. The new rhythm classification algorithm uses a convolutional neural network based architecture and was trained extensively using data collected in a number of development studies.”
Adaptive (vs locked)No
source quote (p.10)
“When development was complete the model was locked, and then evaluated on the Sequestration set as a last test to ensure it had not been over-fit to the development data.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=2,500 patients

Retrospective clinical

n=573 patients

endpoints: device sensitivity; device specificity

Reported performance (2 observations)

sensitivity88.6
source quote (p.11)
“Of those, 124 received an IRNF irregular rhythm notification with concordant AFib on the ECG patch, and the sensitivity was 88.6%.”
specificity99.3
source quote (p.11)
“The AF detection specificity was 99.3%.”

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
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

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/K212516