LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System

K210484

Medtronic, Inc. · cleared 2021-06-11 · product code MXD · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“New to the LINQ II ICM system is the Zelda AI ECG Classification System Models ZA400, ZA410, ZA420, included in this submission.”
Algorithmdeep-learning neural architectures for AF and Pause detection based on the residual convolutional neural network and ensemble models
source quote (p.7)
“The Zelda AI ECG Classification System is powered by deep-learning neural architectures for AF and Pause detection based on the residual convolutional neural network and ensemble models.”
Adaptive (vs locked)No
source quote (p.7)
“The PCCP does not include provisions for implementation of adaptive algorithms that will continuously learn in the field and all algorithm modifications will be locked prior to release to the field.”
PCCPYes
source quote (p.7)
“Medtronic will make future algorithm improvements under a Predetermined Change Control Plan (PCCP).”
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

sample size not stated

endpoints: reduce false alerts from ICM detected AF and Pause episodes while retaining true alerts

standards: ISO 14971:2019, ISO 15223-1:2016, IEC 82304-1:2016, IEC 62304:2006/AMD 1:2015, ANSI/AAMI EC57: 2012, AAMI/ANSI 60601-1:2005 / A1:2012

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

3
recalls in product code, 24mo
3444
MAUDE reports in code, 12mo
+49%
vs code's own 3-yr baseline
2
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K233562 (decision 2023-12-06) from Medtronic, Inc. for a matching device line ("LINQ II Insertable Cardiac Monitor") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K233562

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K221962 (decision 2022-08-25) from Medtronic, Inc. for a matching device line ("LINQ II Insertable Cardiac Monitor") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K221962

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Medtronic Inc.) — same firm and product code, not necessarily this device · initiated 2023-11-03

    It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device position/migration, patient activity, or external electromagnetic interference.

    recall event 93411 (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 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/K210484