Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI

K223288

Brainlab AG · cleared 2023-07-21 · product code HAW · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“The subject device consists of several devices: Cranial Navigation using optical tracking technology, its accessory Automatic Registration IMRI, and Cranial EM System using electromagnetic tracking technology. With this submission, several already existing features are now performed introducing a new algorithm using artificial intelligence and machine learning (AI/ML).”
AlgorithmConvolutional Neuronal Network (CNN) developed using a Supervised Learning approach
source quote (p.7)
“The Al/ML algorithm is a Convolutional Neuronal Network (CNN) developed using a Supervised Learning approach.”
Adaptive (vs locked)No
source quote (p.7)
“This is a static algorithm (locked).”
PCCPFDA source did not state this
Cybersecurity addressedNo

Validation studies (5)

Bench

sample size not stated

endpoints: product specifications; risk analysis; incremental test strategies; performance testing comparing conventional to machine learning based landmark detection and abnormity detection

standards: FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Bench

sample size not stated

standards: IEC 62366-1 “Medical devices – Part 1: Application of usability engineering to medical devices”

Bench

sample size not stated

endpoints: Mean Positional Error of the placed instrument's tip ", "Mean Angular Error of the placed instrument's axis

Bench

sample size not stated

endpoints: Compliance to electrical safety, RFID and EMC

standards: IEC 60601-1, AIM 7351731, IEC 60601-1-2

Bench

sample size not stated

endpoints: Biocompatibility assessment; Cleaning and disinfection evaluation/reprocessing; Mechanical properties of instruments; Aging performance; MRI testing (where applicable)

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

5
recalls in product code, 24mo
1922
MAUDE reports in code, 12mo
-39%
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) K234047 (decision 2024-03-20) from Brainlab AG for a matching device line ("Automatic Registration") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K234047

  • recall_reason_pattern

    Software/algorithm-related recall in product code HAW (Howmedica Osteonics Corp., initiated 2025-11-12): "When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an in" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97988

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 Neurology 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/K223288