ScanNav Anatomy Peripheral Nerve Block

K232787

Intelligent Ultrasound Limited · cleared 2023-10-06 · product code QRG · Anesthesiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“ScanNav Anatomy Peripheral Nerve Block is a software as a medical device (SaMD) which assists qualified healthcare professionals to identify and label relevant anatomical structures in live ultrasound images in preparation for ultrasound guided regional anesthesia prior to needle insertion for patients 18 years of age or older.”
Algorithmdeep learning artificial intelligence algorithms
source quote (p.6)
“It processes these images using deep learning artificial intelligence algorithms and highlights relevant anatomical structures.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=183 scans

endpoints: FP rate: Mis-identification rate of safety critical anatomical structures in the indicated procedures is less than 5%.; Accuracy (TP+TN) rate: Correct highlighting of safety critical anatomical structures in the indicated procedures at least 80% of the time.; FN rate: non-identification rate of safety critical anatomical structures in the indicated procedures is less than 15%.

Bench

sample size not stated

endpoints: Unit test; Integration test; Fault Injection test; Endurance test; Use case test; Software system level test; Requirements traceability test

Reported performance (3 observations)

sensitivity0.978
source quote (p.9)
“FN rate: non-identification rate of safety critical anatomical structures in the indicated procedures is less than 15%.”
specificity0.989
source quote (p.9)
“FP rate: Mis-identification rate of safety critical anatomical structures in the indicated procedures is less than 5%.”
accuracyas written: “Accuracy (TP+TN) rate”0.967
source quote (p.9)
“Accuracy (TP+TN) rate: Correct highlighting of safety critical anatomical structures in the indicated procedures at least 80% of the time.”

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 Anesthesiology 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/K232787