ScanNav Anatomy Peripheral Nerve Block

DEN220024

Intelligent Ultrasound Limited · granted 2022-10-18 · product code QRG · Anesthesiology

FDA De Novo summary for ScanNav Anatomy Peripheral Nerve Block (DEN220024)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
4
Cited predicates
0
Performance observations
9
Product code
QRG
FDA De Novo source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.2)
“ScanNav Anatomy Peripheral Nerve Block is a software medical device which assists anesthetists and other qualified healthcare professionals in the identification of anatomical structures within ultrasound images during ultrasound-guided regional anesthesia (UGRA) procedures by highlighting the relevant anatomical structures in real-time.”
Algorithmdeep learning artificial intelligence technology based on convolutional neural networks (CNNs)
source quote (p.3)
“The device performs the highlighting by using deep learning artificial intelligence technology based on convolutional neural networks (CNNs).”
Adaptive (vs locked)No
source quote (p.3)
“The deep learning models are locked, and they do not continue to learn in the field.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.5)
“The software documentation included management of cybersecurity and:”

Validation studies (4)

Reader study (MRMC)

n=30 other · 1 site(s)

endpoints: Performance-based use scenario tasks and associated root cause analysis (RCA); Knowledge Task and Labeling Validation and associated root cause analysis (RCA); Interview/subjective discussion

Prospective clinical

n=40 patients · 1 site(s)

endpoints: assess and quantify the correct/incorrect highlighting of anatomical structures associated with subject device during UGRA scanning; Frequency of misidentification of structures [%of total, per anatomical region] with ScanNav Anatomy PNB highlighting; frequency of correct identification of structures; frequency of non-identification of structures; frequency of safety issues and probable adverse events

Bench

sample size not stated

endpoints: electrical safety; electromagnetic compatibility

standards: IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION, IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION

Bench

sample size not stated

endpoints: Software verification, validation, and hazard analysis

standards: FDA Guidance document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005.

Reported performance (9 observations)

accuracyas written: “Exact Accuracy Rate (TP+TN) - Axillary”0.977
source quote (p.9)
“Axillary 0.977 97.7%”
accuracyas written: “Exact Accuracy Rate (TP+TN) - ESP”0.888
source quote (p.9)
“ESP 0.888 88.8%”
accuracyas written: “Exact Accuracy Rate (TP+TN) - IS”0.941
source quote (p.9)
“IS 0.941 94.1%”
accuracyas written: “Exact Accuracy Rate (TP+TN) - Pop”0.981
source quote (p.9)
“Pop 0.981 98.1%”
accuracyas written: “Exact Accuracy Rate (TP+TN) - RS”0.968
source quote (p.9)
“RS 0.968 96.8%”
accuracyas written: “Exact Accuracy Rate (TP+TN) - Adductor”0.904
source quote (p.9)
“Adductor 0.904 90.4%”
accuracyas written: “Exact Accuracy Rate (TP+TN) - ST”0.909
source quote (p.9)
“ST 0.909 90.9%”
accuracyas written: “Exact Accuracy Rate (TP+TN) - SC”0.983
source quote (p.9)
“SC 0.983 98.3%”
accuracyas written: “Exact Accuracy Rate (TP+TN) - SFIC”0.762
source quote (p.9)
“SFIC 0.762 76.2%”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: De Novo decision 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
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K232787 (decision 2023-10-06) from Intelligent Ultrasound Limited for a matching device line ("ScanNav Anatomy Peripheral Nerve Block") — a new clearance for the same line is a change event.

    first seen 2026-07-22 · k_number:K232787

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 2026-09-02.

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 De Novo 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.

Related FDA clearances

More AI/ML devices under product code QRG

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

Nerveblox

K250818

Smart Alfa Teknoloji San. Ve Tic. A.S.

cleared 2025-08-15

ScanNav Anatomy Peripheral Nerve Block

K232787

Intelligent Ultrasound Limited

cleared 2023-10-06

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/DEN220024