ScanNav Anatomy Peripheral Nerve Block
DEN220024Intelligent Ultrasound Limited · granted 2022-10-18 · product code QRG · Anesthesiology
Premarket evidence — what FDA accepted
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.”
source quote (p.3)
“The device performs the highlighting by using deep learning artificial intelligence technology based on convolutional neural networks (CNNs).”
source quote (p.3)
“The deep learning models are locked, and they do not continue to learn in the field.”
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)
source quote (p.9)
“Axillary 0.977 97.7%”
source quote (p.9)
“ESP 0.888 88.8%”
source quote (p.9)
“IS 0.941 94.1%”
source quote (p.9)
“Pop 0.981 98.1%”
source quote (p.9)
“RS 0.968 96.8%”
source quote (p.9)
“Adductor 0.904 90.4%”
source quote (p.9)
“ST 0.909 90.9%”
source quote (p.9)
“SC 0.983 98.3%”
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
Not yet tracked — the weekly postmarket refresh hasn't snapshotted this device.
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.
- Final guidance2021-10De Novo Classification Process (Evaluation of Automatic Class III Designation)
De Novo pathway
Final (Oct 2021), issued with the De Novo final rule. Most relevant to first-of-a-kind devices without a predicate (DEN-numbered clearances).
- Draft guidanceAnesthesiology-specific2025-01Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations
Software premarket content
Draft (Jan 2025) on skin-pigmentation performance equity; relevant to AI-based SpO2 estimation. Still draft as of July 2026.
- Final guidance2026-01Clinical Decision Support Software
Clinical decision support · SaMD (general)
New final guidance issued Jan 2026, superseding the Sept 2022 version; narrows the device-CDS scope. Applies to software that informs clinical management.
- Final guidance2026-01General Wellness: Policy for Low Risk Devices
SaMD (general) · Clinical decision support
Revised final (Jan 2026); now addresses noninvasive products estimating physiologic parameters (SpO2, BP, glucose). Reshapes the device / non-device line for AI wellness features.
- Final guidance2025-09Computer Software Assurance for Production and Quality Management System Software
SaMD (general) · Postmarket
Final (Sept 2025). Covers software used in production/QMS (incl. ML development-pipeline tooling), superseding Section 6 of the 2002 GPSV — not device software functions themselves.
- Final guidance2025-06Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions
Cybersecurity · Software premarket content
Reissued June 2025 (retitled 'Quality Management System', was Sept 2023 'Quality System'); adds coverage of FD&C Act §524B cyber devices.
- Final guidance2024-12Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
Predetermined Change Control Plan · AI/ML lifecycle · Software premarket content
Final (Dec 2024). Supersedes the April 2023 AI/ML PCCP draft.
- Final guidance2023-10Electronic Submission Template for Medical Device 510(k) Submissions
Software premarket content
eSTAR has been mandatory for 510(k)s since Oct 2023 — operationally unavoidable, though not AI-specific.
- Final guidance2023-08Off-The-Shelf Software Use in Medical Devices
Software premarket content · SaMD (general)
Final (Aug 2023). Applies when a device incorporates off-the-shelf software components (common in ML stacks).
- Final guidance2023-06Content of Premarket Submissions for Device Software Functions
Software premarket content · SaMD (general)
Final (June 2023); replaced the May 2005 'Software Contained in Medical Devices' guidance. Documentation level drives the software content of the submission.
- Final guidance2022-09Policy for Device Software Functions and Mobile Medical Applications
SaMD (general) · Clinical decision support
Current version Sept 2022. Frames which software functions FDA regulates as devices.
- Final guidance2016-12Postmarket Management of Cybersecurity in Medical Devices
Cybersecurity · Postmarket
- Final guidance2002-01General Principles of Software Validation
SaMD (general) · Software premarket content
Still active except Section 6 (superseded Sept 2025 by the Computer Software Assurance final guidance).
- Draft guidance2025-01Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
AI/ML lifecycle · Software premarket content · Transparency
Draft as of July 2026 (published Jan 2025); finalization is on CDRH's FY2026 agenda but not yet published. Treat as FDA's stated direction, not a binding expectation.
- Draft guidance2024-08Predetermined Change Control Plans for Medical Devices
Predetermined Change Control Plan · Postmarket
Draft (Aug 2024) extending PCCPs beyond AI to all devices under FD&C §515C; not final as of July 2026.
- Guiding principles2024-06Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles
Transparency · AI/ML lifecycle
- Guiding principles2023-10Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
Predetermined Change Control Plan · AI/ML lifecycle
FDA/Health Canada/MHRA joint principles (Oct 2023); companion to the GMLP and Transparency principles.
- Guiding principles2021-10Good Machine Learning Practice for Medical Device Development: Guiding Principles
AI/ML lifecycle · SaMD (general)
FDA/Health Canada/MHRA joint principles (Oct 2021). Foundational, not a binding guidance; IMDRF issued a related GMLP document Jan 2025.
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.