Caption Guidance
DEN190040Bay Labs, Inc. · granted 2020-02-07 · product code QJU · Radiology
Premarket evidence — what FDA accepted
source quote (p.2)
“Caption Guidance is a software-only device that uses artificial intelligence to emulate the expertise of sonographers.”
source quote (p.9)
“The Caption Guidance device is powered by deep learning image analysis algorithms that assist medical professionals in the acquisition of echocardiograms.”
source quote (p.9)
“Caption Health will make future algorithm improvements under a Predetermined Change Control Plan (PCCP).”
source quote (p.9)
“Caption Health will make future algorithm improvements under a Predetermined Change Control Plan (PCCP).”
source quote (p.3)
“The software documentation included: ... 11. Cybersecurity”
Validation studies (4)
Bench
sample size not stated
endpoints: Frame-level prediction of the current pose of the probe; Relative image quality predication of the current pose of the probe; Auto-Capture of clinically-acceptable images and clips; Frame-level PG prediction of the probe maneuver needed to acquire an image/frame of heart; Clip-level PG prediction of the probe maneuver needed to acquire a diagnostic-quality clip
standards: FDA guidance document “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.”, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (UD3-2004)
Retrospective clinical
n=50 patients
endpoints: diagnostic quality images in a high proportion of clips; comparable image quality; high specificity of the auto-capture feature (97.85% of auto-captured clips were diagnostic)
Prospective clinical
n=240 patients
endpoints: Qualitative Visual Assessment of Left Ventricular Size; Qualitative Visual Assessment of Global Left Ventricular Function; Qualitative Visual Assessment of Right Ventricular Size; Qualitative Visual Assessment of Non-Trivial Pericardial Effusion; Qualitative visual assessment of inferior vena cava size; Qualitative visual assessment of right ventricular function; Qualitative visual assessment of left atrial size; Qualitative visual assessment of aortic valve; Qualitative visual assessment of mitral valve; Qualitative visual assessment of tricuspid valve
Standalone
sample size not stated · 1 site(s)
endpoints: 100% of critical tasks passed across all user types; No use errors were found that could cause harm; average of 76% of views were auto-captured per user across all 5 user groups
Reported performance (1 observation)
source quote (p.5)
“Importantly, the high specificity of the auto-capture feature (97.85% of auto-captured clips were diagnostic) demonstrated that a registered sonographer can rely on the auto-capture feature when using Caption Guidance.”
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
NTAP max add-on $1,868.1 (expired) ·
NTAP granted FY2022 for AI-guided cardiac ultrasound image acquisition. Billed under ICD-10-PCS X2JAX47 (new technology group 7). Facility payment only; does not alter the physician professional fee. Discontinued after FY2023.
FDA De Novo DEN190040 decision summaryFY2022 NTAP list (HIA coding review)
Applicable FDA guidance — what the submission is measured against
FDA guidance documents and guiding principles applicable to De Novo AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.
- Final guidanceRadiology-specific2022-09Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions
Radiology CADe/CADx · Software premarket content
Original July 2012; current database date reflects a Sept 2022 reissue. Governs CADe device 510(k) content.
- Final guidanceRadiology-specific2022-09Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions
Radiology CADe/CADx
Original July 2012, revised 2020; current database date Sept 2022. Covers standalone and reader-study performance assessment for CADe.
- Final guidanceRadiology-specific2022-06Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions
Quantitative imaging · Radiology CADe/CADx
Final (June 2022). Relevant to devices outputting quantitative imaging measurements.
- 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).
- 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.