NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System

K182616

NinePoint Medical, Inc. · cleared 2018-11-02 · product code NQQ · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“The purpose of this 510(k) submission is to add an artificial intelligence software tool referred to as Image and Visualization Enhancements (IVE) to the previously cleared, predicate NvisionVLE Imaging System (K153479).”
Algorithmartificial intelligence machine learning technique known as deep learning, artificial neural network
source quote (p.6)
“The segmentation algorithm was developed using an artificial intelligence machine learning technique known as deep learning. Here, an artificial neural network was trained with manually labelled examples of each feature and then locked for real-time inference on new image data acquired by the device.”
Adaptive (vs locked)No
source quote (p.6)
“Here, an artificial neural network was trained with manually labelled examples of each feature and then locked for real-time inference on new image data acquired by the device.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Standalone

n=1,000 patients · 18 site(s)

endpoints: true positive detection fraction; true negative detection fraction

Reported performance (2 observations)

sensitivity0.896CI 84.8%
source quote (p.7)
“Layering 89.6 (205/229) 84.8”
specificity0.929CI 89.1%
source quote (p.7)
“Hypo-Reflective Structures 92.9 (247/266) 89.1”

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
13
MAUDE reports in code, 12mo
+179%
vs code's own 3-yr baseline
1
drift signals on this device
  • adverse_event_inflection

    MAUDE adverse-event reports for product code NQQ: 13 in the 12 months ending 2026-06, vs a 4.7/12mo average over the prior 3 windows (+179%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=NQQ

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Ninepoint Medical Inc.) — same firm and product code, not necessarily this device · initiated 2018-04-11

    Distal tips of the probes may detach from the probe shaft during use.

    recall event 79884 (openFDA)

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 Radiology 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/K182616