HyperSnap Surgical System (HSS)

K250268

Hypervision Surgical · cleared 2025-06-24 · product code SFE · Gastroenterology-Urology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“The HSS is an artificial intelligence (AI) / machine learning (ML) enabled device.”
Algorithmdeep learning-based super-resolution and reconstruction algorithm
source quote (p.6)
“The CCU runs the HyperSnap Software which implements a deep learning approach for super-resolution and reconstruction of acquired snapshot hyperspectral images.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.15)
“Software was developed and verified under FDA's recognised consensus standard IEC 62304 with additional considerations provided in TIR 57 implemented for a secure software development lifecycle that consistently produces devices and software that provide reasonable assurance of cybersecurity.”

Validation studies (4)

Bench

n=12 patients

Bench

sample size not stated

standards: ISO 8600-5, ISO 12233

Bench

sample size not stated

Retrospective clinical

n=3 other

endpoints: the laparoscopic vs open small bowel StO2; detection of qualitative changes in StO2 visualised laparoscopically with the subject device during clamping of small and large bowel mesentery; detection of quantitative changes in StO2 measured laparoscopically with the subject device during clamping of small bowel and large bowel mesentery; repeatability and reproducibility of StO2 quantification metrics reported by the subject device; demonstration of adequate RGB visualisation of predefined anatomical structures; detection of qualitative changes in RGB visualised laparoscopically with the subject device during clamping of small and large bowel

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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 Gastroenterology-Urology 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/K250268