FLASH EVD System (10-0002)

K242480

7D Surgical ULC · cleared 2024-12-27 · product code HAW · Neurology

Premarket evidence — what FDA accepted

Device typesimd
source quote (p.6)
“FLASH EVD System is a stereotactic image guided surgical navigation system during cranial procedures. The FLASH EVD software assists in guiding surgeons during external ventricular drainage (EVD) catheter placement procedures.”
AlgorithmThe system performs registration between preoperatively acquired tomographic data and data captured intraoperatively from an integrated Structured Light scanner, providing guidance data by displaying the locations of tracked navigation tools relative to the patient. Position and orientation data of the tracked navigation tools are linked to the preoperative image data using the system software.
source quote (p.6)
“registration between preoperatively acquired tomographic data and data captured intraoperatively from an integrated Structured Light scanner. Both Systems provide guidance data by displaying the locations of tracked navigation tools relative to the patient. Position and orientation data of the tracked navigation tools are linked to the preoperative image data using the system software.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: absolute accuracy; repeatability of the accuracy; navigation accuracy; Target Registration Error (TRE); Trajectory Angular Error (TAE)

standards: ASTM F2554-10

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

5
recalls in product code, 24mo
1922
MAUDE reports in code, 12mo
-39%
vs code's own 3-yr baseline
1
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code HAW (Howmedica Osteonics Corp., initiated 2025-11-12): "When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an in" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97988

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 Neurology 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/K242480