EpiMonitor

K250515

Empatica Srl · cleared 2025-06-19 · product code POS · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.7)
“The EpiMonitor system consists of a wearable device and mobile application: A wearable medical device called EmbracePlus, A mobile application running on smartphones called "EpiMonitor"”
AlgorithmEpiAlgo (Version 2.1) - Uses algorithms to analyze EDA and accelerometer data to detect patterns in the data that may be associated with GTC seizures.
source quote (p.11)
“EpiAlgo (Version 2.1) - Uses algorithms to analyze EDA and accelerometer data to detect patterns in the data that may be associated with GTC seizures.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.8)
“Cybersecurity activities have been conducted and an assessment made on individual component risks. Documentation has been provided with this application as recommended by the FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". All the EpiMonitor System software components underwent appropriate cybersecurity assessment and testing.”

Validation studies (3)

Bench

sample size not stated

endpoints: equivalence in performance

standards: FDA Radio Frequency Wireless Technology in Medical Devices Guidance, issued August 2013, ISO 10993-1

Retrospective clinical

n=141 patients

endpoints: Positive Percentage Agreement (PPA); false alarm rate per 24 hours (FAR)

Retrospective clinical

n=1,444 patients

endpoints: Positive Percent Agreement (PPA); false alarm rate per 24 hours (FAR)

Reported performance (1 observation)

sensitivity1CI 0.891-0.917
source quote (p.9)
“Table 1 - Positive Percent Agreement applying Low-Sensitivity Mode to Epilepsy Monitoring Unit data age # patients #GTCS # detected GTCS PPA corrected PPA Confidence Interval - PPA >21 12 17 17 1.000 0.905 0.891 0.917”

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
2
MAUDE reports in code, 12mo
+500%
vs code's own 3-yr baseline
0
drift signals on this device

Recalls attributed to this device

  • Recalling firm matches this device's applicant (EMPATICA SRL Via Enrico Stendhal) — same firm and product code, not necessarily this device · initiated 2023-07-13

    May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.

    recall event 93215 (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 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/K250515