Nelli (Version 7.11)

K251506

Neuro Event Labs OY · cleared 2025-11-21 · product code POS · Neurology

FDA 510(k) summary for Nelli (Version 7.11) (K251506)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
2
Cited predicates
1
Performance observations
5
Product code
POS
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Nelli is a seizure detection and monitoring system based upon the analysis of audio/video recording which does not require the patient to be fitted with any body-worn accessory which may interfere with sleep and/or rest. Nelli uses machine learning algorithms to detect and categorize into review priority classes events indicative of seizure activity with a positive motor component.”
Algorithmmachine learning algorithms
source quote (p.5)
“Nelli uses machine learning algorithms to detect and categorize into review priority classes events indicative of seizure activity with a positive motor component.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.8)
“Cybersecurity (documentation per guidance on cybersecurity⁴)”

Validation studies (2)

Bench

sample size not stated

standards: ISO 14971, ISO 15223-1, ISO 7010, IEC 62304, IEC 62366-1, IEC 81001-5-1, AAMI TIR57

Prospective clinical

n=172 patients · 3 site(s)

endpoints: event-level Sensitivity (“Se”, expressed as Positive Percent Agreement) in convulsive seizures (tonic-clonic and bilateral clonic); False Detection Rate (“FDR”, i.e. False Positives per hour) in convulsive seizures (tonic-clonic and bilateral clonic); event-level Sensitivity ("Se", expressed as Positive Percent Agreement) in other major motor seizures (tonic, unilateral clonic, or hyperkinetic seizures with a motor duration over 10s and other motor seizure types with a motor duration over 30s); False Detection Rate (“FDR”, i.e. False Positives per hour) in other major motor seizures (tonic, unilateral clonic, or hyperkinetic seizures with a motor duration over 10s and other motor seizure types with a motor duration over 30s)

standards: 21 CFR §812.2(b)(1), ISO 14155

Reported performance (5 observations)

sensitivity84.5CI [74.6%, 94.2%]
source quote (p.9)
“I: High Priority (Convulsive) ... Sensitivity (%) 84.5% ... Sensitivity* [95% CI] [74.6%, 94.2%]”
detection_rateas written: “False Detection Rate (FDR) (FP/hour) for High Priority (Convulsive)”0.05CI [0.0376, 0.0636]
source quote (p.9)
“I: High Priority (Convulsive) ... FDR d (FP/hour) 0.050 ... FDR d [95% CI] [0.0376, 0.0636]”
detection_rateas written: “False Detection Rate (FDR) (FP/24 hours) for High Priority (Convulsive)”1.2CI [0.902, 1.53]
source quote (p.9)
“I: High Priority (Convulsive) ... FDR (FP/24 hours) [95% CI] 1.20 [0.902, 1.53]”
detection_rateas written: “False Detection Rate (FDR) (FP/hour) for Medium Priority (Other Major Motor)”6.08CI [5.63, 6.54]
source quote (p.9)
“II: Medium Priority (Other Major Motor) ... FDR d (FP/hour) 6.08 ... FDR d [95% CI] [5.63, 6.54]”
detection_rateas written: “False Detection Rate (FDR) (FP/24 hours) for Medium Priority (Other Major Motor)”146CI [135, 157]
source quote (p.9)
“II: Medium Priority (Other Major Motor) ... FDR (FP/24 hours) [95% CI] 146 [135, 157]”

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

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 2026-09-02.

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.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K251506