Cleared Traditional

K202621 - NeuroSENSE Monitoring System, Model NS-901 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence.

K202621 · Neurowave Systems, Inc. · Anesthesiology device
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Aug 2021
Decision
329d
Days
Class 2
Risk

K202621 is an FDA 510(k) clearance for the NeuroSENSE Monitoring System, Model NS-901. Classified as Index-generating Electroencephalograph Software (product code OLW), Class II - Special Controls.

Submitted by Neurowave Systems, Inc. (Cleveland Heights, US). The FDA issued a Cleared decision on August 5, 2021 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 882.1400 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Neurowave Systems, Inc. devices

Submission Details

510(k) Number K202621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2020
Decision Date August 05, 2021
Days to Decision 329 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 139d · This submission: 329d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OLW Index-generating Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02088671 Completed Observational Industry-sponsored

Effectiveness of the NeuroSENSE for Monitoring the Hypnotic Depth of Anesthesia

A Prospective, Blinded, Clinical Study for Assessing the Effectiveness of the NeuroSENSE for Monitoring the Hypnotic Depth of Anesthesia (DOA)

76
Patients (actual)
2
Sites
Condition studied Depth of Anesthesia (DOA)
Eligibility All sexes · 18 Years+
Principal investigator Richard Merchant, MD FRCPC
Sponsor NeuroWave Systems Inc. (industry)
Started 2014-06-01 → Primary completion 2014-12-01 → Completed 2016-10-01
Primary outcome
Prediction probability Pk for the WAVcns for consciousness vs unconsciousness
Secondary outcome
Prediction probability Pk for the WAVcns for responders vs nonresponders to lidocaine aerosol
Study completed - no results published. This trial concluded in 2016 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov