Cleared Traditional

K222680 - DeltaScan Monitor (FDA 510(k) Clearance)

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

K222680 · Prolira B.V. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
149d
Days
Class 2
Risk

K222680 is an FDA 510(k) clearance for the DeltaScan Monitor. Classified as Neuropsychiatric Interpretative Electroencephalograph Assessment Aid (product code NCG), Class II - Special Controls.

Submitted by Prolira B.V. (Utrecht, NL). The FDA issued a Cleared decision on February 2, 2023 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1440 - the FDA neurology 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Prolira B.V. devices

Submission Details

510(k) Number K222680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2022
Decision Date February 02, 2023
Days to Decision 149 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 148d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NCG Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1440
Definition Uses A Patient's Electroencephalograph (eeg) To Provide An Interpretation Of The Patient's Neuropsychiatric Condition. It Is Also Used Only As An Assessment Aid For A Medical Condition For Which There Exists Other Valid Methods Of Diagnosis."
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 Neurology devices follow this clearance model.

Regulatory Consultant

Corolla Clin/Reg Consulting
Paul J Manberg

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT03966274 Completed Observational

DeltaScan Validation Study for the Assessment of Delirium in the ICU and on Wards

A Prospective Multicenter Clinical Validation Study of DeltaScan for the Assessment of Delirium in the Intensive Care Unit and on Wards

434
Patients (actual)
1
Site
Condition studied Delirium
Eligibility All sexes · 18 Years+
Sponsor UMC Utrecht
Started 2019-02-16 → Primary completion 2021-02-12
Primary outcome
The positive and negative predictive value of DeltaScan
Secondary outcome
Sensitivity and Specificity of DeltaScan
Study completed - no results published. This trial concluded in 2021 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