Cleared Traditional

K222680 - DeltaScan Monitor

K222680 is an FDA 510(k) clearance for DeltaScan Monitor, manufactured by Prolira B.V.. The device is a Class 2 Neurology device with product code NCG cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K222680 · Prolira B.V. · Neurology device
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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

FDA 510(k) Submission Details - K222680

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.

NCG Device Classification - Class 2, Special Controls

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