Cleared Traditional

K220095 - ANNE Sleep (FDA 510(k) Clearance)

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

K220095 · Sibel, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Jul 2022
Decision
180d
Days
Class 2
Risk

K220095 is an FDA 510(k) clearance for the ANNE Sleep. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Sibel, Inc. (Niles, US). The FDA issued a Cleared decision on July 11, 2022 after a review of 180 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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. Standard predicate reliance. 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 Sibel, Inc. devices

Submission Details

510(k) Number K220095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2022
Decision Date July 11, 2022
Days to Decision 180 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
41d slower than avg
Panel avg: 139d · This submission: 180d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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
NCT04643782 Completed Interventional

Comparative Study of the ANNE™ One System to Diagnose Obstructive Sleep Apnea

A Single Arm, Open-Label, Multi-Center, and Comparative Study of the Anne Sleep System Versus Polysomnography to Diagnose Obstructive Sleep Apnea: ANNE Program for the Non-Invasive Evaluation of Apnea in Sleep (APNEAs)

287
Patients (actual)
4
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Obstructive Sleep Apnea of Adult
Study design Single group
Eligibility All sexes · 22 Years+ · Healthy volunteers accepted
Sponsor Northwestern University
Started 2021-05-11 → Primary completion 2021-11-17 → Completed 2021-12-27
Primary outcome
Sensitivity and Specificity of Obstructive Sleep Apnea (OSA) Diagnosis Using ANNE Sleep System Compared to Polysomnography
View full study on ClinicalTrials.gov