Cleared Traditional

K062943 - POLYSMITH SLEEP SYSTEM, MODEL NTI5498

K062943 is an FDA 510(k) clearance for POLYSMITH SLEEP SYSTEM, manufactured by Neurotronics, Inc.. The device is a Class 2 Neurology device with product code OLZ cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K062943 · Neurotronics, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
223d
Days
Class 2
Risk

K062943 is an FDA 510(k) clearance for the POLYSMITH SLEEP SYSTEM, MODEL NTI5498. Classified as Automatic Event Detection Software For Polysomnograph With Electroencephalograph (product code OLZ), Class II - Special Controls.

Submitted by Neurotronics, Inc. (Gainesville, US). The FDA issued a Cleared decision on May 9, 2007 after a review of 223 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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.

FDA 510(k) Submission Details - K062943

510(k) Number K062943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2006
Decision Date May 09, 2007
Days to Decision 223 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
74d slower than avg
Panel avg: 149d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLZ Device Classification - Class 2, Special Controls

Product Code OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Automatically Mark Electroencephalograph And Polysomongraph Signals In Order To Aid In Identification Of Such Events And Annotation Of Prolonged Psg Traces; Automatically Calculate Simple Measures Obtained From Recorded Signals (e.g. Magnitude, Time, Frequency And Simple Statistical Measures Of Marked Events); All Output Subject To Verification By Qualified User
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph

All 33
Devices cleared under the same product code (OLZ) and FDA review panel - the closest regulatory comparables to K062943.
SLEEP PROFILER
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BIOSLEEP
K002622 · Oxford Biosignals Limited · Oct 2000
SLEEP STUDY ANALYSIS (SSA) VERSION 96.10
K963631 · Omega Results · Apr 1997