Not Cleared Post-NSE

DEN060006 - COMPUTERIZED LABOR MONITORING SYSTEM (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN060006 · Barnev, Ltd. · Obstetrics & Gynecology device
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Jan 2007
Decision
104d
Days
Class 2
Risk

DEN060006 is an FDA 510(k) submission (not cleared) for the COMPUTERIZED LABOR MONITORING SYSTEM. Classified as System, Monitoring, For Progress Of Labor (product code NPB), Class II - Special Controls.

Submitted by Barnev, Ltd. (Kfar Saba, IL). The FDA issued a Not Cleared (DENG) decision on January 30, 2007 after a review of 104 days.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2800 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Obstetrics & Gynecology review framework.

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Submission Details

510(k) Number DEN060006 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 18, 2006
Decision Date January 30, 2007
Days to Decision 104 days
Submission Type Post-NSE
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 160d · This submission: 104d
Pathway characteristics

Device Classification

Product Code NPB System, Monitoring, For Progress Of Labor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2800
Definition This Monitoring System For Progress Of Labor Provides Intrapartum Measurement Of Cervical Dilation, Fetal Head Station, And/or Other Sentinel Anatomical Markers. This Device Is Intended To Be Used Adjunctively With Other Diagnostic Information In Order To Clinically Follow The Progress Of Labor.
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 Obstetrics & Gynecology devices follow this clearance model.