Cleared Traditional

K140862 - MONICA NOVII WIRELESS PATCH SYSTEM

K140862 is an FDA 510(k) clearance for MONICA NOVII WIRELESS PATCH SYSTEM, manufactured by Monica Healthcare, Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code OSP cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K140862 · Monica Healthcare, Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
146d
Days
Class 2
Risk

K140862 is an FDA 510(k) clearance for the MONICA NOVII WIRELESS PATCH SYSTEM. Classified as Uterine Electromyographic Monitor (product code OSP), Class II - Special Controls.

Submitted by Monica Healthcare, Ltd. (Nottingham, GB). The FDA issued a Cleared decision on August 27, 2014 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2720 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Monica Healthcare, Ltd. devices

FDA 510(k) Submission Details - K140862

510(k) Number K140862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2014
Decision Date August 27, 2014
Days to Decision 146 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 161d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

OSP Device Classification - Class 2, Special Controls

Product Code OSP Uterine Electromyographic Monitor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2720
Definition The Uterine Electromyographic Monitor Is Intended To Pick Up Uterine Emg Signals From Surface Electrodes Placed On The Maternal Abdomen. It Produces A Uterine Activity Tracing And Monitors Women In Labor At Term Gestation With A Singleton Pregnancy.
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 Obstetrics & Gynecology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01889316 Completed Interventional

Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method

75
Patients (actual)
1
Site
Supportive_care
Purpose
Open label
Masking
Condition studied Labor Fetal Anoxia
Study design Single group
Eligibility Female only · 18 Years+
Principal investigator Meg Hill, MBBS
Sponsor University of Arizona
Started 2013-04-01 → Primary completion 2013-11-01 → Completed 2014-01-01
Primary outcome
Efficacy of the Novii when compared to the AN24
Study completed - no results published. This trial concluded in 2014 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.
View full study on ClinicalTrials.gov

Regulatory Peers - OSP Uterine Electromyographic Monitor

All 9
Devices cleared under the same product code (OSP) and FDA review panel - the closest regulatory comparables to K140862.
LaborView™ LV1000 Wireless Electrode System
K190798 · Obmedical Company · Sep 2020
PUREtrace™
K153262 · Nemo Healthcare BV · Feb 2017
LaborView LV1000
K142583 · Obmedical Company · Jan 2015
EUM 100PRO
K131889 · Promedic, Inc. · Apr 2014
SURECALL LABOR MONITOR
K130002 · Reproductive Research Technologies, LP · Jun 2013
MONICA AN24
K112390 · Monica Healthcare, Ltd. · Jul 2012