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K Number
K161902
Device Name
Meridian M110 Fetal Monitoring System
Manufacturer
MINDCHILD MEDICAL
Date Cleared
2017-01-12

(185 days)

Product Code
HGM
Regulation Number
884.2740
Type
Traditional
Panel
OB
Reference & Predicate Devices
K980484,K001407,K003716,K023616,K033320,K040212,K053306,K060241,K080442,K082697,K083162,K090954,K092019,K100481,K101258,K101416,K111979,K112001,K113063,K113426,K120422,K131362,K140384,K142512,K150616,K152562,K160751,K172314,K180493,K182811,K190691,K191986,K192290
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Meridian M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA). The Meridian M110 Fetal Monitoring System acquires and displays the FHR and UA from abdominal surface electrodes that detect the fetal ECG signals, maternal ECG signals, and of uterine muscle contraction signals. Tracings of FHR and UA are displayed onto a primary fetal monitor.

The Meridian M110 Fetal Monitoring System is indicated for use on women who are at ≥ 37 completed weeks, in labor, with singleton pregnancies using surface electrodes on the maternal abdomen. The Meridian M110 Fetal Monitoring System is intended for use by health care professionals in a clinical setting.

Device Description

The Meridian M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA). The Meridian M110 Fetal Monitoring System acquires and displays the FHR and UA from abdominal surface electrodes that detect the fetal ECG signals, maternal ECG signals, and of uterine muscle contraction signals. Tracings of FHR and UA are displayed onto a primary fetal monitor.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria and study details for the Meridian M110 Fetal Monitoring System. The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices, along with its indications for use. It outlines regulatory requirements but does not include performance acceptance criteria or study results.

§ 884.2740 Perinatal monitoring system and accessories.

(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).