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K Number
K991739
Device Name
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
Manufacturer
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
Date Cleared
1999-08-19

(90 days)

Product Code
HGM
Regulation Number
884.2740
Type
Traditional
Panel
OB
Reference & Predicate Devices
k964770,k955559,k852608
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

I. Fetal Surveillance
A Corometrics 120 Series Monitor is used for non-invasive and invasive monitoring of the fetus during the antepartum period as well as throughout labor and delivery (i.e. fetal heart rate and uterine activity monitoring). Fetal movement detection and fetal heart rate alarm options (user selectable high/low and poor signal quality alarms or Spectra alerts) are available.

II. Maternal Monitoring
A Corometrics 120 Series Monitor is intended for monitoring maternal vital signs to help assess maternal well-being. The vital signs which can be measured with these monitor configurations are summarized below.

NOTE: Maternal vital signs provided by the monitor should only be used as an adjunct in patient assessment in conjunction with clinical signs and symptoms.

Blood Pressure. The monitor is intended for use in the non-invasive monitoring of maternal blood pressure (NBP). This monitor is not intended for use in neonatal or pediatric blood pressure monitoring.

Pulse Oximetry. The monitor is intended for use in the non-invasive monitoring of maternal functional oxygen saturation of arterial hemoglobin (MSpO2).

Heart/Pulse Rate. The monitor is intended for use in the non-invasive monitoring of the maternal heart/pulse rate. Additionally, a MECG waveform "snapshot" may be displayed and printed.

NOTE: Only the maximum configuration provides both maternal heart rate and pulse rate data.

Device Description

The 120 Series is intended for monitoring fetal and maternal vital signs: fetal heart rate; optional fetal movement detection, FHR and UA alarms, and maternal uterine activity, heart/pulse rate, blood pressure, and %Sp02. The device is intended for use in a hospital/clinical environment.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for a maternal/fetal monitor. It describes the device, its intended use, and a comparison to predicate devices, but it does not detail specific performance metrics, acceptance criteria, or any studies conducted to validate these criteria.

Therefore, I cannot fulfill the request to provide:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number of experts used or their qualifications.
  4. Adjudication method.
  5. Information about an MRMC comparative effectiveness study or effect size.
  6. Information about a standalone performance study.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How the ground truth for the training set was established.

§ 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).