(90 days)
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Fetal Surveillance .
A Corometrics 120is Maternal/Fetal Monitoring System is used for non-invasive and invasive monitoring of the fetus during the antepartum period as well as throughout invasive monitoning of the retail t rate and uterine activity monitoring). Fetal labor and delivery (f.o. Tour rate alarm options (user selectable high/low and poor signal quality alarms) are available. -
Maternal Monitoring ll
A Corometrics 120is Maternal/Fetal Monitoring System is intended for monitoring A Ooromotho TE016 Maternal well-being. The vital signs which can be material that tights to nonitor configurations are summarized as follows:
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 Blood Pressure (NBP). This monitor is not intended for use in the neonatal or pediatric blood pressure monitoring.
Pulse Oximetry. The monitor is intended for use in the non-invasive monitoring of r also Oximody. The oxygen saturation of arterial hemoglobin (MSpO2).
Heart/Pulse Rate. The monitor is intended for use in the non-invasive monitoring of i leardr ulse Rate. The monto Additionally, an MECG waveform "snapshot" may be displayed and printed.
- NOTE: Only the maximum configuration provides both maternal heart rate and pulse rate data
Bed-to-bed surveillance is available when 120is Series Monitors are networked together
The Corometrics Model 120is Maternal/Fetal Monitor 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.
The provided text is a 510(k) summary for the Corometrics Model 120is Maternal/Fetal Monitoring System. It does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.
The document primarily focuses on:
- Contact Information: Details of the manufacturer and regulatory specialist.
- Device Name and Classification: Proprietary name, common names, and classification (Class II).
- Identification of Legally Marketed Equivalent Devices (Predicate Systems): Lists two predicate devices (120 Series Maternal/Fetal Monitor and QS System) with their manufacturers and k numbers.
- Device Description & Intended Use: Describes the device's purpose, including monitoring fetal heart rate, fetal movement detection, FHR/UA alarms, and maternal vital signs (uterine activity, heart/pulse rate, blood pressure, %SpO2). It specifies use in a hospital/clinical environment.
- Predicate Device Comparison of Technological Characteristics: A table comparing monitoring modes (FHR/UA Monitoring, Maternal Heart/Pulse Rate, NBP, SpO2 Monitoring, MECG Waveform, Fetal movement detection, Surveillance mode) of the 120is, 120 Series, and QS.
- Performance Standards: States that "To date, no performance standards relating to devices of this type have been promulgated by the Food and Drug Administration."
- Additional Information: Mentions that "At the time of this submission, the Model 120is is undergoing extensive testing to ensure that it meets its requirements and design." This statement suggests testing was ongoing but does not provide results, criteria, or study details.
The subsequent pages are the FDA's clearance letter, which confirms substantial equivalence to predicate devices but also does not delve into specific performance study details beyond what was presented in the 510(k) summary.
Therefore, I cannot provide the requested information in a table or answer the specific questions below because the provided text does not contain this information.
To reiterate, the document explicitly states: "To date, no performance standards relating to devices of this type have been promulgated by the Food and Drug Administration." and "At the time of this submission, the Model 120is is undergoing extensive testing to ensure that it meets its requirements and design." This strongly indicates that detailed performance study results and acceptance criteria were not included in this particular 510(k) summary.
§ 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).