Search Results

The Team3 fetal monitors are indicated for use by trained healthcare professionals in non-invasive and invasive monitoring of physiological parameters in pregnant women and fetuses, during the antepartum and intrapartum periods of pregnancy. The Team3 fetal monitors are intended for pregnant women from the 28th week of gestation, through to term and delivery. The devices are intended for use in clinical and hospital-type facilities. Sonicaid Team3 Antepartum is suitable for use when there is a need to monitor the following physiological applications: - Single or twin fetal heart rates by means of ultrasound - Uterine activity externally sensed - Fetal movement maternally sensed and externally via ultrasound - Maternal heart rate and oxygen saturation via pulse oximetry - Maternal non-invasive blood pressure - CTG analysis advises whether a number of defined criteria indicative of a normal cardiograph record has been met Sonicaid Team3 Intrapartum is suitable for use when there is a need to monitor the following physiological applications: - Single or twin fetal heart rates by means of ultrasound and/or FECG - Maternal heart rate via ECG electrodes - Uterine activity externally or internally sensed - Fetal movement maternally sensed and externally via ultrasound - Maternal heart rate and oxygen saturation via pulse oximetry - Maternal non-invasive blood pressure

The Sonicaid Team3, subject device, is a fetal monitoring device designed for perinatal monitoring and includes a software function, the Dawes-Redman CTG Analysis, previously cleared under K992607. The subject device provides non-invasive and invasive monitoring of physiological parameters in pregnant women and fetuses during antepartum and intrapartum periods. The subject device includes systems and accessories intended to perform perinatal monitoring as aligned with product code HGM. Features included in the subject device are the Dawes Redman analysis, used to assess clinically indicated antepartum cardiotocographs (CTGs) in pregnancies from 26 weeks gestation onwards, assisting physicians in identifying normal and nonreassuring traces. The Dawes-Redman software is embedded in the subject device, ensuring integration with the existing hardware. The device is not intended for use in latent or established labor due to the influence of additional factors such as labor contractions and pharmacological agents.

PeriCALM Patterns is intended for use to provide additional secondary information as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at ≥32 weeks gestation for annotation and summary of the fetal heart rate recording for baseline, accelerations and the uterine pressure recording for contractions. WARNING: Evaluation of FHR during labor and patient management decisions should not be based solely on PeriCALM Patterns annotations or summaries and should include inspection of the fetal monitor tracing and consideration of all pertinent clinical information.

PeriCALM Patterns 3.0 is a software device to be used with fetal/maternal monitoring systems. The subject device is a software algorithm to detect, label and measure features (accelerations, decelerations, baseline, and contractions) in electronic fetal monitoring (EFM) records. PeriCALM Patterns 3.0 uses fetal monitor data imported through an interface with an external source or with a third-party clinical information system. PeriCALM Patterns can function in a networked environment or as a standalone workstation. The subject device includes present-day Long and Short-Term Memory (LSTM) neural networks to identify segments of a fetal heart rate tracing corresponding to accelerations, decelerations, baseline as well as uninterpretable segments where is missing tracing. Contraction detection is achieved using the same processes as the predicate device.

The Avalon CL Fetal & Maternal (F&M) Pod & Patch is a device indicated for use by healthcare professionals in a clinical setting for non-invasive monitoring of maternal heart rate (aHR), fetal heart rate (aFHR), and uterine activity (aToco) in women who are at >36 completed weeks, in labor, with singleton pregnancy, using surface electrodes on the maternal abdomen.

The Avalon CL Fetal & Maternal (F&M) Pod and the Avalon CL Fetal & Maternal (F&M) Patch is a beltless battery-powered maternal-fetal monitoring system that non-invasively measures abdominal fetal heart rate (aFHR), abdominal uterine activity (aToco), and abdominal maternal heart rate (aHR). The Avalon CL Fetal & Maternal (F&M) Patch is a single-use disposable adhesive electrode patch designed to be affixed to the maternal abdomen. The Avalon CL Fetal & Maternal (F&M) Pod is a reusable device which, when connected to the Avalon CL Fetal & Maternal (F&M) Patch, picks up electrical signals and converts it to Short Range Radio (SRR). The Avalon CL Fetal & Maternal Pod communicates the data measurement values to the Avalon CL Base Station using Short-Range Radio (SRR). The Avalon CL Base Station in turn relays the information to the connected Philips Fetal-Maternal (FM) Monitor (i.e., FM20, FM30, FM40, and FM50).

The Novii+ Pod is an antepartum and intrapartum Maternal/Fetal Monitor that non-invasively measures fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii+ Pod acquires the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Pod also acquires the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The Pod is indicated for use on women who are at 34 weeks and 0/7 days and greater with singleton pregnancies, using surface electrodes on the maternal abdomen. The Novii Patch is an accessory to the Novii+ Pod that connects directly to the Novii+ Pod and contains the surface electrodes that attach to the abdomen. The Novii+ Interface is an accessory to the Novii+ Pod which provides a means of interfacing the wireless output of the Novii+ Pod to the transducer inputs of a Maternal/Fetal Monitor. The Novii+ Interface enables signals collected by the Novii+ Pod to be printed and displayed on a Maternal/Fetal Monitor and sent to a central network, if connected. The Novii+ Pod Maternal/Fetal Monitor and its accessories are intended for use by healthcare professionals in a clinical setting.

The Novii+ Wireless Patch System (Novii+ system) is a battery-powered maternal-fetal monitoring system that measures abdominal fetal heart rate (FHR), abdominal uterine activity (UA), and abdominal maternal heart rate (MHR). The Novii+ Wireless Patch system is designed as an ambulatory device for the monitoring of a pregnant mother. The monitor enables the abdominal electrophysiological signal to be picked up from three different positions on the maternal abdomen using the 5 electrodes on the Novii Patch. The monitor filters the abdominal signals, converts the abdominal electrophysiological data into a digital format and then processes it in real time to extract the fetal heart rate, maternal heart rate and uterine activity. The result of the processing is transmitted via a Bluetooth connection to the Novii+ Interface device which is an accessory to the Novii+ Pod. The Novii+ Pod (proposed device) is indicated for use on women who are at 34 weeks and 0/7 days and greater with singleton pregnancies with cephalic fetal presentation.

Bloomlife MFM-Pro is indicated for monitoring of maternal heart rate (MHR) and fetal heart rate (FHR) during the antepartum period for singleton pregnancies 32 weeks gestation or later. It is to be used by healthcare professionals, clinics, physicians' offices, antepartum rooms, and in the patient's home on the order of a physician. Bloomlife MFM-Pro is not intended for use in critical care situations or those patients hospitalized for or suspected to have preterm labor. Bloomlife MFM-Pro is not intended to be used for antepartum monitoring (e.g., non- stress testing).

Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate (FHR) and maternal heart rate (MHR) during the antepartum period on pregnant women with a singleton pregnancy at 32 weeks gestation or later. The healthcare professional applies the device to the patient and uses Bloomlife MFM-Pro to generate the Bloomlife MFM-Pro report that provides 5 minutes of fetal heart rate (FHR) and maternal heart rate (MHR) monitoring to the clinic. A typical Bloomlife MFM-Pro session is expected to take 12 minutes; approximately 7 minutes to perform system quality checks and 5 minutes to record data. Signal quality checks continue during recording to ensure data quality. Bloomlife MFM-Pro consists of three main components: the Bloomlife Sensor, the Bloomlife App, and the Bloomlife Cloud. The Bloomlife Sensor measures biopotential signals picked up on the abdominal surface using electrodes and transfers the data to the Bloomlife App via Bluetooth Low Energy. The Bloomlife App is used by a healthcare professional to enter patient information, start'stop recording sessions, and get feedback on data quality and recording status during a recording. The App does not process or visualize data; it acts as a gateway for the raw data measured by the sensor. The Bloomlife Cloud receives the data from the app, stores and processes the data into a Report, which is provided to the clinic via electronic fax. The Cloud Algorithm extracts the maternal heart rate from 50 bpm to 240 bpm within ±7 beats per minute, and fetal heart rate from 50 bpm to 240 bpm within ±10 beats per minute at a sample rate of 4 samples per second.

Mural Perinatal Surveillance is a perinatal monitoring system intended for electronic collection, display, and documentation of clinical data with optional features to store, export, annotate, calculate, and retrieve clinical data. Data is acquired from medical devices, electronic health records, or other data sources on a hospital's network. This device is intended for use by healthcare professionals in clinical support settings for obstetric patients during and after pregnancy. This product is not intended to control of the medical devices providing data across the hospital network. All information or indications provided are intended to support the judgment of medical professionals and are not intended to be the sole source of information for decision making.

Mural Perinatal Surveillance is a software only, information management system designed for the obstetrical (OB) care environment. Its use covers patients during pregnancy, labor, birth and covers newborn documentation. The software interfaces with a healthcare facility's Electronic Medical Records (EMR) and patient monitoring network to collect, display and document relevant patient data. The software combines patient surveillance and alarm capabilities with patient documentation and record keeping into a single application to support patient care for their complete obstetrical care journey.

The Sonicaid Team3 Antepartum and Sonicaid Team3 Intrapartum fetal monitors) are indicated for use by trained healthcare professionals in non-invasive monitoring of physiological parameters in pregnant women and fetuses, during the antepartum and intrapartum periods of pregnancy. The Team3 fetal monitors are intended for pregnant women from the 28th week of gestation, through to term and delivery. The devices are intended for use in clinical and hospital-type facilities. Sonicaid Team3 Antepartum is suitable for use when there is a need to monitor the following physiological applications: 1) Single or twin fetal heart rates by means of ultrasound 2) Uterine activity externally sensed 3) Fetal movement maternally sensed and externally via ultrasound 4) Maternal heart rate and oxygen saturation via pulse oximetry 5) Maternal non-invasive blood pressure Sonicaid Team3 Intrapartum is suitable for use when there is a need to monitor the following physiological applications: 1) Single or twin fetal heart rates by means of ultrasound and/or FECG 2) Maternal heart rate via ECG electrodes 3) Uterine activity externally or internally sensed 4) Fetal movement maternally sensed and externally via ultrasound 5) Maternal heart rate and oxygen saturation via pulse oximetry 6) Maternal non-invasive blood pressure

The Sonicaid Team3 is a mains / battery powered multi-function fetal monitor designed for use in clinical and hospital environments during antepartum and intrapartum phases of pregnancy. The Sonicaid Team3 is designed for use at the bedside; there is a wall mounting bracket available as well as a trolley for fixed or transportable use. The unit may also be used free-standing on a work surface. The units are powered either from local mains electrical supply or an optional internal rechargeable battery. The Sonicaid Team3 fetal monitors include the following: - 8.4" Color LCD Display with LED backlighting. - Touch screen user interface. - Monitoring of up to two fetal heart rates via independent ultrasound transducers. - Monitoring of maternal uterine activity via external tocodynamometer (Toco) or internal intra-uterine pressure (IUP) transducers. - Monitoring of maternal oxygen saturation (SpO2) and heart rate via pulse oximetry sensor. - Monitoring of maternal Non-Invasive Blood Pressure . (NIBP). - Monitoring of fetal heart rate via ECG. - Maternal heart rate (eMHR). - Capture of maternally sensed fetal movements via a cabled switch. - Chart printout via (optional) inbuilt thermal printer - Data output via RS232.

The Philips IntelliSpace Perinatal Obsterical Information Management System is indicated for obsterior and after pregnancy, who require monitoring in a healthcare setting. The Philips IntelliSpace Perinatal system provides: - Basic and advanced fetal trace alarming for both antepartum and intrapartum patients. - Central monitoring of maternal alarming. - Documentation capabilities and data storage. - Viewing and alarming of patient physiologic data, at remote locations, via the healthcare facility Remote Desktop Session (RDS). - An interface to launch the Philips IntelliVue XDS Remote viewing and operating of compatible patient monitors.

The Philips IntelliSpace Perinatal Rev. K.00 is a patient-oriented, departmental information management system for the obstetrical care environment. It covers OB care in so far as it is relevant for GYN visits, pregnancy, labor, birth and newborn documentation. It combines surveillance and alarming with comprehensive patient documentation and data storage into one system that covers the continuum of obstetrical care across one or more pregnancies, from the first antepartum visit until delivery and discharge.

F6/F9 Fetal & Maternal Monitor is intended for non-invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms. F6/F9 Fetal & Maternal Monitor provides Non-Stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC. F6 Express/F9 Express Fetal & Maternal Monitor is intended for monitoring physiological parameters of pregnant women during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms. F6 Express/F9 Express Fetal & Maternal Monitor is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. In addition, it provides a solution for maternal vital signs monitoring. F3/F2 Fetal Monitor is intended for non-invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms. The monitor provides non-stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.

The subject devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. The submission seeks clearance for several devices and their accessories, which were modified since their last 510(k) clearance. The subject devices of the present submission include the F2/F3 and F6/F9 fetal monitors as well as the F6/F9 Express, which provide both fetal and maternal monitoring capabilities. The fetal and maternal physiological parameters that are supported by the EDAN bedside monitors are as follows: - Fetal heart rate (FHR) - Tocodynamometry (TOCO) for external monitoring of uterine contractions . - Fetal Movement (FM) ● - Automated Fetal Movement (AFM) ● - Direct ECG (DECG) for internal monitoring of fetal heart rate - . Intrauterine pressure catheter (IUP) for internal monitoring of uterine contractions - . Maternal ECG (MECG) - . Noninvasive blood pressure (NIBP) was added to F6/F9 Express in this submission - Maternal Sp02 (MSp02) for monitoring pulse rate (PR) . - . Temperature (TEMP) for monitoring maternal temperature

AlertWatch:OB is intended for use by clinicians for secondary monitoring of maternal patients in the labor and delivery unit. AlertWatch:OB is a maternal surveillance system that combines data from validated electronic medical record systems, and displays them in one place. Once alerted by AlertWatch:OB, the clinician must refer to the primary monitor, device, or data source before making a clinical decision.

AlertWatch:OB is a secondary monitoring system used by OB nurses, obstetricians, and OB anesthesiologists to monitor women in the Labor and Delivery (L&D) unit. The purpose of the program is to synthesize a wide range of maternal patient data and inform clinicians of potential problems. Once alerted, the clinician is instructed to refer to the primary monitoring device or EMR before making a clinical decision. AlertWatch:OB should only be connected to EMR systems that have been validated for use with AlertWatch:OB. AlertWatch, LLC performs the validation for each installation site.