The objective of this study is to demonstrate the safety and performance of the Marani Fetal Monitoring Telehealth System (M•care™ System) for use in antenatal monitoring of pregnant women ≥ 32 weeks’ gestation. The M•care System will be evaluated by comparing Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Uterine Contractions (UC) to Doppler FHR, tocodynamometer (TOCO) UC, and Pulse Oximeter MHR measured with an FDA cleared standard of care cardiotocography (CTG) device.
This is a multi-center, single arm, prospective paired comparison trial to determine the equivalence of the Marani M•care System with an FDA cleared Doppler FHR, TOCO UC and Pulse Oximetry MHR standard of care CTG device.
The expected monitoring duration for each subject is a minimum of 60 minutes and maximum of 120 minutes.
Marani Health’s M•care System is a fetal heart rate (FHR), maternal heart rate (MHR), and uterine activity (UA) monitoring system intended for home use by a pregnant woman as prescribed by their healthcare provider.
The M•care™ System is comprised of 3 components:
(1) The M•wrap™, a wearable compression abdominal band with an integrated electronics hub, called the M•core™, mounted to the garment, that interfaces with
(2) the removable Orbital Research SilverBump dry electrodes and
(3) mobile and web-based software applications to securely transmit subject vital data to secure systems
Owing to the unique placement of electrodes within the M•wrap, the functionality of the system is not dependent on fetal position.
The M-care System is being developed In accordance with the requirements of FDA’s Quality System Regulation for Medical Devices, 21CFR Part 820, and ISO13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes. Both FDA and ISO13485 mandate the use of Design Controls to ensure a formalized approach to development of medical devices. Marani Health has established Design Control procedures to ensure that a robust, and uniform product development methodology is being followed. This methodology includes, but is not limited to, the following requirements:
- Design and Development Plans are established, reviewed, updated, and approved.
- • Design Inputs are identified to ensure that design requirements are appropriate and address the intended use.
- • Design Outputs are defined to allow for adequate evaluation of conformance to design inputs.
- • Design Reviews are planned and conducted at appropriate stages during development.
- • Design Verification is performed to ensure the design output meets the design input requirements.
- • Design Validation is performed to confirm that devices conform to defined user needs and intended uses under actual or simulated use conditions.
The output of these activities is maintained in a Design History File in Marani Health’s Quality Management System.