(172 days)
The intended use of the fetal monitoring is the same as for the predicate device Series 50IX (M1350A). It allows non- invasive or invasive monitoring of an ambulant patient during both antepartum testing and labor and delivery in that the monitoring of the FHR via ultrasound or direct ECG, and uterine activity via an external Toco transducer or an internal IUP transducer is possible, additionally it allow maternal heart rate recording via the MECG transducer. The intended use of the maternal parameters NBP and SpO2 is the same as for the predicate devices HP78352C, M1020A and M 1008B It allows the non-invasive measurement of the Noninvasive Bloodpressure ans the Oxygen Saturation , generate alarms, and generate recording on maternal patients.
The Series 50XM (M1350B) is a combination of two subsystems which represent either the functionality of the Fetal Monitor Series 501X (M1350A) or it will represent the functionality of parts of the Patient Monitors HP 78352C or M1020A (SpO2) and M1008B (NBP). The Series 50 XM (M1350B) therefore combines all of the basic fetal monitoring requirements and maternal NBP, SpO2 and ECG in one monitor which is the same intended use as for the predicate device Corometrics Model 118. The fetal parameters are displayed in the same way as that currently used on the Series 50IX (M1350A). The additional maternal parameters are displayed on a separate LCD display situated between the fetal parameters and the recorder. The Series 50XM (M1350B) slightly modifies existing software modules of the Series 50IX (M1350A) Fetal Monitor (which was originally cleared under K900480) and adds a new Software Modules for the maternal parameters, which were original transported from the predicate devices of HP.
This document is a 510(k) premarket notification for a medical device (K954351), which describes the device's intended use and equivalence to predicate devices. It does not contain any information about acceptance criteria, study designs, performance metrics, sample sizes, expert qualifications, or ground truth establishment. The text primarily focuses on:
- Device Description: The Series 50XM (M1350B) combines functionality from existing fetal monitors (M1350A) and patient monitors (HP 78352C, M1020A for SpO2, M1008B for NBP).
- Intended Use: It combines basic fetal monitoring (FHR via ultrasound/direct ECG, uterine activity via Toco/IUP transducers, maternal heart rate via MECG) with maternal NBP and SpO2 monitoring.
- Predicate Devices: Corometrics Model 118 (for the combined device), Series 50IX (M1350A) for fetal monitoring, and HP78352C, M1020A, M 1008B for maternal parameters.
- Technological Characteristics: Slight modification of existing software modules from the Series 50IX and new software modules for maternal parameters ported from HP predicate devices.
- Validation: States that the device was "fully validated (including regression testing)" and claims substantial equivalence.
Therefore, I cannot populate the requested table and information as the provided text does not contain any details regarding the performance study or acceptance criteria.
To answer your request, I would need a different type of document, such as a clinical study report, a validation report, or specific sections within a regulatory submission that detail the device's performance evaluation against predefined criteria.
§ 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).