SERIES 50XM

K954351 · Hewlett-Packard GmbH · HGM · Mar 8, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K954351
• Device Name: SERIES 50XM
• Applicant: Hewlett-Packard GmbH
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Mar 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

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. It allows the non-invasive measurement of the Noninvasive Bloodpressure ans the Oxygen Saturation ,generate alarms, and generate recording on maternal patients.

Device Story

Series 50XM (M1350B) fetal/maternal monitor; combines fetal monitoring (FHR, uterine activity) with maternal parameters (NBP, SpO2, ECG). Inputs: ultrasound/direct ECG transducers for FHR; Toco/IUP transducers for uterine activity; MECG transducer for maternal heart rate; NBP cuff; SpO2 sensor. Operation: processes physiological signals; displays fetal data on primary screen; maternal data on separate LCD; generates alarms/recordings. Used in clinical labor/delivery settings by clinicians. Benefits: integrated monitoring of fetal and maternal status in single unit; facilitates clinical decision-making during labor/delivery.

Clinical Evidence

Bench testing only. Validation included full system validation and regression testing of modified software modules to ensure performance equivalent to predicate devices.

Technological Characteristics

Integrated fetal/maternal monitor. Features ultrasound, direct ECG, Toco, IUP, MECG, NBP, and SpO2 sensing. Includes primary fetal display and secondary maternal LCD. Software-based signal processing; utilizes modified software modules from Series 50IX and transferred modules from HP maternal monitors.

Indications for Use

Indicated for ambulant patients during antepartum testing, labor, and delivery. Includes fetal monitoring (FHR via ultrasound/direct ECG, uterine activity via Toco/IUP, maternal heart rate via MECG) and maternal monitoring (NBP, SpO2).

Regulatory Classification

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.

Predicate Devices

• Fetal Monitor Series 50IX (M1350A) (K900480)
• Corometrics Model 118
• HP 78352C
• M1020A
• M1008B

Submission Summary (Full Text)

{0}

K954351
203

# P -- [510(k)] Summary of Safety and Effectiveness

The Series 50XM (M1350B) is a combination of two subsystems which represent either the functionality of the Fetal Monitor Series 50IX (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 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 M1008B

It allows the non-invasive measurement of the Noninvasive Bloodpressure ans the Oxygen Saturation ,generate alarms, and generate recording on maternal patients.

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.

The HP Series 50XM (M1350B) was fully validated (including regression testing).

The comparison of intended use and technological characteristics of this device to other legally marketed devices taken together with the validation results and other information in this submission indicate that this device is substantially equivalent to legally marketed predicate devices in safety, effectiveness, and intended use.