K Number
K954351
Device Name
SERIES 50XM
Date Cleared
1996-03-08

(172 days)

Product Code
Regulation Number
884.2740
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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.
More Information

Not Found

No
The summary describes a combination of existing monitoring technologies and software modules from predicate devices, with no mention of AI or ML.

No.
The device is used for monitoring fetal and maternal vital signs, not for treating a condition.

Yes

The device monitors fetal heart rate (FHR), uterine activity, maternal heart rate (MECG), non-invasive blood pressure (NBP), and oxygen saturation (SpO2), generating alarms and recordings based on these measurements. This collection and interpretation of physiological data for clinical assessment are characteristic functions of a diagnostic device.

No

The device description explicitly states it is a "combination of two subsystems" and describes physical components like transducers, a recorder, and an LCD display, indicating it is a hardware device with integrated software.

Based on the provided text, this device is not an In Vitro Diagnostic (IVD).

Here's why:

  • Intended Use: The intended use describes monitoring physiological parameters (fetal heart rate, uterine activity, maternal heart rate, blood pressure, and oxygen saturation) directly from the patient. This is in vivo monitoring, not in vitro (testing samples outside the body).
  • Device Description: The device description details the combination of functionalities for monitoring these physiological parameters. There is no mention of analyzing biological samples like blood, urine, or tissue.
  • Lack of IVD Keywords: The text does not contain keywords typically associated with IVDs, such as "sample," "reagent," "assay," "analyte," "laboratory," or "diagnostic test."

The device is clearly described as a patient monitor for use during antepartum testing and labor and delivery.

N/A

Intended Use / Indications for Use

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 M 1008B

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

Product codes (comma separated list FDA assigned to the subject device)

203

Device Description

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 50XM (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.

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

ultrasound

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Corometrics Model 118, Series 50IX (M1350A), HP78352C, M1020A, M 1008B

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K900480

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

K954351

203

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 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 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.