(132 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard physiological monitoring parameters.
No.
The device is solely for monitoring physiological parameters and does not provide any treatment or therapy.
No
Explanation: The device is described as a "Monitor" intended for "monitoring physiological parameters" and providing "Non-Stress testing or fetal monitoring," as well as "maternal vital signs monitoring." While it collects physiological data, its primary purpose is continuous monitoring rather than providing a diagnosis or definitive medical conclusion itself.
No
The device description explicitly lists hardware components and functionalities like FHR, TOCO, ECG, SpO2, NIBP, and temperature monitoring, which are typically associated with physical medical devices, not software-only solutions. The predicate device is also a physical monitor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The FM-9000 Plus Fetal and Maternal Monitor directly monitors physiological parameters of the pregnant woman and the fetus in vivo (within the living body). It uses methods like ultrasound (for FHR), external sensors (for TOCO, NIBP, SpO2, temperature), and potentially internal sensors (for UIP, DECG).
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the patient.
Therefore, the device falls under the category of a physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FM-9000 Plus Fetal and Maternal Monitor is intended for monitoring physiological parameters of pregnant women during antepartumn examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartumn examination rooms, labor and delivery rooms. The FM-9000 Plus Fetal and 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.
Product codes
HGM
Device Description
FM-9000 Plus Fetal and Maternal Monitor
The Fetal & Maternal Monitor provides the following primary features that can be available for the multiple configurations:
- Basic parameters: FHR, TOCO, Event Mark, AFM .
- Dual FHR monitoring .
- Internal parameters: UIP, DECG .
- FHR limit alarm .
Following facilities are also provided in addition to the above:
- Maternal ECG monitoring ●
- Maternal SP02 monitoring ●
- Maternal NIBP .
- Maternal temperature monitoring ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic Ultrasound imaging
Anatomical Site
human body (Fetal)
Indicated Patient Age Range
pregnant women from the 28th week of gestation
Intended User / Care Setting
trained and qualified personnel in antepartumn examination rooms, labor and delivery rooms.
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)
Non-clinical test:
The following quality assurance measures were applied to the development of the Fetal & Maternal Monitor:
- Software testing .
- Hardware testing .
- Safety testing ●
- Environment test ●
- Risk analysis ●
- Final validation ●
Verification and validation testing was done on the FM-9000 Plus Fetal and Maternal Monitor. This premarket notification submission demonstrates that FM-9000 Plus Fetal and Maternal Monitor is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: _ |