(56 days)
The CMS-1000FM Central Monitoring System (hereinafter called "CMS-1000FM") is a clinical data managing software application and is indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting.
The CMS-1000FM is intended to manage perinatal monitoring data acquired from bedside monitors or manual input for viewing at the central nursing station. The system also produces an electronic medical record.
The CMS-1000FM has display fields for the following obstetric data:
- patient demographics
- provider notes
- FHR
- uterine activity (via tocodynamometry or IUP)
- maternal heart rate
- Sp0 2
- NIBP
- respiratory rate
- temperature
- pulse rate
CMS-1000FM Central Monitoring System is a software product that runs on a PC station running the Microsoft Windows XP operating system. The CMS-1000FM Central Monitoring System connects one central station with some bedside fetal / maternal monitors, and carries out centralized monitoring management for many beds. It can monitor a pregnant woman during the whole parturition process, and all the monitoring information can be recorded, saved and printed, and alarm when the parameter exceeds the user defined limit and poor signal quality. At the same time, the old records can be searched conveniently and quickly.
Device features:
- Connect maximum 32 bedside fetal / maternal monitors with Ethernet.
- Display FHR. UA. Maternal HR. PR. SpO2. NIBP. RR and TEMP numeric . on the screen.
- The screen displays all the monitors simultaneously, or displays one . monitor in full screen.
- 24-hour CTG, 1440-group Maternal Vital Sign data, 200-group NJBP data . review.
- Print CTG report, Maternal Vital Sign list, NIBP list on the paper .
- Audible & visible alarm when FHR or maternal vital sign exceeds the user . defined limit or poor signal quality.
- Patient information, CTG, Maternal Vital Sign list and NIBP list can be . saved, and burned into CDs for backup.
- . Support user accessing control
This 510(k) summary does not contain the information requested regarding acceptance criteria or a study proving the device meets said criteria.
The document is a submission for substantial equivalence to a predicate device, focusing on its description, intended use, and comparison to an existing device. It explicitly states: "This premarket notification submission demonstrates that CMS-1000FM Central Monitoring System is substantially equivalent to the predicate device."
Therefore, it does not include:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
- Information on a multi-reader multi-case comparative effectiveness study or the effect size of human readers with/without AI assistance.
- Results from a standalone (algorithm-only) performance study.
- Details on the type or establishment of ground truth for a test or training set.
- Sample size for a training set.
The document primarily serves to establish that the CMS-1000FM Central Monitoring System is technologically similar and has the same intended use as its predicate device (Edan Instruments' MFM-CNS), thereby not requiring specific performance study documentation in this summary.
§ 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).