(328 days)
Not Found
No
The description focuses on data management, display, storage, and basic alarming based on user-defined limits, with no mention of AI or ML terms or functionalities.
No
The device is a clinical data managing software application intended for monitoring and recording perinatal data, and does not provide therapy.
No
The device is described as a "clinical data managing software application" that manages perinatal monitoring data for viewing and record-keeping, and produces an electronic medical record. While it displays vital signs and alarms for out-of-limit parameters, its primary function is data management and display, not the direct diagnosis of a medical condition.
Yes
The device is described as a "clinical data managing software application" and "software production" that runs on a PC station. While it connects to bedside monitors, the description focuses solely on the software's functions of data management, display, storage, and alarming, without mentioning any hardware components included with the device itself. The predicate device is also described as a "Software Application".
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. They are used to provide information for diagnosis, monitoring, or screening.
- MFM-CNS Function: The MFM-CNS is a software application that manages and displays physiological data acquired from external monitoring devices (bedside monitors) or manual input. It does not perform any tests on samples taken from the body. Its primary function is data management, display, and record keeping for clinical monitoring.
- Data Sources: The data it handles (FHR, uterine activity, maternal vital signs) are collected directly from the patient via external sensors or manual entry, not from in vitro samples.
Therefore, the MFM-CNS falls under the category of a clinical data management system for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Maternal Fetal Monitoring – Central Nurse System (MFM-CNS) is a clinical data managing software application and is indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting.
The MFM-CNS 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 MFM-CNS has display fields for the following obstetric data:
- patient demographics
- provider notes
- FHR
- uterine activity (via tocodynamometry or IUP)
- maternal heart rate
- SpO2
- NIBP
- respiratory rate
- temperature
- pulse rate
Product codes
HGM
Device Description
MFM-CNS is a software production who runs on PC station with Microsoft Windows XP operating system. MFM-CNS by connecting one central station with some bedside fetal / maternal monitors, 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 exceed 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 numerics 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 NIBP 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. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare setting.
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)
Test Summary:
The following quality assurance measures were applied to the development of the MFM-CNS Electrocardiograph:
- Software testing
- Risk analysis
- Safety testing
- Performance test
Conclusion:
Verification and validation testing was done on MFM-CNS. This premarket notification submission demonstrates that the subject device MFM-CNS is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CIV-ob Obstetrical Monitoring Software Application (K051175)
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
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510(K)Summary of Safety and Effectiveness
JAN - 6 2011
This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807.92
| Submitter: | Edan Instruments, Inc
3/F - B, Nanshan Medical
Equipments Park, Nanhai Rd 1019#,
shekou, Nanshan Shenzhen,
518067 P.R. China
Tel: +86755 26882220
Fax:+86 755 26882223 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Jiang yucai
Edan Instruments, Inc. |
| Preparing date: | 2010-08-23 |
| Proprietary Name: | Central Monitoring System (model MFM-CNS) |
| Classification
information: | 21 CFR 884.2740 Perinatal monitoring system and accessories
Class II |
| Product code: | HGM |
| Review Panel: | Obstetrics/Gynecology |
| Predicate Devices: | CIV-ob Obstetrical Monitoring Software Application (K051175) |
| Device Description: | MFM-CNS is a software production who runs on PC station
with Microsoft Windows XP operating system. MFM-CNS
by connecting one central station with some bedside fetal /
maternal monitors, 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 exceed the user defined limit
and poor signal quality. At the same time, the old records can |
Device features:
:
be searched conveniently and quickly.
1
- Connect maximum 32 bedside fetal / maternal . monitors with Ethernet.
- Display FHR, UA, Maternal HR, PR, SpO2, NIBP, . RR and TEMP numerics 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 NIBP 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. .
The Maternal Fetal Monitoring - Central Nurse System (MFM-CNS) is a clinical data managing software application and is indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting.
The MFM-CNS 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 MFM-CNS has display fields for the following obstetric data:
- patient demographics ●
- provider notes .
- FHR
- uterine activity (via tocodynamometry or IUP) .
- maternal heart rate .
- SpO2 .
- NIBP
- respiratory rate
- temperature
- pulse rate
1.2 Indications
for Use
l -2
2
Test Summary:
The following quality assurance measures were applied to the development of the MFM-CNS Electrocardiograph:
- Software testing .
- Risk analysis .
- Safety testing .
- Performance test .
Conclusion:
Verification and validation testing was done on MFM-CNS. This premarket notification submission demonstrates that the subject device MFM-CNS is substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
ここで
| 小 | 彩
Edan Instruments, Inc. c/o Mr. William Stern Official Correspondent Multigon Industries, Inc. l Odell Plaza YONKERS NY 10701
Re: K100358
Trade Name: MFM-CNS (Central Monitoring System) Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: December 20, 2010 Received: December 23, 2010
Dear Mr. Stern:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related
4
Page 2
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Stuckert Lemieux MD
lerbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
5
Indications for Use
K100358 510(k) Number:
JAN - 6 2011
.. :
Device Name: Central Monitoring System (model MFM-CNS)
The Maternal Fetal Monitoring – Central Nurse System (MFM-CNS) is a clinical data managing software application and is indicated for antepartum monitoring of pregnant women in a healthcare setting.
The MFM-CNS 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 MFM-CNS has display fields for the following obstetric data:
- . patient demographics
- . provider notes
- . FHR
- uterine activity (via tocodynamometry or IUP) .
- . maternal heart rate
- SpO2 .
- NIBP .
- respiratory rate .
- temperature .
- pulse rate .
| Prescription Use | X | Or | Over the Counter Use | |
|---|---|---|---|---|
| (21 CFR Part 801 Subpart D) | (21 CFR Part 801 Subpart C) |
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and Urological Devices
| 510(k) Number | K100358 | 1-4 |
|---|---|---|
| --------------- | --------- | ----- |