(96 days)
Not Found
No
The description focuses on data management and display, with no mention of AI/ML terms or functions like prediction, analysis beyond basic display, or learning from data.
No
The device is a data management software system for viewing and archiving perinatal monitoring data, not for direct treatment or diagnosis.
No
The device is described as a clinical data managing software application that manages and displays perinatal monitoring data. It does not perform analysis or interpretation of data to arrive at a medical diagnosis. The text explicitly states that the alarm information is "just for reference" and that "the user cannot only depend on the MFM-CNS system to obtain monitoring data." This strongly indicates it is not intended for diagnostic purposes.
Yes
The device is described as a "clinical data managing software application" and its function is to manage data acquired from external bedside monitors or manual input. It operates with "off-the-shelf software and hardware," implying the device itself is the software component running on existing hardware, not a new hardware device with integrated software. The description focuses on software validation and risk analysis, not hardware performance.
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 described as a "clinical data managing software application." Its primary function is to collect, process, and display physiological data (fetal heart rate, uterine activity, maternal vital signs) acquired from bedside monitors or manual input. It does not perform any tests on samples taken from the body.
- Intended Use: The intended use is for "antepartum and intrapartum monitoring of pregnant women in a healthcare setting" and to "manage perinatal monitoring data." This involves observing and managing real-time physiological data, not analyzing biological samples.
The device is clearly focused on data management and display of physiological parameters, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Maternal Fetal Monitoring – Central Nurse System (hereinafter called "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
- fetal heart rate (FHR)
- uterine activity (via tocodynamometry or IUP)
- fetal movement
- maternal heart rate
- SpO2
- non-invasive blood pressure (NIBP)
- respiratory rate
- temperature
- pulse
Product codes (comma separated list FDA assigned to the subject device)
HGM
Device Description
The Maternal Fetal Monitoring – Central Nurse System (hereinafter called "MFM-CNS") is a clinical data managing software application. Its function is to manage clinical data of fetal heart and maternal vital signs (CTG - Cardiotocography), which is automatically acquired from bedside monitors, for the purpose of collecting, processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. It provides electronic medical records and operates with off-the-shelf software and hardware.
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
The MFM-CNS is intended to be used in hospital clinical areas such as monitor units, delivery room, etc. It is intended to be operated by or under guidance of qualified healthcare professionals, not intended for home healthcare environment.
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)
Clinical test:
Clinical testing is not required.
Non-clinical test:
Since the subject is a software only product, EMC and Electrical Safety Evaluation are not required. But the following quality assurance measures were applied to the development of the MFM-CNS to ensure its safety and effectiveness:
- Software testing according to FDA Guidance General Principles of Software Validation dated on Jan. 11, 2002.
- Risk analysis according to ISO 14971: 2007
- Usability analysis according to IEC 62366: 2007
- Software life cycle management according to IEC 62304: 2006
The subject device passed all testing. The tests and analysis were all conducted to ensure the safety and effectiveness, and results show substantial equivalence between the subject device and the predicates.
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.
CIV-ob Obstetrical Monitoring Software Application /K103172/ CIVNET Communication Ltd., Philips OB TraceVue Obstetrical Information Management System/K081203/ Philips Medizin System
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 30, 2015
Edan Instruments Inc. Doug Worth Sr. Director US RA/OA 1200 Crossman Ave, Suite 200 Sunnyvale, California 94089
K143695 Trade/Device Name: Central Monitoring System Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal Monitoring System and Accessories Regulatory Class: Class II Product Code: HGM Dated: December 19, 2014 Received: January 5, 2015
Dear Doug Worth,
Re:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Joyce M. Whang -S
for
Benjamin Fisher Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143695
Device Name Central Monitoring System
The Maternal Fetal Monitoring – Central Nurse System (hereinafter called "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 inout 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
- fetal heart rate (FHR)
- uterine activity (via tocodynamometry or IUP)
- fetal movement
- maternal heart rate
- SpO2
- non-invasive blood pressure (NIBP)
- respiratory rate
- temperature
- pulse
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510 (K) Summary
Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc.
3/F - B, Nanshan Medical
Equipments Park, Nanhai Rd 1019#,
Shekou, Nanshan Shenzhen,
518067 P.R. China
Tel: +86(0755) 26858736
Fax: +1 (408) 418-4059 |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Queena Chen |
| Preparing date: | March 24, 2015 |
| 2. Device name and
classification: | Device Name: Central Monitoring System
Model: MFM-CNS
Classification Name:
21 CFR 884.2740 Perinatal monitoring system and
accessories
Product code: HGM
Regulatory Class: Class II
Review Panel: Obstetrics/Gynecology |
| 3.Premarket
Notification Class III
Certification and
Summary | Not applicable, the subject device is Class II. |
| 4. Predicate Device(s): | CIV-ob Obstetrical Monitoring Software Application
/K103172/ CIVNET Communication Ltd.
Philips OB TraceVue Obstetrical Information Management
System/K081203/ Philips Medizin System |
| 5. Device Description: | The Maternal Fetal Monitoring – Central Nurse System
(hereinafter called "MFM-CNS") is a clinical data managing
software application. Its function is to manage clinical data
of fetal heart and maternal vital signs (CTG -
Cardiotocography), which is automatically acquired from
bedside monitors, for the purpose of collecting, processing
and saving the patient and/or clinical data that is normally
provided on record papers and/or separate bedside monitors.
It provides electronic medical records and operates with |
4
off-the-shelf software and hardware.
The MFM-CNS is intended to be used in hospital clinical areas such as monitor units, delivery room, etc. It is intended to be operated by or under guidance of qualified healthcare professionals, not intended for home healthcare environment. During monitoring, the user should check the results on the bedside monitor in person, even though they could observe the results on the MFM-CNS system interface. The user cannot only depend on the MFM-CNS system to obtain monitoring data, because whether the data provided by the system is accurate depends on the stability of the operating system, the performance of PC station and the network. Although the software has its independent alarm system, the alarm information provided by the system is just for reference.
6. Indications for Use: The Maternal Fetal Monitoring – Central Nurse System (hereinafter called "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
- ●fetal heart rate (FHR)
- ●uterine activity (via tocodynamometry or IUP)
- ●fetal movement
- ●maternal heart rate
- ●SpO2
- ●non-invasive blood pressure (NIBP)
- ●respiratory rate
- ●temperature
- ●pulse
7. Predicate Device Comparison
5
| Item | CIV-obTM (plus) | MFM-CNS 3.82 | SE |
|---|---|---|---|
| Manufacturer/K# | CIVNET Communication | ||
| Ltd./ K103172 | EDAN Instruments/N/A | ||
| Classification | |||
| Classified as per | |||
| FDA regulation | Class II | Class II | Same |
| Network and Hardware | |||
| Hardware | Off-the-shelf computers | ||
| and accessories | Off-the-shelf computers | ||
| and accessories | Same | ||
| Network | |||
| connecting to | |||
| bedside monitor | Ethernet | Ethernet | Same |
| Software | |||
| Display | Fetal heart rate, TOCO, | ||
| maternal vital signs, | |||
| patient demography data, | |||
| and notes. | |||
| Providing the means to | |||
| display multiple beds | |||
| simultaneously. | Fetal heart rate, TOCO, | ||
| maternal vital signs, | |||
| patient demography data, | |||
| and notes. | |||
| Providing the means to | |||
| display multiple beds | |||
| simultaneously. | Same | ||
| Print (locally or | |||
| remotely) CTG, patient | |||
| records, and CIV-obTM | |||
| (plus) data base definition | |||
| (e.g. item names). | Print (locally or | ||
| remotely) CTG and | |||
| patient records. | Different | ||
| Archive | CTG and maternal vital | ||
| signs. | |||
| Providing the ability to | |||
| archive files to a | |||
| secondary or tertiary | |||
| storage medium (i.e. | |||
| optical disk). | |||
| Providing automatic | |||
| archiving of the data. | CTG and maternal vital | ||
| signs. | |||
| Providing the ability to | |||
| archive files to a | |||
| secondary or tertiary | |||
| storage medium (i.e. | |||
| optical disk). | |||
| Saving data | |||
| automatically. | Same | ||
| Alarm | Visual alerts of | ||
| fetal/maternal monitor | |||
| such as out-of-limit heart | |||
| rate or poor signal | |||
| quality. | Visual alerts of | ||
| fetal/maternal monitor | |||
| such as out-of-limit heart | |||
| rate or poor signal | |||
| quality. | Same | ||
| Electronic | |||
| patient record. | Easy interfacing with any | ||
| IT patient record system | |||
| for data acquisition, | |||
| viewing and storage of | Easy interfacing with | ||
| any IT patient record | |||
| system for data | |||
| acquisition, viewing and | Same |
6
| electronic patient record. | storage of electronic patient record. | ||
|---|---|---|---|
| Notes | Providing the user the ability to enter comments and specific data. | Providing the user the ability to enter comments and specific data. | Same |
| Remote Access | Review fetal/maternal monitor data remotely over the TCP/IP. | Review fetal/maternal monitor data remotely over the TCP/IP. | Same |
| Standards compliance | |||
| Detail | IEC 62304 | ||
| IEC 62366 | IEC 62304 | ||
| IEC 62366 | Same | ||
| Intended Use | |||
| Intended use | The CIVNET CIV- ob TM | ||
| (plus) is a clinical data managing software application and is indicated for antepartumn and intrapartumn monitoring of pregnant women in a healthcare setting | The Maternal Fetal Monitoring - Central Nurse System (hereinafter called "MFM-CNS") is a clinical data managing software application and is indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting. | Same | |
| The CIVNET CIV- ob TM | |||
| (plus) is indented to manage perinatal monitoring data acquired from bedside monitors or manual inputs for viewing at the central nursing station. The system also produces an electronic medical record. | |||
| The CIYNET CIV ob TM | |||
| (plus) has display fields for the following obstetric data: patient demographics, provider notes, fetal heart rate | 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: |
7
| (FHR), uterine activity
(via tocodynamometry or
IUP), etc. | patient demographics,
provider notes, fetal
heart rate (FHR), uterine
activity (via
tocodynamometry or
IUP), etc. |
| ------------------------------------------------------------------ | ---------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Item | The Philips OB TraceVue
Obstetrical Information
Management System | MFM-CNS | SE |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Manufacturer/K# | Philips Medizin
System/K081203 | EDAN Instruments/None | |
| | Classification | | |
| Classified as per
FDA regulation | Class II | Class II | Same |
| | Software | | |
| CTG | The Philips OB TraceVue
Obstetrical Information
Management System can
analyze signal loss,
contractions, basal heart
rate, accelerations,
decelerations, short term
variation, long term
variation and other
parameters. | The MFM-CNS can
analyze signal loss,
contractions, basal heart
rate, accelerations,
decelerations, short term
variation, long term
variation and other
parameters. | Same |
| NICHD | The Philips OB TraceVue
Obstetrical Information
Management System can
analyze FHR baseline and
its scope, FHR baseline
variation and its scope,
accelerated number, early
deceleration, late
deceleration, variable
deceleration, prolonged
deceleration, sine curve and
other parameters. | The MFM-CNS can
analyze FHR baseline and
its scope, FHR baseline
variation and its scope,
accelerated number, early
deceleration, late
deceleration, variable
deceleration, prolonged
deceleration, sine curve
and other parameters. | Same |
The subject device shares the same characteristics in most items with the predicate device except in the following one aspect: The predicate device prints the CIV ob ™ (plus) data base definition (e.g. item names) but the subject device does not. MFM-CNS only prints fetal and/or maternal reports such as fetal monitoring graphs or maternal trend lists.
The comparison above shows that the differences do not affect the safety and
8
effectiveness of the MFM-CNS and there are no safety and effectiveness issues relating to the MFM-CNS.
8. Effectiveness and Safety Considerations:
Clinical test:
Clinical testing is not required.
Non-clinical test:
Since the subject is a software only product, EMC and Electrical Safety Evaluation are not required. But the following quality assurance measures were applied to the development of the MFM-CNS to ensure its safety and effectiveness:
- Software testing according to FDA Guidance General Principles of Software Validation dated on Jan. 11, 2002.
- Risk analysis according to ISO 14971: 2007
- Usability analysis according to IEC 62366: 2007
- Software life cycle management according to IEC 62304: 2006
The subject device passed all testing. The tests and analysis were all conducted to ensure the safety and effectiveness, and results show substantial equivalence between the subject device and the predicates.
9. Substantially Equivalent Determination
Verification and validation testing was done on the MFM-CNS and all testing passed pre-specified criteria. Since the testing passed, this premarket notification submission demonstrates that the subject device MFM-CNS is substantially equivalent to the predicate device.