CENTRAL MONITORING SYSTEM

K143695 · Edan Instruments, Inc. · HGM · Mar 30, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K143695
• Device Name: CENTRAL MONITORING SYSTEM
• Applicant: Edan Instruments, Inc.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Mar 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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

Device Story

MFM-CNS is a clinical data management software application for perinatal monitoring. It receives fetal heart rate, uterine activity, maternal vital signs (SpO2, NIBP, respiratory rate, temperature, pulse), and fetal movement data from bedside monitors or manual input via Ethernet. The system processes this data to display real-time obstetric information, generate electronic medical records, and provide visual alarms for out-of-limit heart rates or poor signal quality. Used in hospital clinical areas (e.g., delivery rooms) by healthcare professionals. The system provides a central nursing station interface for viewing multiple patients simultaneously. It does not replace bedside monitoring; users must verify results at the bedside. The system aids clinical decision-making by centralizing patient data and trends, potentially improving monitoring efficiency and record-keeping.

Clinical Evidence

No clinical data. Bench testing only. Software validation performed per FDA guidance (Jan 11, 2002), risk analysis per ISO 14971:2007, usability per IEC 62366:2007, and software life cycle per IEC 62304:2006. All testing passed.

Technological Characteristics

Software-only clinical data management application. Operates on off-the-shelf PC hardware. Connectivity via Ethernet to bedside monitors. Complies with IEC 62304 (software life cycle) and IEC 62366 (usability).

Indications for Use

Indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting.

Regulatory Classification

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.

Predicate Devices

• CIV-ob Obstetrical Monitoring Software Application (K103172)
• Philips OB TraceVue Obstetrical Information Management System (K081203)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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)

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510 (K) Summary

# Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92

| 1. Submitter: | Edan Instruments, Inc.<br>3/F - B, Nanshan Medical<br>Equipments Park, Nanhai Rd 1019#,<br>Shekou, Nanshan Shenzhen,<br>518067 P.R. China<br>Tel: [phone]<br>Fax: [phone] |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Queena Chen |
| Preparing date: | March 24, 2015 |
| 2. Device name and<br>classification: | Device Name: Central Monitoring System<br>Model: MFM-CNS<br>Classification Name:<br>21 CFR 884.2740 Perinatal monitoring system and<br>accessories<br>Product code: HGM<br>Regulatory Class: Class II<br>Review Panel: Obstetrics/Gynecology |
| 3.Premarket<br>Notification Class III<br>Certification and<br>Summary | Not applicable, the subject device is Class II. |
| 4. Predicate Device(s): | CIV-ob Obstetrical Monitoring Software Application<br>/K103172/ CIVNET Communication Ltd.<br>Philips OB TraceVue Obstetrical Information Management<br>System/K081203/ Philips Medizin System |
| 5. Device Description: | The Maternal Fetal Monitoring – Central Nurse System<br>(hereinafter called "MFM-CNS") is a clinical data managing<br>software application. Its function is to manage clinical data<br>of fetal heart and maternal vital signs (CTG -<br>Cardiotocography), which is automatically acquired from<br>bedside monitors, for the purpose of collecting, processing<br>and saving the patient and/or clinical data that is normally<br>provided on record papers and/or separate bedside monitors.<br>It provides electronic medical records and operates with |

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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

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| Item | CIV-obTM (plus) | MFM-CNS 3.82 | SE |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Manufacturer/K# | CIVNET Communication<br>Ltd./ K103172 | EDAN Instruments/N/A | |
| Classification | | | |
| Classified as per<br>FDA regulation | Class II | Class II | Same |
| Network and Hardware | | | |
| Hardware | Off-the-shelf computers<br>and accessories | Off-the-shelf computers<br>and accessories | Same |
| Network<br>connecting to<br>bedside monitor | Ethernet | Ethernet | Same |
| Software | | | |
| Display | Fetal heart rate, TOCO,<br>maternal vital signs,<br>patient demography data,<br>and notes.<br>Providing the means to<br>display multiple beds<br>simultaneously. | Fetal heart rate, TOCO,<br>maternal vital signs,<br>patient demography data,<br>and notes.<br>Providing the means to<br>display multiple beds<br>simultaneously. | Same |
| Print | Print (locally or<br>remotely) CTG, patient<br>records, and CIV-obTM<br>(plus) data base definition<br>(e.g. item names). | Print (locally or<br>remotely) CTG and<br>patient records. | Different |
| Archive | CTG and maternal vital<br>signs.<br>Providing the ability to<br>archive files to a<br>secondary or tertiary<br>storage medium (i.e.<br>optical disk).<br>Providing automatic<br>archiving of the data. | CTG and maternal vital<br>signs.<br>Providing the ability to<br>archive files to a<br>secondary or tertiary<br>storage medium (i.e.<br>optical disk).<br>Saving data<br>automatically. | Same |
| Alarm | Visual alerts of<br>fetal/maternal monitor<br>such as out-of-limit heart<br>rate or poor signal<br>quality. | Visual alerts of<br>fetal/maternal monitor<br>such as out-of-limit heart<br>rate or poor signal<br>quality. | Same |
| Electronic<br>patient record. | Easy interfacing with any<br>IT patient record system<br>for data acquisition,<br>viewing and storage of | Easy interfacing with<br>any IT patient record<br>system for data<br>acquisition, viewing and | Same |

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| | 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<br>IEC 62366 | IEC 62304<br>IEC 62366 | Same |
| Intended Use | | | |
| Intended use | The CIVNET CIV- ob TM<br>(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<br>(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.<br>The CIYNET CIV ob TM<br>(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.<br>The MFM-CNS has display fields for the following obstetric data: | |

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| (FHR), uterine activity<br>(via tocodynamometry or<br>IUP), etc. | patient demographics,<br>provider notes, fetal<br>heart rate (FHR), uterine<br>activity (via<br>tocodynamometry or<br>IUP), etc. |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|

| Item | The Philips OB TraceVue<br>Obstetrical Information<br>Management System | MFM-CNS | SE |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Manufacturer/K# | Philips Medizin<br>System/K081203 | EDAN Instruments/None | |
| | Classification | | |
| Classified as per<br>FDA regulation | Class II | Class II | Same |
| | Software | | |
| CTG | The Philips OB TraceVue<br>Obstetrical Information<br>Management System can<br>analyze signal loss,<br>contractions, basal heart<br>rate, accelerations,<br>decelerations, short term<br>variation, long term<br>variation and other<br>parameters. | The MFM-CNS can<br>analyze signal loss,<br>contractions, basal heart<br>rate, accelerations,<br>decelerations, short term<br>variation, long term<br>variation and other<br>parameters. | Same |
| NICHD | The Philips OB TraceVue<br>Obstetrical Information<br>Management System can<br>analyze FHR baseline and<br>its scope, FHR baseline<br>variation and its scope,<br>accelerated number, early<br>deceleration, late<br>deceleration, variable<br>deceleration, prolonged<br>deceleration, sine curve and<br>other parameters. | The MFM-CNS can<br>analyze FHR baseline and<br>its scope, FHR baseline<br>variation and its scope,<br>accelerated number, early<br>deceleration, late<br>deceleration, variable<br>deceleration, prolonged<br>deceleration, sine curve<br>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

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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.