Who is the manufacturer of Central Monitoring System?

Edan Instruments, Inc. filed the 510(k) submission for Central Monitoring System (K171178).

What is the FDA product code for Central Monitoring System?

HGM. It is classified under 21 CFR 884.2740 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for Central Monitoring System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Central Monitoring System?

EDAN Instrument, Inc. Central Monitoring System, model MFM-CNS v3.82 (K143695).

Who can help prepare an FDA 510(k) submission like Central Monitoring System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Central Monitoring System

K171178 · Edan Instruments, Inc. · HGM · Sep 6, 2017 · Obstetrics/Gynecology

Device Facts

Record ID	K171178
Device Name	Central Monitoring System
Applicant	Edan Instruments, Inc.
Product Code	HGM · Obstetrics/Gynecology
Decision Date	Sep 6, 2017
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. 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. MFM-CNS has display fields for the following obstetric data: patient demographics, provider notes, fetal heart rate (FHR), uterine activity, fetal movement, maternal heart rate, SpO2, non-invasive blood pressure (NIBP), respiratory rate, temperature, pulse rate. MFM-CNS Lite (hereinafter called "Lite") is a clinical data managing software application and is indicated for antepartum monitoring of pregnant women in a healthcare setting. Lite is intended to manage antepartum-monitoring data acquired from bedside monitors and produce electronic medical records. Lite has display fields for the following obstetric data: patient demographics, provider notes, fetal heart rate (FHR), uterine activity, fetal movement.

Device Story

Clinical data management software for perinatal monitoring; acquires data from bedside monitors or manual input; displays obstetric parameters (FHR, uterine activity, maternal vitals, etc.) at central nursing station; generates electronic medical records. Used in hospital clinical areas (e.g., delivery rooms, monitor units) by healthcare professionals. System relies on network stability and PC performance; users must verify results on bedside monitors. Provides visual alerts for out-of-limit heart rates or poor signal quality. Facilitates clinical decision-making by centralizing patient data for review.

Clinical Evidence

Bench testing only. Software verification and validation conducted per FDA guidance for 'major' level of concern. Compliance with IEC 62304 (software lifecycle), ISO 14971 (risk analysis), and IEC 60601-1-8 (alarm systems) confirmed.

Technological Characteristics

Software-only application running on off-the-shelf PC hardware. Connectivity via Ethernet/TCP/IP. Supports Windows XP, 7, 8.1, 10. Complies with IEC 62304 and IEC 62366. Features include data acquisition, display, archiving, and HL7/GDT interface for EMR integration.

Indications for Use

Indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting (MFM-CNS) or antepartum monitoring (MFM-CNS Lite).

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

EDAN Instrument, Inc. Central Monitoring System, model MFM-CNS v3.82 (K143695)

Related Devices

K143695 — CENTRAL MONITORING SYSTEM · Edan Instruments, Inc. · Mar 30, 2015
K103172 — CIV-OB (PLUS) · Civnet Communication, Ltd. · Mar 11, 2011
K102263 — HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0 · Mckesson Information Solutions, LLC · May 5, 2011
K100358 — CENTRAL MONITORING SYSTEM · Edan Instruments, Inc. · Jan 6, 2011
K121208 — OBIX PERINATAL DATA SYSTEM 7.0 · Clinical Computer Systems, Inc. · Jun 14, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/2 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 image of three human profiles facing to the 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 September 6, 2017 Edan Instruments, Inc. % Doug Worth Sr.Dir.US RA/OA Edan Medical 1200 Crossman Ave, Suite 200 Sunnyvale, California 94089 Re: K171178 > Trade/Device Name: Central Monitoring System MFM-CNS Lite v1.1 and MFM-CNS v3.91 Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal Monitoring System and Accessories Regulatory Class: Class II Product Code: HGM Dated: August 4, 2017 Received: August 7, 2017 Dear Doug Worth: 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. {1}------------------------------------------------ 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 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 (DICE) 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 (DICE) 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, # Benjamin R. Fisher -S Benjamin R. Fisher, Ph.D. 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) K171178 #### Device Name Central Monitoring System MFM-CNS v3.91 | Indications for Use (Describe) | | |--------------------------------|--| |--------------------------------|--| 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. 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. MFM-CNS has display fields for the following obstetric data: - □ patient demographics - □ provider notes - □ fetal heart rate (FHR) - □ uterine activity - □ fetal movement - □ maternal heart rate - SpO2 - □ non-invasive blood pressure (NIBP) - □ respiratory rate - □ temperature - □ pulse rate | 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) | | X | Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K171178 Device Name Central Monitoring System MFM-CNS Lite v1.1 Indications for Use (Describe) MFM-CNS Lite (hereinafter called "Lite") is a clinical data managing software application and is indicated for antepartum monitoring of pregnant women in a healthcare setting. Lite is intended to manage antepartum-monitoring data acquired from bedside monitors and produce electronic medical records. Lite has display fields for the following obstetric data: □ patient demographics - □ provider notes - □ fetal heart rate (FHR) - □ uterine activity - □ fetal movement | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| | | | | |X Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ### 510(K) Summary ### Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92 | 1. Submitter: | Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District, Shenzhen, 518122 P.R.China. Tel: +86(0755) 26858736 Fax: +1 (408) 418-4059 | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact person: Preparing date: | Alice Yang April 19, 2017 | | 2. Device name and classification: | Device Name: Central Monitoring System Model: MFM-CNS v3.91, MFM-CNS Lite v1.1 Classification Name/ Product code: 884.2740 Perinatal monitoring system and accessories / HGM Regulatory Class: Class II | | 3. Predicate Device(s): | 1. EDAN Instrument, Inc. Central Monitoring System, model MFM-CNS v3.82, K143695. The predicate device was not the subject of a recall and no reference devices were used in this submission. | | 4. Device Description: | MFM-CNS v3.91 and MFM-CNS Lite v1.1 The MFM-CNS v3.91 and MFM-CNS Lite v1.1 are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS v3.91 additional monitors maternal vital signs. Data are 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. They provide electronic medical records and operate with off-the-shelf | software and hardware. The MFM-CNS v3.91 and MFM-CNS Lite v1.1 are intended to be {5}------------------------------------------------ used in hospital clinical areas such as monitor units, delivery room, etc. They are 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 v3.91 and MFM-CNS Lite v1.1 system interface. The user cannot only depend on the MFM-CNS v3.91 and MFM-CNS Lite v1.1 system to obtain monitoring data, because whether the data provided by the system are accurate depends on the stability of the operating system, the performance of PC station and the network. #### 5. Indications for Use MFM-CNS v3.91: 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. 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. MFM-CNS has display fields for the following obstetric data: patient demographics provider notes fetal heart rate (FHR) uterine activity fetal movement maternal heart rate SpO2 non-invasive blood pressure (NIBP) respiratory rate temperature pulse rate #### MFM-CNS Lite v1.1: MFM-CNS Lite (hereinafter called "Lite") is a clinical data managing software application and is indicated for antepartum monitoring of pregnant women in a healthcare setting. Lite is intended to manage antepartum-monitoring data acquired from {6}------------------------------------------------ bedside monitors and produce electronic medical records. Lite has display fields for the following obstetric data: patient demographics provider notes fetal heart rate (FHR) uterine activity fetal movement ### 6. Predicate Device Comparison The subject device shares the same characteristics in most items with the predicate device except in the following aspects: | Item | MFM-CNS v3.82 | MFM-CNS v3.91 | MFM-CNS Lite v1.1 | | |--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Manufacturer/K# | EDAN Instruments/ K143695 | EDAN Instruments/N/A | EDAN Instruments/N/A | SE | | | Indication for Use | | | | | | MFM-CNS v3.82 | MFM-CNS v3.91 | MFM-CNS Lite v1.1 | | | Indication 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 | 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 | MFM-CNS Lite (hereinafter called "Lite") is a clinical data managing software application and is indicated for antepartum monitoring of pregnant women in a healthcare setting. MFM-CNS Lite is intended to manage antepartum-monitoring data acquired from bedside monitors and produce electronic medical records. The MFM-CNS Lite has display fields for | Different | | | | | | | | | setting. | monitoring data | the following obstetric | | | | The MFM-CNS | acquired from | data: | | | | is intended to | bedside monitors or | Patient demographics, | | | | manage perinatal | manual input for | provider notes, fetal | | | | monitoring data | viewing at the | heart rate (FHR), uterine activity, fetal | | | | acquired from | central nursing | movement. | | | | bedside monitors | station. The system | | | | | or manual input | also produces an | | | | | for viewing at the | electronic medical | | | | | central nursing | record. | | | | | station. The | The MFM-CNS has | | | | | | display fields for | | | | | system also | the following | | | | | produces an | obstetric data: | | | | | electronic | patient | | | | | medical record. | demographics, | | | | | The MFM-CNS | provider notes, fetal heart rate (FHR), | | | | | has display fields | uterine activity, etc. | | | | | for the following | | | | | | obstetric data: | | | | | | patient demographics, | | | | | | provider notes, | | | | | | fetal heart rate | | | | | | (FHR), uterine | | | | | | activity (via | | | | | | tocodynamometry | | | | | | or IUP), etc. | | | | | | | Classification | | | | Classified as per | | | | | | FDA regulation | Class II | Class II | Class II | Same | | | | Network and Hardware | | | | | Off-the-shelf | Off-the-shelf | Off-the-shelf | | | Hardware | computers and | computers and | computers and | Same | | | accessories | accessories | accessories | | | Network | | | | | | connecting to | Ethernet | Ethernet | Ethernet | Same | | bedside monitor | | | | | {7}------------------------------------------------ {8}------------------------------------------------ | | Software | | | | | |---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|-----------| | User Access / Authentication | 16 client | 32 client | 1 client | Different | | | 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. | Fetal heart rate, TOCO, patient demography data, and notes. Providing the means to display multiple beds simultaneously. | Different | | | Supporting beds | 32 | 128 | 6 | Different | | | Print | Print (locally or remotely) CTG and patient records. | Print (locally or remotely) CTG and patient records. | Print (locally) 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). Saving data automatically. | 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. | CTG. Providing the ability to archive files to a secondary or tertiary storage medium (i.e. optical disk). Saving data automatically. | Different | | | 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. | Visual alerts of fetal monitor such as poor signal quality. | Different | | | Electronic patient record | Interfaces with HL7 patient record systems for data | Interfaces with HL7 patient record systems for data acquisition | Interfaces with the Gerätedatenträger -Transfer (GDT) patient record systems | Different | | | | acquisition, viewing and storage of electronic patient record. | viewing and storage of electronic patient record. | for data acquisition, viewing and 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. | Providing the user the ability to enter comments and specific data. | Same | | | CTG | The MFM-CNS 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. | The MFM-CNS Lite can analyze signal loss, contractions, basal heart rate, accelerations, decelerations, short term variation, long term variation and other parameters. | Same | | | NICHD | The MFM-CNS can analyze FHR baseline and its scope, FHR baseline variation and its scope, acceleration 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, acceleration number, early deceleration, late deceleration, variable deceleration, prolonged deceleration, sine curve and other parameters. | The MFM-CNS Lite can analyze FHR baseline and its scope, FHR baseline variation and its scope, acceleration number, early deceleration, late deceleration, variable deceleration, prolonged deceleration, sine curve and other parameters. | Same | | | Remote Access | Review fetal/maternal monitor data | Review fetal/maternal | Local Access | Different | | | | | TCP/IP. | TCP/IP. | | | | Storage capacity | | 100 thousand records | Capacity depends on the size of the hard disk | Capacity depends on the size of the hard disk | Different | | Windows OS Support | | XP、Win7、 Win8.1 | XP、Win7、Win8.1、 Win10 | XP、Win7、Win8.1、 Win10 | Different | | | Standards compliance | | | | | | |…

Central Monitoring System

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

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Central Monitoring System

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

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