CMS-1000FM CENTRAL MONITORING SYSTEM

K112159 · Advanced Instrumentations, Inc. · HGM · Sep 21, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K112159
• Device Name: CMS-1000FM CENTRAL MONITORING SYSTEM
• Applicant: Advanced Instrumentations, Inc.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Sep 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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

Device Story

CMS-1000FM is a software-based central monitoring system for healthcare settings; connects up to 32 bedside fetal/maternal monitors via Ethernet. Inputs include real-time physiological data (FHR, UA, maternal HR, PR, SpO2, NIBP, RR, TEMP) and manual entries. System aggregates, displays, records, and prints data; provides audible/visible alarms for user-defined parameter limits or poor signal quality. Used by clinicians at central nursing stations to manage perinatal data and generate electronic medical records. Benefits include centralized patient oversight, historical data review (24-hour CTG, 1440-group vital signs, 200-group NIBP), and improved clinical workflow through consolidated monitoring and backup capabilities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software application running on a PC with Microsoft Windows XP. Connectivity via Ethernet to bedside monitors. Features include centralized data management, alarm processing, and reporting. No specific hardware materials or sterilization methods described as it is a software-only product.

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

• Central Monitoring System (model MFM-CNS) (K100358)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is: K112159

SEP 2 1 2011

# Submitter

Advanced Instrumentations, Inc. 6800 N.W. 77th Court Miami, FI 33166 Telephone: [phone] Fax:

Registration # 1066270

# Official correspondent :

Jorge Millan, PhD Email: [e-mail] 601 West 20 St Hialeah, FL 33010 Phone : [phone]

Date Prepared:

September 16, 2011

### Device name and classification:

- Device Name: CMS-1000FM Central Monitoring System .
- Classification Name: 884.2740 Perinatal Monitoring System and accessories .
- . Product code: HGM
- Regulatory Class: ● Class II

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K112159
pg. 2 of 3

# Predicate Device:

Central Monitoring System (model MFM-CNS) K100358 Manufacturer: EDAN Instruments

## Device Description:

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

#### Intended Use:

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 .

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K112159
pg. 3 of 3

- . provider notes
- . FHR
- . uterine activity (via tocodynamometry or IUP)
- maternal heart rate .
- Sp0 2 ●
- NIBP .
- . respiratory rate
- . temperature
- pulse rate .

## Comparison to the predicate device:

The subject device has similar technology characteristics and has the same intended use as the predicate device.

## Substantially Equivalent Determination:

This premarket notification submission demonstrates that CMS-1000FM Central Monitoring System is substantially equivalent to the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Advanced Instrumentations. Inc. 6 Jorge Millan. Ph.D. Executive Director Hialeah Technology Center, Inc. 601 West 20 Street HIALEAH FL 33010

CLP 2:11

Re: KI12159

Trade Name: CMS-1000FM Central Monitoring System Regulation Number: 21 CFR & 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: H Product Code: HGM Dated: September 12, 2011 Received: September 14, 2011

Dear Dr. Millan:

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 regilations 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

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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/CDRHOffices/ucm115809.html 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/Reportal?roblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Herbert Remmer MD

Herbert 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

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510(k) Number (if known): K112159.

Device Name:

CMS-1000FM Central Monitoring System

#### Indications for Use:

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

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Donna M. White
(Division Sign-Off)

Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K112159

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