MODEL 2120IS SERIES MATERNAL/FETAL MONITOR

K021135 · Ge Medical Systems Information Technologies · HGM · May 9, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K021135
• Device Name: MODEL 2120IS SERIES MATERNAL/FETAL MONITOR
• Applicant: Ge Medical Systems Information Technologies
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: May 9, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

The 2120is Maternal/Fetal Monitoring System is intended for monitoring fetal and maternal vital signs: fetal heart rate; fetal heart rate high/low/poor signal quality alarms; maternal uterine activity; heart/pulse rate, blood pressure, nondiagnostic maternal ECG and %SpO2. Optional fetal movement detection is available.

Device Story

Corometrics 2120is is a maternal/fetal monitor for clinical use during antepartum, labor, and delivery. Inputs include fetal heart rate (Doppler ultrasound or FECG), uterine activity (intrauterine pressure catheter or tocotransducer), maternal non-invasive blood pressure, maternal pulse oximetry, and maternal ECG. Device processes signals to provide real-time monitoring, alarms for fetal heart rate, and bed-to-bed surveillance via Ethernet networking. It functions as a bedside terminal for the QS system. Clinicians use output data to assess maternal and fetal well-being. Benefits include continuous surveillance of vital signs to support clinical decision-making during pregnancy and childbirth.

Clinical Evidence

No clinical data. Bench testing only, including requirements specification review, code inspections, software and hardware testing, safety testing, environmental testing, and final validation.

Technological Characteristics

Maternal/fetal monitor with configurations for Doppler ultrasound, FECG, intrauterine pressure catheter, tocotransducer, NIBP, pulse oximetry, and MECG. Features Ethernet connectivity for bed-to-bed surveillance and integration with QS system. Software-based monitoring system.

Indications for Use

Indicated for non-invasive and invasive monitoring of the fetus during the antepartum period, labor, and delivery (fetal heart rate, uterine activity, fetal movement). Indicated for monitoring maternal vital signs (non-invasive blood pressure, functional oxygen saturation of arterial hemoglobin, heart/pulse rate, and non-diagnostic ECG) as an adjunct to clinical assessment. Not intended for neonatal or pediatric blood pressure monitoring.

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

• Corometrics Model 2120is Maternal/Fetal Monitor (K012718)
• Masimo SET® 2000 Pulse Oximeter and LNOP® series of sensors and cables (K990966)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

| Date: | April 8, 2002 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems Information Technologies<br>61 Barnes Park Road North<br>Wallingford, CT 06492 USA |
| Contact Person: | Joelle Neider<br>Regulatory Affairs Specialist<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone] |
| Device: Trade Name: | Corometrics Model 2120is Maternal/Fetal Monitor |
| Common/Usual Name: | Maternal/Fetal Monitor |
| Classification Names: | 21 CFR 884.2740 System, Monitoring, Perinatal |
| Predicate Devices: | K012718 Corometrics Model 2120is Maternal/Fetal Monitor<br>K990966 Masimo SET® 2000 Pulse Oximeter and LNOP® series of<br>sensors and cables |
| Device Description: | The 2120is Maternal/Fetal Monitoring System consists of the following<br>features/options that can be available in multiple configurations:<br><ul><li>fetal heart rate (via Doppler Ultrasound of FECG)</li><li>maternal uterine activity (via intrauterine pressure catheter or<br/>tocotransducer</li><li>fetal movement detection</li><li>maternal non-invasive blood pressure (clinician prompted or<br/>automatic)</li><li>maternal pulse oximetry</li><li>maternal heart/pulse rate (MECG) and ECG waveform "snapshot"</li></ul> |
| | The 2120is is a full-featured maternal/fetal monitor. The device is also<br>capable of providing bed-to-bed surveillance when multiple 2120is<br>monitors are connected via an Ethernet network. The monitor is also<br>capable of acting as a bedside terminal to the QS system. In this<br>capacity, the 2120is monitor provides the features of a standard PC QS<br>bedside terminal. |
| Intended Use: | The 2120is Maternal/Fetal Monitoring System is intended for monitoring<br>fetal and maternal vital signs: fetal heart rate; fetal heart rate<br>high/low/poor signal quality alarms; maternal uterine activity;<br>heart/pulse rate, blood pressure, nondiagnostic maternal ECG and<br>%SpO2. Optional fetal movement detection is available. |
| Technology: | The Corometrics Model 2120is Maternal/Fetal Monitor employs the<br>same fundamental scientific technology as the predicate devices. |

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KOZ1135 page 4/2

The Model 2120is Maternal/Fetal Monitor complies with the voluntary Test Summary: The Model 212016 Maternair to of this submission. The following Standards as detailou in Society of the development of the Model 2120is:

- Requirements specification review .
- Code inspections .
- Software and hardware testing .
- Safety testing .
- Environmental testing .
- Final validation .

Conclusion:

The results of these measurements demonstrated that the Model The Tesults of these Thousarentions SET Pulse Oximetry) is as safe, as effective, and performs as well as the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 0 9 2002

Mr. Joelle Neider Corporate Regulatory Affairs GE Medical Systems Information Technologies 61 Barnes Park Road North P.O. Box 333 WALLINGFORD CT 06492-0333 Re: K021135

Trade/Device Name: Corometrics Model 2120is Maternal/Fetal Monitor Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II

Product Code: 85 HGM Dated: April 8, 2002 Received: April 9, 2002

Dear Mr. Neider:

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.

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); 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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known):

### 510(k) filed on April 8, 2002

Device Name:

Corometrics Model 2120is Maternal/Fetal Monitoring System

Indications For Use:

#### Fetal Surveillance | .

A Corometrics 2120is Maternal/Fetal Monitoring System is used for non-invasive and invasive monitoring of the fetus during the antepartum period as well as throughout labor and delivery (i.e. fetal heart rate and uterine activity monitoring). Fetal movement detection and fetal heart rate alarm options (user selectable high/low and poor signal quality alarms) are available.

11 Maternal Monitoring

> A Corometrics 2120is Maternal/Fetal Monitoring System is intended for monitoring maternal vital signs to help assess maternal well-being. The vital signs which can be measured with these monitor configurations are summarized as follows:

NOTE: Maternal vital signs provided by the monitor should only be used as an adjunct in patient assessment in conjunction with clinical signs and symptoms.

Blood Pressure: The monitor is intended for use in the non-invasive monitoring of maternal blood pressure (NBP). This monitor is not intended for use in the neonatal or pediatric blood pressure monitoring.

Pulse Oximetry. The monitor is intended for use in the non-invasive monitoring of maternal functional oxygen saturation of arterial hemoglobin (MSpO2).

Heart/Pulse Rate. The monitor is intended for use in the non-invasive monitoring of the maternal heart/pulse rate. Additionally, an MECG waveform "snapshot" may be displayed and printed.

NOTE: Only the maximum configuration provides both maternal heart rate and pulse rate data.

Bed-to-bed surveillance is available when 2120is Series Monitors are networked together.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="display:inline-block; vertical-align:top;">/</div> | OR | Over-The-Counter Use |
|----------------------|----------------------------------------------------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |

Nancy Broadon

(Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices

| 510(k) Number | K021135 |
|---------------|---------|
|---------------|---------|

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