COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR

K991739 · General Electric Medical Systems Information Techn · HGM · Aug 19, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K991739
• Device Name: COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
• Applicant: General Electric Medical Systems Information Techn
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Aug 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

A Corometrics 120 Series Monitor 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 or Spectra alerts) are available. A Corometrics 120 Series Monitor 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 below. 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 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, a MECG waveform "snapshot" may be displayed and printed. NOTE: Only the maximum configuration provides both maternal heart rate and pulse rate data.

Device Story

120 Series Maternal/Fetal Monitor performs non-invasive and invasive fetal/maternal monitoring; inputs include fetal heart rate (FHR), uterine activity (UA), maternal blood pressure (NBP), pulse oximetry (SpO2), and maternal ECG (MECG). Device processes signals to provide real-time monitoring, alarms (FHR/UA), and MECG waveform snapshots. Used in hospital/clinical environments by healthcare professionals. Output displayed on monitor and printed; assists clinicians in assessing fetal/maternal status during antepartum, labor, and delivery. Benefits include continuous surveillance of maternal/fetal well-being.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Class II maternal/fetal monitor. Features include FHR/UA monitoring, NBP, SpO2, and MECG waveform capability. Connectivity includes display and printing of waveforms/data. Operates as a standalone clinical monitor. No specific materials or software architecture details provided.

Indications for Use

Indicated for non-invasive and invasive fetal monitoring (heart rate, uterine activity) during antepartum, labor, and delivery; and for monitoring maternal vital signs (blood pressure, SpO2, heart/pulse rate) to assess maternal well-being. Not 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

• 120 Series Maternal/Fetal Monitor (k964770)
• Fetal Movement Detection (k955559)
• Spectra 400 Extended Surveillance and Alerts System (k852608)

Reference Devices

• Model 118
• Model 556

Submission Summary (Full Text)

{0}------------------------------------------------

### May 1999

#### 510(k) SUMMARY: Corometrics 120 Series, Version 2.0 10.0

Prepared: May 1999

### [807.92(a)1] Contact Information

Maria Vitug Fouts Sr. Regulatory Compliance Specialist

Address: GE Marquette Medical Systems, Inc. 200 Harry S. Truman Parkway Annapolis, MD 21401

Phone: [phone] Fax: [phone]

### [807.92(a)2| Device Name and Classification

The proprietary name of the modified device to be introduced into interstate commerce is the 120 Series Maternal/Fetal Monitor. Common names include: 120 Series, 120 MFM.

As with the predicate system, the 120 Series (i.e. Model 126, 128, 129 configurations) continue to be Class II devices.

### [807.92(a)3] Identification of Legally Marketed Equivalent Devices (Predicate Systems).

| Predicate System | Manufacturer | k Number |
|-----------------------------------------------------------|----------------------------------------------------|-------------------------|
| 120 Series Maternal/<br>Fetal Monitor | GE Marquette Medical Systems,<br>Inc | k964770,<br>SE: 2/21/97 |
| Fetal Movement<br>Detection | 61 Barnes Park Road North<br>Wallingford, CT 06492 | k955559,<br>SE: 3/5/96 |
| Spectra 400 Extended<br>Surveillance and Alerts<br>System | | k852608,<br>SE: 9/29/85 |

### [807.92(a)4 & 807.92(a)5] Device Description & Intended Use

The 120 Series is intended for monitoring fetal and maternal vital signs: fetal heart rate; optional fetal movement detection, FHR and UA alarms, and maternal uterine activity, heart/pulse rate, blood pressure, and %Sp02. The device is intended for use in a hospital/clinical environment.

D 1672

{1}------------------------------------------------

# [807.92(a)6] Predicate Device Comparison of Technological characteristics

| Monitoring Mode | 120 Series | Model 118 | Model 556 |
|----------------------------------------------------|------------|-----------|----------------|
| FHR/UA Monitoring | Yes | Yes | Not Applicable |
| Maternal Heart/Pulse Rate,<br>NBP, Sp02 Monitoring | Yes | Yes | Yes |
| MECG Waveform | Yes | No | Yes |

# [807.92(b)1, 807.92(b)2 & 807.92(b)3] Performance Standards per the Food, Drug and Cosmetic Act

To date, no performance standards relating to devices of this type have been promulgated by the Food and Drug Administration.

# [807.92(d)] Additional Information

The 120 Series has been extensively tested to meet its requirements and design.

p. Zofz

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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG | 9 1999

Ms. Maria Vitug Fouts Senior Regulatory Compliance Specialist GE Marquette Medical Systems, Inc. 200 Harry S. Truman Parkway, Suite 220 Annapolis, Marvland 21401

Re: K991739 Maternal/Fetal Monitor Corometrics 120 Series, Version 2.0 Dated: May 20, 1999 Received: Mav 21 1999 Regulatory Class: II 21 CFR §884.2740/Procode: 85 HGM

Dear Ms. Fouts:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), piease contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Corometrics Model 120 Series Version 2.0 510(k) Premarket Notification

May 1999

991729 510(k) Number (if known):

Device Name: 120 Series Maternal/Fetal Monitor

Indications for Use:

## I. Fetal Surveillance

A Corometrics 120 Series Monitor 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 or Spectra alerts) are available.

# II. Maternal Monitoring

A Corometrics 120 Series Monitor 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 below.

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 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, a MECG waveform "snapshot" may be displayed and printed.

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

* To be assigned by FDA upon receipt of 510(k) submission.

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

Concurrence if CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.19)

OR

Over the Counter Use

Optional Format 1-2-96

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991739

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