COROMETRICS MODEL 171 AND 172 FETAL MONITOR

K991905 · General Electric Medical Systems Information Techn · HGM · Sep 1, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K991905
• Device Name: COROMETRICS MODEL 171 AND 172 FETAL MONITOR
• Applicant: General Electric Medical Systems Information Techn
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Sep 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

The Corometrics® Model 171/172 Series Monitors are used for monitoring of the fetus during the antepartum period as well as throughout labor and delivery (i.e. fetal heart rate and uterine activity monitoring). The device also has an optional monitoring mode to detect fetal body movements. Maternal NBP Recording Blood Pressure. The monitor has an interface to select external NBP monitors. The Monitor does not process any NBP data but only prints the NBP data , from the external monitor, to its chart recorder.

Device Story

Device monitors fetal heart rate, uterine activity, and fetal movement; provides interface for external maternal NIBP monitor data. Used in hospital/clinical environments by healthcare professionals. Inputs include fetal/maternal physiological signals; device processes these to display and print data via chart recorder. Provides real-time surveillance; includes Hi/Low fetal heart rate notification. Benefits include continuous fetal monitoring during antepartum, labor, and delivery to assist clinical decision-making.

Clinical Evidence

Bench testing only. Device extensively tested to meet requirements and design specifications.

Technological Characteristics

Fetal monitor for heart rate, uterine activity, and fetal movement. Includes interface for external NIBP data printing. Features Hi/Low fetal heart rate notification. Class II device.

Indications for Use

Indicated for fetal heart rate, uterine activity, and fetal movement monitoring during antepartum, labor, and delivery periods. Includes interface for printing external maternal NIBP data.

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 150 Fetal Monitor (K920376)
• Corometrics Spectra 400 Extended Surveillance and Alert Systems (K852608)

Submission Summary (Full Text)

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# SEP | 1 1999

#### 510(k) SUMMARY: Corometrics® Model 171/172 Fetal Monitor 9.0

# Prepared: June 3, 1999

## [807.92(a)1] Contact Information

Richard Cehovsky Regulatory Affairs Manager

Address: GE Marquette Medical Systems, Inc. 61 Barnes Park Road North Wallingford, CT 06492

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 Corometrics Model 171/172 Series Fetal Monitor. Common names include: Model 170 Series, Model 171/172 FM.

As with the predicate Corometrics Model 150 Fetal Monitor and the Corometrics Spectra 400 Extended Surveillance and Alert Systems, the Model 171/172 Series Fetal Monitor is a Class II device.

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

| Predicate System | Manufacturer | K Number |
|-----------------------------------------------------------------------|-----------------------------------------------------------------|-------------------------------------|
| Corometrics Model 150<br>Fetal Monitor | GE Marquette Medical Systems, Inc.<br>61 Barnes Park Road North | k920376, clearance<br>date: 4/27/92 |
| Corometrics Spectra 400<br>Extended Surveillance<br>and Alert Systems | GE Marquette Medical Systems, Inc.<br>61 Barnes Park Road North | K852608, clearance<br>date: 9/29/85 |

# 1807.92(a)4 & 807.92(a)5] Device Description & Intended Use

The Model 171/172 Series Fetal Monitor is intended for monitoring fetal and maternal vital signs: fetal heart rate and maternal uterine activity, fetal movement detection, and an interface for select maternal NIBP monitors. The device is intended for use in a hospital/clinical environment.

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K991905 page zofz

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

| Monitoring Mode | Model 150 | Spectra 400 | Model<br>171/172 |
|-----------------------------------------|-----------|--------------------|------------------|
| Fetal Heart Rate<br>Monitoring | Yes | Yes | Yes |
| Uterine Activity<br>Monitoring | Yes | Yes | Yes |
| FMD detection upgrade kit<br>(Option) | Yes | Can Display<br>FMD | Yes |
| Hi/Low Fetal Heart Rate<br>Notification | No | Yes | 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 Model 171/172 Series Fetal Monitor has been extensively tested to meet its requirements and design.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1999

Mr. Richard Cehovsky Requlatory Affairs Manager GE Marquette Medical Systems, Inc. 61 Barnes Park Road North Wallingford, CT 06492

Re: K991905 Corometrics Model 171 and 172 Fetal Monitor Dated: June 3, 1999 Received: June 4, 1999 Requiatory Class: II 21 CFR §884.2740/Procode: 85 HGM

Dear Mr. Cehovsky:

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, 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 device on our 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 regulation 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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*

510(k) Number (if known):

Device Name: Model 171/172 Series Fetal Monitor

Indications for Use:

#### I. Fetal Surveillance

The Corometrics® Model 171/172 Series Monitors are used for monitoring of the fetus during the antepartum period as well as throughout labor and delivery (i.e. fetal heart rate and uterine activity monitoring). The device also has an optional monitoring mode to detect fetal body movements.

### II. Maternal NBP Recording

Blood Pressure. The monitor has an interface to select external NBP monitors. The Monitor does not process any NBP data but only prints the NBP data , from the external monitor, to its chart recorder.

* 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

David A. Segerson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices an1905 510(k) Number

Optional Format 1-2-96

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