COROMETRICS MODEL 173 FETAL MONITOR

K993751 · Ge Medical Systems Information Technologies · HGM · Feb 2, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K993751
• Device Name: COROMETRICS MODEL 173 FETAL MONITOR
• Applicant: Ge Medical Systems Information Technologies
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Feb 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

The Corometrics® Model 173 Series Monitor is used for monitoring of the fetus throughout labor and delivery (i.e. fetal heart rate via US Transducer, fetal ECG via Spiral Electrode and uterine activity monitoring via TOCO Transducer or IUPC). The device also has an optional monitoring mode to detect fetal body movements. 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

Corometrics Model 173 Series Fetal Monitor monitors fetal/maternal vital signs during labor and delivery; inputs include fetal heart rate (ultrasound transducer or spiral electrode), uterine activity (TOCO transducer or IUPC), and optional fetal movement detection; device interfaces with external NIBP monitors to print maternal blood pressure data; used in hospital/clinical environments by healthcare professionals; provides real-time monitoring and high/low fetal heart rate notifications; aids clinical decision-making during labor; benefits patient through continuous fetal surveillance.

Clinical Evidence

No clinical data provided. The device underwent extensive bench testing to verify design requirements and performance specifications.

Technological Characteristics

Class II fetal monitor; monitors fetal heart rate (US/ECG), uterine activity (TOCO/IUPC), and fetal movement; includes interface for external NIBP monitors; chart recorder output; hospital/clinical use; no specific materials or software architecture details provided.

Indications for Use

Indicated for fetal and maternal monitoring during labor and delivery. Includes fetal heart rate (US/ECG), uterine activity (TOCO/IUPC), optional fetal movement detection, and maternal NIBP data recording.

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 151 Fetal Monitor (k9232077)
• Corometrics Models 171 & 172 Fetal Monitors (K991905)

Submission Summary (Full Text)

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### 2 2000 FEB

K993751 Page 1 of 2

### 510(k) SUMMARY: Corometrics® Model 173 Fetal Monitor 8.0

Prepared: 11/4/99

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

Richard Cehovsky Regulatory Affairs Manager

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

Phone: [phone] Fax:

## [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 173 Series Fetal Monitor. Common names include: Model 173 Series, Model 173 FM.

As with the predicate Corometrics Model 151 Fetal Monitor and the Models 171/172 Fetal Monitors, the Model 173 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 151<br>Fetal Monitor | GE Marquette Medical Systems, Inc.<br>61 Barnes Park Road North | k9232077, clearance<br>date: 3/31/94 |
| Corometrics Models 171<br>& 172 Fetal Monitors | GE Marquette Medical Systems, Inc.<br>61 Barnes Park Road North | K991905, clearance<br>date: 9/1/99 |

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

The Model 173 Series Fetal Monitor is intended for monitoring fetal and maternal vital signs: fetal heart rate, fetal ECG, maternal uterine activity, optional 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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| Monitoring Mode | Model 151 | Model<br>171/172 | Model 173 |
|------------------------------------------------------|------------|------------------|------------|
| Fetal Heart Rate Monitoring<br>via US transducer | Yes | Yes | Yes |
| Fetal ECG via Spiral Electrode | Yes | NO | Yes |
| Uterine Activity Monitoring<br>Via TOCO:<br>Via IUP: | Yes<br>Yes | Yes<br>NO | Yes<br>Yes |
| FMD detection upgrade kit<br>(Option) | No | Yes | Yes |
| Hi/Low Fetal Heart Rate<br>Notification | No | Yes | Yes |

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

## [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 173 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

2 2000 FEB

Mr. Richard Cehovsky Regulatory Affairs Manager GE Marquette Medical Systems A GE Medical Systems Company 61 Barnes Park Road North P.O. Box 333 Wallingford. CT 06492-0333

Re: K993751

Corometrics Model 173 Fetal Monitor Dated: November 4, 1999 Received: November 5, 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 (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 verfir 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), please 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

Image /page/2/Picture/15 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three lines representing the head, body, and legs. The figure is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the logo.

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Model 173 Series Fetal Monitor

Indications for Use:

### I. Fetal Surveillance

The Corometrics® Model 173 Series Monitor is used for monitoring of the fetus throughout labor and delivery (i.e. fetal heart rate via US Transducer, fetal ECG via Spiral Electrode and uterine activity monitoring via TOCO Transducer or IUPC). 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. Severson
Division Sign-Off

0027

Optional Format 1-2-96