COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR

K964770 · Ge Medical Systems Information Technologies · HGM · Feb 21, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K964770
• Device Name: COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
• Applicant: Ge Medical Systems Information Technologies
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Feb 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

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

Device Story

120 Series Maternal/Fetal Monitor; monitors fetal heart rate (FHR), uterine activity (UA), maternal heart/pulse rate, non-invasive blood pressure (NBP), and %SpO2. Adds maternal ECG (MECG) waveform monitoring capability compared to predicate Model 118. Used in hospital/clinical environments by healthcare professionals. Device processes physiological signals to provide real-time vital sign data for clinical assessment of maternal and fetal status.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Class II maternal/fetal monitor. Modalities: FHR, UA, maternal heart/pulse rate, NBP, %SpO2, MECG waveform. Standalone clinical monitor. No specific materials or software architecture details provided.

Indications for Use

Indicated for monitoring fetal heart rate, maternal uterine activity, maternal heart/pulse rate, blood pressure, and %SpO2 in hospital or clinical settings.

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

• Model 118 Maternal/Fetal Monitor (K934959)
• Model 556 Critical Care Monitor (K911310)

Submission Summary (Full Text)

{0}

K964770
p1/2
Corometrics Medical Systems, Inc.
120 Series 510(k) Premarket Notification Submission
November 1996

# 9.0 510(k) SUMMARY: Corometrics 120 Series

FEB 21 1997

Prepared: 26 November 1996

## [807.92(a)1] Contact Information

Maria Vitug Fouts
Sr. Regulatory Compliance Specialist

Address: Corometrics 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 120 Series Maternal/Fetal Monitor. Common names include: 120 Series, 120 MFM.

As with the predicate Model 118, the 120 Series is a Class II device.

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

| Predicate System | Manufacturer | k Number |
| --- | --- | --- |
| Model 118 Maternal/Fetal Monitor | Corometrics Medical Systems, Inc.
61 Barnes Park Road North
Wallingford, CT 06492 | k934959, clearance date: 10/15/94 |
| Model 556 Critical Care Monitor | | k911310, clearance date: 6/10/91 |

## [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; and maternal uterine activity, heart/pulse rate, blood pressure, and %Sp02. The device is intended for use in a hospital/clinical environment.

## [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, NBP, Sp02 Monitoring | Yes | Yes | |
| MECG Waveform | Yes | No | Yes |

{1}

Corometrics Medical Systems, Inc.
120 Series 510(k) Premarket Notification Submission
K964770 P2/2
November 1996

[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.

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