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
Indications for 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.
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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: 203-949-2538
Fax: 203-284-9465
## [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 |
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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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