COROMETRICS FETAL MOVEMENT DETECTION KIT

K955559 · Ge Medical Systems Information Technologies · HGM · Mar 5, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K955559
• Device Name: COROMETRICS FETAL MOVEMENT DETECTION KIT
• Applicant: Ge Medical Systems Information Technologies
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Mar 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Indications for Use

The Corometrics Fetal Movement Detection (FMD) Kit is intended to detect gross fetal body movements and fetal body movements with associated limb movement. Corometrics defines “gross fetal body movement” as the extension, flexion, or rolling over of the fetal trunk about the longitudinal axis of the body and associated limb movements.” Movement of the extremities alone may not be detected. Fetal eye movements will not be detected.

Device Story

Modular hardware/software kit for installation in Corometrics Fetal Monitor; utilizes pulse Doppler ultrasound to detect gross fetal body movements (trunk extension, flexion, rolling) and associated limb movements; excludes isolated extremity or eye movements. System processes Doppler signals to identify movement events; outputs duration of events as horizontal bars on fetal monitor recorder strip chart along heart rate time axis. Used in clinical obstetric settings by physicians/nurses to monitor fetal activity; provides objective documentation of fetal movement to assist in clinical assessment of fetal well-being.

Clinical Evidence

Bench testing and clinical evaluations performed; verified equivalent performance to the Hewlett-Packard Fetal Movement Profile (FMP) predicate device.

Technological Characteristics

Modular hardware/software kit; pulse Doppler ultrasound sensing; integrates with existing Corometrics Fetal Monitor; output via strip chart recorder; no specific material standards or software architecture details provided.

Indications for Use

Indicated for detection of gross fetal body movements and associated limb movements in pregnant patients during fetal 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

• Hewlett-Packard Fetal Movement Profile (FMP) Option in the M1350A Fetal Monitor (K900480)

Submission Summary (Full Text)

{0}

Corometrics Fetal Movement Detection Kit
K955559
510(k)

# Corometrics Fetal Movement Detection Kit
## 510(k) Summary
MAR - 5 1996

Prepared: 30 November 1995

## [807.92(a)1] Contact Information

Maria Vitug Fouts
Regulatory Affairs/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 Corometrics Fetal Movement Detection Kit

Common names include: FMD Kit

As indicated in this premarket notification submission, the Corometrics Fetal Movement Detection Kit is a class II device. To date no formal classification name has been issued for similar devices. Applicable device classification names include: § 884.2960 Obstetric ultrasonic transducer and accessories, and §884.2740, perinatal monitoring system.

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

Hewlett-Packard Fetal Movement Profile (FMP) Option in the M1350A Fetal Monitor (k900480: clearance date - July 2, 1990)

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

The FMD Kit is a modular hardware/software kit that can be installed in a Corometrics Fetal Monitor. The FMD Kit provides the ability to automatically detect fetal movement via pulse Doppler ultrasound and to display the duration of such events on the fetal monitor’s recorder strip chart as horizontal bars along the time scale (time axis) of the heart rate scale.

The Corometrics Fetal Movement Detection (FMD) Kit is intended to detect gross fetal body movements and fetal body movements with associated limb movement. Corometrics defines “gross fetal body movement” as the extension, flexion, or rolling over of the fetal trunk about the longitudinal axis of the body and associated limb movements.” Movement of the extremities alone may not be detected. Fetal eye movements will not be detected.

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{1}

Corometrics Fetal Movement Detection Kit
510(k)

# Corometrics Fetal Movement Detection Kit
## 510(k) Summary
- continued -

Prepared: 30 November 1995

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

| Feature | (Predicate) Hewlett-Packard Fetal Movement Profile (FMP) | Corometrics Fetal Movement Detection (FMD) |
| --- | --- | --- |
| Detection method | Pulse Doppler Ultrasound Technique | Same |
| Detection of gross body movements via ultrasound transducer | Yes | Same |
| Annotated by bar/dot | Yes | Same |
| Annotated by spike waveform | No | Same |
| Optional function | Yes | Same |

[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

Bench testing and clinical evaluations were performed and verified the equivalent performance of the Corometrics Fetal Movement Detection Kit with the Hewlett-Packard Fetal Movement Profile (FMP).

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