K Number
K012718
Device Name
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
Date Cleared
2001-11-13

(90 days)

Product Code
Regulation Number
884.2740
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- Fetal Surveillance . A Corometrics 120is Maternal/Fetal Monitoring System is used for non-invasive and invasive monitoring of the fetus during the antepartum period as well as throughout invasive monitoning of the retail t rate and uterine activity monitoring). Fetal labor and delivery (f.o. Tour rate alarm options (user selectable high/low and poor signal quality alarms) are available. - Maternal Monitoring ll A Corometrics 120is Maternal/Fetal Monitoring System is intended for monitoring A Ooromotho TE016 Maternal well-being. The vital signs which can be material that tights to nonitor configurations are summarized as follows: NOTE: Maternal vital signs provided by the monitor should only be used as an adjunct in patient assessment in conjunction with clinical signs and symptoms. Blood Pressure: The monitor is intended for use in the non-invasive monitoring of Blood Pressure (NBP). This monitor is not intended for use in the neonatal or pediatric blood pressure monitoring. Pulse Oximetry. The monitor is intended for use in the non-invasive monitoring of r also Oximody. The oxygen saturation of arterial hemoglobin (MSpO2). Heart/Pulse Rate. The monitor is intended for use in the non-invasive monitoring of i leardr ulse Rate. The monto Additionally, an MECG waveform "snapshot" may be displayed and printed. - NOTE: Only the maximum configuration provides both maternal heart rate and pulse rate data Bed-to-bed surveillance is available when 120is Series Monitors are networked together
Device Description
The Corometrics Model 120is Maternal/Fetal Monitor is intended for monitoring fetal and maternal vital signs: fetal heart rate; optional fetal movement detection, FHR and UA alarms, and maternal uterine activity, heart/pulse rate, blood pressure, and %Sp02. The device is intended for use in a hospital/clinical environment.
More Information

Not Found

No
The document describes a standard maternal/fetal monitor with vital sign monitoring capabilities and alarms. There is no mention of AI, ML, or any advanced analytical techniques that would suggest the use of such technology.

No
The device is described as a "Maternal/Fetal Monitoring System" and is used for "non-invasive and invasive monitoring" of vital signs. Monitoring devices, while providing critical information for patient care, do not directly provide therapy. Therapy involves active treatment of a disease or condition.

Yes

This device monitors physiological parameters of the mother and fetus (fetal heart rate, uterine activity, maternal vital signs like blood pressure, pulse oximetry, and heart/pulse rate). While it doesn't provide a definitive diagnosis of a disease, the monitoring of these vital signs to assess well-being and identify potential issues during pregnancy and labor aligns with the broad definition of a diagnostic device, as it gathers information to aid in the assessment of health status. The statement "Maternal vital signs provided by the monitor should only be used as an adjunct in patient assessment in conjunction with clinical signs and symptoms" further supports its role in diagnostics, as it provides data to support a medical assessment.

No

The device description explicitly states it is a "Maternal/Fetal Monitor" and describes monitoring fetal and maternal vital signs using hardware components like sensors for fetal heart rate, uterine activity, blood pressure, and SpO2. This is not a software-only device.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The description clearly states the device is a Maternal/Fetal Monitoring System used for non-invasive and invasive monitoring of the fetus and non-invasive monitoring of maternal vital signs (blood pressure, pulse oximetry, heart/pulse rate).
  • No Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient. It directly measures physiological signals from the body.

Therefore, the Corometrics 120is Maternal/Fetal Monitoring System falls under the category of a physiological monitoring device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

  • Fetal Surveillance .
    A Corometrics 120is Maternal/Fetal Monitoring System is used for non-invasive and invasive monitoring of the fetus during the antepartum period as well as throughout invasive monitoning of the retail t rate and uterine activity monitoring). Fetal labor and delivery (f.o. Tour rate alarm options (user selectable high/low and poor signal quality alarms) are available.

  • Maternal Monitoring ll
    A Corometrics 120is Maternal/Fetal Monitoring System is intended for monitoring A Ooromotho TE016 Maternal well-being. The vital signs which can be material that tights to nonitor configurations are summarized as follows:

NOTE: Maternal vital signs provided by the monitor should only be used as an adjunct in patient assessment in conjunction with clinical signs and symptoms.

Blood Pressure: The monitor is intended for use in the non-invasive monitoring of Blood Pressure (NBP). This monitor is not intended for use in the neonatal or pediatric blood pressure monitoring.

Pulse Oximetry. The monitor is intended for use in the non-invasive monitoring of r also Oximody. The oxygen saturation of arterial hemoglobin (MSpO2).

Heart/Pulse Rate. The monitor is intended for use in the non-invasive monitoring of i leardr ulse Rate. The monto Additionally, an MECG waveform "snapshot" may be displayed and printed.

  • NOTE: Only the maximum configuration provides both maternal heart rate and pulse rate data
    Bed-to-bed surveillance is available when 120is Series Monitors are networked together

Product codes

85 HGM

Device Description

The Corometrics Model 120is Maternal/Fetal Monitor is intended for monitoring fetal and maternal vital signs: fetal heart rate; optional fetal movement detection, FHR and UA alarms, and maternal uterine activity, heart/pulse rate, blood pressure, and %Sp02.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

The device is intended for use in a hospital/clinical environment.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

At the time of this submission, the Model 120is is undergoing extensive testing to ensure that it meets its requirements and design.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K964770, K993008

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 884.2740 Perinatal monitoring system and accessories.

(a)
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.(b)
Classification. Class II (performance standards).

0

510(k) Summary: 120is Maternal/Fetal Monitoring System 10.0

KOI 2718

Prepared: August, 2001

[807.92(a)1] Contact Information

Joelle Neider Regulatory Affairs Specialist

GE Medical Systems Information Technologies Address: 61 Barnes Park Road North Wallingford, CT 06492

Phone: 203-949-8232 414-918-8113 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 120is Maternal/Fetal Monitor. Common names include: 120is Maternal/Fetal Monitoring System, Model 120is, and 120is.

As with the predicate system, the 120is Series (i.e. Model 126is, 128is, 129is configurations) continue to be Class II devices.

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

Predicate SystemManufacturerk Number
120 Series Maternal/
Fetal MonitorGE Medical Systems Information
Technologies
61 Barnes Park Road North
Wallingford, CT 06492K964770,
SE: 2/21/97
QS SystemGE Medical Systems Information
Technologies
445 Defense Highway
Annapolis, MD 21401K993008
SE: 12/6/99

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

The Corometrics Model 120is Maternal/Fetal Monitor is intended for monitoring fetal and maternal vital signs: fetal heart rate; optional fetal movement detection, FHR and UA alarms, and maternal uterine activity, heart/pulse rate, blood pressure, and %Sp02. The device is intended for use in a hospital/clinical environment.

1

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

120is Monitoring Mode120 SeriesQS
FHR/UA MonitoringX
Maternal Heart/Pulse
Rate, NBP, SpO2
MonitoringX
MECG WaveformX
Fetal movement detectionX
Surveillance modeX

[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

At the time of this submission, the Model 120is is undergoing extensive testing to ensure that it meets its requirements and design.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2001

Ms. Joelle Neider Corporate Regulatory Affairs GE Medical Systems General Electric Company 61 Barnes Park Road North P.O. Box 333 WALLINGFORD CT 06492-0333 Re: K012718 Trade/Device Name: Model 120is Maternal/Fetal Monitoring System Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: 85 HGM

Dated: August 13, 2001 Received: August 15, 2001

Dear Ms. Neider:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for about in 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

3

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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx(301) 594-4654
Other(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

NOV 1 3 2001

KD12718

510(k) Number (if known): 《012718

Device Name:

Corometrics Model 120is Maternal/Fetal Monitoring System

Indications For Use:

  • Fetal Surveillance .
    A Corometrics 120is Maternal/Fetal Monitoring System is used for non-invasive and invasive monitoring of the fetus during the antepartum period as well as throughout invasive monitoning of the retail t rate and uterine activity monitoring). Fetal labor and delivery (f.o. Tour rate alarm options (user selectable high/low and poor signal quality alarms) are available.

  • Maternal Monitoring ll
    A Corometrics 120is Maternal/Fetal Monitoring System is intended for monitoring A Ooromotho TE016 Maternal well-being. The vital signs which can be material that tights to nonitor configurations are summarized as follows:

NOTE: Maternal vital signs provided by the monitor should only be used as an adjunct in patient assessment in conjunction with clinical signs and symptoms.

Blood Pressure: The monitor is intended for use in the non-invasive monitoring of Blood Pressure (NBP). This monitor is not intended for use in the neonatal or pediatric blood pressure monitoring.

Pulse Oximetry. The monitor is intended for use in the non-invasive monitoring of r also Oximody. The oxygen saturation of arterial hemoglobin (MSpO2).

Heart/Pulse Rate. The monitor is intended for use in the non-invasive monitoring of i leardr ulse Rate. The monto Additionally, an MECG waveform "snapshot" may be displayed and printed.

  • NOTE: Only the maximum configuration provides both maternal heart rate and pulse rate data
    Bed-to-bed surveillance is available when 120is Series Monitors are networked together

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Gradon

(Division Sign-Off)
---------------------

Division of Reproductive, Abdominal,
and Radiological Devices

510(k) NumberK012718
------------------------

Prescription Use V (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)