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.

AI/ML Overview

The provided text is a 510(k) summary for the Corometrics Model 120is Maternal/Fetal Monitoring System. It does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document primarily focuses on:

Contact Information: Details of the manufacturer and regulatory specialist.
Device Name and Classification: Proprietary name, common names, and classification (Class II).
Identification of Legally Marketed Equivalent Devices (Predicate Systems): Lists two predicate devices (120 Series Maternal/Fetal Monitor and QS System) with their manufacturers and k numbers.
Device Description & Intended Use: Describes the device's purpose, including monitoring fetal heart rate, fetal movement detection, FHR/UA alarms, and maternal vital signs (uterine activity, heart/pulse rate, blood pressure, %SpO2). It specifies use in a hospital/clinical environment.
Predicate Device Comparison of Technological Characteristics: A table comparing monitoring modes (FHR/UA Monitoring, Maternal Heart/Pulse Rate, NBP, SpO2 Monitoring, MECG Waveform, Fetal movement detection, Surveillance mode) of the 120is, 120 Series, and QS.
Performance Standards: States that "To date, no performance standards relating to devices of this type have been promulgated by the Food and Drug Administration."
Additional Information: Mentions that "At the time of this submission, the Model 120is is undergoing extensive testing to ensure that it meets its requirements and design." This statement suggests testing was ongoing but does not provide results, criteria, or study details.

The subsequent pages are the FDA's clearance letter, which confirms substantial equivalence to predicate devices but also does not delve into specific performance study details beyond what was presented in the 510(k) summary.

Therefore, I cannot provide the requested information in a table or answer the specific questions below because the provided text does not contain this information.

To reiterate, the document explicitly states: "To date, no performance standards relating to devices of this type have been promulgated by the Food and Drug Administration." and "At the time of this submission, the Model 120is is undergoing extensive testing to ensure that it meets its requirements and design." This strongly indicates that detailed performance study results and acceptance criteria were not included in this particular 510(k) summary.

Summary

{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 System	Manufacturer	k Number
120 Series Maternal/Fetal Monitor	GE Medical Systems InformationTechnologies61 Barnes Park Road NorthWallingford, CT 06492	K964770,SE: 2/21/97
QS System	GE Medical Systems InformationTechnologies445 Defense HighwayAnnapolis, MD 21401	K993008SE: 12/6/99

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

{1}------------------------------------------------

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

120is Monitoring Mode	120 Series	QS
FHR/UA Monitoring	X
Maternal Heart/PulseRate, NBP, SpO2Monitoring	X
MECG Waveform	X
Fetal movement detection	X
Surveillance mode		X

[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) Number	K012718
---------------	---------

Prescription Use V (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).