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 Description

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.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to populate the acceptance criteria and study details. The document is a 510(k) summary for the Corometrics 120 Series Maternal/Fetal Monitor, which was cleared in 1997. It describes the device's intended use and compares its technological characteristics to predicate devices. However, it does not include details about acceptance criteria, device performance metrics, sample sizes for testing or training, ground truth establishment, expert qualifications, or details of a comparative effectiveness study, which are typical for studies involving AI or complex statistical analysis for diagnostic accuracy.

The relevant section simply states: "The 120 Series has been extensively tested to meet its requirements and design." This is a general statement and does not provide specific details about the studies or acceptance criteria themselves.

Therefore, I cannot extract the requested information from this document.

Summary

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K964770

510(k) SUMMARY: Corometrics 120 Series 9.0

FEB 2 1 1997

Prepared: 26 November 1996

[807.92(a)1] Contact Information

Maria Vitug Fouts Sr. Regulatory Compliance Specialist

Corometrics Medical Systems, Inc. Address: 61 Barnes Park Road North Wallingford, CT 06492

Phone: 203-949-2538 203-284-9465 Fax:

[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 NorthWallingford, CT 06492	K934959, clearancedate: 10/15/94
Model 556 CriticalCare Monitor		K911310, clearancedate: 6/10/91

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

[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, SpO2 Monitoring	Yes	Yes
MECG Waveform	Yes	No	Yes

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K964770 D2/2

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

្នែក

The 120 Series has been extensively tested to meet its requirements and design.

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).