MODEL 250 SERIES MATERNAL/FETAL MONITOR

K050583 · Ge Medical Systems Information Technologies · HGM · Jun 21, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K050583
• Device Name: MODEL 250 SERIES MATERNAL/FETAL MONITOR
• Applicant: Ge Medical Systems Information Technologies
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Jun 21, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

The Corometrics 250 Series Maternal/Fetal Monitoring System is intended for monitoring fetal and maternal vital signs: fetal heart rate; optional fetal movement detection, FHR and UA alarms; maternal uterine activity; heart/pulse rate, blood pressure and %SpO2.

Device Story

Corometrics 250 Series is a maternal/fetal monitoring system used in clinical settings (labor/delivery) by healthcare professionals. Inputs include fetal heart rate (Doppler ultrasound or FECG), uterine activity (tocotransducer or intrauterine pressure catheter), maternal non-invasive blood pressure, maternal pulse oximetry (SpO2), and maternal ECG (MECG). The device processes these physiological signals to provide real-time monitoring, waveform snapshots, and alarms for fetal heart rate and uterine activity. Output is displayed on the monitor and printed for clinical review. Clinicians use this data to assess fetal and maternal well-being during pregnancy and labor, facilitating clinical decision-making regarding patient management and intervention.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including requirements specification review, code inspections, software and hardware testing, safety testing, environmental testing, and final validation.

Technological Characteristics

Maternal/fetal monitoring system. Modalities: Doppler ultrasound, FECG, tocotransducer, intrauterine pressure catheter, NIBP, pulse oximetry, MECG. Connectivity: Standalone monitor with display and printing capabilities. Software: Embedded firmware for signal processing and alarm management. Sterilization: Not applicable (non-invasive/external sensors).

Indications for Use

Indicated for non-invasive and invasive monitoring of the fetus during antepartum and labor/delivery (fetal heart rate, uterine activity, fetal movement). Indicated for maternal vital sign monitoring (blood pressure, pulse oximetry, heart/pulse rate) to assess maternal well-being. Not for neonatal or pediatric use.

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

• Corometrics Model 120is Maternal/Fetal Monitor (K032252)
• DINAMAP PRO 1000 with SuperSTAT (K022834)
• Datex Ohmeda SpO2 (K040831)
• Nellcor SpO2 (K012891/K021089/K030930)
• Masimo SpO2 (K033296)

Submission Summary (Full Text)

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K050583

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## JUN 2 1 2005

| 510(k) Summary of Safety and Effectiveness |
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| Date: | March 4, 2005 |
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| Submitter: | GE Medical Systems Information Technologies<br>4502 Woodland Corporate Boulevard<br>Tampa, FL 33614 USA |
| Contact Person: | Tyler Sedone<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Device:<br>Trade Name: | Corometrics Model 250 Series Maternal/Fetal Monitor |
| Common/Usual Name: | Maternal/Fetal Monitor |
| Classification Names: | 21 CFR 884.2740 System, Monitoring, Perinatal |
| Predicate Devices: | K032252 Corometrics Model 120is Maternal/Fetal Monitor<br>K022834 DINAMAP PRO 1000 with SuperSTAT<br>K040831 Datex Ohmeda SpO2<br>K012891/K021089/K030930 Nellcor SpO2<br>K033296 Masimo SpO2 |
| Device Description: | The Corometrics 250 Series Maternal/Fetal Monitoring System consists<br>of the following features/options that can be available in multiple<br>configurations:<br>• fetal heart rate (via Doppler Ultrasound of FECG)<br>• maternal uterine activity (via intrauterine pressure catheter or<br>tocotransducer)<br>• fetal movement detection<br>• maternal non-invasive blood pressure (clinician prompted or automatic)<br>• maternal pulse oximetry<br>• maternal heart/pulse rate (MECG) and ECG waveform "snapshot" |
| Intended Use: | The Corometrics 250 Series Maternal/Fetal Monitoring System is<br>intended for monitoring fetal and maternal vital signs: fetal heart rate;<br>optional fetal movement detection, FHR and UA alarms; maternal<br>uterine activity; heart/pulse rate, blood pressure and %SpO2. |

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The Corometrics 250 Series Maternal/Fetal Monitor complies with the Test Summary: The Ocromethoo 200as detailed in Section 9 of this submission. The . voluntary clariaards ace measures were applied to the development:

- Requirements specification review .
- Code inspections .
- Software and hardware testing .
- Safety testing .
- Environmental testing .
- . Final validation

The results of these measurements demonstrated that the Corometrics Conclusion: The results of these moul Monitor is as safe and effective, and as the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville -MD 20050

JUN 2 1 2005

Mr. Tyler Sedone Senior Regulatory Affairs Specialist GE Medical Systems Information Technologies 4502 Woodland Corporate Boulevard TAMPA FL 33614

Re: K050583 K050583
Trade/Device Name: Corometrics 250 Series Maternal/Fetal Monitoring System Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM

Dated: June 2, 2005 Received: June 13, 2005

Dear Mr. Sedone:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced We have revewed your Section Fronty promotially equivalent (for the indications for use stated in above and have deceminated the do nedicate devices marketed in interstate commerce prior to the enclosure) to regary marketed prodisato device Amendments, or to devices that have been May 28, 1970, the clacultion add of the Frederal Food, Drug, and Cosmetic Act (Act) that reclassified in accordation with the pro nevel application (PMA). You may, therefore, market the do not require approval of a premiations of the Act. The general controls provisions of the Act device, subject to the general concolo prove, 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 (Premarket If your device is classified (see above) miso and controls. Existing major regulations affecting your Approval), it may of subject to securations, Title 21, Parts 800 to 898. In addition, FDA device can be found in the Code of s concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised ular I DA 3 Issuallo of a successions lies with other requirements of the Act of any FDA nas made a decimination mac your as treat agencies. You must comply with all the Federal Statues and regulations administer to registration and listing (21 CFR Part 807); labeling Act S requirements, including, but not mixted to regurements as set forth in the quality systems (QS) (ZT CFR Part 801), good mandacturing practic responses
regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
I have a marketing a financies and continential aggivalence of your device to a This letter will allow you to begin marketing your artise of your device of your device of your device to a legally
premarket notification. The FDA inn in iS on fer vour dev premarket notification. The FDA finding of substantial equivalence of 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 If you desire specific advice for your device on our laveling regulation (1) - 100 - 100 - 100 - 100 the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misoranion on your responsibilities under the Act from the 807.97). You may obtain other general inionnal on your respections of its toll-free number (800) DIVIsion of Bill) 443-6597 or at its Internet address 056-2047 or (2019/01/2019/01/industry/support/index.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

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## K 0505 93

510(k) Number (if known):

Corometrics Model 250 Series Maternal/Fetal Monitoring System

Device Name: Indications For Use:

## Fetal Surveillance 1.

A Corometrics 250 Series Maternal/Fetal Monitoring System is used for non-invasive and A Corometrics 250 Series Maternair-etail Montoning Cyclome as well as throughout labor
invasive monitoring of the fetus during the anteparting . Fetal movement invasive monitoring of the fetus during the antipanse as many of the movement
and delivery (i.e. fetal heart rate a nd uterine activity and novement and delivery (1.6. fetal heart rate and uterine detrice detrice and poor signal quality alarms) are available.

Maternal Monitoring ll

> A Corometrics 250 Series Maternal/Fetal Monitoring System is intended for A Corometrics 250 Senes Maternal Claimonton of well-being. The vital signs
> monitoring maternal vital signs to help assess maternal well-being. The vital signs monitoring matemal vital signs to holp accoconfigurations are summarized as follows:

> NOTE: Maternal vital signs provided by the monitor should only be used as an

Blood Pressure: The monitor is intended for use in the non-invasive monitoring of Blood Pressure. The monitor is intended for use in the Road for use in the neonatal or pediatric blood pressure monitoring.

Pulse Oximetry. The monitor is intended for use in the non-invasive monitoring of Pulse Oximetry. The monitor its inchiles interial hemoglobin (MSpO2).

Heart/Pulse Rate. The monitor is intended for use in the non-invasive monitoring of HeartPulse Kate. The monitor is intentably, an MECG waveform "snapshot" may be displayed and printed.

NOTE: Only the maximum configuration provides both maternal heart rate and pulse rate data.

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

(Division Sign-Off) ( Division of Reproductive, Abo and Radiological Devices 510(k) Number _