I. Fetal Surveillance
A Corometrics 120 Series Monitor is used for non-invasive and invasive monitoring of the fetus during the antepartum period as well as throughout labor and delivery (i.e. fetal heart rate and uterine activity monitoring). Fetal movement detection and fetal heart rate alarm options (user selectable high/low and poor signal quality alarms or Spectra alerts) are available.
II. Maternal Monitoring
A Corometrics 120 Series Monitor is intended for monitoring maternal vital signs to help assess maternal well-being. The vital signs which can be measured with these monitor configurations are summarized below.
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 maternal blood pressure (NBP). This monitor is not intended for use in neonatal or pediatric blood pressure monitoring.
Pulse Oximetry. The monitor is intended for use in the non-invasive monitoring of maternal functional oxygen saturation of arterial hemoglobin (MSpO2).
Heart/Pulse Rate. The monitor is intended for use in the non-invasive monitoring of the maternal heart/pulse rate. Additionally, a MECG waveform "snapshot" may be displayed and printed.
NOTE: Only the maximum configuration provides both maternal heart rate and pulse rate data.
The 120 Series 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.
The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for a maternal/fetal monitor. It describes the device, its intended use, and a comparison to predicate devices, but it does not detail specific performance metrics, acceptance criteria, or any studies conducted to validate these criteria.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used or their qualifications.
- Adjudication method.
- Information about an MRMC comparative effectiveness study or effect size.
- Information about a standalone performance study.
- Type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
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May 1999
510(k) SUMMARY: Corometrics 120 Series, Version 2.0 10.0
Prepared: May 1999
[807.92(a)1] Contact Information
Maria Vitug Fouts Sr. Regulatory Compliance Specialist
Address: GE Marquette Medical Systems, Inc. 200 Harry S. Truman Parkway Annapolis, MD 21401
Phone: 410-573-6294 Fax: 410-573-0408
[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 system, the 120 Series (i.e. Model 126, 128, 129 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 Marquette Medical Systems,Inc | K964770,SE: 2/21/97 |
| Fetal MovementDetection | 61 Barnes Park Road NorthWallingford, CT 06492 | K955559,SE: 3/5/96 |
| Spectra 400 ExtendedSurveillance and AlertsSystem | K852608,SE: 9/29/85 |
[807.92(a)4 & 807.92(a)5] Device Description & Intended Use
The 120 Series 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.
D 1672
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[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, Sp02 Monitoring | Yes | Yes | Yes |
| MECG Waveform | Yes | No | Yes |
[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
The 120 Series has been extensively tested to meet its requirements and design.
p. Zofz
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG | 9 1999
Ms. Maria Vitug Fouts Senior Regulatory Compliance Specialist GE Marquette Medical Systems, Inc. 200 Harry S. Truman Parkway, Suite 220 Annapolis, Marvland 21401
Re: K991739 Maternal/Fetal Monitor Corometrics 120 Series, Version 2.0 Dated: May 20, 1999 Received: Mav 21 1999 Regulatory Class: II 21 CFR §884.2740/Procode: 85 HGM
Dear Ms. Fouts:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), piease contact the Office of Compliance at (301) 594-4613. 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 requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Corometrics Model 120 Series Version 2.0 510(k) Premarket Notification
May 1999
991729 510(k) Number (if known):
Device Name: 120 Series Maternal/Fetal Monitor
Indications for Use:
I. Fetal Surveillance
A Corometrics 120 Series Monitor is used for non-invasive and invasive monitoring of the fetus during the antepartum period as well as throughout labor and delivery (i.e. fetal heart rate and uterine activity monitoring). Fetal movement detection and fetal heart rate alarm options (user selectable high/low and poor signal quality alarms or Spectra alerts) are available.
II. Maternal Monitoring
A Corometrics 120 Series Monitor is intended for monitoring maternal vital signs to help assess maternal well-being. The vital signs which can be measured with these monitor configurations are summarized below.
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 maternal blood pressure (NBP). This monitor is not intended for use in neonatal or pediatric blood pressure monitoring.
Pulse Oximetry. The monitor is intended for use in the non-invasive monitoring of maternal functional oxygen saturation of arterial hemoglobin (MSpO2).
Heart/Pulse Rate. The monitor is intended for use in the non-invasive monitoring of the maternal heart/pulse rate. Additionally, a MECG waveform "snapshot" may be displayed and printed.
NOTE: Only the maximum configuration provides both maternal heart rate and pulse rate data.
- To be assigned by FDA upon receipt of 510(k) submission.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence if CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.19)
OR
Over the Counter Use
Optional Format 1-2-96
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991739
018
§ 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).