(89 days)
k9232077, K991905
Not Found
No
The document describes a standard fetal monitor with basic signal processing and data recording capabilities. There is no mention of AI, ML, or advanced analytical techniques beyond standard vital sign monitoring.
No
The device is a monitor used for surveillance and recording of fetal and maternal vital signs, not for administering therapy.
Yes
The description explicitly states its use for "monitoring of the fetus throughout labor and delivery" and "monitoring fetal and maternal vital signs," which are diagnostic activities. It gathers data (fetal heart rate, fetal ECG, uterine activity, NBP) to assess the physiological state of the patient.
No
The device description explicitly mentions hardware components like US Transducers, Spiral Electrodes, TOCO Transducers, and an interface for external NBP monitors. It is a physical medical device with integrated software.
Based on the provided information, the Corometrics® Model 173 Series Monitor 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 Corometrics® Model 173 Series Monitor monitors physiological parameters directly from the patient (fetus and mother) using external transducers and electrodes. It measures fetal heart rate, fetal ECG, uterine activity, and interfaces with a maternal NBP monitor.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. Its function is to acquire and display real-time physiological signals.
Therefore, the device falls under the category of a medical device used for monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Model 173 Series Fetal Monitor is intended for monitoring fetal and maternal vital signs: fetal heart rate, fetal ECG, maternal uterine activity, optional fetal movement detection, and an interface for select maternal NIBP monitors. The device is intended for use in a hospital/clinical environment.
I. Fetal Surveillance
The Corometrics® Model 173 Series Monitor is used for monitoring of the fetus throughout labor and delivery (i.e. fetal heart rate via US Transducer, fetal ECG via Spiral Electrode and uterine activity monitoring via TOCO Transducer or IUPC). The device also has an optional monitoring mode to detect fetal body movements.
II. Maternal NBP Recording
Blood Pressure. The monitor has an interface to select external NBP monitors. The Monitor does not process any NBP data but only prints the NBP data , from the external monitor, to its chart recorder.
Product codes
85 HGM
Device Description
The Model 173 Series Fetal Monitor is intended for monitoring fetal and maternal vital signs: fetal heart rate, fetal ECG, maternal uterine activity, optional fetal movement detection, and an interface for select maternal NIBP monitors. The device is intended for use in a hospital/clinical environment.
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
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Model 173 Series Fetal Monitor has been extensively tested to meet its requirements and design.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
k9232077, K991905
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
2 2000 FEB
K993751 Page 1 of 2
510(k) SUMMARY: Corometrics® Model 173 Fetal Monitor 8.0
Prepared: 11/4/99
[807.92(a)1] Contact Information
Richard Cehovsky Regulatory Affairs Manager
GE Marquette Medical Systems, Inc. Address: 61 Barnes Park Road North Wallingford, CT 06492
Phone: 203-949-8320 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 Corometrics Model 173 Series Fetal Monitor. Common names include: Model 173 Series, Model 173 FM.
As with the predicate Corometrics Model 151 Fetal Monitor and the Models 171/172 Fetal Monitors, the Model 173 Series Fetal Monitor is a Class II device.
[807.92(a)3] Identification of Legally Marketed Equivalent Devices (Predicate Systems).
| Predicate System | Manufacturer | K Number |
|---|---|---|
| Corometrics Model 151 | ||
| Fetal Monitor | GE Marquette Medical Systems, Inc. | |
| 61 Barnes Park Road North | k9232077, clearance | |
| date: 3/31/94 | ||
| Corometrics Models 171 | ||
| & 172 Fetal Monitors | GE Marquette Medical Systems, Inc. | |
| 61 Barnes Park Road North | K991905, clearance | |
| date: 9/1/99 |
[807.92(a)4 & 807.92(a)5] Device Description & Intended Use
The Model 173 Series Fetal Monitor is intended for monitoring fetal and maternal vital signs: fetal heart rate, fetal ECG, maternal uterine activity, optional fetal movement detection, and an interface for select maternal NIBP monitors. The device is intended for use in a hospital/clinical environment.
1
| Monitoring Mode | Model 151 | Model
171/172 | Model 173 |
|------------------------------------------------------|------------|------------------|------------|
| Fetal Heart Rate Monitoring
via US transducer | Yes | Yes | Yes |
| Fetal ECG via Spiral Electrode | Yes | NO | Yes |
| Uterine Activity Monitoring
Via TOCO:
Via IUP: | Yes
Yes | Yes
NO | Yes
Yes |
| FMD detection upgrade kit
(Option) | No | Yes | Yes |
| Hi/Low Fetal Heart Rate
Notification | No | Yes | Yes |
[807.92(a)6] Predicate Device Comparison of Technological Characteristics
[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 Model 173 Series Fetal Monitor has been extensively tested to meet its requirements and design.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 2000 FEB
Mr. Richard Cehovsky Regulatory Affairs Manager GE Marquette Medical Systems A GE Medical Systems Company 61 Barnes Park Road North P.O. Box 333 Wallingford. CT 06492-0333
Re: K993751
Corometrics Model 173 Fetal Monitor Dated: November 4, 1999 Received: November 5, 1999 Requiatory Class: II 21 CFR §884.2740/Procode: 85 HGM
Dear Mr. Cehovsky:
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 verfir 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 device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in. vitro diagnostic devices), please 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 regulation 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
Image /page/2/Picture/15 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three lines representing the head, body, and legs. The figure is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the logo.
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Model 173 Series Fetal Monitor
Indications for Use:
I. Fetal Surveillance
The Corometrics® Model 173 Series Monitor is used for monitoring of the fetus throughout labor and delivery (i.e. fetal heart rate via US Transducer, fetal ECG via Spiral Electrode and uterine activity monitoring via TOCO Transducer or IUPC). The device also has an optional monitoring mode to detect fetal body movements.
II. Maternal NBP Recording
Blood Pressure. The monitor has an interface to select external NBP monitors. The Monitor does not process any NBP data but only prints the NBP data , from the external monitor, to its chart recorder.
- 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
David A. Severson
Division Sign-Off
0027
Optional Format 1-2-96