(89 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard vital sign monitoring without mentioning any advanced processing or learning capabilities.
No
The device is used for monitoring fetal and maternal vital signs, not for treating any condition.
Yes
The device monitors fetal heart rate, uterine activity, and fetal body movements, which are all diagnostic indicators of fetal well-being. It also records maternal NBP data, further contributing to diagnosis.
No
The device description explicitly states it is a "Model 171/172 Series Fetal Monitor," which is a hardware device with interfaces for external monitors and a chart recorder. It is not described as software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device monitors physiological signals directly from the patient (fetal heart rate, uterine activity, fetal movement, maternal blood pressure). It is a physiological monitoring device, not a device that analyzes biological samples.
The intended use and device description clearly indicate that it is used for monitoring the fetus and mother during pregnancy and labor by measuring vital signs directly from the body.
N/A
Intended Use / Indications for Use
The Model 171/172 Series Fetal Monitor is intended for monitoring fetal and maternal vital signs: fetal heart rate and maternal uterine activity, 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 171/172 Series Monitors are used for monitoring of the fetus during the antepartum period as well as throughout labor and delivery (i.e. fetal heart rate and uterine activity monitoring). 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 171/172 Series Fetal Monitor is intended for monitoring fetal and maternal vital signs: fetal heart rate and maternal uterine activity, 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 171/172 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)
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
SEP | 1 1999
510(k) SUMMARY: Corometrics® Model 171/172 Fetal Monitor 9.0
Prepared: June 3, 1999
[807.92(a)1] Contact Information
Richard Cehovsky Regulatory Affairs Manager
Address: GE Marquette Medical Systems, Inc. 61 Barnes Park Road North Wallingford, CT 06492
Phone: 203-949-8320 Fax: 203-284-9465
[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 171/172 Series Fetal Monitor. Common names include: Model 170 Series, Model 171/172 FM.
As with the predicate Corometrics Model 150 Fetal Monitor and the Corometrics Spectra 400 Extended Surveillance and Alert Systems, the Model 171/172 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 150 | ||
| Fetal Monitor | GE Marquette Medical Systems, Inc. | |
| 61 Barnes Park Road North | K920376, clearance | |
| date: 4/27/92 | ||
| Corometrics Spectra 400 | ||
| Extended Surveillance | ||
| and Alert Systems | GE Marquette Medical Systems, Inc. | |
| 61 Barnes Park Road North | K852608, clearance | |
| date: 9/29/85 |
1807.92(a)4 & 807.92(a)5] Device Description & Intended Use
The Model 171/172 Series Fetal Monitor is intended for monitoring fetal and maternal vital signs: fetal heart rate and maternal uterine activity, fetal movement detection, and an interface for select maternal NIBP monitors. The device is intended for use in a hospital/clinical environment.
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K991905 page zofz
[807.92(a)6] Predicate Device Comparison of Technological Characteristics
| Monitoring Mode | Model 150 | Spectra 400 | Model
171/172 |
|-----------------------------------------|-----------|--------------------|------------------|
| Fetal Heart Rate
Monitoring | Yes | Yes | Yes |
| Uterine Activity
Monitoring | Yes | Yes | Yes |
| FMD detection upgrade kit
(Option) | Yes | Can Display
FMD | Yes |
| Hi/Low Fetal Heart Rate
Notification | No | Yes | 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 Model 171/172 Series Fetal Monitor has been extensively tested to meet its requirements and design.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1999
Mr. Richard Cehovsky Requlatory Affairs Manager GE Marquette Medical Systems, Inc. 61 Barnes Park Road North Wallingford, CT 06492
Re: K991905 Corometrics Model 171 and 172 Fetal Monitor Dated: June 3, 1999 Received: June 4, 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, 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 device on our 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 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
3
510(k) Number (if known):
Device Name: Model 171/172 Series Fetal Monitor
Indications for Use:
I. Fetal Surveillance
The Corometrics® Model 171/172 Series Monitors are used for monitoring of the fetus during the antepartum period as well as throughout labor and delivery (i.e. fetal heart rate and uterine activity monitoring). 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. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices an1905 510(k) Number
Optional Format 1-2-96
24