(89 days)
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.
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.
The provided text does not contain specific information about the acceptance criteria or a detailed study proving the device meets these criteria in the way a modern AI/ML device submission would. Instead, it is a 510(k) summary for a Fetal Monitor, focusing on substantial equivalence to predicate devices and general regulatory information.
Therefore, many of the requested fields cannot be answered based on the provided text.
However, I can extract what is available and acknowledge what is missing:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or detailed performance metrics are provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices (Corometrics Model 151 and Models 171/172 Fetal Monitors). The device "has been extensively tested to meet its requirements and design," but these requirements and designs are not detailed, nor are the specific performance outcomes of these tests.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not mentioned in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as this is a hardware medical device submission rather than an AI/ML algorithm requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated in terms of a "ground truth" for an algorithm. The device's performance would be validated against established medical standards for fetal heart rate, uterine activity, and NBP monitoring, likely using reference instruments or clinical observation, but the details of this validation are not provided.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
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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 151Fetal Monitor | GE Marquette Medical Systems, Inc.61 Barnes Park Road North | k9232077, clearancedate: 3/31/94 |
| Corometrics Models 171& 172 Fetal Monitors | GE Marquette Medical Systems, Inc.61 Barnes Park Road North | K991905, clearancedate: 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.
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| Monitoring Mode | Model 151 | Model171/172 | Model 173 |
|---|---|---|---|
| Fetal Heart Rate Monitoringvia US transducer | Yes | Yes | Yes |
| Fetal ECG via Spiral Electrode | Yes | NO | Yes |
| Uterine Activity MonitoringVia TOCO:Via IUP: | YesYes | YesNO | YesYes |
| FMD detection upgrade kit(Option) | No | Yes | Yes |
| Hi/Low Fetal Heart RateNotification | 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.
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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
§ 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).