(56 days)
I. Fetal Surveillance
A Corometrics 250 Series Maternal/Fetal Monitoring System is used for noninvasive 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) are available.
II. Maternal Monitoring
A Corometrics 250 Series Maternal/Fetal Monitoring System 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 as follows:
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 the 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, an MECG waveform 'snapshot'' may be displayed and printed.
NOTE: Only the maximum configuration provides both maternal heart rate and pulse rate data.
The Corometrics 250cx Series Maternal/Fetal Monitoring System consists of the following features/options that can be available in multiple configurations:
- . fetal heart rate (via Doppler Ultrasound of FECG)
- . maternal uterine activity (via intrauterine pressure catheter or TOCO transducer
- . fetal movement detection
- . maternal non-invasive blood pressure (clinician prompted or automatic)
- . maternal pulse oximetry
- . maternal heart/pulse rate (MECG) and ECG waveform "snapshot"
- . maternal temperature
The provided document is a 510(k) summary for the Corometrics 250cx Series Maternal/Fetal Monitor. This submission is for a design modification of an existing device (Model 250 Series Maternal/Fetal Monitor, K050583) and focuses on changes like the addition of color to the display, an external display, a new serial protocol, an external maternal temperature probe, and additional languages.
The document does not contain acceptance criteria or a study demonstrating that the modified device meets specific performance criteria related to clinical diagnostic accuracy or effectiveness. Instead, it refers to:
- Compliance with voluntary standards: "The Corometrics 250 Series Maternal/Fetal Monitor complies with the voluntary standards as detailed in Tab F of this submission." (Tab F is not provided).
- Verification and validation testing: "The addition of the probe [maternal temperature probe] was included in the verification and validation testing for the modified device."
These statements indicate that the testing performed was primarily for device functionality, safety, and adherence to established industry standards, rather than a clinical study establishing diagnostic performance metrics (like sensitivity, specificity, accuracy) against a ground truth.
Therefore, I cannot populate the requested table or answer most of the questions as the information is not present in the provided text.
Here's a breakdown of what can and cannot be answered based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states compliance with "voluntary standards" and "verification and validation testing" but does not detail specific acceptance criteria or the numerical performance results of a clinical study for diagnostic accuracy.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. There is no mention of a clinical test set size, data provenance, or study design (retrospective/prospective).
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)
- Cannot be provided. Ground truth establishment is not discussed as no clinical study is detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No clinical study, hence no adjudication method.
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
- Cannot be provided. This device is a maternal/fetal monitor, not an AI-assisted diagnostic tool for human readers. No MRMC study or AI assistance is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This refers to algorithm performance; the device is a monitor, not a standalone algorithm in the typical sense of AI-driven diagnostics. The functionality tested was related to hardware and software modifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No clinical ground truth is mentioned in the context of diagnostic performance.
8. The sample size for the training set
- N/A. This device is a monitor and not an AI/machine learning model that typically has a "training set." The development process involved "Risk Analysis," "Requirements specification review," "Design reviews," "Code inspections," "Software and hardware performance testing," "Safety testing," "Environmental testing," and "Final validation" – which are standard engineering/software development practices.
9. How the ground truth for the training set was established
- N/A. See point 8.
In summary, the provided 510(k) document pertains to a design modification of a medical device (maternal/fetal monitor) and focuses on demonstrating that the modified device remains substantially equivalent to its predicate device by confirming functionality, safety, and adherence to standards. It does not include a clinical study establishing diagnostic accuracy metrics against a ground truth in the way one would for a new AI-driven diagnostic device.
{0}------------------------------------------------
510(k) Summary
Submitter Information and Date Prepared
Agata Smieja GE Healthcare 8880 Gorman Road Laurel, MD 20723 USA
DEC 2 0 2007
Phone: 410 888 5218 Mobile: 410 456 0329
Date Prepared: October 19, 2006
Device Identification
MODEL 250 SERIES MATERNAL/FETAL MONITOR Proprietary Name: Classification Names: 21 CFR 884.2740 System, Monitoring, Perinatal
Predicate Device Information
| Predicate Device | 510(k) Number |
|---|---|
| MODEL 250 SERIES MATERNAL/FETAL MONITOR | K050583 |
Intended Use Statement
I. Fetal Surveillance
A Corometrics 250 Series Maternal/Fetal Monitoring System is used for noninvasive 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) are available.
{1}------------------------------------------------
K072976 page 2 of 3
II. Maternal Monitoring
A Corometrics 250 Series Maternal/Fetal Monitoring System 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 as follows:
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 the 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, an MECG waveform 'snapshot'' may be displayed and printed.
NOTE: Only the maximum configuration provides both maternal heart rate and pulse rate data.
Device Description
Device Description: The Corometrics 250cx Series Maternal/Fetal Monitorina System consists of the following features/options that can be available in multiple configurations:
- . fetal heart rate (via Doppler Ultrasound of FECG)
- . maternal uterine activity (via intrauterine pressure catheter or TOCO transducer
- . fetal movement detection
- . maternal non-invasive blood pressure (clinician prompted or automatic)
- . maternal pulse oximetry
- . maternal heart/pulse rate (MECG) and ECG waveform "snapshot"
- . maternal temperature
{2}------------------------------------------------
Technological Characteristics
The Corometrics 250cx Series Maternal/Fetal Monitor employs the same fundamental scientific technology as the predicate device.
Testing
The subject of this special 510(k) Notification is the design modification of the Model 250 Series Maternal/Fetal Monitor for the addition of color to the primary display, addition of an external display that mimics the primary display, addition of a new serial protocol for central station communications, addition of an external maternal temperature probe, and additional languages in the display.
The maternal temperature probe has been cleared for marketing under the premarket notification K011291. The addition of the probe was included in the verification and validation testing for the modified device.
The Corometrics 250 Series Maternal/Fetal Monitor complies with the voluntary standards as detailed in Tab F of this submission. The following quality assurance measures were applied to the development:
- . Risk Analysis
- Requirements specification review ●
- Design reviews .
- Code inspections ●
- Software and hardware performance testing .
- Safety testing .
- Environmental testing
- Final validation
| Prepared by: | AGATA SNIEGA |
|---|---|
| Date | 10/19/07 |
B-003
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 20 2007
Ms. Agata Smieja Global Compliance Leader GE Healthcare 8880 Gorman RD LAUREL MD 20723
Re: K072976
Trade/Device Name: Corometrics 250cx Series Monitor Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: December 6, 2007 Received: December 7, 2007
Dear Ms. Smieja:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{4}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
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
{5}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: MODEL 250cx SERIES MATERNAL/FETAL MONITOR
Indications for Use:
I. Fetal Surveillance
A Corometrics 250 Series Maternal/Fetal Monitoring System is used for noninvasive 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) are available.
II. Maternal Monitoring
A Corometrics 250 Series Moternal/Fetal Monitoring System 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 as follows:
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 the neonatal or pediatric blood pressure monitoring.
{6}------------------------------------------------
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, an MECG woveform 'snapshot" may be displayed and printed.
NOTE: Only the maximum configuration provides both maternal heart rate and pulse rate data.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helen Seeman
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
A=003
§ 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).