(30 days)
-
- Fetal Surveillance
A Corometrics 120 Maternal/Fetal Monitoring System 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) are available.
- Fetal Surveillance
ll Maternal Monitoring
A Corometrics 120 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 120 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 tocotransducer
- fetal movement detection
- maternal non-invasive blood pressure (clinician prompted or automatic)
- maternal pulse oximetry
- maternal heart/pulse rate (MECG) and ECG waveform "snapshot"
The provided text is a 510(k) Summary of Safety and Effectiveness for the Corometrics Model 120 Maternal/Fetal Monitor. It details the device, its intended use, and states that it employs the same fundamental scientific technology as predicate devices. However, it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria.
The "Test Summary" section lists general quality assurance measures applied to the development, such as:
- Requirements specification review
- Code inspections
- Software and hardware testing
- Safety testing
- Environmental testing
- Final validation
The "Conclusion" states that "The results of these measurements demonstrated that the Model 120 Maternal/Fetal Monitor (with Masimo SET Pulse Oximetry) is as safe, as effective, and performs as well as the predicate device."
Without further documentation, it is not possible to complete the requested table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies. The 510(k) summary typically references a more detailed technical file that would contain this information.
Therefore, based solely on the provided text, I cannot describe the acceptance criteria or a detailed study that proves the device meets specific performance metrics.
However, I can extract the information that is present:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Explicitly stated) | Reported Device Performance (Explicitly stated) |
|---|---|
| Not explicitly stated in terms of metrics | The device "is as safe, as effective, and performs as well as the predicate device" (K991739 Corometrics Model 120 Maternal/Fetal Monitor and K992238 Masimo SET® Radical Pulse Oximeter and LNOP® series of sensors and cables). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "Software and hardware testing," "Safety testing," "Environmental testing," and "Final validation" but does not detail the datasets used for these tests.
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 specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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:
- This device is a physical monitor, not an AI diagnostic tool. Therefore, an MRMC study related to human readers improving with AI assistance is not applicable. The comparison is against predicate devices, not human performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is a physical monitor, not a standalone algorithm. Performance demonstrated was likely the integrated system's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified. For a maternal/fetal monitor, ground truth would typically refer to the accuracy of physiological measurements (e.g., actual fetal heart rate, uterine pressure, maternal SpO2 measured by a gold standard), but the document does not detail this.
8. The sample size for the training set:
- Not applicable as this is not an AI/machine learning device that requires a training set in the conventional sense. The "development" process included reviews and various forms of testing.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/machine learning device.
{0}------------------------------------------------
AUG 2 1 2003
K032252
Page 1 of 1
510(k) Summary of Safety and Effectiveness
| Date: | July 21, 2003 |
|---|---|
| Submitter: | GE Medical Systems Information Technologies4502 Woodland Corporate BoulevardTampa, FL 33614 USA |
| Contact Person: | Melissa RobinsonRegulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: 813-887-2133Fax: 813-887-2545 |
| Device: | |
| Trade Name: | Corometrics Model 120 Maternal/Fetal Monitor |
| Common/Usual Name: | Maternal/Fetal Monitor |
| Classification Names: | 21 CFR 884.2740 System, Monitoring, Perinatal |
| Predicate Devices: | K991739 Corometrics Model 120 Maternal/Fetal Monitor |
| K992238 Masimo SET® Radical Pulse Oximeter and LNOP® series ofsensors and cables | |
| Device Description: | The 120 Maternal/Fetal Monitoring System consists of the followingfeatures/options that can be available in multiple configurations: |
| fetal heart rate (via Doppler Ultrasound of FECG)maternal uterine activity (via intrauterine pressure catheter or tocotransducerfetal movement detectionmaternal non-invasive blood pressure (clinician prompted or automatic)maternal pulse oximetrymaternal heart/pulse rate (MECG) and ECG waveform "snapshot" | |
| Intended Use: | The 120 Maternal/Fetal Monitoring System is intended for monitoringfetal and maternal vital signs: fetal heart rate; optional fetal movementdetection, FHR and UA alarms; maternal uterine activity; heart/pulserate, blood pressure and %SpO2. |
| Technology: | The Corometrics Model 120 Maternal/Fetal Monitor employs the samefundamental scientific technology as the predicate devices. |
| Test Summary: | The Model 120 Maternal/Fetal Monitor complies with the voluntarystandards as detailed in Section 9 of this submission. The followingquality assurance measures were applied to the development of theModel 120: Requirements specification reviewCode inspectionsSoftware and hardware testingSafety testingEnvironmental testingFinal validation |
| Conclusion: | The results of these measurements demonstrated that the Model 120Maternal/Fetal Monitor (with Masimo SET Pulse Oximetry) is as safe,as effective, and performs as well as the predicate device. |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them, resembling a bird in flight. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2003
Ms. Melissa Robinson Regulatory Affairs Specialist GE Medical Systems Information Technologies 4502 Woodland Corporate Blvd. TAMPA FL 33614
Re: K032252
Trade/Device Name: Corometrics Model 120 Maternal/Fetal Monitor Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system with accessories
Regulatory Class: II Product Code: 85 HGM Dated: July 21, 2003 Received: July 22, 2003
Dear Ms. Robinson:
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 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.
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.
{2}------------------------------------------------
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer 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 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
{3}------------------------------------------------
16032252 510(k) Number (if known):
Corometrics Model 120 Maternal/Fetal Monitoring System Device Name:
Indications For Use:
-
- Fetal Surveillance
A Corometrics 120 Maternal/Fetal Monitoring System 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) are available.
- Fetal Surveillance
ll Maternal Monitoring
A Corometrics 120 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
A. Leymm
(Division Sign-O Division of Reproductive, Abdomina (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).