(106 days)
The Corometrics 250 Series Maternal/Fetal Monitoring System is intended for monitoring fetal and maternal vital signs: fetal heart rate; optional fetal movement detection, FHR and UA alarms; maternal uterine activity; heart/pulse rate, blood pressure and %SpO2.
Fetal Surveillance: A Corometrics 250 Series Maternal/Fetal Monitoring System is used for non-invasive and invasive monitoring of the fetus during the antepartum as well as throughout labor and delivery (i.e. fetal heart rate and uterine activity and movement detection and poor signal quality alarms) are available.
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 available in various configurations are summarized as follows: Blood Pressure: The monitor is intended for use in the non-invasive monitoring of blood pressure. It 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 arterial hemoglobin (MSpO2). Heart/Pulse Rate: The monitor is intended for use in the non-invasive monitoring of heart/pulse rate. Optionally, an MECG waveform "snapshot" may be displayed and printed.
The Corometrics 250 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 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 for the Corometrics 250 Series Maternal/Fetal Monitor. It describes the device, its intended use, and states that it complies with voluntary standards and the predicate device. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information such as sample sizes, ground truth establishment, or expert qualifications.
The document indicates that the device was deemed "substantially equivalent" to predicate devices, implying that its performance is considered comparable. The "Test Summary" simply lists development and testing activities (requirements review, code inspections, software/hardware testing, safety testing, environmental testing, final validation) and concludes that "The results of these measurements demonstrated that the Corometrics...Monitor is as safe and effective, and as the predicate device."
Therefore, based solely on the provided text, the following information cannot be extracted:
- A table of acceptance criteria and the reported device performance: This information is not present. The document only states that the device "complies with the Test Summary...as detailed in Section 9 of this submission" and that "The results of these measurements demonstrated that the Corometrics...Monitor is as safe and effective, and as the predicate device." No specific performance metrics or acceptance criteria are listed.
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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 mentioned. This device is a maternal/fetal monitor, not an AI-assisted diagnostic imaging device, so an MRMC study with human readers assisting AI is unlikely to be relevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
In summary, the provided document does not contain the detailed performance study information requested. It is a regulatory submission summary primarily focused on substantial equivalence to predicate devices and general software/hardware development practices rather than detailed clinical performance metrics and their validation studies.
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JUN 2 1 2005
| 510(k) Summary of Safety and Effectiveness |
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| Date: | March 4, 2005 |
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| Submitter: | GE Medical Systems Information Technologies4502 Woodland Corporate BoulevardTampa, FL 33614 USA |
| Contact Person: | Tyler SedoneSenior Regulatory Affairs SpecialistPhone: 813-887-2133Fax: 813-887-2545 |
| Device:Trade Name: | Corometrics Model 250 Series Maternal/Fetal Monitor |
| Common/Usual Name: | Maternal/Fetal Monitor |
| Classification Names: | 21 CFR 884.2740 System, Monitoring, Perinatal |
| Predicate Devices: | K032252 Corometrics Model 120is Maternal/Fetal MonitorK022834 DINAMAP PRO 1000 with SuperSTATK040831 Datex Ohmeda SpO2K012891/K021089/K030930 Nellcor SpO2K033296 Masimo SpO2 |
| Device Description: | The Corometrics 250 Series Maternal/Fetal Monitoring System consistsof the following features/options that can be available in multipleconfigurations:• fetal heart rate (via Doppler Ultrasound of FECG)• maternal uterine activity (via intrauterine pressure catheter ortocotransducer)• fetal movement detection• maternal non-invasive blood pressure (clinician prompted or automatic)• maternal pulse oximetry• maternal heart/pulse rate (MECG) and ECG waveform "snapshot" |
| Intended Use: | The Corometrics 250 Series Maternal/Fetal Monitoring System isintended for monitoring fetal and maternal vital signs: fetal heart rate;optional fetal movement detection, FHR and UA alarms; maternaluterine activity; heart/pulse rate, blood pressure and %SpO2. |
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The Corometrics 250 Series Maternal/Fetal Monitor complies with the Test Summary: The Ocromethoo 200as detailed in Section 9 of this submission. The . voluntary clariaards ace measures were applied to the development:
- Requirements specification review .
- Code inspections .
- Software and hardware testing .
- Safety testing .
- Environmental testing .
- . Final validation
The results of these measurements demonstrated that the Corometrics Conclusion: The results of these moul Monitor is as safe and effective, and as the predicate device.
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Image /page/2/Picture/2 description: The image shows a logo with a stylized bird figure and some text. The bird figure is composed of three curved lines that suggest the shape of a bird in flight. The text is arranged in a circular fashion around the bird figure, but it is not fully legible. The logo appears to be a simple, black-and-white design.
Food and Drug Administration 9200 Corporate Boulevard Rockville -MD 20050
JUN 2 1 2005
Mr. Tyler Sedone Senior Regulatory Affairs Specialist GE Medical Systems Information Technologies 4502 Woodland Corporate Boulevard TAMPA FL 33614
Re: K050583 K050583
Trade/Device Name: Corometrics 250 Series Maternal/Fetal Monitoring System Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM
Dated: June 2, 2005 Received: June 13, 2005
Dear Mr. Sedone:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced We have revewed your Section Fronty promotially equivalent (for the indications for use stated in above and have deceminated the do nedicate devices marketed in interstate commerce prior to the enclosure) to regary marketed prodisato device Amendments, or to devices that have been May 28, 1970, the clacultion add of the Frederal Food, Drug, and Cosmetic Act (Act) that reclassified in accordation with the pro nevel application (PMA). You may, therefore, market the do not require approval of a premiations of the Act. The general controls provisions of the Act device, subject to the general concolo prove, 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 If your device is classified (see above) miso and controls. Existing major regulations affecting your Approval), it may of subject to securations, Title 21, Parts 800 to 898. In addition, FDA device can be found in the Code of s concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised ular I DA 3 Issuallo of a successions lies with other requirements of the Act of any FDA nas made a decimination mac your as treat agencies. You must comply with all the Federal Statues and regulations administer to registration and listing (21 CFR Part 807); labeling Act S requirements, including, but not mixted to regurements as set forth in the quality systems (QS) (ZT CFR Part 801), good mandacturing practic responses
regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k)
I have a marketing a financies and continential aggivalence of your device to a This letter will allow you to begin marketing your artise of your device of your device of your device to a legally
premarket notification. The FDA inn in iS on fer vour dev premarket notification. The FDA finding of substantial equivalence of 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 If you desire specific advice for your device on our laveling regulation (1) - 100 - 100 - 100 - 100 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" (21 CFR Also, please note the regulation entitled, "Misoranion on your responsibilities under the Act from the 807.97). You may obtain other general inionnal on your respections of its toll-free number (800) DIVIsion of Bill) 443-6597 or at its Internet address 056-2047 or (2019/01/2019/01/industry/support/index.html.
Sincerely yours,
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
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K 0505 93
510(k) Number (if known):
Corometrics Model 250 Series Maternal/Fetal Monitoring System
Device Name: Indications For Use:
Fetal Surveillance 1.
A Corometrics 250 Series Maternal/Fetal Monitoring System is used for non-invasive and A Corometrics 250 Series Maternair-etail Montoning Cyclome as well as throughout labor
invasive monitoring of the fetus during the anteparting . Fetal movement invasive monitoring of the fetus during the antipanse as many of the movement
and delivery (i.e. fetal heart rate a nd uterine activity and novement and delivery (1.6. fetal heart rate and uterine detrice detrice and poor signal quality alarms) are available.
Maternal Monitoring ll
A Corometrics 250 Series Maternal/Fetal Monitoring System is intended for A Corometrics 250 Senes Maternal Claimonton of well-being. The vital signs
monitoring maternal vital signs to help assess maternal well-being. The vital signs monitoring matemal vital signs to holp accoconfigurations are summarized as follows:
NOTE: Maternal vital signs provided by the monitor should only be used as an
Blood Pressure: The monitor is intended for use in the non-invasive monitoring of Blood Pressure. The monitor is intended for use in the Road for use in the neonatal or pediatric blood pressure monitoring.
Pulse Oximetry. The monitor is intended for use in the non-invasive monitoring of Pulse Oximetry. The monitor its inchiles interial hemoglobin (MSpO2).
Heart/Pulse Rate. The monitor is intended for use in the non-invasive monitoring of HeartPulse Kate. The monitor is intentably, an MECG waveform "snapshot" may be displayed and printed.
NOTE: Only the maximum configuration provides both maternal heart rate and pulse rate data.
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
(Division Sign-Off) ( Division of Reproductive, Abo and Radiological Devices 510(k) Number _
§ 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).