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The 2120is Maternal/Fetal Monitoring System is intended for monitoring fetal and maternal vital signs: fetal heart rate; fetal heart rate high/low/poor signal quality alarms; maternal uterine activity; heart/pulse rate, blood pressure, nondiagnostic maternal ECG and %SpO2. Optional fetal movement detection is available.

A Corometrics 2120is 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.

A Corometrics 2120is 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.

Bed-to-bed surveillance is available when 2120is Series Monitors are networked together.

The 2120is 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 2120is is a full-featured maternal/fetal monitor. The device is also capable of providing bed-to-bed surveillance when multiple 2120is monitors are connected via an Ethernet network. The monitor is also capable of acting as a bedside terminal to the QS system. In this capacity, the 2120is monitor provides the features of a standard PC QS bedside terminal.

The provided text describes the 510(k) summary for the Corometrics Model 2120is Maternal/Fetal Monitor. It outlines the device description, intended use, and indicates that the device's technology is the same as its predicate devices. However, the document does not include specific acceptance criteria or a detailed study proving the device meets those criteria in the way typically found for AI/ML-based medical devices.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through:

• Compliance with voluntary standards: This is a common approach for traditional medical devices.
• Internal validation processes: Requirements specification review, code inspections, software and hardware testing, safety testing, environmental testing, and final validation.

Therefore, the requested information cannot be fully provided as the submission does not contain details about:

• A table of acceptance criteria with reported performance metrics like sensitivity, specificity, or AUC.
• Sample sizes for test sets, data provenance, or expert ground truth establishment for performance evaluation.
• Adjudication methods, MRMC studies, or standalone algorithm performance.
• Training set details or ground truth establishment for a machine learning model.

This is consistent with the nature of a 510(k) submission for a non-AI/ML device where the focus is on demonstrating substantial equivalence to a legally marketed predicate through adherence to standards and robust internal development/testing processes, rather than a prospective clinical performance study with specific metrics.

Summary of what can be extracted/inferred:

• Compliance with voluntary standards.
• Successful completion of internal validation steps: Requirements specification review, Code inspections, Software and hardware testing, Safety testing, Environmental testing, Final validation.
  The reported performance is that the device "is as safe, as effective, and performs as well as the predicate device" (Corometrics Model 2120is Maternal/Fetal Monitor and Masimo SET® Pulse Oximetry). |
  | 2. Sample size for test set and data provenance | Not applicable/not provided. The submission focuses on device engineering, safety, and functional testing rather than a clinical performance study with a test set of patient data for an algorithm. |
  | 3. Number of experts and qualifications for ground truth (test set) | Not applicable/not provided. |
  | 4. Adjudication method (test set) | Not applicable/not provided. |
  | 5. MRMC comparative effectiveness study and effect size | No. This is not an AI/ML device, so such a study is not relevant or performed. |
  | 6. Standalone (algorithm only) performance study | No. This is a hardware monitor, not an algorithm. |
  | 7. Type of ground truth used | For the functional and safety testing, the "ground truth" would be established by engineering specifications, regulatory standards, and expected physiological responses, verified through direct measurement and comparison to known accurate instruments (e.g., during calibration and validation for SpO2 or NIBP). |
  | 8. Sample size for the training set | Not applicable/not provided. This is not an AI/ML device that requires a "training set" in the machine learning sense. |
  | 9. How the ground truth for the training set was established | Not applicable/not provided. |

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