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Avalon Fetal Monitor FM20:
Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, non-invasive blood pressure, pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas and in private households.

Avalon Fetal Monitor FM30:
Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas and in private households.

The Philips Avalon Fetal Monitors FM20 and FM30 are intended for noninvasive monitoring of parameters of pregnant women during antepartum testing and labor and delivery. The FM30 is additionally intended for invasive monitoring. All monitors are intended for monitoring fetal and maternal heart rates, uterine activity, maternal noninvasive blood pressure, and additionally for the FM30, oxygen saturation (SpO2). All monitors are intended for generating alarms for displaying, storing and recording patient data and related waves, transmitting patient data to a patient information and surveillance system on a network, and for postpartum monitoring of the mother.

The provided 510(k) summary (K071800) for the Philips Avalon Fetal Monitors FM20 and FM30 does not contain information related to specific acceptance criteria or details of a study proving device performance against such criteria.

This 510(k) is a premarket notification for a modification to an already cleared device: the Philips Avalon Fetal Monitors FM20 and FM30 (cleared under K052795 and K062137). The modification only introduces the capability for healthcare professionals to monitor pregnant women in private households.

Therefore, the submission relies on the substantial equivalence to the previously cleared devices and does not present new performance study data. The document focuses on regulatory classification, intended use, and substantial equivalence, rather than detailed performance metrics.

Based on the provided text, I cannot complete the requested information for the acceptance criteria and the study that proves the device meets them. The pertinent sections of the request that cannot be addressed due to the lack of information in the document are:

1. A table of acceptance criteria and the reported device performance: Not available.
2. Sample sized used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
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/Available. (The device is not AI-assisted).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/Available. (The device does not involve a standalone algorithm for diagnostic performance).
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

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