(165 days)
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.
Avalon Fetal Monitor FM40: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, 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 and in antepartum testing areas,
Avalon Fetal Monitor FM50: 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 and in antepartum testing areas.
The Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50 offer monitoring of fetal and maternal heart rates, uterine activity, maternal ECG, maternal non-invasive blood pressure (NIBP) and oxygen saturation (Sp02) with pulse rate, during antepartum testing and labor and delivery.
The Avalon Fetal/Maternal Monitor FM20 provides the following external measurement parameters:
- Up to three Fetal Heart Rates (FHR) via ultrasound (US)
- Fetal Movement Profile
- Uterine activity via external Toco
- Maternal Pulse Rate
- Maternal Heart Rate (MHR) via maternal ECG
- Non-invasive blood pressure (NIBP)
The Avalon FM30 shares all the features and capabilities of the Avalon FM20. In addition, the Avalon FM30 provides the following external and internal measurement parameters:
- Single Fetal Heart Rate via direct ECG (DECG)
- Twin Fetal Heart Rates via direct ECG (DECG) and/or ultrasound
- Uterine activity via intrauterine pressure (IUP)
- Maternal ECG (MECG)
- Pulse oximetry (maternal Sp02).
*) Note: maximum three FHR's can be monitored.
The Avalon Fetal/Maternal Monitor FM40 provides the following external measurement parameters:
- Up to three Fetal Heart Rates (FHR) via ultrasound (US)
- Fetal Movement Profile
- Uterine activity via external Toco
- Maternal Pulse Rate
- Maternal Heart Rate (MHR) via maternal ECG
- Non-invasive blood pressure (NIBP).
- Pulse oximetry (maternal Sp02).
The Avalon FM50 shares all the features and capabilities of the Avalon FM40. In addition, the Avalon FM50 provides the following external and internal measurement parameters:
- Single Fetal Heart Rate via direct ECG *) (DECG)
- Twin Fetal Heart Rates , via direct ECG (DECG) and/or ultrasound "
- Uterine activity via intrauterine pressure , (IUP)
- Maternal ECG (MECG) ,
" Note: maximum three FHR's can be monitored.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary (K102958) does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics in a readily extractable table format.
Instead, it refers to the existing specifications cleared for the predicate devices as the basis for Pass/Fail criteria. The study concluded that the modified algorithm met these unstated criteria.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance (Explicitly Stated) |
|---|---|
| "Pass/Fail criteria were based on the specifications cleared for the predicate devices" (K071800 and K092028). | "test results showed substantial equivalence." |
| "The results demonstrate that the Philips Avalon Fetal Monitors meet all reliability requirements and performance claims." | The improved ultrasound performance algorithm addressed "problems with halving and doubling of the fetal heart rate and mistaken display of maternal heart rate for fetal heart rate." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Some tests included the use of previously recorded patient traces," but doesn't quantify the number of traces or patients.
- Data Provenance: Not explicitly stated. The term "previously recorded patient traces" suggests retrospective data, but the country of origin is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not mentioned. It's unclear how ground truth was established from the "previously recorded patient traces" or if any adjudication was performed for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, there is no mention of a multi-reader, multi-case comparative effectiveness study involving human readers with and without AI assistance.
- Effect Size: Not applicable, as no MRMC study was reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Yes, the document describes "system level and regression tests" and testing of "the improved ultrasound performance algorithm." This implies a standalone evaluation of the algorithm's performance in addressing the identified issues of heart rate inaccuracies (halving, doubling, maternal heart rate mistaken for fetal). The focus of the 510(k) is on the algorithm modification itself.
7. Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated. The document mentions using "previously recorded patient traces." For evaluating the accuracy of fetal heart rate detection and differentiation from maternal heart rate, an accurate reference (e.g., from a different, highly accurate monitoring method, or expert review of the original traces) would be required, but this is not detailed.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The document discusses an "improved ultrasound performance algorithm" which was a modification to existing devices. There is no mention of a "training set" in the context of machine learning or AI development in this summary. The algorithm improvement seems to be a programmatic enhancement rather than a machine learning model trained on data.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established for Training Set: Not applicable, as no training set for an AI/ML model is indicated. The improvements described are algorithm modifications to address specific known problems with heart rate detection.
§ 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).