Avalon Fetal/Maternal 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, oxygen saturation, 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, in private households and during transports in healthcare facilities.
Avalon Fetal/Maternal 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, in private households and during transports in healthcare facilities.
Avalon Fetal/Maternal 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/Maternal 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 legally marketed Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40, and FM50 offer monitoring of fetal and maternal heart rates, uterine activity, maternal ECG wave, maternal non-invasive blood pressure (NIBP) and oxygen saturation (SpO2) 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 via maternal ECG, Non-invasive blood pressure (NIBP), Pulse oximetry (maternal SpO2).
The Avalon Fetal/Maternal Monitor FM30 shares all the features and capabilities of the Avalon FM20. In addition, the Avalon FM30 provides the following external and internal measurement parameters: One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG), Uterine activity via intrauterine pressure (IUP), Maternal ECG (MECG) wave. Note: maximum three fetal heart rates 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 via maternal ECG, Non-invasive blood pressure (NIBP), Pulse oximetry (maternal SpO2).
The Avalon Fetal/Maternal Monitor FM50 shares all the features and capabilities of the Avalon FM40. In addition, the Avalon FM50 provides the following external and internal measurement parameters: One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG), Uterine activity via intrauterine pressure (IUP), Maternal ECG (MECG) wave. Note: maximum three fetal heart rates can be monitored.
Device Modifications: Operation of the models FM20 (M2702A) and FM30 (M2703A) with an internal rechargeable power source (optional) to support fetal/maternal monitoring during transport within healthcare facilities. Modification of the existing Toco transducer M2734A to include maternal pulse measurement, using plethysmography at an alternative body location (abdomen). The modified transducer is labeled M2734B 'Toco MP'. Automated antepartum fetal/maternal trace interpretation and printout the resulting non-stress test (NST) report. The new software G.02.xx, which is a modification of the software F.01.xx (cleared with K102958) to support the before listed modifications / additions. Additionally, the option to equip the Avalon Fetal/Maternal Monitors with maternal SpO2 measurement is enabled now also for the model FM20 (M2702A).
This submission describes the Philips Avalon Fetal/Maternal Monitor FM20/30, FM40/50, Release G.0. The primary focus of the provided text regarding new functionalities is on the M2734B 'Toco MP' transducer, which measures maternal pulse rate via plethysmography at the abdomen, and automated antepartum fetal/maternal trace interpretation and NST report generation.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format for the modified device functionalities. Instead, it states that "Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence." For the new Toco MP transducer, the performance is reported as meeting the requirements through comparison with ECG-derived maternal heart rate.
| Acceptance Criteria Category | Specific Criteria (from predicate specifications, inferred) | Reported Device Performance (for modified features) |
|---|---|---|
| M2734B Toco MP Transducer | Accuracy of maternal pulse rate measurement (over full range) | Maternal pulse rate obtained from Toco MP transducer was recorded, compared, and evaluated against ECG-derived maternal heart rate (MECG). Implied to be accurate and meet predicate specifications for heart rate monitoring. |
| Antepartum Trace Interpretation & NST Report | Comparative performance against OB TraceVue G.00 (K100420) | Comparative test performed against the implementation in OB TraceVue G.00. Implied to be equivalent or better. |
| Overall Safety & Effectiveness | As safe, as effective, and perform as well or better than predicate devices. No new questions concerning safety or effectiveness. | "Non-clinical and clinical verification and validation results demonstrate that the Avalon fetal/maternal monitors with software G.02.xx are as safe, as effective, and perform as well or better as the predicate devices with software F.01.xx. The modified devices do not introduce new questions concerning the safety or effectiveness and are, therefore, substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- M2734B Toco MP Transducer Clinical Study: The document states, "For the clinical validation of the M2734B 'Toco MP' transducer a clinical study has been performed. The patient population was covering a variety of body mass indices (BMI) and skin colors."
- Sample Size: The exact numerical sample size for this clinical study is not specified in the provided text.
- Data Provenance: The country of origin is not specified. The study is described as a "clinical study," implying it was prospective, gathering new data for the validation.
- Non-clinical Testing: "Some tests included the use of previously recorded patient raw signals and traces." This suggests some retrospective data was used in the non-clinical testing phase. The origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The document describes clinical studies and comparative tests but does not detail the process of establishing ground truth with expert involvement for the test set, nor the number or qualifications of such experts.
4. Adjudication Method for the Test Set
This information is not provided in the document. The text mentions "compared and evaluated" for the Toco MP transducer data, but no specific adjudication method (e.g., 2+1, 3+1, none) is described.
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
- No MRMC study was mentioned. The device involves "automated antepartum fetal/maternal trace interpretation and printout the resulting non-stress test (NST) report." This implies an algorithmic interpretation. While the NST report might assist human readers, no study comparing human readers with and without this AI assistance, or quantifying an effect size, is described. The comparison was for the algorithm's output against a predicate algorithm (OB TraceVue G.00).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance test for the antepartum trace interpretation algorithm was done. The document states: "Comparative test of antepartum fetal/maternal trace interpretation and NST report against the implementation in OB TraceVue G.00 (K100420)." This testing evaluates the algorithm's output independently by comparing it to an existing cleared algorithm, which is a form of standalone performance evaluation against a defined standard.
7. The Type of Ground Truth Used
- For the M2734B Toco MP Transducer: The ground truth for maternal pulse rate was "ECG derived maternal heart rate (MECG)." This is a well-established and highly accurate physiological measurement, serving as a reliable reference standard.
- For the Automated Antepartum Trace Interpretation/NST Report: The ground truth was the "implementation in OB TraceVue G.00 (K100420)." This means the new algorithm's output was compared to the output of a previously cleared, predicate software. This isn't a direct "pathology" or "outcomes data" ground truth, but rather a comparative standard against a known, accepted performance of another device.
8. The Sample Size for the Training Set
- The document does not specify a training set nor its sample size. The description of modifications primarily concerns new hardware (Toco MP transducer) and software features (NST report, internal power source). While the NST report would likely involve some form of algorithmic development, no details about its training data are provided.
9. How the Ground Truth for the Training Set Was Established
- As no training set is described, information on how its ground truth was established is not provided.
§ 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).