(258 days)
The Avalon CL Fetal & Maternal (F&M) Pod & Patch is a device indicated for use by healthcare professionals in a clinical setting for non-invasive monitoring of maternal heart rate (aHR), fetal heart rate (aFHR), and uterine activity (aToco) in women who are at >36 completed weeks, in labor, with singleton pregnancy, using surface electrodes on the maternal abdomen.
The Avalon CL Fetal & Maternal (F&M) Pod and the Avalon CL Fetal & Maternal (F&M) Patch is a beltless battery-powered maternal-fetal monitoring system that non-invasively measures abdominal fetal heart rate (aFHR), abdominal uterine activity (aToco), and abdominal maternal heart rate (aHR). The Avalon CL Fetal & Maternal (F&M) Patch is a single-use disposable adhesive electrode patch designed to be affixed to the maternal abdomen. The Avalon CL Fetal & Maternal (F&M) Pod is a reusable device which, when connected to the Avalon CL Fetal & Maternal (F&M) Patch, picks up electrical signals and converts it to Short Range Radio (SRR). The Avalon CL Fetal & Maternal Pod communicates the data measurement values to the Avalon CL Base Station using Short-Range Radio (SRR). The Avalon CL Base Station in turn relays the information to the connected Philips Fetal-Maternal (FM) Monitor (i.e., FM20, FM30, FM40, and FM50).
The provided FDA 510(k) summary for the Philips Avalon CL Fetal & Maternal (F&M) Pod & Patch focuses heavily on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical characteristics rather than a detailed clinical study report with specific acceptance criteria and performance metrics for the device's accuracy in monitoring FHR, MHR, and UA.
Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance (e.g., accuracy, sensitivity, specificity, agreement with ground truth for FHR, MHR, and UA) is not explicitly detailed in this document. The document primarily discusses non-clinical tests for safety, electrical performance, and biocompatibility.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific clinical performance acceptance criteria (e.g., accuracy ranges for FHR) and reported device performance from an effectiveness standpoint. Instead, it details non-clinical technical acceptance criteria related to safety, electrical performance, and biocompatibility, which the device met.
| Criterion Category | Specific Criterion / Test | Acceptance Criterion (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Met acceptance criteria as defined in test requirements | Met |
| Sensitization (ISO 10993-10) | Met acceptance criteria as defined in test requirements | Met | |
| Irritation (ISO 10993-10) | Met acceptance criteria as defined in test requirements | Met | |
| Electrical Safety | ANSI AAMI ES60601-1 | Compliance with standard for basic safety and essential performance | Passed |
| EMC/Wireless | IEC 60601-1-2 | Compliance with standard for electromagnetic disturbances | Passed |
| IEEE ANSI C63.27 | Compliance with standard for evaluation of wireless coexistence | Passed | |
| IEC/TR 60601-4-2 | Compliance with standard for electromagnetic immunity | Passed | |
| Alarm Systems | IEC 60601-1-8 | Compliance with standard for alarm systems | Passed |
| Battery Safety | IEC 62133-2 | Compliance with standard for lithium systems | Passed |
| Software/Firmware | FDA Guidance compliance | Compliance with "Content of Premarket Submissions for Device Software Functions" | Documentation provided and reviewed |
| Cybersecurity | FDA Guidance compliance | Compliance with "Cybersecurity in Medical Devices" guidance | Documentation provided and reviewed |
| Performance Bench | Inspection of labeling and pouch sealing | N/A (Visual inspection) | Met |
| Impedance/tensile strength/pull-off force/noise level/conductivity/offset voltage/defibrillation overload (new and aged patches) | Met acceptance criteria as defined in test requirements | Met | |
| In vivo testing: integrity, detachment/reattachment, and performance (impedance, noise level, MHR, conductivity) after shower and usage | Met acceptance criteria as defined in test requirements | Met | |
| Peel-off force of each electrode and central sticker | Met acceptance criteria as defined in test requirements | Met | |
| MHR/FHR/UA accuracy after storage at various temperatures | Met acceptance criteria as defined in test requirements | Met | |
| Signal transmission continuity | Met acceptance criteria as defined in test requirements | Met |
Regarding MHR/FHR/UA accuracy, the document states for "Performance Bench" that "MHR/FHR/UA accuracy after stored in room (23℃), high (32℃) and low (2-8℃) temperature" were conducted and "met the acceptance criteria as defined in the test requirements." However, the specific numerical acceptance criteria for accuracy (e.g., mean absolute difference, percentage agreement, etc.) and the reported numerical performance regarding MHR/FHR/UA accuracy are not provided in this summary. This suggests that these accuracy tests were likely bench tests under controlled conditions, not a clinical trial comparing device readings to a clinical ground truth.
2. Sample Size for Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of a clinical performance study with human subjects to evaluate the accuracy of FHR, MHR, and UA measurements. The in-vivo testing mentioned under "Performance Bench" refers only to "integrity, detachment/reattachment, and performance (impedance, noise level, MHR, conductivity) after shower and usage (8 hours/32 hours) for the patch (Novii Patch)." This does not sound like a large-scale clinical accuracy study.
Therefore, based on the provided text alone:
- Sample size for the test set: Not explicitly stated for clinical performance as commonly understood for device accuracy. The "in vivo testing" details are too limited to determine sample size or its direct relation to device accuracy claims.
- Data provenance: Not explicitly stated. The type of testing suggests it might be internal company testing rather than an independent clinical trial.
3. Number of Experts and Qualifications for Ground Truth
Given the lack of a detailed clinical performance study report, there is no information provided regarding the number or qualifications of experts used to establish ground truth for a clinical test set for FHR, MHR, or UA.
4. Adjudication Method
Again, due to the absence of a detailed clinical performance study, there is no information provided on any adjudication method (e.g., 2+1, 3+1) for a clinical test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human readers or AI assistance in this context. This device appears to be a monitoring system for physiological parameters, not an AI-assisted diagnostic imaging or interpretation tool.
6. Standalone Performance
The device itself is a "standalone" monitoring system in the sense that it performs its measurements (aHR, aFHR, aToco) via its electrodes and pod, then relays this data to a Philips Fetal-Maternal (FM) Monitor for display. The performance tests ("Performance Bench") assess the device's ability to measure these parameters. However, the exact "standalone" clinical accuracy metrics (e.g., sensitivity, specificity, accuracy vs. a gold standard) are not provided. The phrase "standalone performance" is generally associated with diagnostic algorithms, which doesn't seem to be the primary claim here.
7. Type of Ground Truth Used
For the non-clinical performance "MHR/FHR/UA accuracy after stored in room (23℃), high (32℃) and low (2-8℃) temperature," the type of ground truth used is not specified. It likely refers to controlled laboratory measurements against calibrated reference standards, rather than clinical ground truth like pathology, expert consensus, or outcomes data. For clinical performance data (which is not detailed), common ground truths for FHR, MHR, and UA would be internal fetal monitoring (IUPC for UA, fetal scalp electrode for FHR) or expert interpretation of existing monitoring tracings (though this isn't mentioned).
8. Sample Size for the Training Set
No information is provided about a "training set." This term is typically associated with machine learning or AI algorithm development. While the device uses signal processing (template matching, filtering, confidence tagging) to identify fECG and mECG complexes, the document does not describe the development or training of such algorithms or any associated data sets used for this purpose.
9. How Ground Truth for the Training Set Was Established
As no training set is discussed, there is no information provided on how ground truth for a training set was established.
In summary, the provided FDA summary focuses on demonstrating substantial equivalence through technical and non-clinical performance and safety testing. It lacks detailed clinical performance data (e.g., accuracy, sensitivity, specificity) against a clinical ground truth, specific sample sizes for clinical evaluations, or information about expert consensus or adjudication methods for such clinical data, which are typically found in clinical study reports for devices claiming diagnostic or interpretative capabilities.
§ 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).