(165 days)
The Sonicaid™ Freedom Wireless Fetal Monitoring System ('Freedom') is a wireless transducer system for monitoring fetal heart movement and maternal contractions during intrapartum and antepartum periods of pregnancy.
It is an optional accessory for use with Huntleigh Healthcare Limited's Sonicaid™ FM820 and FM830 Encore Fetal Monitors ('FM800E Monitors') as an alternative to their wired transducers. When connected to an FM800E Monitor, the system monitors:
• Uterine activity by using an external, pressure-sensitive TOCO transducer, and
• Fetal Heart Rate (FHR) by pulsed Doppler ultrasound using an external Ultrasound transducer.
Freedom is suitable for use with pregnant women in clinical and hospital facilities. The transducers are water tight allowing pregnant women to be monitored while they are mobile, stationary or in a bath or shower environment.
This system should only be used by, or under the supervision of, a licensed physician or other health practitioner who is trained in the use of FHR monitors.
The Sonicaid™ Freedom is intended to monitor fetal heart movement and uterine activity by using wireless, non-invasive transducers on pregnant women during antepartum and intrapartum phases of pregnancy. This system is an optional accessory that must be connected to, and used with, a Sonicaid™ FM800E Monitor when a woman wishes to be mobile or in a water environment when being monitored or giving birth.
The Freedom has three major components; the Receiver and Ultrasound ('US') and Tocograph ('TOCO') transducers. The wireless transducers are powered by internal batteries that are recharged when docked on the Receiver.
The Sonicaid ™Freedom operates in the WMTS frequency bandwidth. There are 100 selectable channels available for use. If there is interference when installing the system, then the channel may be changed to achieve clear transmission.
The Huntleigh Healthcare Ltd. Sonicaid™ Freedom Wireless Fetal Monitoring System (K132650) did not report specific acceptance criteria or a dedicated clinical study to demonstrate its performance relative to specific metrics. Instead, the submission relies on demonstrating substantially equivalent performance to a predicate device through bench tests.
Here’s a breakdown of the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) are not explicitly stated for the device's main function of fetal monitoring. The performance is indirectly demonstrated by showing comparability to the predicate device through bench tests.
| Acceptance Criteria Category | Specific Metric (Not Explicitly Stated) | Reported Device Performance (as demonstrated by bench tests) |
|---|---|---|
| Acoustic Output | Compliance with IEC 60601-2-37 | Achieved compliance. Ultrasound transducer elements have similar structure and acoustic output levels are comparable to predicate, within safety limits. |
| Environmental Requirements | Compliance with ISO 60068-2 | Achieved compliance. |
| Electrical Safety | Compliance with EN 60601-1 | Achieved compliance. |
| EMC | Compliance with EN 60601-1-2 / FCC | Achieved compliance. |
| Software | Compliance with EN 62304 | Achieved compliance. |
| Material Biocompatibility | Compliance with ISO 10993 | Achieved compliance. |
| FHR and UA Detection | Not explicitly quantified. Performance of Ultrasound and TOCO transducers is comparable to Sonicaid™ FM800E transducers (which are wired, not the predicate). This implies similar accuracy and reliability in detecting FHR and UA. | |
| Wireless Communication | Range, signal strength, interference handling, battery life. | Comparable to predicate device. WMTS frequency band used, 100 selectable channels. Indicators for interference, low battery, out-of-range provided. |
| Water Ingress Rating | Water tightness for use in water environments. | Same as predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable/not reported. The submission did not involve a clinical test set with patient data for performance evaluation. Performance was assessed through simulated bench tests.
- Data Provenance: Not applicable, as there were no clinical test sets or patient data involved. The tests were simulated bench tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No expert-established ground truth was reported for a clinical test set, as no clinical tests were performed.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set or adjudication method was reported.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical tests were required to determine substantial equivalence between the Freedom and the predicate device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- The device itself is a fetal monitoring system that collects data, not an algorithm that interprets data. While the performance of the transducers (the "standalone" components for data acquisition) was assessed through bench tests, it's not a "standalone algorithm" in the typical sense of AI. The system is designed to be used by trained health practitioners.
7. The Type of Ground Truth Used
- For the technical and safety aspects, the "ground truth" was established by compliance with recognized standards (e.g., IEC, ISO, EN, FCC) and by comparison to the established performance of existing Sonicaid™ FM800E transducers (for FHR and UA detection) and the predicate device (Avalon CTS Cordless Fetal Transducer System) for overall system functionality and design. There was no clinical ground truth (e.g., pathology, outcomes data) based on patient results provided.
8. The Sample Size for the Training Set
- Not applicable. This device is a hardware system for signal acquisition, not an AI/machine learning algorithm requiring a "training set" for model development.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as no training set was used.
§ 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).