(176 days)
The iCareNewlife Fetal Doppler is indicated for monitoring fetal heart rate during the antepartum period as a general indication of fetal well-being. The device is for heart sounds through the speaker only. The device is intended to be used by health care professionals including registered nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices.
The device is a hand-held ultrasonic fetal heart beat detector, which can detect the Fetal Heart Rate (FHR). The built-in speaker of the device allows for listening of the fetal heartbeat. The device is generally applied to above 16 weeks gestation.
Ultrasonic wave is transmitted from one piezoelectric ceramic at the front of the uterus of the pregnant women. Echo is received by the other piezoelectric ceramic at the front of the probe when ultrasonic wave reaches the fetal heart. Then it is converted into voltage. This Doppler signal is detected and demodulated from the received signal. And the Doppler frequency is consistent with the rhythm of the fetal systole and diastole. Once cardiac valves vibrate and a Doppler frequency excursion is formed. lt is transmitted an output signal of cardiac valves vibrating, and it is sent to the loudspeaker for getting a rhythmical sound with the fetal heartbeat.
The device is powered by a 9V alkaline battery.
Here's an analysis of the provided text regarding the iCareNewlife Fetal Doppler, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Fetal Doppler JPD-100S, K110124) rather than explicit acceptance criteria defined by the manufacturer for this specific device. However, by comparing the subject device to the predicate, we can infer some performance benchmarks that were considered acceptable for market clearance.
| Descriptor | Acceptance Criteria (Inferred from Predicate) | Reported Device Performance (iCareNewlife Fetal Doppler) |
|---|---|---|
| Intended Use | Detect Fetal Heart Rate (FHR) | Detect FHR |
| Sensitivity | From 12 weeks gestation | From 16 weeks gestation |
| Mode of Operation | Continuous wave | Continuous wave |
| Ultrasound Frequency | 3.0 MHz | 2.5 MHz |
| Ultrasonic Power | 13.3 mW | ≤ 22 mW |
| Area Corresponding to Entrance Beam Dimensions | 2.65 cm² | 1.57 cm² |
| Acoustic Output | 5.02 mW/cm² | 14.01 mW/cm² (actual max value measured) |
| Acoustic Output Safety Limit | ≤ 20 mW/cm² (for unfocused CW FHR devices) | 14.01 mW/cm² (below limit) |
| FHR Measuring Range | 50-210 bpm | 50-210 bpm |
| FHR Resolution | 1 bpm | 1 bpm |
| Accuracy | ± 2 bpm | ± 2 bpm |
| FHR Readout | Speaker sound | Speaker sound |
| Power Supply | 9V alkaline battery | 9V alkaline battery |
| Transducer Housing Material | ABS plastic | ABS plastic |
| Biocompatibility | Meet ISO 10993 standards | Passed Cytotoxicity, Sensitization, Irritation tests |
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-2-37 | Complies with IEC 60601-1, IEC 60601-2-37 |
| Electromagnetic Compatibility (EMC) | Comply with IEC 60601-1-2 | Complies with IEC 60601-1-2 |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not provide details on a specific clinical test set sample size or its provenance (country of origin, retrospective/prospective). The "Performance Data" section primarily describes bench testing, biocompatibility testing, electrical safety, and EMC testing. The comparison to the predicate device is a theoretical assessment based on specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. Since there is no described clinical test set, there's no mention of experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set
This information is not provided in the document, as a clinical test set with an adjudication method is not 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
This document describes a Fetal Doppler, which is a device for detecting fetal heart rate through sound. It is not an AI-assisted diagnostic imaging system that would involve human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and was not done.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The iCareNewlife Fetal Doppler is a standalone device in the sense that it directly outputs fetal heart sounds via a speaker, and heart rate measurements (if displayed). It doesn't appear to be an "algorithm only" device that relies on a separate human interpretive step for its primary function of detecting the FHR. The "Performance Data" section details the device's technical specifications and compliance with safety and performance standards for its direct operation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the technical performance characteristics (e.g., FHR measuring range, accuracy, acoustic output), the "ground truth" would have been established through calibrated measurement instruments and standardized testing procedures during bench testing. For biocompatibility, electrical safety, and EMC, compliance was determined against recognized international standards (ISO 10993, IEC 60601 series). There is no mention of clinical ground truth (e.g., expert consensus on observed fetal heart rates, pathology, or outcomes data) for a clinical performance study.
8. The Sample Size for the Training Set
This information is not provided in the document. The device does not appear to involve machine learning or AI algorithms that would require a "training set" in the conventional sense. The "Performance Data" describes traditional engineering and safety testing.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" for an AI algorithm mentioned, information on how its ground truth was established is not applicable and therefore not provided.
§ 884.2660 Fetal ultrasonic monitor and accessories.
(a)
Identification. A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.(b)
Classification. Class II (performance standards).