(198 days)
The Fetal Doppler is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home. The device is intended for use at or after 16 weeks gestation.
The Fetal Doppler, model TK-T802CR, is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats and sounds. The Fetal Doppler is used for non-invasive detection and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. It has two hand-held components, a main unit and a probe. The main unit consists of the main board, power module, battery, speaker, and LCD screen. The probe consists of the ultrasonic transducers for transmission and for signal reception. The ultrasonic signal is continuously transmitted at a frequency of 2.0, 2.5, or 3.0 MHz, depending on the probe settings selected.
This document describes the premarket notification (510(k)) for the Shenzhen Taikang Medical Equipment Co., Ltd. Fetal Doppler. The FDA has determined the device is substantially equivalent to legally marketed predicate devices.
Acceptance Criteria and Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Vcomin Technology Limited Company Fetal Doppler, Model: FD-200D). The performance data provided is largely in the form of testing against applicable standards and showing similarity/equivalence to the predicate device, rather than explicit acceptance criteria and reported performance in a quantitative table for each functional aspect of the device in a clinical study.
However, based on the provided text, we can infer some key performance aspects and their reported outcomes:
| Acceptance Criteria (Inferred from Predicate Equivalence & Standards) | Reported Device Performance |
|---|---|
| Indications for Use: Detect fetal heart rate in hospital, clinic, community, and home, used by healthcare professionals at or after 16 weeks gestation. | Same as predicate. The Fetal Doppler is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home. The device is intended for use at or after 16 weeks gestation. |
| Design: Hand-held, battery-powered audio Doppler device; main unit displays FHR. | Same as predicate. A main unit and a probe. The main unit displays FHR. |
| Mode of Action: Doppler ultrasound, continuous wave. | Same as predicate. Doppler ultrasound, continuous wave. |
| Ultrasound Frequency: 2.0 MHz, 2.5 MHz, and 3.0 MHz. | Same as predicate. 2.0 MHz, 2.5 MHz, and 3.0 MHz. |
| FHR Measuring Range: 50-210 bpm. | Same as predicate. 50-210 bpm. |
| FHR Accuracy: ±2 bpm. | Same as predicate. ±2 bpm. |
| FHR Resolution: 1 bpm. | Same as predicate. 1 bpm. |
| Biocompatibility: Non-cytotoxic, non-irritating, non-sensitizing for patient-contacting components. | Demonstrated conformity. Testing per ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (sensitization), and ISO 10993-10:2010 (irritation) showed the materials were non-cytotoxic, non-irritating, and non-sensitizing. |
| Electrical Safety & EMC: Compliance with relevant IEC standards (IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2). | Demonstrated conformity. Testing successfully completed against IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, and IEC 62133 (for batteries). |
| Software Verification & Validation: Compliance with FDA guidance for moderate software level of concern. | Demonstrated conformity. Software verification and validation conducted and documentation provided in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005 for a moderate software level of concern. |
| Use-Life: Adequate operational lifespan. | Testing completed. Use-Life Testing was performed. Specific duration/results not detailed in this summary. |
| Fetal Heart Rate Accuracy: Accurate detection of FHR. | Testing completed. Fetal Heart Rate Accuracy Testing was performed. Specific performance data (e.g., mean absolute error) is not detailed in this summary, but the device meets the ±2 bpm accuracy specification which is "Same" as the predicate. |
| Acoustic Output: Within safe limits according to standards. | Testing completed. Acoustic output testing per NEMA UD 2-2004(R2009) and FDA guidance for Track 1 devices. The subject device's ISATA values (e.g., 2.0MHz - ISATA: 6.01mW/cm²) are different (lower for 2MHz, 2.5MHz, and 3.0MHz) than the predicate, but this difference does not raise new questions of safety and effectiveness, implying they are within safe and acceptable limits. |
Study Details:
The provided text from the 510(k) summary does not describe a clinical study with human subjects, a test set, expert readers, or ground truth establishment in the manner typically associated with AI/ML device evaluations. This submission is for a traditional medical device (Fetal Doppler) where substantial equivalence is demonstrated through engineering and performance testing against standards, and comparison to a predicate device.
Therefore, the following points are not applicable or not detailed in this specific 510(k) summary, as it's not a submission for an AI/ML-based device:
- Sample size used for the test set and the data provenance: Not applicable in the context of a clinical test set for AI/ML. The performance testing was likely conducted in a lab environment using appropriate phantoms, simulators, or controlled setups as per the referenced standards (e.g., IEC 60601-2-37 for ultrasonic medical diagnostic equipment).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a Fetal Doppler's accuracy would be established through calibrated instruments or reference measurements, not expert consensus on images.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study. The device is a diagnostic tool, not an AI assistance system for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "standalone" hardware device, not an algorithm. Its performance is evaluated intrinsically.
- The type of ground truth used: For FHR accuracy, the ground truth would be precise, known heart rate simulations from equipment or calibrated reference measurements. For biocompatibility, it's lab test results comparing to established biological responses. For electrical safety, it's compliance with specified measurement limits.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
In summary, for this Fetal Doppler (K211940), substantial equivalence was demonstrated primarily through:
- Comparison to a predicate device (K182526) showing sameness in intended use, design, mode of action, and core FHR specifications.
- Non-clinical performance testing against recognized international and national standards for biocompatibility (ISO 10993), electrical safety and electromagnetic compatibility (IEC 60601 series), battery safety (IEC 62133), software verification (FDA guidance), use-life, FHR accuracy (IEC 60601-2-37), and acoustic output (NEMA UD 2 and FDA guidance).
The documentation asserts that any differences in technological characteristics (like acoustic output) do not raise new questions of safety and effectiveness, thus supporting the substantial equivalence determination.
§ 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).