(279 days)
The Doppler FHR Detector (Model BF-500D+ and BF-560) is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound in patients with singleton pregnancies after 12 weeks of gestation. The device is intended to be used by health care professionals in a hospital, clinic, community, and home setting.
The Fetal Doppler is a hand-held device for non-invasive measurement and display of the fetal heart beat utilizing Doppler ultrasound. The device consists of two main components, the main unit and probe. The main unit consists of the main board, power module, battery, speaker, and liquid crystal display(LCD) screen. The wired probe consists of the transducer and includes two angled semi-circle ultrasonic crystals, one for transmission and one for reception. The ultrasonic signal is continuously transmitted at one frequency.
The difference between BF-500D+ and BF-560 are shown as below:
- BF-500D+ is powered by a 9V rechargeable Ni-MH battery, and adapter is packaged with the unit; BF-560 is powered by three pieces of 1.5V AA alkaline disposable batteries.
- BF-500D+ will display Fetal heart rate, sound volume, and battery indicator; BF-560 will also display the selected working frequency besides in addition to the features of the BF-500D+.
- the two models have different probe shapes.
This 510(k) clearance letter pertains to a Doppler FHR Detector, a device intended to detect fetal heartbeats, display fetal heart rate, and play the fetal heart sound. The document describes non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.
It's important to note that this document does not describe a study involving human subjects or AI-assisted diagnostic read-outs. Therefore, sections related to multi-reader multi-case studies, expert adjudication for ground truth for test sets, and the impact of AI assistance on human readers are not applicable.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a structured, quantitative table for all performance aspects. Instead, it demonstrates compliance with recognized standards and successful completion of various tests. The tables in the original document ("Table 6-1: Comparison between the predicate device BF-500B and the subject device BF-500D+" and "Table 6-2: Comparison between the predicate device BF-500B and the subject device BF-560") provide a comparison of technical characteristics and indicate "Same" or "Different" for each item, implying that similarity or acceptable differences were the internal criteria for many parameters.
For the performance tests explicitly mentioned in section 7, the reported device performance is that the device "complied with requirements" or "successfully passed all aspects of the testing." I will create a table summarizing the performance parameters that have a quantifiable criterion or a clear pass/fail outcome from the provided text.
| Performance Characteristic/Test | Acceptance Criteria (Implied/Explicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 (Cytotoxicity, Skin Sensitization, Irritation) based on nature/duration of patient contact. | Patient contacting materials subjected to and passed testing (Cytotoxicity, Skin Sensitization, Irritation) in accordance with ISO 10993-1. |
| Electrical Safety | Compliance with IEC 60601-1 and AAMI/ANSI ES 60601-1. | Device found to comply with IEC 60601-1 and AAMI/ANSI ES 60601-1. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | Device found to comply with IEC 60601-1-2. |
| Ultrasound & Acoustic Testing | Compliance with IEC 60601-2-37 and Acoustic Output testing per IEC 62359:2017 and FDA guidance. | System found to comply with IEC 60601-2-37 and Acoustic Output testing per IEC 62359:2017 and FDA Guidance. |
| Software Verification & Validation | Compliance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for moderate software level of concern. | Testing conducted and completed with no outstanding anomalies; documentation provided as recommended by FDA guidance. |
| Use Life (Durability) | Device performance and durability maintained over proposed service life of 609 hours under continuous operation, simulated cleaning/disinfection, battery cycling, and key-fatigue testing. | Device successfully passed all aspects of use life testing, including continuous operation, simulated maintenance, and stress testing. |
| FHR Measuring Range (BF-500D+ & BF-560) | 65 bpm ~ 210 bpm (implied by comparison with predicate measuring range of 50 bpm ~ 210 bpm and stating a common range for both subject devices) | 65 bpm ~ 210 bpm |
| Accuracy (BF-500D+ & BF-560) | ± 2bpm | ± 2bpm |
| Resolution (BF-500D+ & BF-560) | 1 bpm | 1 bpm |
| Acoustic Output Power (BF-500D+) | Less than 1.8 W | Less than 1.8 W |
| Acoustic Output Power (BF-560) | Less than 1.5 W | Less than 1.5 W |
| Iob (BF-500D+ & BF-560) | ≤ 10 mW/cm² | ≤ 10 mW/cm² |
| pr (BF-500D+ & BF-560) | 1 MPa | 1 MPa |
| Ispta (BF-500D+ & BF-560) |
§ 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).