(69 days)
The BT-200T is a Fetal Monitor for measuring Fetal Heart Rate, Data is displayed on a front panel LCD display, Fetal heart may be measured by means of Doppler ultrasound.
BT-200T is pocket size Fetal Monitor for measuring Fetal Heart rate, Pulse Doppler and uterine contraction of pregnant women. It is intended to aid a comprehensive check for the well being of single fetus.
Bistos' BT-200T is a pocket size Fetal Monitor that measures the fetal heart rate and out puts the fetal sound through built-in speaker. By measuring fetal heart rate (FHR), they are able to predict fetal well-being. BT-200T irradiates ultrasound wave to the abdomen of a pregnant women to detect. The Doppler Frequency signal and analyze, displays the heart rate in LCD screen. The device also provides the heart sound from the heart of fetus.
This 510(k) submission for the Bistos BT-200T Fetal Monitor is primarily based on substantial equivalence to a predicate device (Bistos BT-200, K052190). As such, the information provided focuses on demonstrating equivalence rather than detailed de novo efficacy studies with specific acceptance criteria and performance metrics typically found in submissions for novel devices.
However, Section 9 describes a "Voluntary performed Clinical safety test result attached (E) - *HR Accuracy Measuring Report (E-1)". This is the most relevant section for performance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document refers to an "HR Accuracy Measuring Report (E-1)" but does not present the specific acceptance criteria or the reported performance data within the text. For a full understanding, this report would need to be reviewed.
Based on the typical requirements for Fetal Heart Rate (FHR) monitors, the acceptance criteria would likely be related to accuracy and precision of FHR measurement compared to a gold standard. Without the actual report, the detailed criteria cannot be specified.
Hypothetical table (based on common FHR monitor standards and lack of specific data in the document):
| Acceptance Criteria Category | Specific Metric (Hypothetical) | Acceptance Limit (Hypothetical) | Reported Device Performance (From E-1 report - Not in provided text) |
|---|---|---|---|
| FHR Accuracy | Mean Absolute Difference (MAD) | ≤ 5 bpm | Not specified in provided document |
| FHR Accuracy | Bias (mean difference) | ≤ 3 bpm | Not specified in provided document |
| FHR Accuracy | Standard Deviation | ≤ 5 bpm | Not specified in provided document |
| FHR Detection Range | FHR Detection Range | 50-240 bpm | Not specified in provided document |
| False Alarm Rate | False Alarm Rate |
§ 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).