(89 days)
F6/F9 Fetal & Maternal Monitor is intended for non-invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.
F6/F9 Fetal & Maternal Monitor provides Non-Stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternally monitor one of the FHRs with DECG and uterine activity with an IUPC.
F6 Express/F9 Express Fetal & Maternal Monitor is intended for monitoring physiological parameters of pregnant women during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.
F6 Express/F9 Express Fetal & Maternal Monitor is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. In addition, it provides a solution for maternal vital signs monitoring.
F series Fetal & Maternal Monitor, including F6, F6 Express, F9, F9 Express which provides the following primary features that can be available for the multiple configurations:
• Basic parameters: FHR, TOCO, Event Mark, AFM
• Dual FHR monitoring
• Internal parameters: IUP/DECG
• FHR limit alarm
• Software for data transmission to PC, which means the subject device can be connected to Central Nursing System provided by EDAN, which has been cleared by K100358.
• Quick printing for stored waveform
• Lithium battery for continuous working
• Maternal ECG monitoring
• Maternal SpO2 monitoring
• Maternal NIBP
• Maternal temperature monitoring
• Used with FTS-3 Fetal Telemetry System (hereinafter called FTS-3)
This document is a 510(k) Pre-market Notification for the Edan Instruments Fetal & Maternal Monitor (models F6, F6 Express, F9, F9 Express), seeking to demonstrate substantial equivalence to previously cleared predicate devices. The submission focuses on non-clinical performance data.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a dedicated "acceptance criteria" table in the format of pass/fail metrics. Instead, it provides a "Predicate Device Comparison" table that lists performance specifications for the subject devices and the predicate device. The implied acceptance criterion for each parameter is that the subject device's performance is "Same" or "Different" but without raising new questions of safety or effectiveness.
Below is a summarized table consolidating various performance parameters and their comparison to the predicate device, indicating the reported performance:
| Item | Implied Acceptance Criterion | Subject Device Performance (F6/F6 Express/F9/F9 Express) | Predicate Device Performance (K100797, F9 Express & K023931, Avalon CTS) | Meets Acceptance Criterion? |
|---|---|---|---|---|
| FHR | Maintain/Match Predicate | |||
| Technique | Pulse Doppler w/ autocorrelation | Pulse Doppler with autocorrelation processing | Pulse Doppler with autocorrelation processing | Yes (Same) |
| Pulse Repetition Freq. | 2 KHz | 2 KHz | 2 KHz | Yes (Same) |
| Pulse Duration | 92 μs | 92 μs | 92 μs | Yes (Same) |
| Ultrasound Frequency | 1.0MHz±10% | 1.0MHz±10% | 1.0MHz±10% | Yes (Same) |
| Spatial-Peak Temporal Avg. Intensity | Ispta |
§ 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).