(336 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. Alternatively, it can internally 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.
F3/F2 Fetal 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.
The 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. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.
The subject devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. The submission seeks clearance for several devices and their accessories, which were modified since their last 510(k) clearance.
The subject devices of the present submission include the F2/F3 and F6/F9 fetal monitors as well as the F6/F9 Express, which provide both fetal and maternal monitoring capabilities.
The fetal and maternal physiological parameters that are supported by the EDAN bedside monitors are as follows:
- Fetal heart rate (FHR)
- Tocodynamometry (TOCO) for external monitoring of uterine contractions .
- Fetal Movement (FM) ●
- Automated Fetal Movement (AFM) ●
- Direct ECG (DECG) for internal monitoring of fetal heart rate
- . Intrauterine pressure catheter (IUP) for internal monitoring of uterine contractions
- . Maternal ECG (MECG)
- . Noninvasive blood pressure (NIBP) was added to F6/F9 Express in this submission
- Maternal Sp02 (MSp02) for monitoring pulse rate (PR) .
- . Temperature (TEMP) for monitoring maternal temperature
This document describes the regulatory submission for Fetal & Maternal Monitors (Models F6, F6 Express, F9, F9 Express) and Fetal Monitors (Models F2, F3) by Edan Instruments, Inc. It is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to previously marketed predicate devices.
The document does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices based on technical specifications and regulatory safety/performance testing. The performance data provided are related to general device functionality, electrical safety, electromagnetic compatibility, and sensor evaluations, rather than demonstrating performance against an AI algorithm's specific performance targets (like sensitivity, specificity, or accuracy) on a clinical test set.
Therefore, many of the requested elements pertaining to an AI/algorithm study (such as ground truth establishment, sample sizes for training/test sets in an AI context, expert qualifications, or MRMC studies) are not present in this document.
However, I can extract information related to the device's technical specifications and the types of performance data submitted for its clearance, which could be interpreted as acceptance criteria for a traditional medical device, rather than an AI.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a formal "acceptance criteria table" with specific numerical targets and results in the way an AI performance study would. However, it lists technical specifications for the new devices and compares them to predicate devices, indicating that "Same" values or minor acceptable "Different" values (with justification) serve as the "acceptance criteria" for substantial equivalence for these non-AI features.
Here's an attempt to structure relevant technical specifications from the comparison tables (pages 7 and 12-15), which imply the "acceptance criteria" through their "Comparison" column:
| Metric (Implied Acceptance Criteria) | Device Performance (F6/F6 Express/F9/F9 Express) | Predicate Performance (K150901 F9 Express) | Comparison |
|---|---|---|---|
| Manufacturer | Edan Instruments, Inc. | Edan Instruments, Inc. | Same |
| K# | K174042 | K150901 | Different |
| Intended use | Same as predicate | Described in doc | Same |
| Anti-electric-shock degree | FHR1, FHR2, TOCO, FM, IUP: BF; SpO2, NIBP: BF (Defibrillator-proof); DECG:CF; ECG, TEMP: CF (Defibrillator-proof); FTS-3: FHR1, FHR2, TOCO: BF (Defibrillator-proof). | Same as subject device | Same |
| Safety (flammable gas) | Equipment not suitable for use in presence of flammable gases | Same as subject device | Same |
| Protection against Water Ingress | Main Unit: IPX1; US/TOCO Transducers: IPX8; FTS-3: Base station: IPX1, Transducers: IPX8 | Same as subject device | Same |
| Working mode | Continuous running equipment | Same as subject device | Same |
| FHR Technique | Pulse Doppler with autocorrelation processing | Same as subject device | Same |
| FHR Pulse Repetition Frequency | 2 KHz | Same as subject device | Same |
| FHR Effective Radiating Area | F9/F9 Express/FTS-3: 942 mm² ± 15% (12 ultrasound crystals); F6/F6 Express: 628 mm² ± 15% (8 ultrasound crystals); F6/F6 Express /FTS-3: 549.5 mm²± 15% (7 ultrasound crystals) | F9/F9 Express /FTS-3: 942 mm² ± 15% (12 ultrasound crystals); F6/F6 Express: 628 mm² ± 15% (8 ultrasound crystals) | Different |
| TOCO Range | 0-100 | Same as subject device | Same |
| TOCO Resolution | 1 | Same as subject device | Same |
| DECG Technique | Peak-peak detection technique | Same as subject device | Same |
| DECG Heart Rate Counting Range | 30 bpm ~ 240 bpm | Same as subject device | Same |
| IUP Pressure Range | 0 ~ 100mmHg (0.0~13.3 kPa) | Same as subject device | Same |
| IUP Sensitivity | 5uV/V/mmHg | Same as subject device | Same |
| IUP Resolution | 1mmHg (0.1 kPa) | Same as subject device | Same |
| IUP Zero Mode | Automatic/Manual | Same as subject device | Same |
| MECG Heart Rate Range | 30-240BPM | Same as subject device | Same |
| MECG Defibrillator Protection | YES | Same as subject device | Same |
| MECG HR averaging method | Heart rate is computed by averaging the 12 most recent RR intervals. | Same as subject device | Same |
| SpO2 Measuring Range | 50% ~ 100% | Same as subject device | Same |
| SpO2 Resolution | 1% | Same as subject device | Same |
| SpO2 Pulse Rate Measurement Range | 30-240BPM | Same as subject device | Same |
| SpO2 Pulse Rate Measuring Accuracy | ±3BPM | Same as subject device | Same |
| SpO2 Emitted light energy |
§ 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).