(195 days)
The FM-3000 Fetal Monitor is intended for non-invasive and 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.
It provides Non-stress testing for pregnant women from the 28th week of gestation. It can externally monitor the fetal heart rate using ultrasound and uterine activity via a pressure sensing transducer. Alternatively, it can internally monitor one of the fetal heart rates with an electrocardiograph and uterine activity with an intrauterine pressure catheter.
With non-invasive ultrasound Doppler, external pressure sensing transducer and direct fetal electrocardiograph technique, the FM-3000 Fetal Monitor provides Non-Stress testing for pregnant women from the 28th week of gestation. It can externally monitor the fetal heart rate using ultrasound and uterine activity. Alternatively, it can internally monitor one of the fetal heart rate with direct fetal electrocardiograph technique and uterine activity with an Intrauterine Pressure Catheter.
The Fetal monitor can be connected with Central Monitoring System via a RJ45 interface. Also it can be connected to wireless network module via a DB9 interface, and the wireless network module will complete the data switch of the monitor and the Obstetrical Central Monitoring System.
The FM-300 is not intended for use in intensive care units, operating rooms or for home use.
This document describes a 510(k) premarket notification for the FM-3000 Fetal Monitor. The core of this submission is to demonstrate substantial equivalence to a predicate device, the F3 Fetal Monitor (K102140) from EDAN Instruments.
Based on the provided information, the device relies entirely on the demonstration of substantial equivalence to a predicate device, with no new performance data or studies conducted specifically for the FM-3000. Therefore, it does not contain the detailed acceptance criteria and study data as one might expect for a novel device.
Here's a breakdown of the requested information based solely on the provided text:
1. A table of acceptance criteria and the reported device performance
The document explicitly states: "The FM-3000 Fetal Monitor is identical to the predicate device in terms of design, materials, specifications, and manufacturing. Therefore, no new testing was needed to support substantial equivalence."
This means there are no new acceptance criteria or reported device performance metrics specifically for the FM-3000 Fetal Monitor because it claims to be identical to its predicate. The acceptance criteria and performance data would have been established and met by the predicate device (F3 Fetal Monitor K102140) to obtain its clearance.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. No new test set or data was used for the FM-3000 Fetal Monitor. The device claims substantial equivalence to a predicate, implying that previous studies on the predicate device would have established its performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. No new test set or ground truth establishment was performed for the FM-3000 Fetal Monitor.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No new test set or adjudication was performed for the FM-3000 Fetal Monitor.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The FM-3000 Fetal Monitor is not an AI-assisted device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The FM-3000 Fetal Monitor is not an algorithm-only device. It is a physical monitoring system for fetal vital signs.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No new ground truth establishment was performed for the FM-3000 Fetal Monitor. For the predicate device, it would likely have been clinical validation against established fetal monitoring practices and potentially comparison to other validated monitoring systems, though the document does not provide details on the predicate's original ground truth.
8. The sample size for the training set
Not applicable. The FM-3000 Fetal Monitor is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. The FM-3000 Fetal Monitor is not a machine learning or AI device that requires a training set.
Summary of the K141194 submission for FM-3000 Fetal Monitor:
The manufacturer, Advanced Instrumentations, Inc., successfully argued for 510(k) clearance by demonstrating substantial equivalence to an existing predicate device, the EDAN Instruments F3 Fetal Monitor (K102140). The key argument is that:
- "The FM-3000 Fetal Monitor is identical to the predicate device in terms of design, materials, specifications, and manufacturing."
- "There are no differences in technological characteristics between the two devices."
- "The only difference between the predicate device and the FM-3000 Fetal Monitor is the device name and branding in the labeling."
Therefore, the performance of the FM-3000 Fetal Monitor is asserted to be the same as the predicate device, and no new studies or data were deemed necessary to support this claim. The safety and effectiveness of the FM-3000 are directly linked to the established safety and effectiveness of the predicate.
§ 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).