(148 days)
The Cadence Fetal Monitor , model 2001 for singletons and model 2002 for twins, is a fetal monitor for monitoring fetal well being during the antepartum period. It performs what is commonly called the non stress test.
The Cadence Fetal Monitor 2001/2002 is to be used by trained medical personnel in hospitals clinics, physicians offices, and in the patients home by prescription or doctors orders.
The Cadence Fetal monitor is a perinatal monitoring system for non-invasively measuring, displaying and printing out in graphic form on a strip chart recorder maternal abdominal contractions and fetal heart rate for either a singleton fetus or twin fetuses during the last trimester. A manual hand held pushbutton marker for patient identification of contractions is also part of the monitor. The Cadence Fetal monitor uses one or two ultrasound transducers for monitoring the fetal heart rate (FHR) depending on whether there is a singleton or twin pregnancy. The multi crystal , broad band ultrasound transducer operates at a frequency of 2 mHz. The ultrasound transducer or transducers are placed on the maternal abdomen by means of one or two belts and transmits the ultrasound signal to the fetal heart(s). The transducer(s) also receive the echo from the fetal heart(s) and processes the echoes determining the fetal heart rate(s) The TOCO transducer is also placed on the maternal abdomen with a belt and it detects the forward displacement of the maternal abdominal muscles during a contraction. The TOCO transducer is a tocotonometer which operates on the strain gauge principle to measure displacement. The central section of the TOCO transducer is depressed by the forward displacement of the abdominal muscles during a contraction. It is used for assessing frequency and duration of uterine contractions. It gives an indication of contractions pressure.
The fetal heart rate(s) and TOCO percent contractions pressure are displayed on numerical readouts and printed out on a strip chart recorder in graphic form.
A fetal event marker pushbutton is also available for the patient to identify contractions manually by pushing the button on the fetal event marker.
The Cadence Fetal Monitor device was deemed substantially equivalent to predicate devices (Sonicaid 820 and Corometrics 171/172) based on
- principles of operation
- specifications
- performance
This means that the device meets the same acceptance criteria as the predicate devices. The submission indicates that "Extensive safety, performance testing, and validation" were performed to ensure the device met "all of its functional requirements and performance specifications" and complied with safety standards. However, specific acceptance criteria and detailed performance results from this testing are not explicitly reported in the provided text.
Based on the information provided, here's a summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Acceptance Criteria (Derived from Predicate Comparison) | Cadence 2001/2002 Performance |
|---|---|
| Fetal Heart Detection: Pulsed Doppler With Auto-Correlation | Yes |
| Fetal Heart Rate Display Units: 1 BPM | 1 BPM |
| Fetal Heart Rate Range: 50-210 BPM (Predicate ranges 30-240 BPM / 50-210 BPM) | 50-210 BPM |
| Ultrasound Frequency: 2 MHz (Predicate ranges 1.15-2.0 MHz) | 2 MHz |
| Fetal Heart Rate Alarms: Yes | Yes |
| Toco Transducer Type: Strain gauge | Strain gauge |
| Toco Range (relative units): 0-100 | 0-100 |
| Toco Resolution (relative units): 1 | 1 |
| Chart Recorder: Yes | Yes |
| Numeric Display Of Results: Yes | Yes |
| Ultrasound Power (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).