(352 days)
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No
The description focuses on standard signal processing and measurement techniques (Doppler frequency analysis, pressure sensors) and does not mention any AI/ML terms or capabilities.
No
The device is a fetal monitor used to measure and display fetal heart rate and uterine contractions, aiding in assessment, not treatment.
Yes
The device is intended to "aid comprehensive assessment for the well being of single fetus" by measuring and displaying fetal heart rate and uterine contraction, which are used by trained healthcare personnel for evaluating a patient's condition.
No
The device description explicitly states that the FC-700 is a fetal monitor that irradiates ultrasound waves and uses pressure sensors to measure fetal heart rate and uterine contractions. These are hardware components, not software-only functions.
Based on the provided information, the FC-700 fetal monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- FC-700 Function: The FC-700 directly interacts with the patient (pregnant woman) by using ultrasound and pressure sensors applied to the abdomen. It measures physiological parameters (fetal heart rate and uterine contraction) in vivo (within the living body).
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient.
Therefore, the FC-700 falls under the category of a physiological monitoring device rather than an IVD.
N/A
Intended Use / Indications for Use
FC-700 is the fetal monitor that measures, displays numerical value of measured results by LED, prints graphically the fetal heart rate and uterine contraction of a pregnant woman, and also provides the sound from the heart of fetus. It is intended to aid comprehensive assessment for the well being of single fetus.
It intended to be used by trained healthcare personnel. It is not intended for home use.
Product codes (comma separated list FDA assigned to the subject device)
HGM
Device Description
FC-700 is the fetal monitor that measures the fetal heart rate and uterine contraction. FC-700 irradiates ultrasound wave to the abdomen of a pregnant woman and detects the Doppler frequency signal reflected from the heart of the fetus. FC-700 analyzes detected signal and displays the numerical values of the fetal heart rate by LED. FC-700 measures the uterine contraction values of a pregnant woman by pressure sensors, analyzes measured value and displays the numerical values of the uterine contraction by LED. FC-700 provides the sound from the heart of fetus. FC-700 prints graphically the heart rate of the fetus and the values of uterine contraction.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Ultrasound
Anatomical Site
Abdomen of a pregnant woman
Indicated Patient Age Range
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Intended User / Care Setting
trained healthcare personnel. It is not intended for home use.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests were conducted for electrical safety (IEC60601-1), EMC (IEC60601-1-2), and biocompatibility (ISO10993).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).