(352 days)
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.
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. I C-700 prints graphically the heart rate of the fetus and the values of uterine contraction.
This is a 510(k) summary for a medical device and describes a comparison to a predicate device, not a study evaluating the device's performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted directly from this document.
The document states that the FC-700 is "substantial equivalent to predicated device COROMETRICS MONITOR (K991905)". This means that the device's safety and effectiveness are deemed equivalent to the predicate device based on its similarity in technological characteristics, rather than a new clinical study with specific acceptance criteria.
However, I can provide what's available and point out what's missing:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated in the document as such for FC-700 performance) | Reported Device Performance (as presented for FC-700) |
|---|---|
| Not explicitly stated. The document implies equivalence to the predicate device's performance. | Fetal Heart Rate (FHR): Measures and displays numerical values. |
| Not explicitly stated. | Uterine Contraction (UC): Measures and displays numerical values. |
| Not explicitly stated. | Fetal Movement Detection: Provides this function. |
| Not explicitly stated. | High/Low Heart Rate Alarm: Provides this function. |
| Not explicitly stated. | Printing Monitoring Results: Prints graphically. |
| Not explicitly stated. | Interface through RS232: Provides this function. |
| Electrical Safety (Implied: Compliance with IEC60601-1) | Tested for electrical safety according to IEC60601-1. |
| Electromagnetic Compatibility (Implied: Compliance with IEC60601-1-2) | Tested for electromagnetic compatibility according to IEC60601-1-2. |
| Biocompatibility (Implied: Compliance with ISO10993) | Tested for biocompatibility in accordance with International Standard: Biological Evaluation of Medical Devices (ISO10993). |
Missing Information and Reasoning:
- 1. A table of acceptance criteria and the reported device performance: As explained above, the document doesn't provide specific quantitative acceptance criteria for the FC-700's performance (e.g., accuracy, precision for FHR or UC measurements) and corresponding reported performance metrics from a formal study. Instead, it relies on substantial equivalence to a predicate device. The performance characteristics listed are functions the device performs, not quantitative performance metrics against acceptance criteria.
- 2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical performance study with a test set. The evaluation is based on technological characteristics comparison.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical performance study is described.
- 4. Adjudication method for the test set: Not applicable. No clinical performance study is described.
- 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. This is a medical device (fetal monitor), not an AI-based diagnostic tool. There is no mention of an MRMC study or AI assistance.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a fetal monitor, not an algorithm, and its use inherently involves human interaction (trained healthcare personnel).
- 7. The type of ground truth used: Not applicable. No clinical performance study is described. The "ground truth" for this submission is the performance and safety profile of the predicate device.
- 8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that involves a training set.
- 9. How the ground truth for the training set was established: Not applicable. No training set is involved.
Summary:
This 510(k) submission establishes substantial equivalence to a predicate device (COROMETRICS MODEL 171 AND 172 FETAL MONITOR, K991905) by comparing technological characteristics and adherence to recognized standards for safety and EMC. It does not present a standalone clinical performance study with specific acceptance criteria and detailed quantitative results as would be typical for more novel devices or those undergoing a PMA pathway.
§ 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).