(81 days)
Cadence series Fetal 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. It is not intended for use in intensive care units, operating rooms or for home use.
There are four models included in Cadence series Fetal monitor: Cadence, Cadence Dual, Cadence Pro and Cadence II.
The Fetal Monitor can provide different configurations according to different user requirements, FHR1 (Fetal Heart Rate 1), FHR2 (Fetal Heart Rate 2), TOCO, FM (remote marker), AFM (automatic fetal movement mark), FS (fetal stimulator, optional). The user can select the monitors according to requirements.
The Fetal monitor can be connected with Central Monitoring System via 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.
Cadence II adopts 5.7"LCD, and the collected data, trends, and monitoring parameters are displayed at the same screen. A built-in thermal recorder is used to record the monitoring information.
The data collected and stored by Fetal Monitor can be real-time transferred to PC or Obstetrical Central Monitoring System and can be managed and printed by the Insight software.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Edan Instruments Fetal Monitor:
Based on the provided text, the submission is a 510(k) premarket notification for a Fetal Monitor, which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria through rigorous clinical studies for a new technology. Therefore, many of the typical acceptance criteria and study elements you've requested are not explicitly detailed in this type of submission.
Here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are primarily based on equivalence to the predicate devices in terms of intended use, design, principle of operations, performance, and fundamental scientific technology. There are no explicit quantitative performance metrics or acceptance criteria stated in the document in the format of a clinical study endpoint.
| Acceptance Criterion (Inferred from Substantial Equivalence) | Reported Device Performance (Inferred) |
|---|---|
| Intended Use Equivalence: Monitoring physiological parameters of pregnant women during antepartum examination, labor, and delivery. | "YES - The intended use for the Fetal Monitor is equivalent to that for the predicate device." |
| Technological Equivalence: No new types of safety or effectiveness questions raised by technological characteristics. | "NO - The technological characteristics of the Fetal Monitor raise no new types of safety or effectiveness questions." |
| Design, Principle of Operations, Performance, and Fundamental Scientific Technology Equivalence: The device maintains equivalence to predicate devices. | "All design control activities including safety risk analysis and the verification and validation activities conducted as related to the risks proved that the modified Fetal Monitor is substantially equivalent in intended use, design, principle of operations, performance, and contains the same fundamental scientific technology as the predicate device listed above." |
| Fetal Heart Rate Detection: Functionality for 1 MHz PW transducer for fetal heart rate detection. | The device includes a "1 MHz PW waterproof fetal probe" with the intended use of "Diagnostic ultrasound imaging or fluid flow analysis of the human body" specifically for "Fetal" clinical application under "PWD" (Pulsed Wave Doppler) mode. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical "test set" in the context of a performance study to establish new acceptance criteria. The activities mentioned are "verification and validation activities" related to design control, which are typically engineering and functional tests rather than human-subject clinical trials for performance endpoints.
- Sample Size for Test Set: Not applicable/Not specified in the provided text, as this is a substantial equivalence submission, not a de novo performance study.
- Data Provenance: Not applicable/Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The document does not describe a clinical study that involved experts establishing ground truth for a test set. This type of submission relies on established safety and efficacy of predicate devices.
4. Adjudication Method for the Test Set
Not applicable. No clinical study for performance evaluation involving adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. The document makes no mention of an MRMC study or any comparative effectiveness study with human readers, with or without AI assistance. The Fetal Monitor is a monitoring device, not an interpretative AI algorithm for image analysis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a traditional fetal monitor, not an AI algorithm. Its function is to collect and display physiological data, not to perform standalone diagnostic interpretations without human involvement.
7. The Type of Ground Truth Used
Not applicable in the context of a clinical performance study. The "ground truth" here is effectively the accepted performance and safety of the legally marketed predicate devices to which the new device is compared for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. The device described is a hardware medical device (Fetal Monitor) and does not inherently involve machine learning algorithms that require a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See #8.
Summary of Device and Regulatory Context:
The submission for the Edan Instruments Fetal Monitor (models Cadence, Cadence Dual, Cadence Pro, Cadence II) is a 510(k) premarket notification. This regulatory pathway means the manufacturer is claiming that their new device is "substantially equivalent" to one or more legally marketed predicate devices and therefore does not require a new premarket approval (PMA) application, which would necessitate extensive clinical trials to establish de novo safety and effectiveness.
The "study" that proves the device meets the "acceptance criteria" (which are fundamentally criteria for substantial equivalence) consisted of:
- Verification and validation activities related to design control and risk analysis. These are typically engineering tests to ensure the device performs according to its specifications and is safe.
- Demonstrating equivalence in intended use, technological characteristics (no new safety/effectiveness questions), design, principle of operations, performance, and fundamental scientific technology to the predicate devices (Cadence [K040903] and Cadence II [K073221]).
The FDA's letter states that "We have reviewed your Section 510(k) premarket notification... and we have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." This confirms that the device met the criteria for substantial equivalence based on the provided information, rather than specific performance metrics from a large-scale clinical study.
§ 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).