Search Results

Using the 2.3 MHz probe: Early detection of fetal life, detection of multiple pregnancies, fetal screening from early gestation through delivery, general indication of fetal well being. Using the 5.1 Mhz probe: Detection of blood flow in the peripheral vascular system of the body

The Cadence system utilizes the well understood principle of Doppler shift of an ultrasound signal to detect the flow of blood within the body. The system consists of a base unit that contains the speaker, the volume and on/off controls. The base unit is connected to a 2.3 MHz CW transducer, or to a 5.1 MHz CW transducer via a coil cord. The Cadence operates from a single 9 volt battery.

This document describes the Medasonics Cadence Doppler Ultrasound System (K991441), a device cleared in 1999. The submission does not contain a study that establishes acceptance criteria through performance data; instead, it relies on substantial equivalence to legally marketed predicate devices. Therefore, many of the requested details about acceptance criteria and study design are not present in this 510(k) summary.

Here's a breakdown of the information that can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table with specific acceptance criteria (e.g., sensitivity, specificity, accuracy) or quantitative performance metrics for the Cadence Doppler Ultrasound System. The device's safety and effectiveness are established through substantial equivalence to predicate devices, rather than through a performance study against predefined criteria.

2. Sample Size Used for the Test Set and Data Provenance

No test set or performance study data is included in this 510(k) summary. The submission is based on a claim of substantial equivalence.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable, as no dedicated test set requiring expert-established ground truth is described in this submission.

4. Adjudication Method for the Test Set

Not applicable, as no test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned or provided in this 510(k) summary. The submission does not include any information about human reader performance with or without AI assistance, as the device is a Doppler Ultrasound System, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable, as the device is a standalone hardware Doppler Ultrasound System, not an algorithm, and its performance is not evaluated in an "algorithm only" context.

7. Type of Ground Truth Used

Not applicable, as no performance study with a formally established ground truth is presented in this 510(k) summary.

8. Sample Size for the Training Set

Not applicable, as this device submission does not relate to machine learning or AI models that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this device submission does not involve machine learning or AI models.

Summary of Device and Regulatory Approach (from the provided text):

The Medasonics Cadence Doppler Ultrasound System is a Class II device (per 21 CFR 884.2660) intended for:

• 2.3 MHz probe: Early detection of fetal life, detection of multiple pregnancies, fetal screening from early gestation through delivery, general indication of fetal well-being.
• 5.1 MHz probe: Detection of blood flow in the peripheral vascular system of the body.

The device's substantial equivalence was established against:

• Medasonics Incorporated Models FP3B and BF4B (Pre-amendment devices)
• Huntleigh Technologies Dopplex II Pocket Doppler (K930200, cleared 6/24/94)

The FDA reviewed the 510(k) notification and determined the device to be substantially equivalent to the legally marketed predicate devices. The clearance was conditional upon the submission of a post-clearance special report containing complete information, including acoustic output measurements based on production line devices, as requested in Appendix G of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." This condition is a manufacturing and safety verification, not a performance study to establish acceptance criteria for a diagnostic outcome.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device