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The intended use of "The Advance Catheter for HSG and SIS" is for the delivery of contrast media or saline during hysterosalpingogram (HSG) and saline infusion sonohysterography (SIS) into the female reproductive tract for examination of the uterus and/or fallopian tubes.

The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or selective evaluation of fallopian tube patency.

The Advance Catheter for HSG and SIS will be available in 5F size for patients with a nulliparous cervix and 7F size for patients with a multiparous cervix.

The "The Advance Catheter for HSG and SIS (Advance Catheter) consist of a plastic tube, the distal end of which has an inflatable balloon. When the balloon is inflated inside the uterus, the device seals the cervix. A stopcock is provided at the proximal end of the device to allow inflation of the balloon with a syringe. The center lumen is open through the device to the distal end, and the device has a luer connector at the proximal end for injecting fluids.

An introducing sheath is placed over the tube to provide a stiffener and quide. The sheath can be placed into the endocervix to the level of the internal os with no dilatation required; therefore, allowing the catheter to pass easily through the cervix and into the uterine cavity. The Advance catheter like its predicate will be available in 5F and 7F sizes.

This summary describes the acceptance criteria and study information for "The Advance Catheter for HSG and SIS" based on the provided 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The submission does not explicitly state sample sizes for tests such as biocompatibility, flow rate, or tensile strength. It refers to "test reports in sections 15 and 18," which are not provided in this excerpt. The tests appear to be non-clinical, laboratory-based performance tests, not human trials. Therefore, data provenance related to human subjects (e.g., country of origin, retrospective/prospective) is not applicable.

3. Number of Experts and Qualifications for Ground Truth

The provided document does not indicate the use of experts to establish a "ground truth" for the test set in the context of diagnostic accuracy. The study focused on engineering performance characteristics and substantial equivalence to legally marketed devices.

4. Adjudication Method

Not applicable. The study primarily describes non-clinical performance testing and a comparison to predicate devices, not an assessment requiring expert adjudication of a test set.

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

No MRMC comparative effectiveness study was conducted or reported in this submission. This device is an instrument for delivering contrast media, not a diagnostic imaging AI with human-in-the-loop performance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical catheter, not an algorithm.

7. Type of Ground Truth Used

For the non-clinical tests (biocompatibility, flow rate, tensile strength), the "ground truth" was defined by pre-specified engineering requirements and ISO standards (e.g., ISO10993). For the overall device, the "ground truth" for regulatory clearance was substantial equivalence to existing legally marketed devices, demonstrating comparable safety and effectiveness based on similar design, materials, and intended use.

8. Sample Size for Training Set

Not applicable. This device is a physical medical instrument, not a machine learning model requiring a training set.

9. How Ground Truth for Training Set was Established

Not applicable. As described above, there was no training set in the context of an algorithm.

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