Search Results

The UroGen Ureteral Catheter is indicated for use by physicians for facilitating access to the urinary tract through a retrograde route and may be used in conjunction with a guidewire or for the injection of gels or fluids into the urinary tract.

The device is a single use ureteral catheter, designed to assist in access to the upper urinary tract using standard endoscopic technique for drainage and delivery of gels or fluids. The catheter is indicated for use by physicians for facilitating access to the urinary tract through a retrograde route and may be used in conjunction with a guidewire or for the injection of gels or fluids into the urinary tract.

The catheter is supplied sterile in a Tyvek pouch with a sterilization indicator. The catheter is inserted into the body for a typical duration of less than 1 hour. The catheter is placed over a guidewire of up to 0.038 inches in diameter that is prepositioned through the urological tract.

The UroGen Ureteral Catheter is indicated for use by physicians for facilitating access to the urinary tract through a retrograde route and may be used in conjunction with a guidewire or for the injection of gels or fluids into the urinary tract.

Here's an analysis of the acceptance criteria and the study data provided for the UroGen Ureteral Catheter:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria in a dedicated table. Instead, it lists the types of tests performed and indicates that they were "successfully completed" or "addressed by bench testing and validation." The implicit acceptance criterion for each test is that the device must meet the requirements of the referenced standard or, in the case of an internal standard, perform as intended without raising safety or effectiveness concerns.

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

The document does not specify the exact sample sizes used for each individual test. It generally states that "testing was conducted." The provenance of the data is from laboratory testing and not from human patient data (retrospective or prospective). The location of the testing laboratories is not specified, but the applicant's address is Ra'anana, Israel, and New York, NY, USA.

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

This information is not applicable to this submission. The "ground truth" for device performance in this context is established by the technical specifications of the referenced standards and internal engineering specifications, not by expert interpretation of clinical data or images.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical study data where multiple experts assess the same cases. For device bench testing, the assessment is based on objective measurements and compliance with predefined technical criteria from standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/imaging devices where human readers interpret medical images. This submission describes a physical medical device (catheter) and its bench testing.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

This concept is not directly applicable. The device itself is a standalone physical product. The performance studies described are essentially "standalone" in the sense that they evaluate the device's physical properties and functionality without human patient interaction during the tests described.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the UroGen Ureteral Catheter in these studies relates to:

• Compliance with International Standards: The device's performance is compared against the established specifications and requirements outlined in internationally recognized standards (e.g., ISO 10993, ISO 10555, ASTM F623-99, EN 13868, EN 1616, ISO 594, ANSI/AAMI/ISO 11135, AAMI/ISO 11138, EN 1422).
• Internal Standard Specifications: For the "Instillation force test," an internal standard was used, implying predefined engineering specifications for acceptable performance.
• Safety and Effectiveness Principles: The ultimate "ground truth" for regulatory clearance is that the device is as safe and effective as its predicate device without raising new safety or effectiveness concerns.

8. The Sample Size for the Training Set

This information is not applicable. "Training sets" are relevant for machine learning or AI models. The UroGen Ureteral Catheter is a physical medical device, and its design and manufacturing process do not involve a training set in the context of AI.

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

This information is not applicable, as there is no training set for this device.

Ask a specific question about this device