Search Results

The Urinary Catheter is indicated for use to facilitate access to the urinary tract through a retrograde route for the delivery of gels or fluids into the urinary tract.

The Urinary Catheter is a single use 12 Fr or 16 Fr urethral catheter with a fixed female Luer lock hub. The catheter has a Coudé (Tiemann) tip, is 40 cm long. The catheter tube is made of Polyvinylchloride (PVC) and the Luer lock hub is made of Polycarbonate. The catheter is uncoated. The device is designed to assist in access to the urinary bladder using standard technique for drainage and delivery of gels or fluids. The catheter is indicated for use by healthcare professionals for facilitating access to the urinary tract through a retrograde route, for the delivery of gels or fluids into the urinary tract. The catheter is supplied sterile in a Tyvek pouch. The catheter is inserted into the body for a typical duration of less than 1 hour.

I cannot fulfill your request to describe the acceptance criteria and study proving device performance as the provided text is a 510(k) summary for a urinary catheter, which is a physical medical device, not an AI/ML-driven device.

The questions you've asked (e.g., number of experts, ground truth, MRMC study, training data) are relevant to the evaluation of AI/ML-powered medical devices, specifically those that analyze data (like images) to provide diagnostic or prognostic information. The provided document describes the regulatory clearance for a physical urinary catheter based on its substantial equivalence to predicate devices and bench testing for physical characteristics like flow rate, kink resistance, and tensile force.

Therefore, the information required to answer your questions (acceptance criteria for AI performance, clinical study results for AI, ground truth establishment, training set details) is not present in this document.

Ask a specific question about this device

The Cystoject Syringe Lever Device is intended for use in the administration of sterile materials under aseptic conditions, in a clinical urology setting, by a clinician and in accordance with the best judgment of a physician.

The Cystoject Syringe Lever is a reusable device that is intended for use in the delivery of sterile materials under aseptic conditions, in a clinical urology setting, by a clinician and in accordance with the best judgment of the physician. The Cystoject Syringe Lever body contains a housing for holding a standard syringe and a lever that pushes the syringe's plunger when the user rotates its knob. A clutch mechanism allows the user to quickly move the lever to the syringe plunger's position. The Cystoject Syringe Lever does not require an energy source, does not utilize electrical components, and does not utilize software or hardware. The Cystoject Syringe Lever does not come into direct or indirect contact with the patient nor with fluids intended for instillation. The Cystoject Syringe Lever is provided non-sterile as a reusable, reprocessable device to be cleaned and sterilized or high-level disinfected before each use. The Cystoject Syringe Lever indicated for use with a 30 mL syringe.

The provided text describes a 510(k) premarket notification for the "Cystoject Syringe Lever." This is a device for administering sterile materials, not an AI/ML powered device, therefore the typical acceptance criteria and study information for AI/ML devices, such as performance metrics, sample sizes for test and training sets, expert qualifications, and MRMC studies, are not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device (Uroject12 Syringe Lever) based on intended use, technological characteristics, and non-clinical performance tests.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

The document states that "The results of the validation testing demonstrate that the Cystoject Syringe Lever met all predetermined acceptance criteria." However, the specific acceptance criteria and detailed performance results are not publicly available in this FDA letter/summary. The performed tests were:

2. Sample size used for the test set and the data provenance:

Not applicable. The described tests are non-clinical (validation testing of the physical device), not an evaluation of diagnostic accuracy using a test set of medical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is not an AI/ML device that requires expert-established ground truth for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. The "ground truth" for a mechanical device's performance would be engineering specifications and functional requirements.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that utilizes a training set.

9. How the ground truth for the training set was established:

Not applicable.

Ask a specific question about this device

The Uroject 12 Syringe Lever Device is intended for use in the administration of sterile materials under aseptic conditions, in a clinical urology setting, by a clinician and in accordance with the best judgment of a physician.

The Uroject12 Syringe Lever body contains syringe housing for holding a standard 20 mL syringe and a dispensing mechanism that is manually operated by rotating a knob that presses the syringe piston. A clutch mechanism facilitates fast adaptation of the injection mechanism to the syringe piston position. The Uroject12 Syringe Lever is a reusable, reprocessed device to be sterilized before each use and cleaned after use.

The compatible syringes to be used with the Uroject12 are: 20 mL MEDALLION® syringe (Catalog Number MSS121, Merit Medical, Salt Lake City, UT, USA) and 20 mL MEDALLION® COP syringe (Catalog Number COP121PC, Merit Medical, Salt Lake City, UT, USA).

The provided text describes the Uroject12 Syringe Lever, a device for administering sterile materials in a clinical urology setting. This document is a 510(k) summary submitted to the FDA, asserting substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not list specific numerical acceptance criteria for performance metrics (like accuracy, precision, or specific failure rates) and their corresponding reported device performance values in a table. Instead, it states:

"The results of the validation testing demonstrated that the Uroject12 Syringe Lever is considered safe and effective for its intended use."

The primary "acceptance criterion" appears to be demonstrating substantial equivalence to the predicate device, especially concerning the new reprocessing instructions.

Study Information

Based on the provided document, the study conducted was focused on the reprocessing instructions for the device, not its core operational performance, as the device itself hasn't changed.

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not explicitly stated in terms of the number of devices or cycles tested for the high-level disinfection and automated cleaning processes.
   • Data Provenance: Not specified, but generally, validation testing for medical devices is conducted in controlled laboratory settings. The applicant is UroGen Pharma Ltd., located in Israel. The data would be prospective, as it's validation testing for new instructions.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Not applicable/Not mentioned. The validation testing pertained to the efficacy of cleaning and disinfection processes, which typically involve microbiological and chemical testing against established standards, not expert clinical interpretation.

3. Adjudication Method for the Test Set:

   • Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., imaging studies) to resolve discrepancies among experts. This validation focused on objective performance metrics related to reprocessing.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC comparative effectiveness study was not done. The document focuses on performance validation related to reprocessing, not a comparison of human reader performance with or without AI assistance.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • Not applicable. The Uroject12 Syringe Lever is a physical medical device, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.

6. The Type of Ground Truth Used:

   • For the validation of high-level disinfection and automated cleaning processes, the "ground truth" would be established microbiological and chemical standards for cleanliness, sterility, and material compatibility after reprocessing. The document implicitly states that the validation "demonstrated that the Uroject12 Syringe Lever is considered safe and effective for its intended use" after these processes.

7. The Sample Size for the Training Set:

   • Not applicable. The device is not an AI/ML algorithm, so there is no "training set."

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set for this type of device.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence for a physical medical device, specifically addressing new reprocessing instructions. It does not contain the detailed study design, performance metrics, and expert-based ground truth information typically found for AI/ML devices or clinical trials assessing diagnostic accuracy. The "study" mentioned refers to validation testing of cleaning and disinfection protocols.

Ask a specific question about this device

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

The Uroject 12 Syringe Lever Device is intended for use in the administration of sterile materials under aseptic conditions, in a clinical urology setting, by a clinician and in accordance with the best judgment of a physician.

The Uroject12 Syringe Lever body contains syringe housing for holding a standard 20 mL syringe and a dispensing mechanism that is manually operated by rotating a knob that presses the syringe piston. A clutch mechanism facilitates fast adaptation of the injection mechanism to the syringe piston position. The Uroject12 Syringe Lever is a reusable, reprocessed device to be sterilized before each use and cleaned after use.

The compatible syringes to be used with the Uroject12 are: 20 mL MEDALLION® syringe (Catalog Number MSS121, Merit Medical, Salt Lake City, UT, USA) and 20 mL MEDALLION® COP syringe (Catalog Number COP121PC, Merit Medical, Salt Lake City, UT, USA).

Here's an analysis of the provided text regarding the Uroject12 Syringe Lever, extracting information about its acceptance criteria and the study proving it meets them.

It's important to note upfront that this document is an FDA 510(k) K180345 clearance letter and summary for a medical device, not an AI/ML medical device. Therefore, the questions related to AI/ML specific aspects like "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only without human-in-the-loop performance)," "training set," and "ground truth for the training set" are not applicable to this submission. This document describes a physical medical device (a syringe lever) and its performance through bench testing, not an AI algorithm.

Acceptance Criteria and Study Proving Device Meets Criteria

The document focuses on demonstrating the substantial equivalence of the Uroject12 Syringe Lever to a predicate device through performance data from bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device