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Intermittent catheters are indicated for routine transient intermittent drainage of the bladder. The cather is inserted through the urethra.

GentleCath Glide intermittent catheter is intended for adult use only.

A hydrophilic urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids from the bladder. The tip/distal end of the tube are inserted into the urethra and the funnel/connector end is used to drain the urine or can be connected to a urine drainage bag. The device is made using Polyolefin Based Synthetic Thermoplastic Elastomer (TPE) as base material with the addition of an additive material is hydrophilic and makes the surface slippery when wetted with water.

The document provided is a 510(k) premarket notification for a medical device called "GentleCath Glide Intermittent Catheter." It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence. However, it does not contain a study that establishes acceptance criteria for specific performance metrics and then reports the device's performance against those criteria in the format requested.

The "Performance Testing - Bench" section (Page 4) mentions that the following comparison tests were performed to demonstrate equivalence:

1. Flow Rate
2. Catheter Tensile properties
3. Coefficient of Friction

It states: "The laboratory testing shows no differences that would indicate the GentleCath Glide Intermittent Urinary Catheter would be any less safe or effective than the predicate devices. All the parameters are similar or superior for the GentleCath Glide Intermittent Urinary Catheter."

However, detailed numerical acceptance criteria for these tests or specific reported performance values for the GentleCath Glide, linked to a formal study with defined sample sizes, ground truth, or expert involvement, are not provided in this document. The document focuses on demonstrating substantial equivalence through a feature-by-feature comparison with predicates rather than presenting a performance study with acceptance criteria.

Therefore, most of the requested information cannot be extracted directly from this document.

Missing Information:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or its effect size.
• Details of a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

The document only broadly states that the device's flow rate, tensile properties, and coefficient of friction were "similar or superior" to predicate devices, without providing specific quantitative data or acceptance thresholds for these performance parameters.

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The Cure Catheter ® Hydrophilic Coated is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage. The urinary catheter comes in a variety of sizes, packaged sterile for single-use.

The Cure Catheter ™ Hydrophilic Coated is an intermittent urinary catheter intended to be used by adult and pediatric males and females for the purpose of bladder drainage. The catheter is manufactured with conventional medical grade PVC. The surface is coated with a hydrophilic low-friction coating (polyvinyl pyrrolidone, or PVP) and, when activated with water it becomes slippery and ready to use. The straight and Coudè tip configurations have been designed to eliminate trauma to the urethra and are offered in a variety of sizes. Each catheter is provided in sterile, single-use packages.

The provided text is a 510(k) summary for the Cure Catheter® Hydrophilic Coated. It predominantly focuses on demonstrating substantial equivalence to predicate devices based on device features, materials, and intended use, rather than on detailed performance criteria suitable for AI/ML devices. Therefore, much of the requested information (acceptance criteria for performance metrics, details of studies with test sets, ground truth establishment, sample sizes for training/test sets, expert qualifications, MRMC studies, and standalone performance) is not applicable or not provided in the document.

The document states that performance testing was conducted through "design verification and design validation activities," and these support the device's functionality and safety/effectiveness. However, specific acceptance criteria and detailed quantitative results from these tests are not provided in this summary.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not provided. The document does not detail specific "test sets" in the context of typical AI/ML performance studies. It refers to "design verification and design validation activities," which are general engineering and quality assurance processes, but doesn't quantify samples or data provenance in this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable / Not provided. The device is a physical medical device (urinary catheter), not an AI/ML diagnostic tool requiring expert-established ground truth on a test set of data.

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

• Not applicable / Not provided. See point 3.

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 / Not done. This is a physical device, not an AI system designed to aid human readers.

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

• Not applicable / Not done. This is a physical device.

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

• Not applicable. For a physical device like a catheter, "ground truth" typically refers to engineering specifications, material properties, and clinical performance in terms of safety and efficacy (e.g., ability to drain bladder without complications). The document states biocompatibility and functional performance were verified, implying such engineering and potentially in-vitro/in-vivo testing was done, but specific "ground truth" establishment methods as one would define them for an AI/ML device are not relevant or detailed.

8. The sample size for the training set:

• Not applicable / Not provided. This is not an AI/ML device.

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

• Not applicable / Not provided. This is not an AI/ML device.

Summary of Study that Proves the Device Meets Acceptance Criteria:

The document broadly states that:

• "Studies conducted per US FDA General Program memorandum #G95-1 indicate that the Cure Catheter ™ Hydrophilic Coated is biocompatible and safe for its intended use."
• "Product evaluation, through design verification and design validation activities, supports the device's functionality without new questions of safety or effectiveness."

These statements imply a series of standard medical device testing, likely including:

• Biocompatibility testing: To ensure the materials (PVC, hydrophilic coating) are safe for contact with the human body, following standards like ISO 10993.
• Physical and Mechanical Testing: To verify properties like tensile strength, catheter tip integrity, coating durability, flow rates, and lubricity.
• Sterilization Validation: To ensure the sterilization process is effective.
• Packaging Validation: To ensure sterility is maintained until use.
• Potentially, simulated use or in-vitro performance testing: To confirm the hydrophilic coating's activation and low friction properties under simulated physiological conditions.

However, the 510(k) summary does not provide specific details on the methodologies, sample sizes, or quantitative results of these "studies," as its primary purpose is to demonstrate substantial equivalence to existing predicate devices, rather than a detailed report of novel performance data. The FDA's clearance (K132500) confirms that based on the provided information, the device was deemed substantially equivalent to already legally marketed devices.

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The BEVER™ intermittent catheter is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder -voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain.

BEVERTM Intermittent Catheter is sterile, single use device to be designed as an intermittent pathway for drainage of the bladder. It is available for men, women and children, in uncoated and coated variants and in two different tip configurations of Nelaton (straight and rounded) and Tiemann (curved and tapered) respectively. There are two polished drainage eyelets on the catheter in various configurations and types. The uncoated catheter consists of a tubular polyvinyl chloride catheter shaft with attached a drainage funnel. The catheter is available in sizes 6Fr ~ 22Fr in 2Fr increments for Nelaton-tip and sizes 8Fr ~ 22Fr in 2Fr increments for Tiemann-tip. The coated catheter consists of a tubular polyvinyl chloride catheter shaft, coated with a hydrophilic low-friction coating, with attached a drainage funnel, and a sterile water packet is placed in the package. The surface of coated catheter is hydrophilic and when the coated catheter is activated with the sterile water in the attached water packet, it becomes slippery and thus reduces friction against the urethra.

The provided text describes the regulatory submission for the BEVER™ Intermittent Catheter, primarily focusing on demonstrating substantial equivalence to predicate devices rather than an efficacy study with specific acceptance criteria related to clinical performance. The "Device Performance" section refers to compliance with EN standards, and then details a series of biocompatibility tests.

Therefore, many of the requested elements for a study proving device meets acceptance criteria (such as sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for test and training sets) are not applicable or not provided in this regulatory submission document.

However, I can extract the information relevant to the acceptance criteria and performance as presented:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria here are based on compliance with established standards (EN and ISO) and the qualitative outcomes of the conducted tests (e.g., no cytotoxicity, non-irritant, no sensitization, no tearing). There are no specific quantitative performance metrics like sensitivity, specificity, or accuracy mentioned as this is a medical device (catheter) and not an AI/diagnostic device.

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

• Cytotoxicity Test: L-929 mouse fibroblast cells were used. The specific number of replicates or wells is not explicitly stated but implied by the use of "a 96-well microplate." Data provenance is laboratory testing.
• Irritation Test: Test articles were contacted with vaginal tissue (animal model implied). The number of test subjects (animals) is not specified. Data provenance is laboratory testing.
• Sensitization Test: Ten test guinea pigs (per extract) for the test group and five control guinea pigs (per vehicle) for the control group were used. Data provenance is laboratory testing (animal study).
• Packaging Shipment Testing: 2 pieces of packaged-products were submitted for testing. Data provenance is laboratory testing.
• Shelf Life Testing: The sample size for accelerated and real-time aging studies is not specified in the provided text. Data provenance is laboratory testing.

The country of origin for the data (tests) is not explicitly stated, but the submitter is based in Hangzhou, China, suggesting the testing was likely conducted there or overseen by the Chinese manufacturer. All studies appear to be prospective studies conducted for regulatory submission.

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

• Not applicable. The tests performed are laboratory-based assays (e.g., cell viability, tissue examination, animal skin reaction, physical integrity) whose "ground truth" is determined by the experimental results and established biological/physical standards, rather than expert consensus on complex diagnostic images or clinical scenarios. No human expert interpretation to establish a ground truth is mentioned beyond standard laboratory practice.

4. Adjudication Method for the Test Set

• Not applicable. As noted above, the tests are laboratory-based with objective measurements (e.g., cell viability assays, macroscopic/microscopic tissue examination, visual inspection for tearing). There is no mention of a subjective "test set" requiring adjudication in the context of clinical or diagnostic performance.

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. This document describes a medical device (intermittent catheter), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or human reader improvement with AI are not relevant.

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

• Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Biocompatibility (Cytotoxicity, Irritation, Sensitization): Ground truth was established based on the results of standardized biological assays interpreted against pre-defined criteria in ISO 10993 standards and the control groups. For example, cell viability percentage for cytotoxicity, macroscopic and microscopic evaluation for irritation, and skin reaction scoring for sensitization.
• Physical/Material/Packaging/Sterility/Shelf Life: Ground truth was established by demonstrating compliance with specific EN and ISO standards and by meeting the device specifications after various tests (e.g., physical inspection, sterility indicator, stability testing).

8. The Sample Size for the Training Set

• Not applicable. This is a medical device, not an AI/machine learning model, so there is no concept of a "training set" in this context. The manufacturing processes and material selection might be informed by historical data or R&D, but not a formally defined "training set" for an algorithm.

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

• Not applicable, as there is no training set mentioned for this medical device.

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