Search Results

The InCare Pre-lubricated Intermittent Catheter is indicated for use by male, female and pediatric patients for the purpose of bladder drainage. The Catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.

The InCare Advance and Advance Plus Intermittent Catheters are pre-lubricated with gel to promote easy insertion and user convenience. The catheter gel is contained in an integral reservoir, which eliminates gel migration throughout the package. The InCare Advance and Advance Plus catheters are sterile, non-latex, polyvinyl chloride catheters. A unique manufacturing process ensures that the eyes of the intermittent catheters are polished and smooth to help eliminate trauma to the urethra, reducing the possibility of hematuria. The catheter packaging has been designed to facilitate easy opening for those users with limited dexterity. Both catheters incorporate a no-touch design, which enables the user to easily insert the catheter without direct hand contact, thus reducing the possibility of contamination. The InCare Advance Plus Intermittent Catheter has an introducer tip that is intended to reduce reoccurring UTI and a collection bag to contain urine. The InCare Advance Plus is also available in a kit known as InCare Advance Plus Kit. The InCare Advance and Advance Plus pre-lubricated intermittent catheters are available in various sizes and with a straight or coude tip to accommodate a wide range of male, female, and pediatric end users.

The provided text is a 510(k) Summary for the InCare Pre-lubricated Intermittent Catheters. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance acceptance criteria through a clinical study. Therefore, much of the requested information (acceptance criteria, study details, sample sizes, expert involvement, ground truth, effect size with AI assistance, etc.) is not typically included or required in a 510(k) Summary for a device like this.

The 510(k) summary focuses primarily on:

• Identifying the device and its intended use.
• Comparing its technological characteristics to legally marketed predicate devices.
• Demonstrating biocompatibility through established guidelines and standards.

Here's an analysis of the provided text in relation to your request:

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

• Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for device performance. The primary "acceptance" relies on demonstrating substantial equivalence to predicate devices, meaning it works similarly (design, materials, intended use) and addresses basic safety (biocompatibility).
• Reported Device Performance: Instead of performance metrics, the document describes features designed for performance and safety:
  • Pre-lubricated with gel for easy insertion and user convenience.
  • Gel contained in an integral reservoir to prevent migration.
  • Sterile, non-latex, PVC material.
  • Polished and smooth eyes to prevent urethral trauma and hematuria.
  • Packaging designed for easy opening for users with limited dexterity.
  • No-touch design to reduce contamination.
  • InCare Advance Plus has an introducer tip to reduce recurring UTIs and a collection bag.

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

• The document does not describe a clinical "test set" or a study involving human subjects to evaluate these performance characteristics. The assessment primarily relies on a biocompatibility assessment based on established principles and guidelines (United States Pharmacopoeia, G95-1, ISO 10993-1). This is a non-clinical evaluation of the materials.

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 as there was no clinical test set or ground truth established by experts in the context of device performance in humans. The "ground truth" for biocompatibility would be the results of standard biocompatibility tests interpreted by toxicologists or materials scientists, but these details are not provided.

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

• Not applicable as there was no clinical test set requiring adjudication.

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 device is an intermittent catheter, not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic imaging systems, often involving AI.

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

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

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

• For biocompatibility, the "ground truth" is based on the results of standardized biological safety tests (e.g., cytotoxicity, sensitization, irritation) and their comparison against established thresholds and guidelines mentioned (USP, ISO 10993-1). There is no mention of expert consensus, pathology, or outcomes data in the context of a clinical study for this 510(k).

8. The sample size for the training set

• Not applicable. This device is not an AI model, so there is no "training set."

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

• Not applicable. This device is not an AI model, so there is no "training set" or ground truth established for it.

In summary, the provided document outlines a 510(k) submission focused on demonstrating substantial equivalence and biocompatibility, not comprehensive performance criteria through clinical studies. The "study" mentioned is a "biocompatibility assessment" based on established regulatory guidelines and standards rather than a clinical trial with human subjects and performance metrics.

Ask a specific question about this device