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The product is intended for intermittent catheterization to drain urine from the urinary bladder. The product is intended for use on patients who are not capable of voluntary urination.
The proposed device is intended for use in the drainage of urine from the urinary bladder. The proposed active intermittent catheterization on patients who are not capable of rno production. This product is not designed for use as an indwelling catheter.

The Tyco Healthcare/Kendall DOVER® ROB-NEL Catheter is a sterile, single use, Intermittent urinary drainage catheter extruded from thermo-sensitive Polyvinyl chloride (PVC) material.

This 510(k) summary (K040897) describes a medical device, the Tyco Healthcare/Kendall DOVER® ROB-NEL Catheter, which is a urological catheter. It is a sterile, single-use, intermittent urinary drainage catheter made from thermo-sensitive PVC, intended for intermittent catheterization to drain urine from the urinary bladder in patients who are not capable of voluntary urination.

This submission is a Predicate-based submission and therefore does not include a study to prove the device meets acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (Tyco Healthcare/Kendall DOVER® ROB-NEL Catheter, 510(K) number K810216). This type of submission typically focuses on comparing the new device's intended use, technological characteristics (materials, design), and performance to the predicate device, rather than conducting new clinical performance studies with acceptance criteria, ground truth, or expert review.

Here's a breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Substantial Equivalence to Predicate Device:	The proposed DOVER® ROB-NEL Catheter is substantially equivalent to the predicate device (K810216) in intended use, physical, functional, and performance characteristics, materials, and design.
   Biocompatibility:	Meets requirements of ISO 10993, Part 1, with the FDA modified matrix presented in memorandum G95-1.

2. Sample size used for the test set and the data provenance: Not applicable. No specific test set to evaluate performance against acceptance criteria in the manner described for algorithmic devices. The "test set" here is essentially the comparison of the new device's design and materials to the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth established by experts in the context of a performance study for this device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication method described as there was no performance study with a test set of data points requiring expert review.

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 is a physical medical device (catheter), not an AI/software device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this 510(k) is the established safety and effectiveness of the legally marketed predicate device, as demonstrated through its history of use and compliance with regulatory standards.

8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/software device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" proving the device meets acceptance criteria is a substantial equivalence comparison to a legally marketed predicate device (Tyco Healthcare/Kendall DOVER® ROB-NEL Catheter, K810216) and nonclinical biocompatibility testing.

• Substantial Equivalence: The manufacturer asserts that the proposed device is substantially equivalent to the predicate device in its intended use, function, mode of operation, physical characteristics, functional characteristics, performance characteristics, materials, and design. This means the new device is considered as safe and effective as the predicate device without requiring new clinical trials to demonstrate effectiveness.
• Biocompatibility Testing: The device underwent biocompatibility testing to ensure its materials are safe for contact with the human body. This testing demonstrated that the device "meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1." This is a standard nonclinical evaluation for medical devices to assess potential adverse biological reactions.

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The Memcath Urology Catheter is intended to provide an intermittent pathway for draining fluids from the bladder.

The Memcath Urology Catheter is designed as an intermittent pathway for drainage of the bladder. The device consists of a PVC catheter tube with pre-loaded, self-deploying PTFE sheath membrane to increase lubricity during insertion. This catheter system also includes a polyurethane snap ring and polycarbonate/acrylic guide ring to secure the sheath.

The Memcath Urology Catheter is intended to provide an intermittent pathway for draining fluids from the bladder. The device was found substantially equivalent to the Sherwood-Davis & Geck Argyle Rob-Nel Urological Catheter (K810216).

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not specify the sample sizes used for each test. The studies were conducted by Memcath Technologies LLC and submitted to the FDA in the United States. They appear to be prospective tests performed on newly manufactured devices.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The ground truth for these tests is based on established engineering and materials performance standards for medical devices and their intended use, rather than expert clinical consensus in interpreting data.

4. Adjudication Method for Test Set

Not applicable. The tests are objective measurements against defined specifications.

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

Not applicable. This device is a physical medical catheter, not an AI/software-as-a-medical-device (SaMD) that typically undergoes MRMC studies.

6. Standalone Performance Study

Yes, standalone performance studies were conducted. The "Testing" section explicitly states that "Products were tested for" a list of attributes, and "All product testing met specifications." This indicates that the device's performance was evaluated independently against pre-defined criteria.

7. Type of Ground Truth Used

The ground truth used for these performance tests is based on engineering specifications and established regulatory standards for urological catheters, often with reference to predicate devices. For example, "Flow Rate," "Stiffness," and "Kink Resistance" have objective, measurable benchmarks that must be met. "SAL" pertains to sterility standards, and "EtO Residuals" to acceptable levels of ethylene oxide post-sterilization.

8. Sample Size for Training Set

Not applicable. This device is a physical medical device, not an AI/machine learning model, so there is no "training set."

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for a physical medical device.

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