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The Radionics Equi-Flow™ Valve, Ventricular Catheter, and Peritoneal Catheter with EZ-Coat™ are indicated for the treatment of hydrocephalus. They are devices designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the peritoneal cavity. The Equi-Flow™ Valve with EZ-Coat™ is indicated for patients where excessive reduction of intraventricular pressure or volume may be caused by the siphoning effect of hydrostatic pressure in the distal catheter of the shunt system.

The Equi-Flow Valve™ with EZ-Coat, the EZ-Coat™ Ventricular Catheter, and the EZ-Coat™ Peritoneal Catheter are designed for use as a cerebrospinal fluid shunts. The Equi-Flow Valve with EZ-Coat is a membrane valve with an integral Siphon Limiting Device. The Siphon Limiting Device limits the reduction of the intraventricular pressure and volume caused by the siphoning effect caused by elevation of the ventricular catheter in relation to the distal catheter (often caused by the patient sitting or standing). This 510(k) covers the use of a hydrophilic surface modification that has been incorporated into the commercially available Equi-Flow Valve and Catheters. This material was subjected to and passes biocompatibility testing like the unmodified commercially available valves and catheters designed to meet the requirements of the ISO Standard 10993. In addition, performance testing was performed on the valves with the EZ-Coat modification to confirm valve performance. There is no change to the designs. dimensions, or specifications of the valves with the use of the EZ-Coat surface modification.

This 510(k) submission (K980903) for the Radionics Equi-Flow™ Valve and Catheters with EZ-Coat™ describes a modification to an existing device (addition of a hydrophilic surface modification). As such, the study primarily focuses on demonstrating that the modified device performs similarly to the predicate device and meets established biocompatibility standards. This is not a typical AI/ML device submission, and therefore many of the requested criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable.

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Acceptance Criteria and Device Performance (for a physically modified medical device)

The submission focuses on demonstrating that the addition of the "EZ-Coat™" hydrophilic surface modification does not negatively impact the device's safety or performance compared to the unmodified predicate and that it meets biocompatibility standards.

Study Details (as inferable for a non-AI/ML device modification)

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

   • Not Applicable / Not provided for specific performance testing. The submission confirms biocompatibility testing and performance testing were done, but the sample sizes or provenance of these tests are not detailed in this summary. These are typically laboratory-based engineering and biological tests, not clinical studies with patient data.

2. 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. This is a physical device modification, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis. Biocompatibility and performance testing are typically assessed by engineers and toxicologists against established standards.

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

   • Not Applicable. This concept is for clinical data interpretation, which is not the focus here.

4. 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:

   • No. This is a physical medical device, not an AI/ML product that assists human readers.

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

   • Yes, in the context of device performance. The performance testing mentioned ("Performance testing was performed on the valves with the EZ-Coat modification to confirm valve performance") would be a standalone evaluation of the device's physical properties against its specifications. There is no "algorithm" or "human-in-the-loop" concept here.

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

   • Established engineering specifications and ISO standards. For biocompatibility, the ground truth is compliance with ISO Standard 10993. For valve performance, the ground truth would be the pre-defined performance specifications of the predicate device.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device. There is no concept of a "training set."

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

   • Not Applicable. As above, no training set for an AI/ML algorithm.

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