(233 days)
The Rivulet™ Ventricular Catheter is designed for use as the proximal component of CSF Flow Control Shunts used in shunting cerebrospinal fluid from the ventricles of the brain to the peritoneal cavity or the right atrium of the heart.
The Rivulet™ Ventricular Catheter is a proximal catheter used in the shunting of cerebrospinal fluid (CSF), allowing for the drainage of CSF from the ventricles of the brain. The Rivulet Catheter has varying sized, evenly spaced inlet flow holes located within 1.15 cm (0.45") of the tip of the catheter. The Rivulet Catheter is designed to equalize the distribution of inflowing CSF across all of the inlets holes as well as allow for intraventricular positioning of the inlet flow holes further away from the choroid plexus.
The Rivulet Catheter is available in two (2) shunt system connector styles: standard and snap shunt. The Rivulet Catheter with a standard connector measures 15 cm (5.9") in length, 0.15 cm (.06") in inner diameter, 0.25 cm (0.10") in outer diameter. The Rivulet Snap Shunt Catheters are available in lengths ranging from 4 cm (1.6") to 14 cm (5.5"). The Rivulet Catheters contain length markers to aid in determining depth of placement. To facilitate the placement and use of the Rivulet Catheters, procedural accessories supplied with the Rivulet Catheter include a stainless steel stylet, and a Right Angle Clip or Snap Base.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Medtronic Rivulet™ Ventricular Catheter:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Similar Technological Characteristics to Predicate Devices | "The Rivulet Catheter has similar technological characteristics to the currently marketed predicate devices..." |
| Conforms to ISO 7197 | "...and conforms to the ISO 7197 Neurosurgical implants - Sterile single-use hydrocephalus shunts and components." |
| Equalized CSF Flow Across Inlet Holes | "The Rivulet Catheters incorporate inlet flow hole configuration changes that allow the CSF to flow in a more equalized manner across all inlet holes..." |
| Allows for Intraventricular Positioning Further from Choroid Plexus | "...and allows for intraventricular positioning of the inlet holes further away from the choroid plexus in normalized ventricles." |
| Indications for Use, Function, Implantation Techniques, Performance Characteristics, Design Specifications, and Test Standards are the Same as Predicate | "Medtronic Neurosurgery submits that the indications for use, function, implantation techniques, performance characteristics, design specifications, and test standards of the Rivulet Catheter are the same as the previously reviewed and cleared Ventricular Catheter and Ventriculostomy Reservoir." |
| Substantial Equivalence, Safety, and Efficacy | "Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the Rivulet Catheter based upon the predicate and currently marketed devices." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a numerical sample size for a test set in the context of a clinical study or performance evaluation with human subjects. The evaluation relies primarily on comparison to predicate devices and adherence to an international standard.
The data provenance is not directly applicable in the sense of clinical study data from a specific country, as the argument is based on design equivalency and conformance to standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The device approval appears to be based on engineering design, comparison to predicate devices, and adherence to an international standard, rather than a clinical trial requiring ground truth establishment by a panel of experts.
4. Adjudication Method for the Test Set
This information is not provided and is not relevant to the type of device evaluation described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done as described in the document. The device is a medical implant (ventricular catheter), not a diagnostic or AI-assisted interpretation tool. The comparison is between the new device's design and existing predicate devices, along with conformance to an ISO standard.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not Applicable. This device is a physical medical component, not an algorithm, and therefore does not have a "standalone" algorithmic performance in the context of AI or diagnostic imaging.
7. Type of Ground Truth Used
The "ground truth" for this submission appears to be established through:
- Predicate Device Performance: The known and accepted performance characteristics of the Medtronic PS Medical® Ventricular Catheter (K792007) and Medtronic Ventriculostomy Reservoir (K874498).
- International Standard Conformance: Adherence to ISO 7197 Neurosurgical implants - Sterile single-use hydrocephalus shunts and components.
- Engineering Design and Testing (Implicit): While not detailed, the claims of "similar technological characteristics" and "equalized flow" imply underlying engineering design, testing, and validation demonstrating these features.
8. Sample Size for the Training Set
Not Applicable. This document describes the submission for a medical device (catheter), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it does not apply.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).