(22 days)
The Integra NeuroSciences Contour-Flex Valve and Shunt System is used in treatment of patients with hydrocephalus. It is a component of a system designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site such as the atrium of the heart or to the peritoneal cavity.
The Integra NeuroSciences Contour-Flex™ Valve is a multi-function membrane valve with occluders and integral connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the bram. It incorporates a central reservoir for pumping and injection, proximal and distal occluders, and a fully flexible profile. The Contour-Flex Valve design includes a flat siliconc membrane, which provides resistance to CSF flow. The flat silicone membrane seats on a conical polypropylene base. This base is integral to a rigid outlet port. The design allows for accurate and precise regulation of CSF flow due to its structural integrity. The flat silicone membrane also prevents retrograde flow of CSF. The Contour-Flex valve is available in two s izes: R egular a nd S mall. B oth s izes a re a vailable in 3 pressure/flow c haracteristics ranges: low, medium, and high
This document (K033698) describes a 510(k) premarket notification for the Contour-Flex™ Valve and Shunt System, a medical device used in the treatment of hydrocephalus. The focus of this submission is on demonstrating substantial equivalence to a previously cleared device, rather than a clinical study evaluating novel performance against specific acceptance criteria in a clinical setting.
Therefore, many of the requested elements for a study that proves the device meets acceptance criteria are not directly applicable or available in this document. The "study" described here is primarily a series of engineering and performance tests to ensure the modified device functions similarly to its predicate.
Here's the information extracted from the provided text, addressing the points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety | Provided sterile and non-pyrogenic. | "The Contour-Flex™ Valve and Shunt Systems are provided sterile and non-pyrogenic." |
| Pressure/Flow Characteristics | Not explicitly stated, but implied to be equivalent to the predicate device and within specified ranges (low, medium, high). The design "allows for accurate and precise regulation of CSF flow due to its structural integrity." | "The Contour-Flex™ Valve and Shunt Systems have been tested for pressure/flow..." (No specific quantitative results are provided, but the conclusion states "The modified Contour-Flex™ Valve and Shunt System is substantially equivalent...") |
| Leakage | Not explicitly stated, but implied to be acceptable and equivalent to the predicate. The flat silicone membrane "also prevents retrograde flow of CSF." | "...leakage..." (Tested against, but no specific results beyond stating it was tested.) |
| Anti-reflux | Not explicitly stated, but implied to function as intended to prevent retrograde flow. | "...antireflux..." (Tested against.) The flat silicone membrane "also prevents retrograde flow of CSF." |
| Flushing Capability | Not explicitly stated, but implied to function correctly. | "...flushing capability..." (Tested against.) The device incorporates "a central reservoir for pumping and injection." |
| Catheter Elongation | Not explicitly stated, but implied to meet durability and flexibility requirements. | "...catheter elongation..." (Tested against.) |
| Catheter Bending | Not explicitly stated, but implied to meet durability and flexibility requirements. The device features a "fully flexible profile." | "...and bending..." (Tested against.) |
| Markings | Visually clear and correct. | "...markings visual inspection..." (Tested against.) |
| Pull Testing | Not explicitly stated, but implied to demonstrate adequate strength and secure connections. | "...pull testing..." (Tested against.) |
| Radiopacity | Not explicitly stated, but implied to be radiopaque for visualization. | "...and radiopacity." (Tested against.) |
| Overall Equivalence | The modified device does not affect the intended use, the fundamental scientific technology, and does not raise new issues of safety and effectiveness compared to the predicate. | "The modified Contour-Flex™ Valve and Shunt System is substantially equivalent to the unmodified Contour-Flex Valve and Shunt System. The modifications do not affect the intended use, the fundamental scientific technology of the device, and do not raise new issues of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. The document refers to "systems" and individual "components" being tested but does not give specific numbers for how many units were subjected to each test.
- Data Provenance: The tests are described as engineering/performance tests conducted on the device itself.
- Country of Origin: Integra NeuroSciences Implants SA is located in Sophia Antipolis Cedex, France. It's highly probable the testing was conducted at their facilities or by contracted labs, likely in Europe.
- Retrospective or Prospective: These are prospective tests performed on the manufactured device components to verify design specifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. For these engineering performance tests, "ground truth" is established by adherence to predefined engineering specifications and validated test methods, not by expert clinical review of test results in the same way it would be for a diagnostic AI device.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where multiple human readers assess cases and a consensus is needed for ground truth. For these performance tests, the outcome is typically pass/fail based on objective measurements against criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. This document describes a 510(k) submission for a physical medical device (hydrocephalus shunt system), not a diagnostic AI algorithm. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not conducted or reported here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This is not an AI algorithm.
7. The Type of Ground Truth Used
- Engineering Specifications and Performance Standards: The "ground truth" for these tests is the pre-defined engineering specification or performance standard (e.g., a specific pressure/flow rate, acceptable leakage level, visual appearance criteria) that the device must meet.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. There is no training set for an AI algorithm. The design and performance specifications would have been established through engineering design processes, previous device iterations (like the predicate device), industry standards, and regulatory requirements.
§ 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).