(17 days)
The HAKIM ® Precision Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.
The HAKIM ® Programmable Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.
The Codman HAKIM® Precision and Programmable Valve Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.
Hydrocephalus is a condition caused by the excessive accumulation of CSF in the ventricles of the brain due to a disturbance of CSF secretion, flow, or absorption, which causes a rise in intracranial pressure (ICP). To relieve ICP, CSF can be diverted through a shunting device, such as the HAKIM® valve, to another body cavity where it is absorbed and subsequently excreted.
Both the HAKIM® Precision and Programmable valves are pressure regulating valves which maintain intraventricular pressure at a constant level. The HAKIM® Precision valves are fixed pressure valves and are available in 5 different opening pressure ranges: The HAKIM® Programmable valves not having fixed pressures, permit non-invasive adjustment of the valve opening pressure, in order for the surgeon to increase or decrease the valve's opening pressure, and can be adjusted to 18 different opening pressure settings.
The purpose of this Special 510(k) premarket notification is to request a material formulation change to the valve introducers that are used as accessories to the Hakim® Precision and Programmable Valve Systems.
Here's a breakdown of the acceptance criteria and study information for the Codman® HAKIM® Precision and Programmable Valve System, based on the provided 510(k) summary:
Key Takeaway: This 510(k) submission is for a material formulation change to an accessory (valve introducers), not the main valve system itself. Therefore, the "acceptance criteria" and "device performance" primarily revolve around demonstrating that this material change does not negatively impact the performance of the overall system or the introducers themselves. No clinical studies proving the device's efficacy for treating hydrocephalus were performed for this specific submission, as the fundamental device design and efficacy were established by previous predicate device clearances.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Properties (Introducer) | No adverse effect on the functional flex characteristics of the valve introducers due to the material change. | Functional flex testing was successfully completed, demonstrating no impact on performance. |
| Mechanical Properties (Introducer) | No adverse effect on the pull strength or integrity of the valve introducers due to the material change. | Pull testing was successfully completed, demonstrating no impact on performance. |
| Biocompatibility | The new material formulation for the valve introducers must meet established biocompatibility standards. | Biocompatibility testing was performed in accordance with ISO-10993-1 and FDA Blue Book G95-1, indicating compliance. |
| Overall System Performance | The material formulation change to the valve introducers must not affect the performance of the HAKIM® Precision and Programmable Valve System. | Performance data (functional flex, pull, biocompatibility testing) demonstrates that the materials formulation change to the Hakim® Precision and Programmable valve introducers has no effect on the performance of the HAKIM® Precision and HAKIM® Programmable Valve System. |
| Indications for Use | The material change does not alter the established indications for use of the overall valve system. | Explicitly stated that "The material formulation change of the valve introducers does not affect the indications for use or the intended use of the HAKIM® Precision and Programmable Valve System." |
| Technological Characteristics | The material change does not alter the design, performance characteristics, or principles of operation of the overall valve system or the introducers themselves. | Explicitly stated that "The material formulation change of the valve introducers does not affect the design, performance characteristics, or principles of operation of the HAKIM® Precision and Programmable Valve Systems. The technological characteristics of the modified valve introducers are identical to those of the predicate valve introducer devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test (functional flex, pull, biocompatibility). However, these are typically engineering and materials tests, and the sample size would be determined by relevant ISO/ASTM standards or internal validation protocols.
- Data Provenance: The tests were conducted internally by Codman & Shurtleff, Inc. This is prospective internal testing, not data derived from patient studies in a specific country.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable in the traditional sense. For this type of material formulation change, "ground truth" is established by adherence to recognized engineering standards (e.g., ISO, FDA Blue Book) and successful completion of specific physical and chemical tests. The "experts" would be the engineers, material scientists, and regulatory specialists within Codman & Shurtleff, Inc. who designed and oversaw the testing and analysis.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (like 2+1 or 3+1 by multiple experts) are typically used in clinical studies or image review where subjective interpretation or complex diagnostic decisions require consensus. For material and functional bench testing, the results are quantitative and objective, and successful completion is typically determined by meeting predefined numerical or qualitative criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This was not a clinical effectiveness study. The submission relates to a material change in an accessory, not a new or significantly modified device requiring a comparative clinical performance assessment.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
- Not applicable. This device is a physical medical device (a shunt system and its accessories), not an AI algorithm.
7. Type of Ground Truth Used
- The "ground truth" for demonstrating the safety and effectiveness of the material change was based on established engineering standards, material science principles, and functional performance benchmarks derived from the predicate devices. This includes:
- Compliance with ISO-10993-1 (Biological evaluation of medical devices).
- Compliance with FDA Blue Book G95-1 (Biocompatibility guidance).
- Successful completion of functional flex testing and pull testing for the introducers, presumably against predetermined specifications that ensure equivalence to the predicate.
8. Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this 510(k) submission. This is not an AI or machine learning device. The material change was evaluated through testing against standards and functional requirements.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, this question is not relevant.
§ 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).