(137 days)
The HAKIM Micro Programmable (HMP) Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus.
The HMP Valve System is a hydrocephalus shunt designed to allow the surgeon to change the valve opening pressure without surgical intervention. Intraventricular pressure is maintained at a constant level by the device's ruby ball-in-cone valve seat design. The center of a flat spring is attached to a fixed fulcrum, with one end resting on the ruby ball and the other end resting on an eighteen position spiral staircase shaped cam that rotates on a titanium pivot. When the cam rotates the tension on the spring changes as the distal end of the spring moves up or down the cam. The opening pressure of the valve is thereby adjusted. During programming, the programmer transmits a coded magnetic signal to the device, causing the cam to rotate. The device has 18 pressure settings, ranging from 30mm to 200mm H20, in 10mm increments.
Acceptance Criteria and Study for the HAKIM Micro Programmable Valve System
The provided text describes the HAKIM Micro Programmable Valve System, its intended use, and a comparison to a predicate device, but it does not explicitly state specific acceptance criteria or details of a comprehensive study that demonstrates the device meets those criteria.
Instead, the submission states: "Performance testing was conducted to confirm device functionality for its intended use as a hydrocephalus shunt. Results of all testing demonstrate that the HAKIM Micro Programmable Valve System is equivalent to currently marketed products in its performance as a hydrocephalus shunt."
This indicates that the "study" was primarily focused on demonstrating substantial equivalence to an existing predicate device (CODMAN HAKIM Micro Precision Valve System, K973774) rather than meeting predefined, quantitative acceptance criteria. The FDA's 510(k) clearance process often relies on this substantial equivalence model.
Therefore, many of the requested details regarding specific acceptance criteria, sample sizes, ground truth establishment, and expert involvement are not available in the provided document.
However, based on the information provided, we can infer some aspects:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence and Intended Use) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Functionality as a hydrocephalus shunt: Must provide constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus. | "Performance testing was conducted to confirm device functionality for its intended use as a hydrocephalus shunt." |
| Equivalence to predicate device (CODMAN HAKIM Micro Precision Valve System - K973774): In terms of intended use, materials, design, manufacturing, and function. | "Results of all testing demonstrate that the HAKIM Micro Programmable Valve System is equivalent to currently marketed products in its performance as a hydrocephalus shunt." |
| Pressure regulation: Maintain selected pressure within an acceptable range. (Implied by the predicate device and the HAKIM Micro Programmable Valve's mechanism). | Device has 18 pressure settings, ranging from 30mm to 200mm H2O, in 10mm increments. |
| Programmability: Ability to change valve opening pressure without surgical intervention. | "The variable pressure setting feature is only available with the HMP Valve System..." "During programming, the programmer transmits a coded magnetic signal to the device, causing the cam to rotate." |
| Mechanical integrity and durability: (Implied for an implantable device) | Not explicitly detailed, but part of general performance testing for implantable devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. The document refers to "Performance testing" but does not quantify the number of devices or scenarios tested.
- Data Provenance: Not specified. Given it's a 510(k) submission from a US company, it's highly likely the testing was conducted in a controlled lab environment, potentially within the US. The type of testing (e.g., in-vitro bench testing, animal models) is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. Given the nature of a medical device, it's likely that engineers, medical professionals, and quality assurance personnel were involved, but their specific roles in "ground truth" establishment (beyond verifying device function) are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The testing described appears to be objective performance evaluation (e.g., pressure measurements, flow rates) rather than subjective interpretation requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not mentioned or implied. This type of study is more common for diagnostic imaging or interpretation tasks, not for the direct functional performance of a mechanical implantable device like a shunt.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: This concept doesn't directly apply here as it's a mechanical device, not an algorithm. The "device performance" described would inherently be standalone from human intervention once implanted and programmed, focused on its physical function of regulating CSF pressure. There's no AI or algorithmic component described in its operation.
7. The Type of Ground Truth Used
- Ground Truth Type: For a mechanical device like this, the "ground truth" would be established through objective physical measurements and engineering specifications. This would involve:
- Bench Testing: Measuring actual pressure regulation, flow rates, and programmability against design specifications.
- Functional Equivalence: Demonstrating that its performance parameters (e.g., pressure range, stability) are comparable to the predicate device.
- Material Compatibility/Biocompatibility: (Implied for an implantable device, though not detailed in the summary).
8. The Sample Size for the Training Set
- Sample Size (Training Set): This concept is not applicable as the HAKIM Micro Programmable Valve System is a mechanical device, not a machine learning or AI-driven system that requires a "training set" in the conventional sense. Its "design" and "manufacturing" would be based on engineering principles and iterative development, not data-driven training.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment (Training Set): As mentioned above, this is not applicable for this type of device. The "ground truth" during development would be the engineering specifications, performance targets, and safety requirements derived from medical understanding of hydrocephalus and prior shunt designs.
§ 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).