(112 days)
The Codman Hakim Precision Fixed Pressure Valve Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.
The Codman Hakim Programmable Valves Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.
The Codman Hakim® Precision Fixed Pressure and Programmable Valves are implantable, sterile, single use devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus. Hydrocephalus is a condition caused by 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 a Hakim Precision Valve or Hakim Programmable Valve, to another body cavity where it is a subsequently absorbed. Both the Codman Hakim Precision Fixed Pressure 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 Codman Hakim Programmable Valves, not having fixed pressures, permit non-invasive adjustment of the valve opening pressure. The Codman Hakim Programmable Valves can be adjusted to 18 different opening pressure settings.
The provided text describes a 510(k) premarket notification for Hakim Programmable Valves and Hakim Precision Fixed Pressure Valves. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new device's performance against specific targets.
Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes, expert involvement, and ground truth establishment are not applicable or not explicitly stated in the provided document. The submission is for minor changes (material and dimensional) to an existing device, and relies on bench testing and an equivalency assessment.
Here's a breakdown of the information that can be extracted and a clear indication of what is not available from the given FDA letter:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for the device's clinical performance. Instead, it demonstrates that the device passed a series of performance and biocompatibility tests, indicating compliance with established standards. The acceptance criteria for the tests are implied by the "Pass" outcome, meaning they met the requirements of the specified standards (e.g., ISO 7197, ASTM F1980).
| Test | Acceptance Criteria (Implied by standard) | Reported Device Performance |
|---|---|---|
| Product Shelf Life Testing per ASTM F1980 | Met requirements of ASTM F1980 | Pass |
| Functional Testing per ISO 7197 | Met requirements of ISO 7197 | Pass |
| Functional Testing per ASTM F647 | Met requirements of ASTM F647 | Pass |
| MRI Spatial Gradient Testing per ASTM F2052 | Met requirements of ASTM F2052 | Pass |
| X-Ray Testing per ASTM F640 | Met requirements of ASTM F640 | Pass |
| MTT and MTS Cytotoxicity Studies per ISO 10993-5 | Met requirements of ISO 10993-5 | Pass |
| Guinea Pig Maximization Sensitization Studies per ISO 10993-10 | Met requirements of ISO 10993-10 | Pass |
| Intracutaneous Irritation Studies in Rabbits per ISO 10993-10 | Met requirements of ISO 10993-10 | Pass |
| Acute Systemic Toxicity Study in Mice per ISO 10993-11 | Met requirements of ISO 10993-11 | Pass |
| Rabbit Pyrogen Studies per USP 42 – NF 37 | Met requirements of USP 42 – NF 37 | Pass |
| Subcutaneous Implantation Studies in Rabbits, 1 Week and 4 Weeks per ISO 10993-6 | Met requirements of ISO 10993-6 | Pass |
| Systemic Toxicity and Local Effects Study in Rabbits Following Subcutaneous Implantation, 13 Weeks per ISO 10993-6 and ISO 10993-11 | Met requirements of ISO 10993-6 and ISO 10993-11 | Pass |
| Bacterial Reverse Mutation Studies per ISO 10993-3 and ISO/TR 10993-33 | Met requirements of ISO 10993-3 and ISO/TR 10993-33 | Pass |
| In Vitro Mouse Lymphoma Studies per ISO 10993-3 and ISO/TR 10993-33 | Met requirements of ISO 10993-3 and ISO/TR 10993-33 | Pass |
| Hemolysis on Extract Studies per ISO 10993-4 and ASTM F756 | Met requirements of ISO 10993-4 and ASTM F756 | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for each individual test. The document states "All testing was performed on production equivalent devices," implying a sufficient number of units to conduct the referenced tests, but the exact count is not given.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing is described as "performance bench test results" and "biocompatibility testing results," indicating lab-based testing rather than patient data. These appear to be prospective tests conducted for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This submission does not involve clinical studies requiring expert ground truth for a test set. The tests are bench and biocompatibility studies against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As there are no clinical trials or interpretations of complex data like medical images by multiple experts, no adjudication method is cited.
5. 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. An MRMC study was not conducted and is not relevant to this device submission, which involves physical CSF shunting devices, not AI-assisted reading.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the tests performed is the compliance with the specified international and national standards (e.g., ISO 7197, ASTM F1980, ISO 10993 series, USP). The "Pass" outcome indicates the device met the objective criteria defined within these standards.
8. The sample size for the training set
- Not Applicable. This refers to a medical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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).