(27 days)
HAKIM™ Precision Valve System: The Nonprogrammable Valve System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
HAKIM™ (and HAKIM™ Micro) Programmable Valve Shunt System: The HAKIM™ Programmable Valve Shunt System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
SiphonGuard™ CSF Control Device: The SiphonGuard™ device can be used as a component of hydrocephalus shunt systems designed to shunt CSF from the lateral ventricles of the brain into the peritoneal cavity or right atrium of the heart. The SiphonGuard™ device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an erect position.
The devices that are the subject of this Special 510(k): Device Modification are identical to their respective predicate predecessors, with the exception of one material component. The proposed alternative epoxy is the single difference in the devices.
The provided text is a 510(k) summary for a medical device modification, specifically regarding the CODMAN HAKIM™ Precision, Programmable, Micro Programmable Valve Systems and the SiphonGuard™ CSF Control Device. The core of this submission is a material change (alternate epoxy) to existing devices.
Therefore, the study performed is not a typical performance study comparing a device's diagnostic or therapeutic efficacy against a ground truth. Instead, it focuses on demonstrating that the new material does not negatively impact the device's established performance.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintain the established performance and safety of the predicate devices for their intended use despite the material change (alternate epoxy). | "This submission relied upon appropriate bench and biocompatibility testing necessary to support the device for its intended use." (Implies successful completion of these tests, demonstrating that the new epoxy does not compromise device performance or biocompatibility.) |
Explanation: The acceptance criteria here are implicitly that the modified devices (with the new epoxy) demonstrate equivalence to the predicate devices in terms of performance and safety, as assessed through bench and biocompatibility testing. The "reported device performance" is the statement that these tests were performed and were "appropriate... to support the device for its intended use," which signifies that the modifications meet the safety and effectiveness requirements.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set used in the bench and biocompatibility testing. The data provenance is not explicitly stated. Given that it's a 510(k) submission for a material modification, these would typically be retrospective tests conducted by the manufacturer in a laboratory setting (bench testing) and possibly with in vitro or animal studies for biocompatibility, rather than human clinical trials with geographical data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For a material change and bench/biocompatibility testing, the "ground truth" is typically defined by established engineering specifications, material science standards, and biocompatibility guidelines. These are assessed by engineers, material scientists, and toxicologists, rather than medical experts establishing a diagnostic ground truth. The document does not specify the number or qualifications of these experts.
4. Adjudication Method for the Test Set
Not applicable. This type of submission does not involve adjudication of expert readings or diagnoses. The "adjudication" would be internal technical review and approval by the manufacturer's quality and regulatory teams to ensure the test results meet the defined criteria, followed by FDA review of the submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, with and without AI assistance, to assess the AI's impact on diagnostic accuracy. This submission concerns a material change in existing Shunt Systems and a CSF Control Device, which are implantable mechanical devices.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. There is no algorithm or AI component in these mechanical devices.
7. The Type of Ground Truth Used
The ground truth for this type of submission (material change) would be based on:
- Engineering specifications and performance standards: Ensuring the modified device meets predefined mechanical, flow, and durability specifications.
- Biocompatibility standards: Demonstrating that the new epoxy material is non-toxic and compatible with the human body as per recognized international standards (e.g., ISO 10993 series).
8. The Sample Size for the Training Set
Not applicable. There is no AI model involved that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI model, there is no training set or associated ground truth.
§ 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).