(85 days)
The Codman Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
The Codman Certas Plus Programmable Valve is a sterile, single use, implantable device designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.
The Codman Certas Plus Programmable Valve is a pressure-regulating valve utilizing the ruby ball-in-cone principle with a pressure inducing spring design. Intraventricular pressure is maintained by the ball and cone valve seat design. As the differential pressure across the shunt increases, the ball further displaces from the cone, through which CSF flows, thereby increasing flow and re-establishing the selected pressure. The ball is manufactured of synthetic ruby, as is the matching cone. Together these components provide a precise fit for regulating the flow of CSF through the valve.
The valve is available with 8 different performance settings for constant intraventricular pressure and drainage of CSF. Seven (7) of the settings provide for a change in operating pressure, with a range of 25 to 215 mmH2O. The eighth setting provides a minimum opening pressure of '400' mmH20, thus allowing a physician to turn the valve "virtually off" without the need to surgically remove the valve to limit flow. The pressure of the valve is set preoperatively and can be noninvasively changed post-implantation by using the Codman Certas Tool Kit, which employs magnetic force to select one of the 8 settings.
The provided text describes a 510(k) premarket notification for the Codman Certas Plus Programmable Valve, where the manufacturer is seeking to expand its indications for use to include ventriculo-atrial (VA) shunting. The key focus of the submission is to demonstrate substantial equivalence to a predicate device for this expanded use.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance/Results |
|---|---|---|
| Bench Testing | Reflux testing per ISO 7197:2009 and ASTM F647:1994 (R2006) for Neurosurgical Implants (Hydrocephalus Shunts) | "The test results met the acceptance criteria" |
| Bench Testing | Shelf Life testing | "The test results met the acceptance criteria" |
| Biocompatibility | Evaluation per ISO 10993-1, ISO 10993-4, and FDA draft guidance (2013) for devices with blood contact (VA shunting). | "The evaluation concluded that additional biocompatibility testing was not required." (This implies that the existing materials were deemed biocompatible for blood contact, or the risk was mitigated by similarity to the predicate and existing data). The same distal catheter, cleared for the predicate for VA shunting, was noted to be the only difference in sterilization method, which suggests prior approval based on similar material composition for blood contact. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Bench Testing: The document does not specify the exact sample sizes used for reflux testing or shelf-life testing.
- Data Provenance: The data comes from internal testing conducted by Codman, the device manufacturer. It is prospective testing, performed specifically to support this 510(k) submission for expanded indications. The country of origin of the data is not explicitly stated, but the submitter is Codman & Shurtleff, Inc., based in Raynham, MA, USA, and Medos International SARL in Le Locle, Switzerland.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- No external experts were used to establish ground truth for the bench testing. The "ground truth" for these tests is defined by the international standards (ISO and ASTM) and internal company specifications for performance.
4. Adjudication Method for the Test Set
- No adjudication method is described as the testing performed was objective bench testing against pre-defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No MRMC comparative effectiveness study was done. This filing is for a physical medical device (a programmable valve) and not an AI/imaging diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
- For bench testing, the ground truth is defined by international consensus standards (ISO 7197:2009, ASTM F647:1994 (R2006)) and internal company specifications that ensure the device meets predefined performance characteristics (e.g., reflux limits, shelf life stability).
- For biocompatibility, the ground truth is based on regulatory and scientific standards (ISO 10993-1, ISO 10993-4) and FDA guidance, often relying on established material safety data.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI device that requires a training set. The device itself is the product under review.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
§ 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).