(78 days)
The CODMAN Certas Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
The CODMAN Certas Therapy Management System allows the noninvasive reading or adjustment of the valve setting.
The Certas Programmable Valve System is designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular pressure and drainage of CSF. The Therapy Management System allows the user to non-invasively adiust the opening pressure setting before and after implant.
The Certas Programmable Valve is available with and without the legally marketed SIPHONGUARD CSF Control Device and the Codman BACTISEAL Catheters as well as accessories needed to facilitate placement and use of the valve.
The Certas Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
The Certas Therapy Management System allows the noninvasive reading or adjustment of the valve setting.
The provided text describes a 510(k) submission for the CODMAN CERTAS Programmable Valve System and CODMAN CERTAS Therapy Management System, focusing on demonstrating substantial equivalence to a predicate device after extending its shelf life from 1 year to 5 years.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical thresholds, but rather implied by "no change" and "maintained" functionality. The performance data demonstrates that these criteria were met.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Packaging integrity maintained for 5 years after accelerated aging | "The packaging stability study shows that there was no change in post-sterile seal strength after accelerated aging." |
| Product functionality maintained for 5 years after accelerated aging | "The product stability testing evaluated Adjustment and Indication capability, Pressure-Flow, as well as Leak and Reflux testing per EN ISO 7197:2009 after 5 years of accelerated aging. The test results demonstrate that the Certas Valve is substantially equivalent to the predicate device." |
| No changes to intended use, materials, or principles of operation | "No changes are being made to the intended use, performance characteristics, materials, and principles of operation of the valve or its accessories." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the stability testing (both packaging and product). It refers to "packaging stability study" and "product stability testing" without providing specific numbers of units tested.
- Sample Size: Not explicitly stated.
- Data Provenance: The studies were conducted by the manufacturer, Medos International Sarl, as part of their regulatory submission. The context suggests these were prospective tests designed specifically to demonstrate the extended shelf life. The country of origin of the data is not specified beyond the company's location (Switzerland/US branch).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable (N/A) to this device submission. This submission concerns a physical medical device (a valve system) and its mechanical/functional performance after aging, not an AI/software device that requires expert-established ground truth for diagnostic or interpretative tasks. The "ground truth" here is the physical measurement of performance parameters (e.g., seal strength, pressure-flow, leak, reflux) against established engineering standards (EN ISO 7197:2009).
4. Adjudication Method for the Test Set
This is N/A for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are typically used for expert reviews in image analysis or clinical assessments where there might be inter-observer variability. For objective physical device testing, the results are measured against defined performance specifications.
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
This is N/A. This submission is for a physical medical device (hydrocephalus shunt valve) for which MRMC comparative effectiveness studies with or without AI assistance are not relevant. This type of study is typically performed for AI-powered diagnostic tools or image analysis software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is N/A. The device is a physical valve system and a programming system, not an algorithm, so a standalone algorithm performance study is not relevant.
7. The Type of Ground Truth Used
The ground truth used for this testing is based on:
- Objective physical measurements: Assessing parameters like seal strength, adjustment/indication capability, pressure-flow characteristics, and leak/reflux.
- Engineering Standards: Conformance to recognized international standards like EN ISO 7197:2009 for hydrocephalus shunts. The "ground truth" is that the device must continue to meet these functional and safety specifications after accelerated aging.
8. The Sample Size for the Training Set
This is N/A. This device is not an AI/machine learning product, so there is no "training set" in the context of data-driven model development. The product development likely involved engineering design and testing, but not a data-based training set.
9. How the Ground Truth for the Training Set was Established
This is N/A for the same reasons as 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).