(58 days)
Use of the Codman EDS3 CSF External Drainage System is indicated for draining cerebrospinal fluid (CSF) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated.
The Codman EDS3 CSF External Drainage System (Codman EDS3 System) is designed to collect cerebral spinal fluid (CSF) from the patient at a controlled rate based on differential pressure between the device and the patient. Collecting CSF from the patient is performed in efforts to reduce elevated intracranial pressure (ICP) post trauma. The EDS3 device is comprised of four (4) main parts: ventricular catheter, patient drain line, base frame burette tube assembly and a collection bag. The ventricular catheter is placed into one of the ventricles in the brain or in the subarachnoid space and is then connected to the patient drainage line. CSF flows from the brain through the patient line and enters into the 100 mL graduated burette tube assembly, where it is collected over a period of time to calculate a flow rate. The burette tube assembly can then be raised or lowered along the base frame, thereby adjusting the differential pressure to achieve the appropriate flow rate. Once the burette tube height is set, the collected CSF is then drained into the attached 700 ml collection bag. The EDS3 System is a complete, disposable unit that is provided sterile and is available with or without a ventricular catheter.
The provided document describes the Codman EDS3 CSF External Drainage System (K162437), which is essentially an updated version of a previously cleared device (K061568). The primary change in the subject device is the use of a different adhesive (Loctite 3924 instead of Loctite 3341) for bonding tubing lines. Therefore, the acceptance criteria and studies focus on demonstrating that this change does not negatively impact the device's safety and effectiveness.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Test Method / Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Visual Inspection | PIC-CL205063 (Ensure finished product meets design specifications) | Pass Visual Standards | Pass |
| Pressurized Leak and Flow | TM-TM095 (Ensure leak-free product assembly) | Pass Leak and Flow Test | Pass |
| Tensile and Torque Testing | TM-TM227, TM-TM100234 (Ensure product meets functional specifications) | Pass Tensile and Torque Strength Specification | Pass |
| Shelf Life | Ensure the product remains functional after sterilization and 3 years of aging. | Meet functional criteria after 2x EtO sterilization and 3 years of aging | Pass |
| Biocompatibility | ISO 10993 (Evaluate the Loctite 3924 material to ensure that it is a safe substitute for Loctite 3341) | Pass Cytotoxicity Testing, Pass Irritation and Sensitization Testing, No evidence of systemic Toxicity, Pass Dermal Irritation Test, No evidence of Pyrogenic response, No evidence of potential to cause Hemolysis, Pass Physiochemical attributes review | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each bench test (e.g., number of devices tested for tensile strength or shelf life). It's a summary document, and typically, detailed test reports would contain this information.
Regarding data provenance:
- Country of origin: Not specified, but likely the US given the submission to the FDA.
- Retrospective or prospective: The bench tests described are prospective in nature, as they involve testing newly manufactured devices with the new adhesive according to established protocols.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This question is not directly applicable in the context of this device and study. The "ground truth" for this type of device (a medical drainage system) is not established by expert consensus or interpretations in the same way it would be for an AI diagnostic algorithm. Instead, it's established by pre-defined performance specifications (acceptance criteria) based on engineering, material science, and regulatory standards. The "experts" involve the engineers and scientists who designed the tests and reviewed the results, but they are not adjudicating observational data.
4. Adjudication Method for the Test Set:
Not applicable. The tests are objective and based on measurable parameters (e.g., leak detection, force measurements, chemical analysis). There's no human "adjudication" of the test results in the way it's done for interpreting medical images. The results are directly compared to the pre-established numerical or qualitative "Pass/Fail" acceptance criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (especially those involving image interpretation by human readers, potentially augmented by AI) to assess the impact on human performance. The Codman EDS3 CSF External Drainage System is a physical medical device, not a diagnostic tool where human reader performance is a direct output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, a standalone (algorithm-only) performance study was not done. This device is not an algorithm; it's a physical medical device. The "performance" refers to its physical and functional attributes.
7. The Type of Ground Truth Used:
The ground truth for this study is based on engineering specifications, material science standards (e.g., ISO 10993 for biocompatibility), and established medical device performance requirements. The acceptance criteria are essentially the "ground truth" against which the device's performance is measured. These are not pathology results, expert consensus on disease, or patient outcomes data in this context.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical device, not an AI, machine learning, or software algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of 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).