(244 days)
External Drainage System allows for drainage of cerebrospinal fluid (CSF) from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP).
The External Drainage System includes a tubing, drainage bag, drip chamber and scale plate. It is provided sterile and can be connected to a drainage catheter, which is connected to a patient line, via a luer connection and ultimately to a drainage bag. The drainage catheter is not included in the subject device. The External Drainage System provides a closed system for the drainage of cerebrospinal fluid (CSF) from the ventricles of the brain or the lumbar subarachnoid space. During the draining, the cerebrospinal fluid will be collected in a drainage bag.
The provided text describes the acceptance criteria and study results for an "External Drainage System," which is a Class II medical device used for draining cerebrospinal fluid.
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Item | Test Method Description | Reported Device Performance |
|---|---|---|
| Device size requirements | To determine if the size of the device components is within specifications. | Pass |
| Fluid leakage by pressure decay test | To establish that the tubing meets fluid leakage specifications. | Pass |
| The volume and scale of the drip chamber | To determine if the volume and scale of the drip chamber is within current specifications. | Pass |
| Integrity of air vent filter of the drip chamber | To determine if the integrity of air vent filter of drip chamber is within current specifications. | Pass |
| Integrity of air vent filter of the drainage bag | To determine if the integrity of air vent filter of drainage bag is within current specifications. | Pass |
| Packaging integrity | To determine if the packaging integrity is within current specifications. | Pass |
| Package sealing strength | To determine if the sealing strength of the package is within current specifications. | Pass |
| Sterility | To determine if the sterility of the device is within current specifications for ethylene oxide. | Pass |
| Endotoxin testing | To determine if the endotoxin of the device is within specifications of 2.15 EU/device. | Pass |
| In vitro Cytotoxicity Test | Test article extracts showed no evidence of cytotoxicity. | Non-cytotoxic |
| Skin sensitization tests | Test article extracts showed no evidence of causing skin sensitization in the guinea pig. | Non-sensitizing |
| Intracutaneous reactivity test | The test article extracts showed no evidence of intracutaneous reactivity in rabbit. | Non-irritant |
| Acute systemic toxicity test | The test article extracts showed no evidence of acute systemic toxicity (No mortality, clinically normal animals, acceptable body weight data). | Non-toxic acutely |
| Material mediated pyrogenicity test | The test article met the requirements for the absence of pyrogens. | Non-pyrogenic |
| In vitro hemolysis study | Hemolytic index of test article was 0.8%. | Non-hemolytic |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each of the performance and biocompatibility tests. It broadly states that "The following test were performed to verify that the performance of the subject device is substantially equivalent to the performance of the predicate device. Testing included side-by-side comparison data with the predicate device."
The data provenance is not explicitly mentioned in terms of country of origin or whether it was retrospective or prospective. However, based on the context of a 510(k) submission, these are non-clinical (bench and biocompatibility) tests conducted to demonstrate equivalence to a predicate device. This implies the tests were specifically designed and performed for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the data presented. The "ground truth" concept is typically relevant for studies involving diagnostic accuracy or clinical interpretation where expert consensus is needed to determine the true state of a condition. The tests described here are physical performance and biocompatibility assessments, not diagnostic or interpretive tasks. The "ground truth" for these tests is based on objective measurements and established scientific/regulatory standards.
4. Adjudication method for the test set
This information is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are used in studies where human readers independently interpret data, and discrepancies need to be resolved. The tests here are objective measurements.
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
There is no mention of a multi-reader multi-case (MRMC) study or any AI assistance. This device is a physical medical device (External Drainage System), and the testing described is non-clinical performance and biocompatibility, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
There is no mention of a standalone algorithm performance study. As stated above, this is a physical medical device, not an algorithm.
7. The type of ground truth used
For the performance tests (e.g., device size, fluid leakage, sterility), the "ground truth" is derived from pre-defined engineering specifications and regulatory standards. For biocompatibility tests, the "ground truth" regarding safety is established by validated laboratory assays (e.g., cytotoxicity assays, sensitization tests) and their interpretation against acceptable limits set by regulatory guidance (e.g., ISO 10993).
8. The sample size for the training set
This information is not applicable as this device is not an AI/machine learning system that requires training data.
9. How the ground truth for the training set was established
This information is not applicable as this device is not an AI/machine learning system that requires a training set.
§ 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).