(84 days)
The use of IRRAflow® CNS System is indicated when intracranial pressure monitoring is required and for externally draining intracranial fluid as a means of reducing intracranial pressure in patients where an external drainage and monitoring system is needed.
The IRRAflow® CNS System is an intracranial pressure (ICP) monitoring and drainage system. The IRRAflow® CNS System consists of an IRRAflow Control Unit and two sterile disposable parts, the IRRAflow Tube Set and the IRRAflow Catheter. The drainage flow of cerebrospinal fluid (CSF) into the IRRAflow Catheter is uni-directional and gravity-driven; there is no recirculation of the CSF. A parallel line from the saline infusion bag is used in case clearance at the tip of the catheter is required. The IRRAflow Tube Set has a cassette that clicks on to the IRRAflow Control Unit and aligns the tubing against a peristaltic pump and pinch valve. An aspiration bag is attached to the Control Unit tape measure, defining the height of the bag relative to the catheter's tip position in the patient's head and thus controlling the speed of drainage. The tubing and catheter can be disconnected and connected by standard Luer-Lock connectors. Settings can be changed via the user interface on the Control Unit. The default mode provides drainage and measuring ICP, allowing single bolus injections when indicated. The bolus injections allow the catheter to be flushed when it becomes clogged. CSF or intracranial fluid samples can be taken from the aspiration port.
The provided document (K192289) describes the 510(k) clearance for the IRRAflow® CNS System. This is a medical device and not an AI/ML algorithm. Therefore, many of the specific questions related to AI/ML model performance, such as MRMC studies, ground truth establishment for training data, and expert consensus for test sets, are not applicable.
However, I can extract the acceptance criteria and the claimed performance of the device based on the testing reported for this medical device.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are demonstrated by passing various bench, electrical, and biocompatibility tests. The "Results" column in Table 3 indicates the device's performance against these criteria, which is consistently "PASS."
Table of Acceptance Criteria and Reported Device Performance (Derived from Table 3):
| Test Category | Acceptance Criteria Summary | Reported Performance |
|---|---|---|
| Biocompatibility Testing | ||
| Systemic Toxicity, Mediated Pyrogen | Saline extract of the test article causes no febrile response in rabbits. | PASS: Determined to be non-pyrogenic. |
| Acute Systemic Toxicity, Injection Test | No toxic effects from single-dose systemic injection in mice. | PASS: No abnormal clinical signs indicative of toxicity. |
| Irritation/Intracutaneous Reactivity Test | No local irritation in dermal tissues of rabbits from leached chemicals. | PASS: No abnormal clinical signs. |
| Indirect Hemolysis (Extract) Test | Demonstrate non-hemolytic properties. | PASS: All test method acceptance criteria met. |
| Cytotoxicity (MEM Elution) Test | No cytotoxicity of extractable substances. | PASS: All test method acceptance criteria met. |
| Sensitization Test | No allergenic potential or sensitizing capacity. | PASS: No abnormal clinical signs. |
| Genotoxicity | No structural chromosome aberrations in Chinese Hamster Ovary (CHO) cells. | PASS: All test method acceptance criteria met. |
| Implant Study | Acceptable local effects after implantation. | PASS: All test method acceptance criteria met. |
| Subacute Toxicity | Demonstrate no toxicological hazard related to subacute/subchronic and chronic toxicity. | PASS: All test method acceptance criteria met. |
| Bench and Electrical Testing | ||
| IRRAflow® CNS System Verification | Comply with documented system requirements. | PASS: System complies with documented requirements. |
| IRRAflow® CNS System Validation | Comply with established device requirements. | PASS: System complies with documented requirements. |
| IRRAflow® CNS System Static Analysis | No errors encountered during static analysis of software. | PASS: No errors encountered. |
| Basic Safety Test | Meets criteria for Input, Heating, Leakage Current, Dielectric Voltage tests. | PASS: Acceptance criteria has been met. |
| Electromagnetic Compatibility test | Compliance with IEC 60601-1-2:2014 Class B. | PASS: Acceptance criteria has been met. |
| IRRAflow Catheter Performance Test | Tensile test results meet requirements. | PASS: Acceptance criteria has been met. |
| IRRAflow Catheter Torsion and Shear Test | Torsion and shear test results meet requirements. | PASS: Acceptance criteria has been met. |
| IRRAflow Catheter Drainage Flow Test | Drainage testing methods and results meet requirements. | PASS: Acceptance criteria has been met. |
| Shelf Life / Package Integrity Testing | ||
| Validation of sterile barrier | Meet design and standards requirements for sterile barrier. | PASS: Acceptance criteria has been met. |
| Packaging Peel Test | Seal testing results for packaging meet requirements. | PASS: Acceptance criteria has been met. |
| Aging Test | Demonstrate appropriate requirements for transportation and aging are met. | PASS: Acceptance criteria has been met. |
| Sterilization Testing | ||
| Sterilization process for IRRAflow Catheter and Tube Set | Effectiveness of electron beam radiation (Catheter) and Ethylene Oxide (Tube Set) sterilization. | PASS: Acceptance criteria has been met. |
Regarding the specific questions that are more relevant to AI/ML studies (and why they are not directly applicable here):
-
Sample sizes used for the test set and the data provenance: This device is a hardware system, not an AI/ML diagnostic. The "sample size" for testing refers to the number of units or biological samples used in bench, electrical, and biocompatibility tests. For example, biocompatibility tests might involve a certain number of rabbits or mice. The "data provenance" is not specified beyond the tests themselves (e.g., "saline extract of the test article," "dermal tissues of rabbits"). These are laboratory tests, not clinical data sets from patients. All tests listed in Table 3 were conducted to demonstrate substantial equivalence and safety/effectiveness of the device itself, not an algorithm's performance on patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic algorithms, refers to a definitive diagnosis or finding. For a physical medical device like the IRRAflow® CNS System, "ground truth" is established through physical, chemical, and biological performance standards (e.g., whether a material is cytotoxic, whether a mechanical component withstands stress, whether electrical safety standards are met). These are determined by established laboratory methods and validated instrumentation, not by human expert consensus on medical images or clinical data.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, for the reasons mentioned above. Adjudication is a process for resolving discrepancies in expert interpretations of data (e.g., radiologists reviewing an image). This device's performance is measured against engineering and biological standards.
-
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: Not applicable. MRMC studies are used to evaluate the impact of an AI diagnostic tool on human reader performance. This device is a physical system for intracranial fluid management and pressure monitoring, not an AI diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for this device's acceptance is based on adherence to established engineering standards (e.g., IEC 60601-1-2 for electromagnetic compatibility, ISO 10993 series for biocompatibility) and direct physical/chemical measurements (e.g., tensile strength, flow rates). These are objective measurements rather than interpretations of clinical data.
-
The sample size for the training set: Not applicable. There is no AI model to train.
-
How the ground truth for the training set was established: Not applicable. There is no AI model to train.
In summary, the provided document details the regulatory clearance of a physical medical device (IRRAflow® CNS System) through a 510(k) submission. The acceptance criteria and performance are demonstrated via a series of non-clinical (bench, electrical, biocompatibility, sterilization, and packaging) tests against predetermined engineering and biological standards, rather than through clinical studies involving human readers or AI algorithms.
§ 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).