(134 days)
The use of IRRAflow Active Fluid Exchange System is 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® Active Fluid Exchange System (AFES) is an intracranial pressure (ICP) monitoring and drainage system intended for use by professional medical hospital personnel, trained and experienced in neurosurgical medical care. 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. The IRRAflow Drainage Collection System is attached to the Control Unit, using the Laser Leveler for defining the height of the Drainage Collection System relative to the catheter's tip position in the patient's head. This positioning is used for 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 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 Drainage Collection System.
The provided text is a 510(k) premarket notification decision letter from the FDA regarding the IRRAflow Active Fluid Exchange System (AFES). The purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device, specifically regarding changes to the Tube Set and Drainage Collection System. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating that the modified device's performance is equivalent to, or better than, the predicate device.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria alongside numerical performance results for the device. Instead, it relies on a "PASS" or "FAIL" outcome for various verification and validation tests. The acceptance criteria for these tests are implied to be established by the test protocols and industry standards (e.g., "Pressure accuracy per protocol," "Durability, flow and freedom from leakage per protocol").
Here's a table summarizing the tests performed and their reported outcomes:
| Test Category | Test Performed | Reported Device Performance (Result) |
|---|---|---|
| Biocompatibility Testing | Cytotoxicity (MEM Elution) | PASS |
| Sensitization Test | PASS | |
| Irritation/Intracutaneous Reactivity Test | PASS | |
| Acute Systemic Toxicity, Injection Test | PASS | |
| Systemic Toxicity, Mediated Pyrogen | PASS | |
| Genotoxicity (on various strains of bacteria) | PASS | |
| Genotoxicity (on mouse lymphoma cells) | PASS | |
| Bench and Electrical Testing | Electrical Requirements Verification (Pressure accuracy) | PASS |
| Mechanical Performance Verification (Durability, flow, freedom from leakage) | PASS | |
| Life Cycle Verification Test (Simulated use for reliability) | PASS | |
| Shelf Life / Package Integrity Testing | Simulated Distribution Test (ASTM D4332-14, ASTM D4169-22 Cycle 13) | PASS |
| Package Integrity Test (ASTM F1886-16, ASTM F2096-11) | PASS | |
| Package Seal Strength Test (EN 868-5:2009) | PASS | |
| Aging Test (Accelerated and real-time aging) | PASS | |
| Sterilization Testing | Sterilization Process Validation (Ethylene Oxide for Cassette and Drainage System) | PASS |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for any of the tests listed in Table 3.
The data provenance is not explicitly stated beyond general descriptions of the tests (e.g., "The Minimal Essential Media (MEM) Elution test," "This test was designed to evaluate the allergenic potential"). There is no mention of country of origin or whether the tests were retrospective or prospective. Given the nature of these tests (bench, electrical, biocompatibility, sterilization validation), they are typically conducted as prospective laboratory studies rather than clinical studies using patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests performed are primarily engineering and laboratory-based, often following standardized protocols. Therefore, the concept of "ground truth" established by clinical experts (like radiologists for imaging devices) would not directly apply to these types of performance tests. The "ground truth" here is implied by adherence to established test methods and acceptable performance limits defined by those methods.
4. Adjudication method for the test set
This information is not provided and is generally not applicable to the types of performance tests described (biocompatibility, electrical, mechanical, shelf life, sterilization). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and a consensus is needed to establish a definitive ground truth.
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 indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The device is a physical system for fluid exchange and pressure monitoring, not an AI-powered diagnostic tool for image interpretation or similar tasks that would typically involve human readers and AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the IRRAflow AFES is a medical device for intracranial pressure monitoring and fluid drainage, not an algorithm or AI system. Its performance is evaluated through engineering and biological safety tests.
7. The type of ground truth used
For the performance tests described (biocompatibility, electrical, mechanical, shelf life, sterilization), the "ground truth" is based on:
- Established Test Standards and Protocols: Such as ASTM D4332-14, ASTM D4169-22 Cycle 13, ASTM F1886-16, ASTM F2096-11, EN 868-5:2009.
- Defined Acceptance Criteria: These criteria are inherent to the test methods and are designed to ensure safety and effectiveness (e.g., pressure accuracy per protocol, freedom from leakage per protocol).
- Laboratory Measurements and Observations: The results are direct measurements or observations within controlled laboratory environments.
It's not "expert consensus," "pathology," or "outcomes data" in the clinical sense, but rather adherence to predefined engineering and biological safety specifications.
8. The sample size for the training set
This question is not applicable because the IRRAflow AFES is a hardware medical device with specific Tube Set and Drainage Collection System modifications, not a machine learning or AI model that requires a "training set."
9. How the ground truth for the training set was established
This question is 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).