(33 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. It 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. A parallel line from the saline infusion bag is used for clearance at the tip of the catheter. 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. CSF or intracranial fluid samples can be taken from the aspiration port. The submission also includes the IRRAflow® Laser Leveler, a reusable accessory to be utilized in conjunction with the IRRAflow® CNS system to assist in setting the height of the control unit by generating a laser mark.
This document describes the design verification and validation for an accessory, the IRRAflow® Laser Leveler, to an existing medical device, the IRRAflow® CNS System. The main device (IRRAflow® CNS System) itself has not undergone any changes, and therefore no new performance data was required for it. The focus of this submission is on the laser leveler accessory.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Implied by "Pass" result) | Reported Device Performance |
|---|---|---|
| Dimensional | Units meet dimensional specifications. | Pass |
| Visual (laser) | Units have legible labeling and are free of damage and/or foreign particulate. | Pass |
| Visual (Packaging) | Packaging is free of damage and labels are legible. | Pass |
| Functional Testing | Button press operates correctly, vertical position test passes, laser spot alignment is correct, auto shutoff test passes, trunnion articulation is functional. | Pass |
| IEC 60825-1 (Laser safety) | Wavelength and conformance to IEC 60825-1 standard are met. | Pass |
| IEC 60529 (IP22) (Fluid ingress) | Conformance to the IP2X requirements of IEC 60529 Edition 2.2 is met. | Pass |
| ASTM D4332-14 - Package environmental conditioning | Withstand conditioning at Extreme Cold (-30°C), Tropical (+40°C, 90% RH), and Desert (+60°C, 15% RH) for 24 hours. | Pass |
| ASTM D4169-16, Distribution cycle 13 | Withstand specified air (intercity) and motor freight (local) transportation for single packages up to 150 lb. (61.8 kg). | Pass |
| Schedule A Initial manual handling - ASTM D5276-98 Box | Withstand six impacts (Top, two adjacent bottom edges, two diagonally opposite bottom corners, bottom) at drop heights dependent on weight per procedure. | Pass |
| Schedule C Vehicle stacking - ASTM D642-15 | Package systems withstand compression per the computed load value in section 11.4. | Pass |
| Schedule F Loose load vibration - ASTM D999-08 | Withstand 60 minutes of repetitive shock test (rotary motion) with dwell time distributed as specified (50% bottom, 50% side and end orientations). | Pass |
| Schedule I Low Pressure Test - ASTM D6653-13 | Withstand low pressure equivalent to 14,000 feet (446 torr) for 60 minutes, with specified ramp rates. | Pass |
| Schedule E Vehicle Vibration – ASTM D4729-17 Truck and Air | Withstand Truck Spectrum (Low, Medium, High) and Air Spectrum vibrations at specified frequency ranges and overall intensities for durations outlined per standard. | Pass |
| Schedule J Concentrated Impact - ASTM D6344-04 | Withstand concentrated impact (cylindrical mass at 32 inches drop height, 5.4 J) to all 6 faces of the box (or all wrapped faces excluding base for plastic wrapped loads), unless shipper meets specific Mullen Burst/ECT strength. | Pass |
| Schedule A Final Manual handling – ASTM D5276-99 Box | Withstand six impacts (vertical edge, two adjacent side faces, one top corner, one adjacent top edge, bottom – with the last impact at twice the specified height) at drop heights dependent on weight per procedure. | Pass |
| ASTM F19880-16 Accelerated Aging Testing | Withstand accelerated aging equivalent to 6 months of real-time aging, simulated over 10 days at +65°C (uncontrolled RH), based on a Q10 value of 2 and a real-time room temperature of +23°C. | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample size for each test. It generally refers to "units" or "packages" being tested. For certain tests like "Schedule A Initial manual handling - ASTM D5276-98 Box", it mentions "Six (6)" impacts, which implies a sample size of at least one unit per test setup.
- Data Provenance:
- Development and testing for the laser leveler was performed at a contract manufacturer, Meraqi Medical, Inc. (Freemont, CA).
- Laser testing was performed at a sub-contractor, Intertek (Menlo Park, CA).
- This indicates the data originates from the USA.
- The studies mentioned are verification and validation tests performed during the design and manufacturing process of the laser leveler. These are typically prospective tests aimed at confirming product specifications and safety.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable to this submission. The laser leveler is a physical accessory designed to assist with a spatial alignment task. The tests performed are engineering-focused (dimensional, functional, safety, environmental, packaging), not clinical performance evaluations requiring expert assessment for "ground truth". The "ground truth" for these tests is defined by established engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable. As these are engineering verification and validation tests against established standards and specifications, there is no need for a human adjudication method in the context described (like consensus in image interpretation). The results are objective measurements (e.g., passing a specific temperature range, meeting a safety standard).
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 information is not applicable. The device (IRRAflow® CNS System with Laser Leveler) is not an AI-powered diagnostic imaging system or an AI-assisted interpretation tool. It's a medical device system for intracranial pressure monitoring and fluid drainage, with an accessory to aid in physical alignment. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. The IRRAflow® CNS System and its laser leveler accessory are physical medical devices, not an algorithm. The laser leveler functions as a tool that assists a human operator in a physical setup task; it is not a standalone algorithm performing automated analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for the verification and validation tests listed is based on established engineering standards, safety requirements, and design specifications. For example, for IEC 60825-1, the ground truth is "conformance to the IEC 60825-1 standard for laser safety". For dimensional tests, it's the design specification for the dimensions of the unit. For packaging tests, it's the ability to withstand specific environmental and physical stressors as defined by ASTM standards.
8. The sample size for the training set
- This information is not applicable as the IRRAflow® Laser Leveler is not an AI system that requires a training set. It is a physical device that underwent engineering verification and validation.
9. How the ground truth for the training set was established
- This information is not applicable for the same reason as described in 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).