(52 days)
The LimiTorr™ Volume Limiting External Drainage and Monitoring Systems allow for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and to monitor ICP.
The LimiTorr™ Volume Limiting External CSF Drainage and Monitoring Systems are designed to externally drain cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space to a drainage bag in selected patients. The systems connect to a ventricular or lumbar catheter via a luer connection to a patient line and ultimately to a drainage bag. In most of the systems, the patient line is connected to a graduated burette that is then connected to the drainage bag. CSF can be collected and measured in the burette and subsequently emptied into the drainage bag by opening the stopcock placed in line between the burette and the drainage bag. These systems are designed for single use only. The Limitorr™ Volume Limiting External CSF Drainage and Monitoring Systems include a mechanism designed to limit the volume of CSF colleted to a nominal volume. The volume limiting mechanism consists of a valve mounted to the top of the float that rises as the fluid collects in the burette and seals when the nominal volume is reached.
This report outlines the acceptance criteria and study details for the LimiTorr™ Volume Limiting External CSF Drainage and Monitoring Systems, as described in the provided 510(k) summary (K072929).
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it refers to substantial equivalence to a predicate device and lists general areas of testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Integrity | Adhesion/Bond Strength: Tested for strength of bonded components. Performance indicates components maintain integrity under expected use. |
| Fluid Containment | Leakage: Tested for leakage. Performance indicates no unintended fluid escape. |
| Drainage Functionality | Drainage: Tested for proper drainage. Performance indicates efficient and controlled CSF removal. |
| Volume Limiting Mechanism | Sealing Mechanism Performance: Tested to ensure the valve, mounted on the float, rises with fluid and seals when the nominal volume is reached, effectively limiting collected CSF volume. |
| Packaging Robustness | Package Integrity: Tested to ensure sterile barrier and protection of the device until use. Performance indicates packaging is intact and protective. |
| Safety Features | Needlestick Injury Reduction: Needleless sampling sites designed to reduce needlestick injuries and subsequent exposure to infected fluids. (No specific performance metric provided, but design addresses the risk). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing described appears to be bench testing performed by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set. The tests performed ("strength of bonded components, leakage, drainage, sealing mechanism performance and package integrity") are typically objective engineering tests and do not require expert interpretation of clinical data or images.
4. Adjudication Method for the Test Set
As the tests are objective engineering assessments and no human interpretation of results is indicated, no adjudication method (like 2+1 or 3+1) was employed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed or mentioned. The device is a physical medical device for fluid drainage, not an AI-assisted diagnostic or interpretive tool. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study for an algorithm was performed. The device is a physical, mechanical system for CSF drainage, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the tests performed was based on engineering specifications and functional requirements for a medical device of this type. For example, "leakage" or "drainage" performance would be measured against predefined acceptable tolerances and flow rates. The "sealing mechanism performance" would be verified against the design intent of limiting fluid volume.
8. Sample Size for the Training Set
As this is a physical medical device and not an AI/algorithm-based product, the concept of a "training set" is not applicable. The device design is based on engineering principles and prior predicate devices.
9. How Ground Truth for the Training Set Was Established
Since there is no training set for an algorithm, this question is not applicable. The design and safety validations were established through engineering specifications, laboratory testing, and comparison to the predicate device (MoniTorr™ External CSF Drainage and Monitoring Systems) for substantial equivalence.
§ 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).