(109 days)
The MoniTorr ICP™ system allows 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 the monitoring of ICP.
The LimiTorr™ system allows 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 MoniTorr ICP™ External CSF Drainage and Monitoring Systems provide a closed system for the drainage of cerebrospinal fluid (CSF) from the ventricles of the brain or the lumbar subarachnoid space to a drainaqe bag. The system may be used with a pole mounted assembly that allows alignment with the patient and secure positive or neqative pressure level setting. The system also has been designed to provide for ease of patient transport through a compact design and antimicrobial hydrophobic vent feature that resists occlusion.
The LimiTorr™ External CSF Drainage and Monitoring Systems provides a closed system for the CSF from the ventricles of the brain or the lumbar subarachnoid space to an external drainage bag. The LimiTorr volume limiting external CSF drainage system was designed to include a volume limiting valve mechanism which reduces the chances for excessive CSF drainage. The burette in the volume limiting external CSF drainage system contains a volume limiting valve which stops drainage when the pre-determined volume (20ml-30ml) is reached.
Both drainage systems are provided sterile and connect to either ventricular or lumbar catheters (not included in this submission) via a luer connection to a patient line and ultimately to a drainage bag. The indications for use of both MoniTorr and LimiTorr remain unchanged with this submission.
The intent of this 510(k) is to notify FDA of Integra's intent to implement a new stopcock component, make minor dimensional modifications to the stopcock manifold and to add a precaution to the Instruction for Use (IFU) concerning not over-tightening or applying excessive force to the luer lock/fluid filled transducer. The stopcocks control the flow of CSF to allow drainage from the patient, or allow flow to a pressure transducer to determine the intracranial pressure (ICP) of the patient. The stopcocks may be used to allow extraction of CSF from patient line for patient sampling. The proposed stopcock is a 4-way stopcock, with standard port connections, which are both characteristics of the predicate stopcock. The proposed stopcock maintains the same luer port internal diameter as the predicate.
The provided document describes the acceptance criteria and supporting studies for the Integra LifeSciences MoniTorr ICP External CSF Drainage and Monitoring System and LimiTorr Volume Limiting External CSF Drainage and Monitoring System. This submission focuses on changes to a stopcock component and a labeling precaution, asserting substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document details various performance bench tests and biocompatibility tests performed on the new stopcock component. The acceptance criterion for all these tests is that the device (with the new stopcock) meets current specifications, demonstrating substantial equivalence to the predicate.
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Torque to Failure | Average torque to failure within current specifications. | All results passed. |
| Average Peak Moment | Average peak moment within current specifications. | All results passed. |
| Peak Tensile Force to overcome bond strength | Average tensile force to remove bonded tubing within specifications. | All results passed. |
| Resistance to Flow | Resistance to flow within current specifications. | All results passed. |
| Leakage Test | Pressure decay in patient line within current specifications. | All results passed. |
| 30 Day functionality test for LimiTorr and MoniTorr (Torque to Failure, Peak Moment, Peak Tensile Force) | Continued to meet current specifications after 30 days. | All results passed. |
| Design Validation | Meets user needs, can be operated safely and effectively. | All results passed. |
| Cytotoxicity ISO Elution Method | No cytotoxicity or cell lysis. | Non-cytotoxic. |
| ISO Guinea Pig Maximization Sensitization | No delayed dermal contact sensitization. | Non-sensitizing. |
| ISO Intracutaneous Study in Rabbits | Met requirements for non-irritation. | Non-irritating. |
| ISO Acute Systemic Toxicity Study in Mice | No mortality, clinically normal, acceptable body weight. | Non-toxic acutely. |
| USP Rabbit Material-Mediated Pyrogenicity | Absence of pyrogens. | Non-pyrogenic. |
| ASTM Hemolysis | Hemolytic index of 0.0%. | Non-hemolytic. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state specific numerical 'sample sizes' for each individual performance test (e.g., number of stopcocks tested for torque to failure). It broadly states that "Testing was successfully completed for all protocols above."
For biocompatibility testing, it is stated that the "device tested (Safeport with Handle) is identical to the proposed stopcock," indicating that the biocompatibility data was leveraged from the stopcock vendor. The provenance of this data is therefore external, coming from the vendor's testing. The nature of these tests (e.g., testing on samples of the material or components) implies they are retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a 510(k) submission for device modifications based on non-clinical (bench and biocompatibility) testing, not a study involving human interpretation or diagnoses where "experts" would establish "ground truth" in the clinical sense. Therefore, this information is not applicable. The "ground truth" here is defined by the established industry standards and internal specifications for medical devices.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is a non-clinical device modification submission, not a study requiring adjudication of human-interpreted data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed or required as all conducted performance tests appropriately support a determination of substantial equivalence compared to the predicate devices."
6. If a Standalone (i.e., algorithm only without human-in-the-loop) Performance Study Was Done
Not applicable. This device is not an AI/algorithm-based diagnostic tool. It is a physical medical device (fluid drainage and monitoring system).
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance and biocompatibility studies is based on:
- Current specifications: Internal design specifications, engineering requirements, and functional parameters set by the manufacturer.
- Established standards: Adherence to recognized international standards like ISO 10993-1 for biocompatibility and other relevant industry standards for medical device performance.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/machine learning algorithm, so there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no 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).