(80 days)
Camino 110-4B OLM Intracranial Pressure Monitoring Kit: The use of the OLM Intracranial Pressure Monitoring Kit by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure in the parenchyma or the subarachnoid space, is clinically important.
Camino 110-4BT Intracranial Pressure-Temperature Monitoring Kit: The Camino Intracranial Pressure Temperature Monitoring Kit is indicated for use by qualified neurosurgeons for measurement of intracranial pressure and temperature in the parenchyma.
Camino 110-4G Post Craniotomy Subdural Pressure Monitoring Kit: The use of the Post Craniotomy Subdural Pressure Monitoring Catheter by a qualified neurosurgeon is indicated when direct pressure measurement subdural space, post craniotomy, is clinically important.
Camino 110-4L Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting: The Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Model 110-4L is indicated for use by a qualified Neurosurgeon when direct measurement of intracranial pressure in the parenchyma or subarachnoid space is clinically important. The Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Model 110-4L is intended to be used only through a Licox Brain Oxygen Monitoring System Bolt.
The Camino 110-4 Intracranial Pressure Monitoring catheters are sterile transducer-tipped pressure or pressure/temperature monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature. The Camino 110-4B is used for Intraparenchymal Pressure Monitoring and the Camino 110-4BT is used to simultaneously measure intracranial pressure and temperature in the parenchyma. The Camino 110-4G is used for Post Craniotomy Subdural Pressure Monitoring, and the Camino 110-4L is intended for use with the Licox Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma.
The provided document is a 510(k) summary for the Integra LifeSciences Corporation's Camino 110-4 Intracranial Pressure Monitoring catheters. This submission is for a modification to existing devices (Camino 110-4B, 110-4BT, 110-4G, and 110-4L) specifically related to the addition of MRI Safety Information to their labeling. The core devices themselves, their indications for use, and performance specifications remain unchanged from their predicate devices.
Therefore, the "acceptance criteria" and "device performance" in this context refer to the established safety and performance of the predicate devices, for which the current devices are being shown to be substantially equivalent with an update to labeling. The study described focuses on demonstrating the impact of the MR environment on the devices and justifying the "MR Unsafe" labeling, rather than an efficacy study for diagnostic or therapeutic performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for MRI Compatibility) | Reported Device Performance (Summary of results from testing) |
|---|---|
| Radio Frequency (RF) Heating: Demonstrate safety under MR environment. | Testing performed under best and worst-case heating conditions in a 1.5 Tesla (T) MRI environment, following ASTM Standard 2182-02a. The specific quantitative results are not provided, but the conclusion of the risk/benefit analysis suggests the heating potential is high under certain conditions. |
| Magnetically Induced Displacement Force: Demonstrate safety under MR environment. | Testing performed in accordance with ASTM F2052-06. Specific quantitative results are not provided. |
| Magnetically Induced Torque: Demonstrate safety under MR environment. | Testing performed in accordance with ASTM F2213-06. Specific quantitative results are not provided. |
| Image Artifacts: Characterize image artifacts under MR environment. | Artifact images provided in accordance with ASTM F2119. Specific details of the artifacts are not provided. |
| Substantial Equivalence to Predicate Devices: Maintain identical indications for use, function, manufacturing, sterilization, packaging, basic designs, operating principles, performance specifications, and implanted materials. | The proposed devices are stated to be identical to their respective predicate devices in all these aspects. The only difference is the addition of MRI Safety Information to the labeling. |
Conclusion from Testing: Based on the risk/benefit analysis, due to the high heating potential under certain conditions in an MR environment, the devices were determined to be MR Unsafe. The labeling was updated to reflect this.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "sample size" in terms of patient data or clinical cases. The testing described is primarily bench testing for MRI compatibility on the devices themselves (Camino 110-4BT, 110-4G, and 110-4L catheters). The provenance of this test data would be from laboratory experiments, not from patient data, and therefore is not applicable in terms of country of origin or retrospective/prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The ground truth for this submission relates to the physical properties and interaction of the devices with an MR environment, as determined by standardized engineering tests (ASTM standards). It does not involve expert interpretation of clinical data or images.
4. Adjudication Method for the Test Set
Not applicable. This was a technical/engineering assessment against ASTM standards, not a clinical adjudication process.
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
No MRMC study was conducted. This submission is for a medical device (intracranial pressure monitoring catheter) and its MRI compatibility labeling update, not for an AI diagnostic or assistive tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" for the MRI compatibility testing was defined by established ASTM (American Society for Testing and Materials) standards for evaluating medical devices in an MR environment (specifically ASTM 2182-02a, F2052-06, F2213-06, and F2119). The ground truth for substantial equivalence is the set of characteristics of the legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This submission does not involve an AI algorithm with a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI algorithm.
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).