(18 days)
The Camino® Intracranial Pressure for Use Monitoring Catheter with Indications 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® 110-4L Catheter is a sterile transducer-tipped pressure monitoring catheter with accessory items to be used as a diagnostic tool for rapidly determining and continually monitoring intracranial pressure. The 110-4L is to be used in conjunction with LICOX® IM2 or IM3 bolt and Camino® Intracranial Pressure Monitors model MPM-1 or V420 and their associated cables.
This 510(k) premarket notification for the Camino® Intracranial Pressure Monitoring Catheter with LICOX® IMC Bolt Fitting, Model 110-4L primarily focuses on demonstrating substantial equivalence to a previously cleared version of the same device. As such, it does not detail a separate clinical or performance study with specific acceptance criteria related to disease diagnosis or outcome prediction.
Instead, the "acceptance criteria" here relate to the safety and mechanical integrity of the modified device, and the "study" is a series of non-clinical tests to confirm these aspects.
Here's a breakdown of the requested information based on the provided text, noting where specific information is not present (which is typical for a substantial equivalence submission unless significant performance changes are made):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Safety - Biocompatibility | Compliance with FDA G95-1 and ISO 10993 standards for materials. | "Biocompatibility studies were conducted per FDA G95-1 and ISO 10993 and have demonstrated that the materials used to manufacture the Camino® 110-4L catheter are safe for its intended use." |
| Mechanical Integrity | Mechanical soundness for intended use (e.g., pressure, pull, and bend). | "In addition, the Camino® 110-4L catheter was subjected to extensive mechanical testing, which included pressure, pull and bend tests. Results of the testing showed that the catheter design was mechanically sound and safe for its intended use." |
| Manufacturing Process | Compliance with US FDA and European Standards. | "The Camino® 110-4L catheter manufacturing process complies with the United States Food and Drug Administration and European Standards for the manufacturing of medical devices." |
| Substantial Equivalence | Equivalence in function and intended use to the predicate device. | "The modified Camino® 110-4L catheter is substantially equivalent in function and intended use to the original Camino® Intracranial Pressure Monitoring Catheter with LICOX® IMC Bolt Fitting, Model 110-4L." and "The modifications do not affect the intended use or the fundamental scientific technology of the device." (Conclusion from the submitter) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated for the biocompatibility or mechanical testing. For mechanical testing, it would likely involve multiple units of the device tested under various conditions.
- Data Provenance: Not specified, but the tests were likely conducted internally by Integra NeuroSciences or by a contract lab on their behalf. The submission is for a medical device manufactured in the USA, so studies would typically be conducted according to US and international standards. This is a pre-market notification and focuses on the device itself, not 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 applicable for this type of submission. The "ground truth" here is the adherence to engineering specifications and safety standards, which is established by adherence to protocols and standard testing methodologies, not by expert medical consensus on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of clinical images or data. Here, the "test set" refers to physical device units and tests.
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, an MRMC comparative effectiveness study was not done. This device is an intracranial pressure monitoring catheter, which is a sensor for direct measurement. It is not an AI-powered diagnostic imaging device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical catheter that directly measures pressure; it does not involve algorithms for interpretation that could be tested in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this submission is related to engineering specifications, recognized safety standards (e.g., ISO 10993), and mechanical performance parameters. For example, pressure transducer accuracy or structural integrity under specific forces. It is not related to clinical outcomes or diagnoses.
8. The sample size for the training set
- This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The design and validation are based on engineering principles and regulatory standards rather than data-driven model training.
9. How the ground truth for the training set was established
- This information is not applicable for the same reasons as point 8.
§ 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).