(71 days)
The CODMAN® Intracranial Bolt is indicated for use as a component of an intracranial pressure (ICP) monitoring system designed to achieve direct ICP monitoring. Specifically, the CODMAN® Intracranial Bolt is intended to secure an ICP transducer during direct ICP monitoring in both subdural and intraparenchymal applications.
The CODMAN® Intracranial Bolt is composed of the following six components: (1) bolt, (2) wing nut, (3) compression cap, (4) compression grommet, (5) washer, and (6) obturator/dura pierce (packaged with bolt assembly). The bolt component is screwed into the cranium in order to secure the transducer. This is achieved through compression of the grommet via tightening of the compression cap. Additionally, a wing nut is provided as a component of the assembly as a means of bolt insertion, and a washer is provided if thread depth variation is desired. Finally, an obturator/dura pierce is provided to clear the inner lumen of the bolt and pierce the dura prior to transducer insertion. All patient contacting components are constructed of fully biocompatible implant materials.
This document is a 510(k) Pre-market Notification for the CODMAN® Intracranial Bolt, a medical device for intracranial pressure (ICP) monitoring. The document asserts "substantial equivalence" to predicate devices, but does not describe acceptance criteria, performance data, or a specific study proving the device meets acceptance criteria.
The 510(k) summary focuses on device description, intended use, and its substantial equivalence to previously marketed devices (CODMAN® MicroSensor™ Skull Bolt and Camino ICP Bolt), circumventing the need for extensive clinical performance studies that newer, novel devices might require.
Therefore, for this specific document:
- 1. A table of acceptance criteria and the reported device performance: Not provided. The submission relies on "substantial equivalence" to predicate devices.
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set or performance data is presented.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment is described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is a physical medical instrument, not an AI or imaging diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical instrument.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- 8. The sample size for the training set: Not applicable. No training set is described.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided text from the 510(k) submission does not contain information regarding acceptance criteria or a study proving the device meets such criteria. Instead, the submission relies on demonstrating substantial equivalence to predicate devices based on intended use, materials, design, and principles of operation.
§ 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).