(319 days)
The use of a Trilogy system by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure is clinically important, when the patient may require CSF drainage in the course of their care and when data from one or more parameters may be deemed useful in providing optimum patient management.
This submittal covers a device that allows the placement of a ventricular catheter and up to three probes through one bolt. The pressure sensor is an air-based system that has a deformable chamber. The pressure in the chamber mirrors ICP. It is transmitted to an external transducer. The submittal also includes several procedure accessories, a device that sets the proper length of a probe to be inserted into the Trilogy, a tripod that indicates the correct drill angle, a series of tubes that fit on the shank of the bolt that cause the distal end of the bolt to stop when it reaches the inner table, an improved drill bit stop and an improved pump that injects air into the catheter's sensing system.
This document is a 510(k) premarket notification for a medical device called Trilogy. It describes modifications to an intracranial pressure monitoring device and its accessories. However, the provided text does not contain a study that proves the device meets specific acceptance criteria.
The document primarily focuses on describing device modifications and evolutionary changes to the existing MPS Oxiport and MPS Oxiport Plus devices. It mentions that "The ability of the sensor to work in parenchymal tissue is described in K003905," referring to a previous 510(k) submission, but the details of that study or its acceptance criteria are not included here. The current submission is a 510(k) for changes to an already approved device, suggesting that the focus is on demonstrating substantial equivalence rather than a de novo clinical trial with specific performance Acceptance Criteria.
Therefore, I cannot provide the requested table or answer most of the questions because the document does not report any acceptance criteria or the results of a study designed to prove the device meets those criteria.
Here's what can be extracted based on the provided text, and where the information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document |
Missing Information/Not Applicable based on document:
- Sample size used for the test set and the data provenance: Not mentioned. No test set or study data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. No test set or ground truth establishment is described.
- Adjudication method: Not mentioned.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned. The document describes a device, not a diagnostic AI.
- Standalone (algorithm only without human-in-the-loop performance) study: Not mentioned. The document describes a physical medical device and its components, not an algorithm.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not applicable. This is a physical device, not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of what the document does describe:
- Submitted by: InnerSpace
- New Device Names: Trilogy
- Predicate Device: K072379 MPS Oxiport Plus
- Device Modifications:
- Three probe capability: Added a third probe channel to the manifold, requiring a 10% larger bolt diameter to accommodate it. The guidance system was re-engineered using two thin-wall tubes instead of a single injection-molded part, maintaining similar brain volume displacement.
- Pressure Sensor: Moved the sensor higher on the catheter to avoid entering the ventricle, addressing the "slit ventricle problem" and allowing readings in parenchymal tissue. States that the ability of the sensor to work in parenchymal tissue is described in K003905.
- Evolutionary Modifications (Entered For The Record):
- Air Injection System: Modified to remove residual air before injecting new air, ensuring a consistent starting air charge and correcting ICP readings regardless of initial ICP.
- Drill Angle Tripod: A tripod device to help surgeons visualize the correct drill angle for burr holes before drilling. It does not control the drill during the process.
- Drill Stop: Redesigned to be a two-piece assembly with an integrated spacer, simplifying its use and increasing likelihood of surgeon compliance. It allows the drill bit to advance through the skull but not beyond.
- Bolt Stop: Tubes of defined lengths are provided to match skull thickness, ensuring the bolt is screwed in to the proper depth without the surgeon needing to count turns.
- Probe Length Measuring Tube: A system using a measuring tube and T-B fitting to consistently set the length of a probe inserted into the brain.
In conclusion, this document is a regulatory submission describing design changes and evolutions of a medical device, not a report of a study with specific acceptance criteria and performance data for those criteria.
§ 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).