(139 days)
The ICP Monitor is intended for use as an interface between compatible strain gauge type pressure transducers and standard physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor. The CereLink ICP Extension cable is intended for use as a connecting cable between the ICP input channel of the CereLink ICP Monitor and a CereLink ICP Sensor.
The CereLink ICP Monitor is indicated for use in the ICU or Operating Room (OR) environment for monitoring intracranial pressure (ICP) via a solid-state sensor placed directly in parenchymal tissue or integrated into an external ventricular drainage catheter placed in the ventricle. In addition to monitoring ICP and activating alarms when the intracranial pressure is outside user-set limits, the device performs these functions:
- Displays ICP Waveform
- Displays Mean ICP numeric
- Displays the historic mean pressure as a trend
- Displays trend statistics (Pressure Time Dosage (PTD), time above threshold, boxplot, histogram)
- Stores 14-days' worth of mean ICP values
- Stores 24 hours of pressure waveform
- Can capture and store screen-shots
- Can download various data to a USB device for printing or analysis
- Real-time data streaming of mean ICP and waveform via USB connection
- Connect to external patient monitor
The CereLink ICP Monitor can be transported with the hospital to continuously record data. The monitor includes a 7" color touch screen that is compatible with the use of gloves. The monitor is provided to the user with a CereLink ICP Extension Cable, external power supply, and comes equipped with an internal rechargeable battery. The monitor has one output channel to transfer physiological data to a compatible Patient Monitor, as well as one input channel to receive ICP readings from the implanted CereLink ICP sensor. The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable; the CereLink ICP Monitor connects to compatible patient monitors through the patient monitor interface cables.
The provided text describes a 510(k) premarket notification for a medical device, the CereLink ICP Monitor and CereLink ICP Extension Cable, which are intended for intracranial pressure monitoring. The document outlines acceptance criteria and performance testing for these devices, particularly focusing on modifications made to the extension cable.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance/Conclusion |
|---|---|---|
| Mechanical Tests | Not explicitly stated | Pass |
| Electrical Testing (Impedance Measurement) | Not explicitly stated | Pass |
| Out of Range Failure Test (using electrical stress setup) | Recovery within specified time after correct connection of patient lead | All CereLink Systems recovered from failure within specified amount of time. Pass |
| 30 Day ICP Drift Test (using electrical stress setup) | Meet specification | ICP drift met the specification. Pass |
| Mean Time Between Failure Calculation Test | Not explicitly stated | Pass |
| Simulated Environment Validation Test (13 days) | Not explicitly stated | Pass |
| Label Verification Test | Not explicitly stated | Pass |
| Drawing Verification Test | Not explicitly stated | Pass |
| Summative Usability Report | Not explicitly stated | Pass |
| Biocompatibility: ISO 10993-5:2009 | Not explicitly stated | Pass |
| Biocompatibility: ISO 10993-10:2021 | Not explicitly stated | Pass |
| Biocompatibility: ISO 10993-23:2021 | Not explicitly stated | Pass |
| Electrical Safety: IEC 60601-1: 2005+AMD1:2012+AMD2:2020 | Not explicitly stated | Pass |
| Electrical Safety: IEC 60601-1-6: 2010+AMD1:2013+AMD2:2020 | Not explicitly stated | Pass |
| Electrical Safety: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 | Not explicitly stated | Pass |
| Electrical Safety: IEC 60601-1-2:2014+AMD1:2020 | Not explicitly stated | Pass |
| Electrical Safety: IEC 62366-1:2015+AMD1:2020 | Not explicitly stated | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to "the CereLink Systems" being exposed to the electrical stress setup. It does not provide a specific number for the sample size (e.g., number of devices or test units) used in these tests.
The data provenance is from bench testing as explicitly stated ("Performance Bench Test Results"). This indicates controlled laboratory conditions. There is no mention of country of origin for the data, and the nature of the tests (bench) makes the retrospective/prospective distinction less relevant in the typical clinical study sense. However, the tests are for design verification and validation, implying they were conducted prospectively to assess the new design.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This submission pertains to a hardware device (ICP monitor and cable) and its electrical and mechanical performance, not an AI/software device that requires human expert review to establish ground truth for image or diagnostic interpretation. The testing relies on established engineering and medical device standards.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this is not an AI/software device requiring subjective interpretation or adjudication by experts. The tests are objective performance evaluations against specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The device is a hardware ICP monitor and cable, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm-based device. The "performance" refers to the physical and electrical characteristics of the monitor and cable. The tests described (ICP Drift, Out-of-Range Failure, Electrical Safety, etc.) are essentially "standalone" performance evaluations of the device itself.
7. The Type of Ground Truth Used:
The ground truth for the device's performance is based on engineering specifications and internationally recognized standards (e.g., ISO, IEC). For the specific "Out-of-Range Failure Test," the ground truth for "failure" is when the device enters the out-of-range state, and the "recovery" is when it exits that state within a specified time, which are objective, measurable outcomes in a controlled "electrical stress setup" designed to reproduce these failures.
8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this hardware device.
§ 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).