(37 days)
CereLink ICP Sensor Basic Kit (82-6850); CereLink ICP Sensor Metal Skull (82-6851); CereLink ICP Sensor Plastic Skull (82-6852)
Indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
CereLink ICP Sensor Ventricular Catheter Kit (82-6854)
Indicated when direct intraventricular pressure monitoring is required. The kit is indicated for use in ICP monitoring and cerebrospinal fluid (CSF) drainage applications
The CereLink ICP Sensor Kits are used to monitor intracranial pressure (ICP) through either a stand-alone probe, or a probe coupled with an External Ventricular Drainage (EVD) catheter. The probe, also known as the CereLink ICP Sensor is intended to be used in conjunction with all of Codman's neuromonitoring devices: the Codman ICP Express Monitor (product code 82-6634) and the DirectLink ICP Module (product code 82-6828). The ICP Express and DirectLink are intended for use in ICUs. The CereLink ICP Sensor converts the pressure sensor to a voltage signal. The monitor provides power to the sensor, interprets the voltage signal from the sensor, and displays the corresponding pressure measurements taken by the sensor during a patient's treatment and during patient transport. There is no change to the currently marketed Codman ICP Express or DirectLink as a result of the probe modifications described in this submission.
The CereLink ICP Sensor contains a small, thin pressure sensor used to measure the intracranial pressure. The sensing element uses a strain gauge located at the tip of the probe. The sensing element is protected by a titanium housing and is exposed to the environment via a silicone membrane. The sensor is connected via wires to a plastic connector housing, and the wires are snaked through a nylon catheter. The connector housing includes a compensation/calibration passive circuit on a Printed Circuit Board (PCB). Additionally, the CereLink ICP Sensor's connector housing includes a new memory PCB board. When the CereLink ICP Sensor is used with either the ICP Express or DirectLink, it functions identically to the cleared predicate Codman Microsensors. Additionally, the connector housing has an electrical connector to attach to any of the monitoring devices.
The CereLink ICP Sensor Kits include components needed to facilitate the surgical implantation of the Cerelink ICP sensor. The components that will be included with the proposed CereLink ICP Sensor Kits are currently cleared devices, and are identical to the components currently packaged within the predicate Codman Microsensor Kits (i.e. there are no changes being made to the kit components, only the ICP sensor is being modified). Each component and their function are described in the Description section of the Instructions for Use for each kit.
The provided text is a 510(k) Summary for the CereLink ICP Sensor Kits, describing the device and its substantial equivalence to a predicate device. It is not an AI/ML device, and therefore does not contain information on acceptance criteria for algorithm performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
The document focuses on demonstrating that the modified device (CereLink ICP Sensor Kits) is substantially equivalent to a previously cleared device (Codman Microsensor Kits) by showing that it has:
- The same indications for use and intended use.
- The same fundamental scientific technology and basic design.
- Incorporates the same materials for the implantable portion.
- Uses the same packaging and sterilization methods.
The changes primarily involve minor differences in the plastic connector housing (e.g., shape, addition of PCB and memory PCB, pad printing replacing a paper label) and updated labeling.
Instead, the document details performance testing for a medical device (intracranial pressure sensor) related to its physical and functional attributes, not AI/ML algorithm performance.
Here's a breakdown of the information that is present in the document, which primarily focuses on traditional medical device testing and comparisons for regulatory submission:
1. Table of Acceptance Criteria and Reported Device Performance:
The document includes a "Summary of Testing" table (page 8) that lists various performance tests, relevant standards, and the general "Result" for the subject device. However, it does not provide specific numerical acceptance criteria or reported performance values in a typical table format that would be expected for AI/ML performance metrics (e.g., accuracy, sensitivity, specificity with numerical thresholds).
Instead, the results are qualitative and confirm that the device "met the established acceptance criteria and is therefore substantially equivalent to the predicate" or "Pass".
| Test Category | Standards/Criteria | Reported Performance/Result |
|---|---|---|
| Bench Testing (including MRI Compatibility) | EN 62366:2008 (Usability engineering), ASTM F2052-15 (MRI displacement force), ASTM F2182-11a (MRI RF heating), ASTM F2119-07 (MRI image artifacts), ASTM F2213-06 (MRI torque), ASTM F2503-13 (MRI marking) | "Pass - subject device design met the established acceptance criteria and is therefore substantially equivalent to the predicate" (page 8) |
| Electrical Safety and Electromagnetic Compatibility Testing | IEC 60601-1 (General requirements), IEC 60601-1-2 (Electromagnetic disturbances), IEC 60601-1-6 (Usability), IEC 60601-1-9 (Environmentally conscious design) | "Pass - subject device design met the established acceptance criteria and is therefore substantially equivalent to the predicate" (page 8, also detailed on page 9: "The CereLink ICP Sensor design is compliant for Electrical Safety and EMC per IEC 60601-1 2nd and 3th editions.") |
| Sterilization | EN ISO 11135:2014 (Ethylene Oxide Sterilization), EN ISO 10993-7:2008/AC2009 (Ethylene Oxide Sterilization Residuals), EN ISO 11737-2:2009 (Sterility tests), ANSI ST72:2011 (Bacterial endotoxins) | "Pass - subject device design met the established acceptance criteria and is therefore substantially equivalent to the predicate" (page 8, also detailed on page 10: "validated to ensure a sterility assurance level (SAL) of 10^-6", "ethylene oxide residuals can be reduced to an acceptable level", "successfully adopted into Codman's existing sterilization cycle.") |
| Shelf Life - Functionality Testing | EN ISO 11607-1:2009 (Packaging - Materials), EN ISO 11607-2:2006 (Packaging - Validation) | "Pass - subject device design met the established acceptance criteria and is therefore equivalent to the predicate" (page 8, also detailed on page 10: "The shelf life for the proposed CereLink ICP Sensor Kits will be 2 years (same as predicate Codman Microsensor Kits).") |
| Biocompatibility | EN ISO 10993-1:2009/AC2010 (Biological Evaluation of Medical Devices), FDA's Guidance document, "Use of International Standard ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process " issued on June 16, 2016. | "Non-cytotoxic, Non-sensitizing, Non-irritating, Non-toxic, Non-pyrogenic, Non-mutagenic, Non-clastogenic, Non-toxic, and Met USP 37 limits where applicable" (page 9, also detailed on page 10: "test results... demonstrates that the proposed Cerelink ICP Sensor Kits are biocompatible.") |
| Functional Pressure Range | Not explicitly stated as a test in the table, but listed as a "Device Characteristic" in comparison table. | -50mmHg to 250mmHg (Same as predicate) (page 7) |
| Functional Over Pressure Range Without Damage | Not explicitly stated as a test in the table, but listed as a "Device Characteristic" in comparison table. | -700mmHg to 1250mmHg (Same as predicate) (page 7) |
| Zero Drift | Not explicitly stated as a test in the table, but listed as a "Device Characteristic" in comparison table. | No greater than 5mmHg over 30 days (Same as predicate) (page 7) |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not applicable to this document as it describes a physical medical device, not an AI/ML algorithm. The "test set" here refers to the actual physical devices subjected to bench testing, sterilization validations, and biocompatibility assessments, rather than a dataset of images or patient records. No information on data provenance (country, retrospective/prospective) is relevant or provided beyond the general understanding that testing was conducted by or for the manufacturer (Codman & Shurtleff, Inc. in Raynham, Massachusetts).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This is not applicable to a physical device submission like this. Ground truth in this context would be physical measurements, chemical analyses, and adherence to engineering and biological safety standards, not expert consensus on interpretations.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for human interpretation of data, typically in studies involving subjective assessments or labeling of complex medical images, which is not what this document addresses.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was done, as this is not an AI/ML device that assists human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance:
Not applicable. This device is an intracranial pressure sensor, whose performance is measured physically (e.g., pressure readings, electrical characteristics, material safety), not as an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is established through:
- Adherence to recognized international and national standards (e.g., ISO, ASTM, IEC) for medical devices.
- Bench testing to verify physical and functional characteristics (e.g., MRI compatibility, electrical safety, pressure range).
- Sterilization validation confirming a specific sterility assurance level.
- Biocompatibility testing to ensure no adverse biological reactions.
- Comparison to the predicate device's established performance and characteristics, demonstrating "substantial equivalence."
8. The Sample Size for the Training Set:
Not applicable. There is no concept of a "training set" for this type of physical medical device in the context of this submission. The "training" here would be the design, engineering, and manufacturing processes.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set as described for AI/ML algorithms.
§ 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).