(273 days)
Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
Use of the CODMAN MICROSENSOR Plastic/Metal Skull Bolt Kit is indicated when direct intracranial pressure (ICP) monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications.
Use of the Ventricular Catheter Kit is indicated when direct intraventricular pressure monitoring is required. The kit is indicated for use in ICP monitoring and cerebrospinal fluid (CSF) drainage applications.
The Microsensor monitors intracranial pressure (ICP) through either a stand-alone probe, or a probe coupled with an EVD catheter, and is intended to be used in conjunction with the Codman ICP Express (product code 82-6635) neuromonitoring platform products. The ICP Express and Codman Microsensor are intended for use in Intensive Care Units (ICUs). The Microsensor converts the pressure signal to a voltage signal. The monitor provides power to the Microsensor, interprets the voltage signal from the Microsensor, and displays the corresponding pressure measurements taken by the Codman Microsensor during a patient's treatment and during patient transport. There is no change to the Codman ICP Express monitor as a result of the probe modifications described in this submission.
The Codman Microsensor probe contains a small, thin and delicate 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 and has an electrical connector to attach the ICP Express monitoring box.
The Codman Microsensor Kits include components needed to facilitate the surgical implantation of the ICP Microsensor. The components that will be included with the proposed Codman Microsensor are currently cleared devices, and are identical to the components currently packaged within the current Codman Microsensor kits (i.e. via this 510k, there are no changes being made to the kit components, only the Microsensor is being updated). Each component and their function are described in the Description section of the Instructions for Use for each kit.
The provided text describes the Codman Microsensor Kits, an intracranial pressure monitoring device, and the studies conducted to demonstrate its substantial equivalence to a predicate device. The information is presented in the context of a 510(k) premarket notification.
Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided document:
Acceptance Criteria and Reported Device Performance
The document outlines acceptance criteria and performance through a series of bench tests. The relevant information is summarized in "Table 4. Verification and Validation Bench Tests" and implicitly stated through "PASS" results for each test.
| Acceptance Criteria (Test Purpose/Method Summary) | Reported Device Performance (Results) |
|---|---|
| Long Term Accuracy: Confirm pressure accuracy, linearity, hysteresis, and sensitivity over time. | PASS |
| Long Term Drift: Confirm drift characteristic over time and evaluate for fluid ingress into the probe's sensing element. (Specifically, the comparison table notes "No greater than 5mmHg over 30 days" as the proposed device's drift, which is an improvement over the predicate's "No greater than 5mmHg/7days"). | PASS |
| Temperature Sensitivity: Confirm sensitivity of pressure output to temperature changes. | PASS |
| Seal Integrity: Confirm no fluid ingress into the probe's sensing element. | PASS |
| Bond Strength: Confirm mechanical strength and meet pull force requirements. | PASS |
| Flexibility: Confirm flexibility (coiling) and its effect on pressure measurement. | PASS |
| Kink: Confirm kink resistance and its effect on pressure measurement. | PASS |
| Connector Cycles and Impedance: Confirm reliability of the connector by measuring input/output impedance after connect/disconnect simulation and meeting specifications. | PASS |
| Zero Offset: Confirm initial zero offset of the pressure sensor is within the specified value. | PASS |
| Heat Transfer: Confirm heat dissipation of the implantable portion does not exceed ANSI AAMI NS28(1988)-R(2010) recommended maximum temperature. | PASS |
| Frequency Response: Confirm frequency response (bandwidth) of the device. | PASS |
| Environmental: Confirm device is not affected by transportation (vibration, drops), can be stored at specified temp/humidity, and operates within expected environmental conditions. | PASS |
| Critical Dimensions: Confirm physical dimensions and that samples meet product drawing. | PASS |
| MRI Compatibility: Confirm functionality of the device before and after exposure to 1.5T MRI and 3T MRI. | PASS |
| MRI Safety: (Refer to Table 5, which lists specific ASTM standards.) | PASS |
| Radiopacity: Confirm device has a radiopaque feature detectable in an X-ray image. | PASS |
| CT Scan Compatibility: Confirm functionality before and after a CT scan exposure. | PASS |
| Over Pressure: Confirm device can withstand extreme pressures without damage. | PASS |
| Calibration Stability: Confirm sensitivity of probe calibration to impacts to the device's housing. | PASS |
| Sterilization: (EO Residual Testing per ISO 10993-7:2008 (R) 2012). | PASS |
| Biocompatibility: (Refer to Table 6 and 7, which list specific tests). | PASS |
| ICP Express Compatibility: Confirm device works as intended with the ICP Express Monitor. | PASS |
Study Details:
-
Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (number of devices or measurements) used for each individual bench test listed in Table 4.
- Data Provenance: The studies are described as "Bench Testing" and "Biocompatibility Testing," implying laboratory-controlled experiments rather than human or animal subject data, except for some biocompatibility tests which use animal models. No country of origin for the data is explicitly mentioned, but the submission is to the U.S. FDA, and relevant standards like ASTM and ISO are cited. The studies are prospective in nature, conducted specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the evaluation relies on physical and chemical measurements against engineering specifications and industry standards, not on expert interpretation of complex clinical data to establish a ground truth. The "ground truth" here is defined by established scientific principles and performance metrics.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable as the studies are bench tests and biocompatibility evaluations, which involve objective measurements and adherence to predetermined standards rather than subjective human interpretation requiring adjudication.
-
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an intracranial pressure monitoring transducer, not an AI-assisted diagnostic imaging device that would typically involve human readers or AI algorithms for interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical medical device (a pressure transducer), not a software algorithm or AI model.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance evaluation is based on engineering specifications, established physical measurement methods, and compliance with recognized industry standards (e.g., ASTM, ISO). For biocompatibility, it's based on biological responses in animal models and in vitro tests (cytotoxicity, sensitization, irritation, pyrogenicity, mutagenicity, implantation, hemolysis) against accepted safety thresholds.
-
The sample size for the training set:
- This is not applicable as the device is a physical medical device and does not involve AI or machine learning algorithms that require training sets.
-
How the ground truth for the training set was established:
- This is not applicable for the same reason as point 7.
§ 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).