(127 days)
The intended use of the DirectLink Module is to enable the connection of Codman intracranial pressure sensors to an available invasive blood pressure input channel on select commercially available third party patient bedside monitor systems.
The DirectLink ICP Extension Cable is intended for use as a connecting cable between the DirectLink ICP Module and a Codman Microsensor ICP Transducer.
The Patient Monitor Interface Cable is intended for use as a connecting cable between DirectLink ICP Module, and selected patient monitors available from third party suppliers.
The DirectLink ICP Module is a direct interface to connect the CODMAN MICROSENSOR® ICP Transducers to a patient bedside monitor, allowing the user to do the following:
- . Zero the ICP sensor
- Provide zero reference and calibration signals to the patient bedside . monitor
- . Transfer the ICP readings to the patient bedside monitor for visualization and data storage/processing.
The module does not have its own source of power, but is powered through connection to the patient monitor.
In order to connect the DirectLink Module to the Microsensor and to the bedside monitor two cables (the DirectLink ICP Extension Cable and the Patient Monitor Interface Cable) are needed. These cables are described below. (Cont.) DirectLink ICP Extension Cable The DirectLink ICP Extension Cable is required to connect the DirectLink ICP Module and the CODMAN MICROSENSOR ICP Transducer. The extension cable is reusable and is supplied non-sterile. The cable can be wiped down before each use with combination wipes (Quarternary Ammonium/Isopropyl Alcohol), or 70% isopropyl alcohol, or can be sterilized by autoclave before each use. Patient Monitor Interface Cable The Patient Monitor Interface Cable is used as a connecting cable between the DirectLink ICP Module, and selected patient monitors available from third party suppliers. The interface cable is reusable and is supplied non-sterile. The cable can be wiped down before each use with combination wipes (Quarternary Ammonium/Isopropyl Alcohol), or 70% isopropyl alcohol.
Here's a breakdown of the acceptance criteria and supporting study details based on the provided text, where applicable:
It's important to note that the provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study demonstrating the device's efficacy against specific performance metrics in a clinical setting with human subjects. The testing described is primarily bench testing and verification/validation of the device's functional performance.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state a table of quantitative acceptance criteria with corresponding reported device performance values in the format commonly seen in clinical efficacy studies. Instead, it lists types of tests performed to support substantial equivalence. The "Acceptance Criteria" here are implicitly that the device performs as expected and comparably to the predicate device in these tests, and meets relevant safety standards.
| Acceptance Criteria (Implicit from Tests Performed) | Reported Device Performance (Implicit from Study Conclusion) |
|---|---|
| DirectLink ICP Module: | |
| Accuracy (e.g., of ICP measurements) | Met expectations; device determined substantially equivalent. |
| Output Impedance, Zero Short Term Drift, Sensor Signal Stability | Met expectations; device determined substantially equivalent. |
| Accuracy and Symmetry of the Pressure Reference Signals | Met expectations; device determined substantially equivalent. |
| Power Consumption and Input Impedance | Met expectations; device determined substantially equivalent. |
| Wiping Test (evaluating cleanability) | Met expectations for reusability with specified cleaning methods. |
| Hardware Diagnostic Test | Met expectations for proper functioning. |
| DirectLink ICP Extension Cable & Patient Monitor Interface Cables: | |
| Cable Baseline Tests (mating/demating force, flex cycles) | Met expectations for mechanical durability and connection integrity. |
| Cable Autoclave Tests (autoclave, wiping, flex cycles, operating cycles) | Met expectations for sterilization (autoclave) and reusability with specified cleaning methods. |
| Documents and Drawings Review | Met regulatory and design specifications. |
| Complete System – DirectLink ICP Modules and Cables: | |
| Transit Test (evaluating robustness during transport) | Met expectations for structural integrity after transport simulation. |
| Summative Usability Test – Part 1 - Surgeons | Met expectations for user interaction and safety by intended users. |
| Summative Usability Test – Part 2 – Nurses | Met expectations for user interaction and safety by intended users. |
| Functionality and Performance Testing of the DirectLink System Connected to a Patient Monitor including Cables Mating | Met expectations for seamless integration and correct data transfer with various patient monitors. |
| 60601-1 and 60601-1-2 Test (Electrical Medical Equipment Safety Standards) | Compliant with relevant electrical safety and electromagnetic compatibility standards. |
| PPQ Validation for DirectLink ICP Module and Cables (Process Performance Qualification) | Manufacturing processes validated to consistently produce devices meeting specifications. |
| Biocompatibility | Not applicable as devices are not intended to contact the patient. |
| Absence of requirement for Animal Studies/Clinical Studies | Not required due to similarity to predicate device and satisfactory bench testing results, implying performance equivalence to predicate. |
Study Details:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a "sample size" in terms of patient data. The testing described is primarily bench testing involving a number of physical device units and components. The exact number of units/components tested is not provided in this summary.
- Data Provenance: The testing was conducted by Medos International SARL (the manufacturer) as part of their premarket notification (510(k)) submission. This is internal verification and validation data. No specific country of origin for data (e.g., patient data) is mentioned as it's not a clinical study. The device manufacturer is based in Switzerland with a US contact.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the Summative Usability Tests (Part 1 - Surgeons, Part 2 - Nurses), experts (surgeons and nurses) were used to evaluate usability. The number of experts and their specific qualifications (e.g., years of experience) are not specified in this summary. However, these experts would have provided feedback against usability criteria rather than establishing a "ground truth" for a medical condition.
- For the technical and performance bench tests, "ground truth" would be established by reference standards, calibrated equipment, and engineering specifications, rather than clinical experts.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of imaging or clinical findings by multiple readers. This type of adjudication is not applicable to the bench testing and usability evaluations described for this device.
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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 MRMC comparative effectiveness study was done. This device is an intracranial pressure monitoring module and cables, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this question is not relevant to the provided document.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a hardware module and cables, not an algorithm. Its function is to facilitate the connection and data transfer of an already existing ICP transducer to a patient monitor. Its "performance" is its ability to accurately and reliably transmit signals, not to interpret or diagnose.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the technical and performance tests (e.g., accuracy, impedance, power consumption), the "ground truth" would be the known and precisely controlled input signals/conditions generated by test equipment, and validated standards (e.g., electrical safety standards).
- For usability tests, the "ground truth" would be subjective user experience and feedback against predefined usability criteria, from the perspective of the intended users (surgeons, nurses).
- There is no mention of expert consensus, pathology, or outcomes data as this was not a clinical efficacy study.
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The sample size for the training set:
- Not applicable. This device is a hardware accessory (module and cables), not a machine learning or AI algorithm. Therefore, there is no "training set."
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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).