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.

Device Description

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.

AI/ML Overview

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:

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.
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.
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.
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.
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.
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.
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."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this hardware device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 22, 2016

Medos International SARL c/o Dr. Elena Jugo Codman Neuro 325 Paramount Drive Raynham, MA 02767

Re: K152670

Trade/Device Name: DirectLink ICP Module DirectLink Extension Cable Patient Monitor Interface Cables Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: Class II Product Code: GWM Dated: December 18, 2015 Received: December 21, 2015

Dear Dr. Elena Jugo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

William J. Heetderks -S

for

Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K152670

Device Name DirectLink™ ICP Module DirectLink™ ICP Extension Cable Patient Monitor Interface Cable

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--	--	--	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary 7.

Codman Neuro I. Submitter 325 Paramount Drive Raynham, MA 02767

On behalf of: Medos International SARL Chemin-Blanc 38 CH 2400 LeLocle, Switzerland

Phone: 305-265-6802 305-265-6889 Fax:

Contact Person: Elena Jugo Date of Submission: September 16, 2015

II. Device

Name of Device	DirectLink ICP Module
	DirectLink Extension Cable
	Patient Monitor Interface Cables
Common Name	Intracranial pressure monitoring device
Classification Name	Intracranial Pressure Monitoring Device (21 CFR 882.1620)
Regulatory Class	II
Product Code	GWM

III. Predicate Device

Codman CU-II (ICP Express), K945585

DirectLink ICP Module IV. Device Description

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.

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510(k) Summary (Cont)

IV. Device In order to connect the DirectLink Module to the Microsensor and to the bedside Description 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. The intended use of the DirectLink ICP Module is to enable the connection of V. Indications Codman intracranial pressure sensors to an available invasive blood pressure input for Use 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.

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510(k) Summary (Cont)

VI.Comparison toPredicateDevice	Based upon the intended use, design, function, comparison to the currentlymarketed device, and testing performed, it is concluded that the DirectLinkICP Module and related cables are substantially equivalent to the predicateCodman CU-II (ICP Express), and therefore, do not raise any new questionsof safety and effectiveness.
VII.PerformanceData	The following performance data have been provided in support of the substantialequivalence determination.
	Bench TestingValidation and verification testing were performed on the DirectLink ICPModule, the ICP Extension Cable, and the Patient Monitor Interface Cables.
	Testing was performed on each individual component, as well as on the entiresystem. Table 2 lists the tests performed.
	Table 2. Validation and Verification Tests
	DirectLink ICP Module
	Accuracy Test
	Output Impedance, Zero Short Term Drift, Sensor Signal Stability TestA - Researces and Campeon - the - Desember Decamers Defenser - Simmel - Part

Accuracy and Symmetry of the Pressure Reference Signals Test Power Consumption and Input Impedance Test

Wiping Test Hardware Diagnostic Test

DirectLink ICP Extension Cable and Patient Monitor Interface Cables

Cable Baseline Tests (mating and demating force, flex cycles) Cable Autoclave Tests (autoclave, wiping, flex cycles, operating cycles) Documents and Drawings Review

Complete System – DirectLink ICP Modules and Cables

Transit Test

Summative Usability Test – Part 1 - Surgeons

Summative Usability Test – Part 2 – Nurses

Functionality and Performance Testing of the DirectLink System Connected to a Patient Monitor including Cables Mating

60601-1 and 60601-1-2 Test PPQ Validation for DirectLink ICP Module and Cables

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510(k) Summary (Cont)

VII.PerformanceData, cont.	Biocompatibility TestingBiocompatibility testing was not performed as these devices are not intendedto contact the patient.
	Animal StudiesNo animal studies were required as appropriate verification of the new intended usewas achieved based on the similarities of the proposed device to the predicatedevices, and from results of bench testing.
	Clinical StudiesClinical data are not necessary to demonstrate substantial equivalence of theDirectLink ICP Module and associated cables to the predicate device.
VIII.Conclusion	Based upon the intended use, design, materials, function, comparison to currentlymarketed device, and testing performed it is concluded that the DirectLink ICPModule and associated cables are substantially equivalent to the predicate CodmanCU II (ICP Express) and therefore, do not raise any new questions of safety andeffectiveness.

Regulation Number and Section

§ 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).