DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables

K152670 · Medos International SARL · GWM · Jan 22, 2016 · Neurology

Device Facts

• Record ID: K152670
• Device Name: DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables
• Applicant: Medos International SARL
• Product Code: GWM · Neurology
• Decision Date: Jan 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2

Indications for Use

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 Story

DirectLink ICP Module acts as an interface between Codman Microsensor ICP transducers and third-party patient bedside monitors; enables zeroing of ICP sensors; provides zero reference and calibration signals to the monitor; transfers ICP readings for visualization and storage. Powered by the connected patient monitor. Used in clinical settings by healthcare providers. Facilitates integration of specialized ICP sensors into standard bedside monitoring workflows; allows continuous ICP monitoring to support clinical decision-making in neurocritical care.

Clinical Evidence

Bench testing only. Validation and verification included accuracy tests, output impedance, zero short-term drift, sensor signal stability, power consumption, hardware diagnostics, cable mechanical testing (flex cycles, mating force), and system-level usability testing with surgeons and nurses. Compliance with 60601-1 and 60601-1-2 standards was verified. No clinical or animal studies were required.

Technological Characteristics

Interface module and cabling system. Materials compatible with cleaning via quaternary ammonium/isopropyl alcohol or 70% isopropyl alcohol; extension cable autoclavable. Powered via connection to patient monitor. Connectivity: proprietary interface to Codman sensors and standard invasive blood pressure input channels on third-party monitors. Hardware-based signal conditioning and calibration.

Indications for Use

Indicated for patients requiring intracranial pressure (ICP) monitoring via Codman Microsensor ICP Transducers, facilitating signal transmission to third-party bedside patient monitors.

Regulatory Classification

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.

Predicate Devices

• Codman CU-II (ICP Express) (K945585)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 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.

| 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: [phone] 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.<br>Comparison to<br>Predicate<br>Device | Based upon the intended use, design, function, comparison to the currently<br>marketed device, and testing performed, it is concluded that the DirectLink<br>ICP Module and related cables are substantially equivalent to the predicate<br>Codman CU-II (ICP Express), and therefore, do not raise any new questions<br>of safety and effectiveness. | | |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| VII.<br>Performance<br>Data | The following performance data have been provided in support of the substantial<br>equivalence determination. | | |
| | Bench Testing<br>Validation and verification testing were performed on the DirectLink ICP<br>Module, the ICP Extension Cable, and the Patient Monitor Interface Cables. | | |
| | Testing was performed on each individual component, as well as on the entire<br>system. 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 Test<br>A - 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.<br>Performance<br>Data, cont. | Biocompatibility Testing<br>Biocompatibility testing was not performed as these devices are not intended<br>to contact the patient. |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Animal Studies<br>No animal studies were required as appropriate verification of the new intended use<br>was achieved based on the similarities of the proposed device to the predicate<br>devices, and from results of bench testing. |
| | Clinical Studies<br>Clinical data are not necessary to demonstrate substantial equivalence of the<br>DirectLink ICP Module and associated cables to the predicate device. |
| VIII.<br>Conclusion | Based upon the intended use, design, materials, function, comparison to currently<br>marketed device, and testing performed it is concluded that the DirectLink ICP<br>Module and associated cables are substantially equivalent to the predicate Codman<br>CU II (ICP Express) and therefore, do not raise any new questions of safety and<br>effectiveness. |
| | |