(127 days)
Not Found
No
The device description and performance studies focus on hardware connectivity and signal transfer, with no mention of AI/ML algorithms or data processing beyond visualization and storage.
No
The device is described as an interface module and cables designed to connect intracranial pressure sensors to patient bedside monitors for data transfer and visualization, with no direct therapeutic function.
Yes.
The device is intended to connect intracranial pressure sensors to a patient bedside monitor for visualization and data storage/processing of ICP readings, which are used for patient monitoring and clinical assessment. This function is inherently diagnostic as it provides critical physiological data to aid in diagnosis and treatment decisions.
No
The device description explicitly mentions hardware components (DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cable) and describes physical characteristics and testing related to these hardware components.
Based on the provided information, the DirectLink Module and its associated cables are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for connecting intracranial pressure sensors to patient bedside monitors to enable visualization and data transfer of ICP readings. This is a physiological measurement taken directly from the patient's body, not a test performed on a sample (like blood, urine, or tissue) outside of the body.
- Device Description: The description reinforces the intended use by detailing how the module facilitates the transfer of ICP readings to a bedside monitor. It doesn't mention any analysis of biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes in a sample
- Use in a laboratory setting
- Diagnosis of diseases based on sample analysis
The device is a medical device used for monitoring a physiological parameter (intracranial pressure) directly from a patient. It acts as an interface and signal conditioner, not a diagnostic test performed on a sample.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GWM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing Validation and verification testing were performed on the DirectLink ICP Module, the ICP Extension Cable, and the Patient Monitor Interface Cables. Testing was performed on each individual component, as well as on the entire 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
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
Biocompatibility Testing Biocompatibility testing was not performed as these devices are not intended to contact the patient.
Animal Studies No animal studies were required as appropriate verification of the new intended use was achieved based on the similarities of the proposed device to the predicate devices, and from results of bench testing.
Clinical Studies Clinical data are not necessary to demonstrate substantial equivalence of the DirectLink ICP Module and associated cables to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one in front of the other. The profiles are rendered in a simple, abstract style.
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.
1
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 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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3
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.
4
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.
5
510(k) Summary (Cont)
| VI.
Comparison to
Predicate
Device | Based upon the intended use, design, function, comparison to the currently
marketed device, and testing performed, it is concluded that the DirectLink
ICP Module and related cables are substantially equivalent to the predicate
Codman CU-II (ICP Express), and therefore, do not raise any new questions
of safety and effectiveness. | | |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| VII.
Performance
Data | The following performance data have been provided in support of the substantial
equivalence determination. | | |
| | Bench Testing
Validation and verification testing were performed on the DirectLink ICP
Module, the ICP Extension Cable, and the Patient Monitor Interface Cables. | | |
| | Testing was performed on each individual component, as well as on the entire
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
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
6
510(k) Summary (Cont)
| VII.
Performance
Data, cont. | Biocompatibility Testing
Biocompatibility testing was not performed as these devices are not intended
to contact the patient. |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Animal Studies
No animal studies were required as appropriate verification of the new intended use
was achieved based on the similarities of the proposed device to the predicate
devices, and from results of bench testing. |
| | Clinical Studies
Clinical data are not necessary to demonstrate substantial equivalence of the
DirectLink ICP Module and associated cables to the predicate device. |
| VIII.
Conclusion | Based upon the intended use, design, materials, function, comparison to currently
marketed device, and testing performed it is concluded that the DirectLink ICP
Module and associated cables are substantially equivalent to the predicate Codman
CU II (ICP Express) and therefore, do not raise any new questions of safety and
effectiveness. |
| | |