(37 days)
Not Found
No
The device description focuses on the hardware components (sensor, wires, PCB, etc.) and its function of converting pressure to a voltage signal for display on existing monitors. There is no mention of AI, ML, or any data processing beyond basic signal interpretation and display. The performance studies are standard bench, electrical safety, sterilization, shelf life, and biocompatibility tests, not related to AI/ML performance.
No.
The device is clearly indicated for monitoring intracranial pressure, not for therapy. It provides real-time data to aid in patient treatment but does not directly treat the condition.
Yes
Explanation: The device is indicated for "direct ICP monitoring" and measures "intracranial pressure". Monitoring and measuring physiological parameters like pressure are functions of a diagnostic device.
No
The device description clearly details physical components like a pressure sensor, strain gauge, titanium housing, silicone membrane, wires, plastic connector housing, and PCBs. It is a hardware device with embedded electronics.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is intended for direct monitoring of intracranial pressure (ICP) by being surgically implanted into the body (subdural, intraparenchymal, or intraventricular).
- Device Description: It's a sensor that measures pressure within the body and converts it to an electrical signal for display on a monitor.
- Lack of In Vitro Activity: IVDs are used to examine specimens from the human body (like blood, urine, tissue) outside the body to provide information about a physiological state, disease, or congenital abnormality. This device does not perform any testing or analysis on bodily fluids or tissues in vitro.
The device is an invasive medical device used for physiological monitoring in vivo.
N/A
Intended Use / Indications for Use
CereLink ICP Sensor Basic Kit (82-6850); CereLink ICP Sensor Metal Skull (82-6851); CereLink ICP Sensor Plastic Skull (82-6852)
Indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
CereLink ICP Sensor Ventricular Catheter Kit (82-6854)
Indicated when direct intraventricular pressure monitoring is required. The kit is indicated for use in ICP monitoring and cerebrospinal fluid (CSF) drainage applications.
Product codes (comma separated list FDA assigned to the subject device)
GWM
Device Description
The CereLink ICP Sensor Kits are used to monitor intracranial pressure (ICP) through either a stand-alone probe, or a probe coupled with an External Ventricular Drainage (EVD) catheter. The probe, also known as the CereLink ICP Sensor is intended to be used in conjunction with all of Codman's neuromonitoring devices: the Codman ICP Express Monitor (product code 82-6634) and the DirectLink ICP Module (product code 82-6828). The ICP Express and DirectLink are intended for use in ICUs. The CereLink ICP Sensor converts the pressure sensor to a voltage signal. The monitor provides power to the sensor, interprets the voltage signal from the sensor, and displays the corresponding pressure measurements taken by the sensor during a patient's treatment and during patient transport. There is no change to the currently marketed Codman ICP Express or DirectLink as a result of the probe modifications described in this submission.
The CereLink ICP Sensor contains a small, thin 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 (PCB). Additionally, the CereLink ICP Sensor's connector housing includes a new memory PCB board. When the CereLink ICP Sensor is used with either the ICP Express or DirectLink, it functions identically to the cleared predicate Codman Microsensors. Additionally, the connector housing has an electrical connector to attach to any of the monitoring devices.
The CereLink ICP Sensor Kits include components needed to facilitate the surgical implantation of the Cerelink ICP sensor. The components that will be included with the proposed CereLink ICP Sensor Kits are currently cleared devices, and are identical to the components currently packaged within the predicate Codman Microsensor Kits (i.e. there are no changes being made to the kit components, only the ICP sensor is being modified). Each component and their function are described in the Description section of the Instructions for Use for each kit.
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
Contraindications (82-6851, 82-6852)
Use of the skull bolt is contraindicated in children less than one year of age.
Contraindications (82-6854)
Ventriculostomy is contraindicated in patients with coagulopathy, or active infection in the area of the catheter. Use of the Ventricular Catheter is contraindicated in children less than one year of age.
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: Application of usability engineering to medical devices. Design met established acceptance criteria.
ASTM F2052-15: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Imaging. Design met established acceptance criteria.
ASTM F2182-11a: Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging. Design met established acceptance criteria.
ASTM F2119-07: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants. Design met established acceptance criteria.
ASTM F2213-06: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment. Design met established acceptance criteria.
ASTM F2503-13: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. Design met established acceptance criteria.
Electrical Safety and Electromagnetic Compatibility Testing:
IEC 60601-1 - Part 1: General requirements for basic safety and essential performance. Pass.
IEC 60601-1-2: Collateral Standard: Electromagnetic disturbances - Requirements and tests. Pass.
IEC 60601-1-6: Collateral standard: Usability. Pass.
IEC 60601-1-9: Collateral Standard: Requirements for environmentally conscious design. Pass.
All tests indicated that the design met the established acceptance criteria and is substantially equivalent to the predicate.
Sterilization:
EN ISO 11135: 2014: Validation and Routine Control of Ethylene Oxide Sterilization. Pass.
EN ISO 10993-7:2008/AC2009: Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals. Design met established acceptance criteria.
EN ISO 11737-2:2009: Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process. Design met established acceptance criteria.
ANSI ST72:2011: Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing. Design met established acceptance criteria.
All tests indicated that the design met the established acceptance criteria and is substantially equivalent to the predicate.
Shelf Life - Functionality Testing Complete after Two Year Accelerated Aging:
EN ISO 11607-1: 2009 / EN ISO 11607-2: 2006: Packaging for Terminally Sterilized Medical Devices (Parts 1 & 2). Pass.
All tests indicated that the design met the established acceptance criteria and is substantially equivalent to the predicate.
Biocompatibility - ICP Probe Tip and Tubing & Electrical Housing Connector:
EN ISO 10993-1:2009/AC2010: Biological Evaluation of Medical Devices: Part 1: Evaluation and testing with a risk management process. Non-cytotoxic, Non-sensitizing, Non-irritating, Non-toxic, Non-pyrogenic, Non-irritant, Non-mutagenic, Non-clastogenic, Non-toxic, and Met USP 37 limits where applicable. Subject device design met the established acceptance criteria and is therefore substantially equivalent to the predicate.
No animal studies were required.
No clinical studies were required.
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/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The word "Administration" is on the second line.
November 8, 2017
Codman & Shurtleff, Inc Megan Palumbo Regulatory Affairs Project Lead 325 Paramount Drive Raynham, Massachusetts 02767
Re: K173192
Trade/Device Name: CereLink ICP Sensor Basic Kit (82-6850), CereLink ICP Sensor Metal Skull (82-6851), CereLink ICP Sensor Plastic Skull (82-6852), CereLink ICP Sensor Ventricular Catheter Kit (82-6854) Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM Dated: September 29, 2017 Received: October 2, 2017
Dear Ms. Palumbo:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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.
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 of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173192
Device Name
CereLink ICP Sensor Basic Kit (82-6850); CereLink ICP Sensor Metal Skull (82-6851); CereLink ICP Sensor Plastic Skull (82-6852); CereLink ICP Sensor Ventricular Catheter Kit (82-6854)
Indications for Use (Describe)
CereLink ICP Sensor Basic Kit (82-6850); CereLink ICP Sensor Metal Skull (82-6851); CereLink ICP Sensor Plastic Skull (82-6852)
Indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
CereLink ICP Sensor Ventricular Catheter Kit (82-6854)
Indicated when direct intraventricular pressure monitoring is required. The kit is indicated for use in ICP monitoring and cerebrospinal fluid (CSF) drainage applications
| 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
I. Submitter Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767
Establishment Registration Number: 1226348
Contact: Megan Palumbo Phone: (508) 828-3571 Fax: (508) 977-6979
Date of Submission: September 29, 2017
II. Device
| Device Proprietary Name | CereLink ICP Sensor Kits |
|---|---|
| Common Name | Intracranial Pressure Transducer |
| Classification Name | Intracranial Pressure Monitoring Devices (21 CFR |
| 882.1620) | |
| Regulatory Classification | II |
| Product Code | GWM |
| Rx or OTC Designation | Rx Only |
The predicate device for this submission is the Codman Microsensor Kits III. Predicate Device (K153347), which was cleared on August 19, 2016.
IV. Device The CereLink ICP Sensor Kits are used to monitor intracranial pressure (ICP) Description through either a stand-alone probe, or a probe coupled with an External Ventricular Drainage (EVD) catheter. The probe, also known as the CereLink ICP Sensor is intended to be used in conjunction with all of Codman's neuromonitoring devices: the Codman ICP Express Monitor (product code 82-6634) and the DirectLink ICP Module (product code 82-6828). The ICP Express and DirectLink are intended for use in ICUs. The CereLink ICP Sensor converts the pressure sensor to a voltage signal. The monitor provides power to the sensor, interprets the voltage signal from the sensor, and displays the corresponding pressure measurements taken by the sensor during a patient's treatment and during patient transport. There is no change to the currently marketed Codman ICP Express or DirectLink as a result of the probe modifications described in this submission.
The CereLink ICP Sensor contains a small, thin 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
4
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 (PCB). Additionally, the CereLink ICP Sensor's connector housing includes a new memory PCB board. When the CereLink ICP Sensor is used with either the ICP Express or DirectLink, it functions identically to the cleared predicate Codman Microsensors. Additionally, the connector housing has an electrical connector to attach to any of the monitoring devices.
The CereLink ICP Sensor Kits include components needed to facilitate the surgical implantation of the Cerelink ICP sensor. The components that will be included with the proposed CereLink ICP Sensor Kits are currently cleared devices, and are identical to the components currently packaged within the predicate Codman Microsensor Kits (i.e. there are no changes being made to the kit components, only the ICP sensor is being modified). Each component and their function are described in the Description section of the Instructions for Use for each kit.
| V. Indications The table below describes the Indications for Use statements for each of the 4 | |
|---|---|
| for Use | proposed CereLink ICP Sensor Kit product codes. |
| CereLink ICP Sensor Kit Indications for Use | ||||
|---|---|---|---|---|
| Device | ||||
| Description | Proposed | |||
| Product | ||||
| Code | Proposed Indications for Use | |||
| CereLink | ||||
| ICP Sensor | ||||
| Basic Kit | 82-6850 | Use of the CERELINK ICP SENSOR 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. | ||||
| CereLink | ||||
| ICP Sensor | ||||
| Metal Skull | ||||
| Bolt Kit | 82-6851 | Use of the CERELINK ICP SENSOR Metal Skull Bolt Kit is indicated when direct ICP | ||
| monitoring is required. The kit is indicated for use in both subdural and | ||||
| intraparenchymal pressure monitoring applications. | ||||
| CereLink | ||||
| ICP Sensor | ||||
| Plastic Skull | ||||
| Bolt Kit | 82-6852 | Use of the CERELINK ICP SENSOR Plastic Skull Bolt Kit is indicated when direct ICP | ||
| monitoring is required. The kit is indicated for use in both subdural and | ||||
| intraparenchymal pressure monitoring applications only. | ||||
| CereLink | ||||
| ICP Sensor | ||||
| Ventricular | ||||
| Catheter Kit | 82-6854 | Use of the CERELINK ICP SENSOR 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. |
5
VI. The CereLink ICP Sensor is substantially equivalent to the predicate device, Comparison to and eligible for the Special 510(k) process, as the proposed device has the Predicate following similarities to the predicate device: Device
- the same indications for use, ●
- the same intended use, ●
- the same fundamental scientific technology,
- incorporates the same basic design (strain gauge ICP sensor connected to a plastic connector housing),
- incorporates the same materials for the implantable portion of the device,
- packaged and sterilized using the same packaging design, materials, and ● processes.
The minor differences between the predicate and subject device are contained within the plastic connector housing:
- a slight difference in device design (shape of plastic connector housing ● top lid, addition of PCB and PCB retainer inside top lid),
- pad printing replaces the paper label on the plastic connector housing (non-implantable component, only in contact with intact skin), and
- the device labeling was updated (i.e. product labels, Instructions for Use and packaging art work).
The table below details the comparison of the predicate and subject devices.
| Comparison of Predicate and Proposed ICP Sensor Kits | ||
|---|---|---|
| Characteristic | Predicate Device: | |
| Codman Microsensor Kits (K153347) | Subject Device: | |
| CereLink ICP Sensor Kits (This | ||
| Submission) | ||
| FDA Product Code | GWM | Same |
| Classification | 21 CFR 882.1620 | Same |
| Classification Name | Device, Monitoring, Intracranial Pressure | Same |
| Indication for Use | 62-6631, 62-6632 & 62-6638 | |
| Indicated when direct ICP monitoring is | ||
| required. The kit is indicated for use in both | ||
| subdural and intraparenchymal pressure | ||
| monitoring applications only. |
62-6633, 62-6653
Indicated when direct intraventricular pressure
monitoring is required. The kit is indicated for
use in ICP monitoring and cerebrospinal fluid
(CSF) drainage applications. | Same as predicate:
82-6850, 82-6851 & 82-6852
Indicated when direct ICP monitoring is
required. The kit is indicated for use in both
subdural and intraparenchymal pressure
monitoring applications only.
82-6854
Indicated when direct intraventricular pressure
monitoring is required. The kit is indicated for
use in ICP monitoring and cerebrospinal fluid
(CSF) drainage applications. |
| Contraindications (82-6850) | This kit is not designed, sold, or intended for
any use except as indicated.
This kit is not designed, sold, or intended for
use as a therapeutic device. | Same |
| Contraindications (82-6851, 82-6852) | Use of the skull bolt is contraindicated in
children less than one year of age. | Same |
6
| Characteristic | Comparison of Predicate and Proposed ICP Sensor Kits | Subject Device: | ||
|---|---|---|---|---|
| Predicate Device: | CereLink ICP Sensor Kits (This | |||
| Submission) | ||||
| Codman Microsensor Kits (K153347) | ||||
| This kit is not designed, sold, or intended for | ||||
| any use except as indicated. | ||||
| This kit is not designed, sold, or intended for | ||||
| use as a therapeutic device. | ||||
| Contraindications (82-6854) | Ventriculostomy is contraindicated in patients | |||
| with coagulopathy, or active infection in the | ||||
| area of the catheter. Use of the Ventricular | ||||
| Catheter is contraindicated in children less than | ||||
| one year of age. | Same | |||
| This kit is not designed, sold, or intended for | ||||
| any use except as indicated. | ||||
| Device Materials | ||||
| Printed Circuit Board | ||||
| (PCB) inside plastic | ||||
| connector housing | Materials are the same for the predicate and proposed devices. | |||
| Memory chip PCB | ||||
| inside plastic connector | ||||
| housing | N/A | Materials are the same as those used in the | ||
| predicate PCB inside the plastic connector | ||||
| housing. | ||||
| Solder Wires | Materials are the same for the predicate and proposed devices. | |||
| Thru-hole resistor | ||||
| located inside plastic | ||||
| connector | Materials are the same for the predicate and proposed devices. | |||
| Epoxy Glue to cap tip of | ||||
| sensor and to join | ||||
| titanium housing to | ||||
| catheter tubing | Materials are the same for the predicate and proposed devices. | |||
| Catheter 100cm tubing | Materials are the same for the predicate and proposed devices. | |||
| Printing on the lid of | ||||
| the plastic connector | ||||
| housing | Paper label | Pad printing with ink | ||
| Sensor Top Label for | ||||
| the plastic connector | ||||
| housing. Includes | ||||
| Product Name, space to | ||||
| enter zero reference | ||||
| number and updated | ||||
| symbols. | Paper, adhesive and laminate | N/A | ||
| Sensor Bottom Label on | ||||
| plastic connector | ||||
| housing | Materials are the same for the predicate and proposed devices. | |||
| Catheter Strain Relief | Materials are the same for the predicate and proposed devices. | |||
| Titanium Case | Materials are the same for the predicate and proposed devices. | |||
| Silicone Membrane | Materials are the same for the predicate and proposed devices. | |||
| Plastic Connector | ||||
| Housing | Materials are the same for the predicate and proposed devices. | |||
| Retainer (in plastic | ||||
| connector housing) | N/A | Materials are the same as those used in the | ||
| predicate plastic connector housing. |
7
| Comparison of Predicate and Proposed ICP Sensor Kits | ||
|---|---|---|
| Characteristic | Predicate Device: | |
| Codman Microsensor Kits (K153347) | Subject Device: | |
| CereLink ICP Sensor Kits (This Submission) | ||
| Note: There is no change to the material used in the components provided with the proposed CereLink ICP Sensor Kits as compared to the current kits. | ||
| Packaging Materials | Materials are the same for the predicate and proposed packaging materials. | |
| Pouch (82-6850, 82-6851, 82-6852, 82-6854) | ||
| Unit Box (82-6850, 82-6851, 82-6852) | ||
| Unit Box (82-6854) | ||
| Blister Lid (82-6850, 82-6851, 82-6852) | ||
| Blister Lid (82-6854) | ||
| Blister Tray (82-6850, 82-6851, 82-6852, 82-6854) | ||
| Device Characteristics | ||
| MRI claim | 1.5T and 3T Conditional | Same |
| Sterilization | Ethylene Oxide | Same |
| Sterility Assurance Level | ||
| (SAL) | 10-6 | Same |
| Shelf Life | 2 years | Same |
| Energy Modality | 5 volts DC when connected to the ICP monitoring device | Same |
| Microsensor Dimensions | Dimensions are the same for predicate and proposed device. | |
| Sensing Element | Strain gauge silicon microchip | Same |
| Functional Pressure Range | -50mmHg to 250mmHg | Same |
| Functional Over Pressure Range Without Damage | -700mmHg to 1250mmHg | Same |
| Input/Output Impedance | 1000 ohms nominal | Same |
| Output Signal (sensitivity) | 5uV/V/mmHg | Same |
| Zero Drift | No greater than 5mmHg over 30 days | Same |
The following performance testing (see "Summary of Testing" table below) has VII. Performance been conducted in support of the substantial equivalence determination. All Data testing was performed on final sterile devices unless otherwise specified.
Because the proposed CereLink ICP Sensor is almost identical to the predicate Codman Microsensor, Codman leveraged many verification tests from the previously cleared Codman Microsensor (K153347). Please see the Summary of Testing table below which identifies the types of tests that were both leveraged from the predicate device, as well as performed on the subject device. All test results were deemed acceptable.
8
| Summary of Testing | |||
|---|---|---|---|
| Test | Standards | Result | |
| Bench Testing | EN 62366:2008 | Application of usability engineering to medical devices | Pass - subject device |
| ASTM F2052-15 | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Imaging | design met the established acceptance criteria and is therefore | |
| ASTM F2182-11a | Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging | substantially equivalent to the predicate | |
| ASTM F2119-07 | Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants | ||
| ASTM F2213-06 | Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment | ||
| ASTM F2503-13 | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment | ||
| Electrical Safety and Electromagnetic Compatibility Testing | IEC 60601-1 - Part 1 | General requirements for basic safety and essential performance | Pass - subject |
| IEC 60601-1-2 | Collateral Standard: Electromagnetic disturbances - Requirements and tests | device design met | |
| IEC 60601-1-6 | Collateral standard: Usability | the established | |
| IEC 60601-1-9 | Collateral Standard: Requirements for environmentally conscious design | acceptance criteria and is therefore substantially equivalent to the predicate | |
| Sterilization | EN ISO 11135: 2014 | Validation and Routine Control of Ethylene Oxide Sterilization | Pass - |
| EN ISO 10993-7:2008/AC2009 | Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals | subject device design met | |
| EN ISO 11737-2:2009 | Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | the established acceptance criteria and is therefore | |
| ANSI ST72:2011 | Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing | substantially equivalent to the predicate | |
| Shelf Life - Functionality Testing Complete after Two Year Accelerated Aging | EN ISO 11607-1: 2009 | ||
| EN ISO 11607-2: 2006 | Packaging for Terminally Sterilized Medical Devices: Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems - Part 2: Validation Requirements for Forming, Sealing, and Assembly Processes | Pass - subject device design met the established acceptance criteria and is therefore | |
| equivalent | |||
| to the | |||
| predicate | |||
| Biocompatibility |
- ICP Probe Tip
and Tubing &
Electrical
Housing
Connector | EN ISO 10993-
1:2009/AC2010 | Biological Evaluation of Medical Devices:
Part 1: Evaluation and testing with a risk
management process | Non-
cytotoxic,
Non-
sensitizing,
Non-
irritating,
Non-toxic,
Non-
pyrogenic,
Non-irritant,
Non-
mutagenic,
Non-
clastogenic,
Non-toxic,
and
Met USP 37
limits where
applicable
Subject
device
design met
the
established
acceptance
criteria and
is therefore
substantially
equivalent
to the
predicate |
9
Bench Testing
Results of verification and validation testing conducted on the CereLink ICP Sensor demonstrated that the proposed device performed as designed, is suitable for the intended use, and is substantially equivalent to the predicate device.
Electrical Safety and Electromagnetic Compatibility Testing
The CereLink ICP Sensor design is compliant for Electrical Safety and EMC per IEC 60601-1 2nd and 3th editions. The CereLink ICP Sensor is listed as an applied part within the Codman ICP Express safety reports and documentation. No additional testing was required as the updates to the new sensor do not affect the performance of the probe or ICP Express, and do not affect patient safety.
Sterilization
The sterilization method of the proposed CereLink ICP product codes is identical to the sterilization method of the predicate Microsensor Kits. The
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CereLink ICP Senor Kits are sterilized via ethylene oxide and have been validated to ensure a sterility assurance level (SAL) of 10to in accordance with ISO 11135:2014. "Validation and Routine Control of a Sterilization Process for Medical Devices" and ISO 11737-2:2009, "Tests of sterility preformed in the definition, validation and maintenance of a sterilization process." Sterilization testing also demonstrated that ethylene oxide residuals can be reduced to an acceptable level in accordance with ISO 10993-7:2008. "Biological Evaluation of Medical Devices – Ethylene Oxide Sterilization Residuals" and the proposed device can be successfully adopted into Codman's existing sterilization cycle.
Shelf-Life Testing
The shelf life for the proposed CereLink ICP Sensor Kits will be 2 years (same as predicate Codman Microsensor Kits). The proposed CereLink ICP Sensor Kits device component materials and packaging materials are identical to those used for the predicate Microsensor Kits.
Biocompatibility Testing
In comparison to the predicate Microsensor Kits, the only new patient contacting material in the Cerelink ICP Sensor Kit is the pad printing ink used on the lid of the sensor's plastic connector housing. The ink will only be in contact with the patient's intact skin. Biocompatibility testing was conducted according to ISO 10993-1 and FDA's Guidance document, "Use of International Standard ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process " issued on June 16, 2016. The test results for the pad printing ink, in conjunction with the existing biocompatibility data for the predicate Microsensor Kits, demonstrates that the proposed Cerelink ICP Sensor Kits are biocompatible.
Animal Studies
No animal studies were required as appropriate verification and validation of the design modifications were achieved based on the similarities of the predicate Microsensor Kits and the proposed CereLink ICP Sensor Kits.
Clinical Studies
No clinical studies were required as appropriate verification and validation of the design modifications were achieved based on the similarities of the predicate Microsensor Kits and the proposed CereLink ICP Sensor Kits.
VIII. Conclusion Based upon the same indications for use, intended use, fundamental scientific technology, comparison to the predicate device, and testing conducted, it is concluded that the CereLink ICP Sensor Kits are substantially equivalent to the predicate device, the Microsensor Kits, and therefore does not raise any new issues of safety and effectiveness.