(95 days)
Use of the Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with Integra™ Camino® Flex Adapter is indicated when direct and continuous intraventricular intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage are required.
The Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with Integra™ Camino® Flex Adapter functions as an entire system that includes the following: Integra Camino Flex Ventricular Catheter Monitoring Kit (Catheter and Accessories) and Integra Camino Flex Adapter (Adapter and Extension Cable), in which the Integra Camino Flex Adapter connects to the previously cleared Camino Advanced Monitor (510(k) K962928 Integra LifeSciences Corporation).
The Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Integra Camino Flex Adapter is indicated when direct and continuous intraventricular intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage are required. The device is a single use, disposable product. The device is comprised of a highly flexible catheter with a tensile member, a pressure sensing tip, an electrical connection to a monitor, and a drainage lumen to allow fluid connection to an extraventricular drainage (EVD) device. The device is designed for the tunneling surgical method and the kit includes the necessary accessories for access and implantation of the catheter. The following Accessories are referenced in 510(k) K904883: Drill, Drill Stop, Set Screw, Hex Wrench, Trocar, Trocar Sheath, Suture Loops, and Male Luer Cap.
The tip of the Integra Camino Flex Ventricular Catheter is implanted within the anterior horn of the left or right lateral cerebral ventricle. A cylindrical volume with a height of at least 11 mm and a diameter of at least 5 mm are required for catheter implantation.
The Integra Camino Flex Adapter performs the functions of receiving the transducer signal from the Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit catheter, amplifying the signal, and transmitting the signal to the Camino® Advanced Monitor. The Integra Camino Flex Adapter converts the signals produced by the Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit catheter sensor. This signal is sent to the Adapter by means of the extension cable to the Camino® Advanced Monitor.
The Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with Integra™ Camino® Flex Adapter is a medical device. The provided text describes the device and its intended use but does not contain information about acceptance criteria or a study proving its performance against such criteria. The document is a 510(k) summary for regulatory clearance, focusing on substantial equivalence to predicate devices, sterilization, and general device description.
Therefore, I cannot provide the requested table, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case study information, standalone performance, or training set details from the provided text. This information would typically be found in a detailed validation or clinical study report, which is not present here.
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K121159
Integra LifeSciences Corporation-Traditional 510(k)
Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with Integra™ Camino® Flex Adapter
JUL 2 0 2012
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| Submitter Information | |
|---|---|
| Name | Integra LifeSciences Corporation |
| Address | 311 Enterprise Drive Plainsboro, NJ 08536 USA |
| Phone number | (609) 750-2309 |
| Fax number | (609) 275-9445 |
| Establishment | 3003418325 |
| Registration Number | |
| Name of contact person | Steven R. Peltier, Vice President, Corporate Regulatory Affairs |
| Date prepared | April 9, 2012 |
| Name of device | |
| Trade or proprietary name | Integra™ Camino® Flex Ventricular Intracranial PressureMonitoring Kit (for Catheter and Accessories) |
| Integra™ Camino® Flex Adapter (for Adapter and Extension Cable) | |
| Common or usual name | Ventricular CatheterIntracranial Pressure Monitoring System |
| Classification name | Device, Monitoring, Intracranial Pressure |
| Classification panel | Neurology |
| Regulation | Class II, under 21 CFR 882.1620 |
| Product Code(s) | GWM |
| Legally marketeddevice(s) to whichequivalence is claimed | Ventrix® Ventricular Tunneling Pressure Monitoring Kit(catalog number: NL950-V; formerly known as the OPTYXcatheter)510(k) K904883Codman® MicroSensor™ Ventricular Catheter Kit510(k) K991222Ventricular Pressure Monitoring Kit, Model 110-4HM510(k) - K914735Combined Intracranial Pressure-Temperature Sensing System(with pre-amplification cable, catalog number PAC1)510(k) K962928 |
| Reason for 510(k)submission | New Device |
| Device description | The Integra™ Camino® Flex Ventricular Intracranial PressureMonitoring Kit with Integra™ Camino® Flex Adapter functions asan entire system that includes the following: Integra Camino FlexVentricular Catheter Monitoring Kit (Catheter and Accessories)and Integra Camino Flex Adapter (Adapter and Extension Cable),in which the Integra Camino Flex Adapter connects to thepreviously cleared Camino Advanced Monitor (510(k) K962928Integra LifeSciences Corporation). |
| The Integra Camino Flex Ventricular Intracranial PressureMonitoring Kit with Integra Camino Flex Adapter is indicatedwhen direct and continuous intraventricular intracranial pressure(ICP) monitoring and cerebrospinal fluid (CSF) drainage arerequired. The device is a single use, disposable product. Thedevice is comprised of a highly flexible catheter with a tensilemember, a pressure sensing tip, an electrical connection to amonitor, and a drainage lumen to allow fluid connection to anextraventricular drainage (EVD) device. The device is designed forthe tunneling surgical method and the kit includes the necessaryaccessories for access and implantation of the catheter. Thefollowing Accessories are referenced in 510(k) K904883: Drill,Drill Stop, Set Screw, Hex Wrench, Trocar, Trocar Sheath, SutureLoops, and Male Luer Cap. | |
| The tip of the Integra Camino Flex Ventricular Catheter isimplanted within the anterior horn of the left or right lateralcerebral ventricle. A cylindrical volume with a height of at least 11mm and a diameter of at least 5 mm are required for catheterimplantation. | |
| The Integra Camino Flex Adapter performs the functions ofreceiving the transducer signal from the Integra Camino FlexVentricular Intracranial Pressure Monitoring Kit catheter,amplifying the signal, and transmitting the signal to the Camino®Advanced Monitor. The Integra Camino Flex Adapter converts thesignals produced by the Integra Camino Flex VentricularIntracranial Pressure Monitoring Kit catheter sensor. This signal issent to the Adapter by means of the extension cable to theCamino® Advanced Monitor. | |
| Sterilization Information | The Integra Camino Flex Ventricular Catheter Monitoring Kit(Catheter and Accessories) is sterilized by ethylene oxide. Testingwas conducted with reference to AAMI TIR 28: 2009, ISO 11135-1:2007, ISO 10993-7:2008, ISO 11737-1:2006, ISO 11737-2:2009,USP <85> and USP <161>. A half-cycle sterilization cycle was |
| Intended use of thedevice | run to confirm that the Integra Camino Flex VentricularIntracranial Pressure Monitoring Kit could be adopted into theOSVII (flow regulating valve) family. Packaging integrity wasconducted with reference to ISO 11607-1:2006, ASTM F1980-07:2011, ISTA 2A:2008, ASTM F2096-04, ASTM F88, andASTM F1929-98:2004. The sterile kits are labeled as non-pyrogenic.Use of the Integra™ Camino® Flex Ventricular IntracranialPressure Monitoring Kit with Integra™ Camino® Flex Adapter isindicated when direct and continuous intraventricular intracranialpressure (ICP) monitoring and cerebrospinal fluid (CSF) drainageare required. |
| Indications for use | Use of the Integra™ Camino® Flex Ventricular IntracranialPressure Monitoring Kit with Integra™ Camino® Flex Adapter isindicated when direct and continuous intraventricular intracranialpressure (ICP) monitoring and cerebrospinal fluid (CSF) drainageare required. |
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Integra LifeSciences Corporation-Traditional 510(k)
Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with
Integra™ Camino® Flex Adapter
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Integra LifeSciences.Corporation-Traditional 510(k)
Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with
Integra™ Camino® Flex Adapter
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Integra LifeSciences Corporation % Mr. Steven R. Peltier Vice President Regulatory Affairs 311 Enterprise Drive Plainsboro, NJ 08536
JUL 2 0 2012
Re: K121159
Trade Name: Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with Integra™ Camino® Flex Adapter Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: Class II Product Code: GWM Dated: June 15, 2012 Received: June 18, 2012
Dear Mr. Peltier:
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 (reporting of medical device-
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Page 2 - Mr. Steven R. Peltier
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
E.A. Kumm, MD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K12iis9
Integra LifeSciences Corporation-Traditional 510(k)
Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with Integra™ Camino® Flex Adapter
Indications for Use
Page 1 of 1.
KIJ | 1 59 510(k) Number (if known):
Device Name:
Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with Integra™ Camino® Flex Adapter
Indications For Use:
The Integra " Camino" Flex Ventricular Intracranial Pressure Monitoring Kit with Integra Camino Flex Adapter is indicated when direct and continuous intraventricular intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage are required.
Prescription Use X (Per 21 CFR 801 Subpart D)
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Q
510(k) Number K121159
§ 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).