(95 days)
No
The description focuses on the physical components, signal processing (amplification and transmission), and connection to a previously cleared monitor. There is no mention of AI, ML, or any algorithms that would suggest learning or intelligent decision-making.
No.
The device is intended for "direct and continuous intraventricular intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage," which are diagnostic and fluid management functions, not therapeutic.
Yes
Explanation: The device is used for "direct and continuous intraventricular intracranial pressure (ICP) monitoring," which involves measuring a physiological parameter to provide information about a patient's medical condition. This falls under the definition of a diagnostic device. While it also allows for CSF drainage (therapeutic), its primary function as described in the "Intended Use" is monitoring pressure, which is a diagnostic activity.
No
The device description explicitly details hardware components including a catheter, adapter, extension cable, and various surgical accessories. It functions as a physical system for direct intracranial pressure monitoring and CSF drainage.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (like blood, urine, tissue). This device is implanted within the body (specifically, the brain ventricle) to directly measure pressure and drain fluid.
- The intended use is direct physiological monitoring and fluid management. It's not analyzing a sample for diagnostic purposes in a lab setting.
- The device description focuses on the physical components for implantation and signal transmission. There's no mention of reagents, sample handling, or laboratory analysis.
Therefore, the Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with Integra™ Camino® Flex Adapter is a medical device used for direct physiological monitoring and intervention, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GWM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraventricular, cerebral ventricle
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)
Not Found
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.
K904883, K991222, K914735, K962928
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
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 Pressure |
| Monitoring Kit (for Catheter and Accessories) | |
| Integra™ Camino® Flex Adapter (for Adapter and Extension Cable) | |
| Common or usual name | Ventricular Catheter |
| Intracranial 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 marketed | |
| device(s) to which | |
| equivalence is claimed | Ventrix® Ventricular Tunneling Pressure Monitoring Kit |
| (catalog number: NL950-V; formerly known as the OPTYX | |
| catheter) | |
| 510(k) K904883 | |
| Codman® MicroSensor™ Ventricular Catheter Kit | |
| 510(k) K991222 | |
| Ventricular Pressure Monitoring Kit, Model 110-4HM | |
| 510(k) - K914735 | |
| Combined 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 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. | |
| Sterilization Information | The Integra Camino Flex Ventricular Catheter Monitoring Kit |
| (Catheter and Accessories) is sterilized by ethylene oxide. Testing | |
| was 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 and USP . A half-cycle sterilization cycle was | |
| Intended use of the | |
| device | run to confirm that the Integra Camino Flex Ventricular |
| Intracranial Pressure Monitoring Kit could be adopted into the | |
| OSVII (flow regulating valve) family. Packaging integrity was | |
| conducted with reference to ISO 11607-1:2006, ASTM F1980- | |
| 07:2011, ISTA 2A:2008, ASTM F2096-04, ASTM F88, and | |
| ASTM F1929-98:2004. The sterile kits are labeled as non- | |
| pyrogenic. | |
| 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. | |
| Indications for use | 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. |
1
Integra LifeSciences Corporation-Traditional 510(k)
Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with
Integra™ Camino® Flex Adapter
2
Integra LifeSciences.Corporation-Traditional 510(k)
Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with
Integra™ Camino® Flex Adapter
3
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-
4
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
5
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