(18 days)
Not Found
MPM-1, V420
No
The summary describes a pressure monitoring catheter and associated hardware, with no mention of AI or ML capabilities.
No.
The device is described as a diagnostic tool for monitoring intracranial pressure, not for treating any condition.
Yes
The device is described as a "diagnostic tool for rapidly determining and continually monitoring intracranial pressure."
No
The device description clearly states it is a "transducer-tipped pressure monitoring catheter" and mentions accessory items and use in conjunction with other hardware components (bolts, monitors, cables). This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside of the body.
- Device Function: The Camino® Intracranial Pressure Monitoring Catheter is a device that is inserted directly into the body (parenchyma or subarachnoid space) to measure intracranial pressure in vivo.
- Intended Use: The intended use clearly states it's for "direct measurement of intracranial pressure in the parenchyma or subarachnoid space," which is an internal measurement.
Therefore, because the device is used for direct measurement within the body rather than testing samples taken from the body, it falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Camino® Intracranial Pressure for Use Monitoring Catheter with Licox IMC Bolt Fitting, Model 110-4L is indicated for use by a qualified Neurosurgeon when direct measurement of intracranial pressure in the parenchyma or subarachnoid space is clinically important. The Camino® Intracranial Pressure Monitoring Catheter with Licox IMC Bolt fitting, Model 110-4L is intended to be used only through a Licox Brain Oxygen Monitoring System Bolt.
Product codes
GWM
Device Description
The Camino® 110-4L Catheter is a sterile transducer-tipped pressure monitoring catheter with accessory items to be used as a diagnostic tool for rapidly determining and continually monitoring intracranial pressure. The 110-4L is to be used in conjunction with LICOX® IM2 or IM3 bolt and Camino® Intracranial Pressure Monitors model MPM-1 or V420 and their associated cables.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
parenchyma or subarachnoid space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified Neurosurgeon
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
Biocompatibility studies were conducted per FDA G95-1 and ISO 10993 and have demonstrated that the materials used to manufacture the Camino® 110-4L catheter are safe for its intended use. In addition, the Camino® 110-4L catheter was subjected to extensive mechanical testing, which included pressure, pull and bend tests. Results of the testing showed that the catheter design was mechanically sound and safe for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Premarket Notification Camino® Model 110-4L Integra NeuroSciences
AUG 2 0 2002
CONFIDENTIAL
Ko22553
Camino® Intracranial Pressure Monitoring Catheter with LICOX® IMC Bolt Fitting
Model 110-4L
510(k) SUMMARY
Submitter's name and address:
Integra NeuroSciences 5955 Pacific Center Blvd. San Diego, CA 92121, USA
Contact person and telephone number:
Nancy A. Mathewson, Esq. Director, Regulatory Affairs (858) 622-2737
Date summary was prepared:
August 1, 2002
Name of the device:
| Proprietary Name: | Camino® Intracranial Pressure Monitoring Catheter with
LICOX® IMC Bolt Fitting, Model 110-4L |
|-----------------------|-------------------------------------------------------------------------------------------------|
| Common Name: | Intracranial Pressure Monitoring Kit |
| Classification Name: | Intracranial Pressure Monitoring Device
Product Code GWM, 21 CFR 882.1620 |
| Classification Panel: | Neurology Device Panel |
Substantial Equivalence:
The modified Camino® Intracranial Pressure Monitoring Catheter with LICOX® IMC Bolt Fitting, Model 1104L is substantially equivalent in function and intended use to the original Camino® Intracranial Pressure Monitoring Catheter with LICOX® IMC Bolt Fitting, Model 110-4L.
Device Description:
The Camino® 110-4L Catheter is a sterile transducer-tipped pressure monitoring catheter with accessory items to be used as a diagnostic tool for rapidly determining and continually monitoring intracranial pressure. The 110-4L is to be
1
510(k) Premarket Notification Camino® Model 110-4L Integra NeuroSciences
used in conjunction with LICOX® IM2 or IM3 bolt and Camino® Intracranial Pressure Monitors model MPM-1 or V420 and their associated cables.
Statement of Intended Use:
The Camino® Intracranial Pressure for Use Monitoring Catheter with Licox IMC Bolt Fitting, Model 110-4L is indicated for use by a qualified Neurosurgeon when direct measurement of intracranial pressure in the parenchyma or subarachnoid space is clinically important. The Camino® Intracranial Pressure Monitoring Catheter with Licox IMC Bolt fitting, Model 110-4L is intended to be used only through a Licox Brain Oxygen Monitoring System Bolt.
Safety:
Biocompatibility studies were conducted per FDA G95-1 and ISO 10993 and have demonstrated that the materials used to manufacture the Camino® 110-4L catheter are safe for its intended use.
In addition, the Camino® 110-4L catheter was subjected to extensive mechanical testing, which included pressure, pull and bend tests. Results of the testing showed that the catheter design was mechanically sound and safe for its intended use.
The Camino® 110-4L catheter manufacturing process complies with the United States Food and Drug Administration and European Standards for the manufacturing of medical devices.
Conclusion:
The modified Camino® 110-4L catheter is substantially equivalent to the original Camino® 110-4L catheter. The modifications do not affect the intended use or the fundamental scientific technology of the device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, with three human profiles incorporated into the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 0 2002
Integra NeuroSciences Nancy A. Mathewson, Esq. Director, Regulatory Affairs 5955 Pacific Center Boulevard San Diego, California 92121
Re: K022553
Trade/Device Name: Camino® Intracranial Pressure Monitoring Catheter with LICOX® IMC Bolt Fitting, Model 110-4L Regulation Number: 882.1620 Regulation Name: Intracranial Pressure Monitoring Devicce Regulatory Class: Class II Product Code: GWM Dated: August 1, 2002 Received: August 2, 2002
Dear Ms. Mathewson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 – Ms. Nancy A. Mathewson
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Milburn
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
APPENDIX B
Indications for Use Statement
510(K) K022553 Number
Device Name: Camino® Intracranial Pressure Monitoring Catheter with LICOX® IMC Bolt Fitting, Model 110-4L
The Camino® Intracranial Pressure for Use Monitoring Catheter with Indications Licox IMC Bolt Fitting, Model 110-4L is indicated for use by a qualified Neurosurgeon when direct measurement of intracranial pressure in the parenchyma or subarachnoid space is clinically important. The Camino® Intracranial Pressure Monitoring Catheter with Licox IMC Bolt fitting, Model 110-4L is intended to be used only through a Licox Brain Oxygen Monitoring System Bolt.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE) Counter Prescription Use (Per 21 CFR 801. 109) vision of General, Restorative and Neurological Devices 11
510(k) Number