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.

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.

AI/ML Overview

This 510(k) premarket notification for the Camino® Intracranial Pressure Monitoring Catheter with LICOX® IMC Bolt Fitting, Model 110-4L primarily focuses on demonstrating substantial equivalence to a previously cleared version of the same device. As such, it does not detail a separate clinical or performance study with specific acceptance criteria related to disease diagnosis or outcome prediction.

Instead, the "acceptance criteria" here relate to the safety and mechanical integrity of the modified device, and the "study" is a series of non-clinical tests to confirm these aspects.

Here's a breakdown of the requested information based on the provided text, noting where specific information is not present (which is typical for a substantial equivalence submission unless significant performance changes are made):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance
Safety - Biocompatibility	Compliance with FDA G95-1 and ISO 10993 standards for materials.	"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."
Mechanical Integrity	Mechanical soundness for intended use (e.g., pressure, pull, and bend).	"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."
Manufacturing Process	Compliance with US FDA and European Standards.	"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."
Substantial Equivalence	Equivalence in function and intended use to the predicate device.	"The modified Camino® 110-4L catheter is substantially equivalent in function and intended use to the original Camino® Intracranial Pressure Monitoring Catheter with LICOX® IMC Bolt Fitting, Model 110-4L." and "The modifications do not affect the intended use or the fundamental scientific technology of the device." (Conclusion from the submitter)

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated for the biocompatibility or mechanical testing. For mechanical testing, it would likely involve multiple units of the device tested under various conditions.
Data Provenance: Not specified, but the tests were likely conducted internally by Integra NeuroSciences or by a contract lab on their behalf. The submission is for a medical device manufactured in the USA, so studies would typically be conducted according to US and international standards. This is a pre-market notification and focuses on the device itself, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable for this type of submission. The "ground truth" here is the adherence to engineering specifications and safety standards, which is established by adherence to protocols and standard testing methodologies, not by expert medical consensus on patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of clinical images or data. Here, the "test set" refers to physical device units and tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is an intracranial pressure monitoring catheter, which is a sensor for direct measurement. It is not an AI-powered diagnostic imaging device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This device is a physical catheter that directly measures pressure; it does not involve algorithms for interpretation that could be tested in a standalone manner.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is related to engineering specifications, recognized safety standards (e.g., ISO 10993), and mechanical performance parameters. For example, pressure transducer accuracy or structural integrity under specific forces. It is not related to clinical outcomes or diagnoses.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The design and validation are based on engineering principles and regulatory standards rather than data-driven model training.

9. How the ground truth for the training set was established

This information is not applicable for the same reasons as point 8.

Summary

{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 withLICOX® IMC Bolt Fitting, Model 110-4L
Common Name:	Intracranial Pressure Monitoring Kit
Classification Name:	Intracranial Pressure Monitoring DeviceProduct 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:

{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

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

Regulation Number and Section

§ 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).