The Integra NeuroSciences Burr Hole Valve and Shunt System is used in treatment of patients with hydrocephalus. The Burr Hole Valve is a component of a system designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site such as the atrium of the heart or to the peritoneal cavity.

Device Description

The Integra NeuroSciences Burr Hole Valve incorporates a membrane valve with integral connectors and domed reservoir to fit into a formal burr hole. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. The Burr Hole design includes a flat silicone membrane, which provides resistance to CSF flow. The silicone membrane scats on a conical polypropylene base. This base is int4egral to a rigid outlet port. The design allows for accurate and precise regulation of CSF flow due to its structural integrity. The flat silicone membrane also prevents retrograde flow of CSF. The Burr Hole valve is available in two sizes designed to fit a 12mm or 16mm formal burr Both sizes are available in three (3) pressure/Now characteristics ranges: low, hole. medium, and high.

AI/ML Overview

The provided text describes a 510(k) summary for the Integra NeuroSciences Burr Hole Valve and Shunt System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies is not applicable or available in this document.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the device's performance in the context of clinical efficacy or diagnostic accuracy. Instead, it details that the device was tested for various physical and functional properties. The "reported device performance" are the results of these tests, which were deemed satisfactory by the manufacturer and accepted by the FDA for substantial equivalence.

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Pressure/Flow	Suitable for shunting cerebrospinal fluid (CSF) in hydrocephalus patients.	Tested and found satisfactory for intended use.
Leakage	No leakage that would compromise the system's function or patient safety.	Tested and found satisfactory for intended use.
Catheter Elongation	Maintain structural integrity under normal physiological conditions.	Tested and found satisfactory for intended use.
Catheter Bending	Maintain structural integrity and patency under normal physiological conditions.	Tested and found satisfactory for intended use.
Markings Visual Inspection	Clear, legible, and accurate markings.	Tested and found satisfactory for intended use.
Pull Testing	Sufficient strength to withstand forces encountered during implantation and use.	Tested and found satisfactory for intended use.
Radiopacity	Visible under imaging for proper placement and monitoring.	Tested and found satisfactory for intended use.
Sterility	Sterile upon delivery.	Provided sterile.
Non-pyrogenicity	Free from pyrogens.	Provided non-pyrogenic.

Explanation: For a 510(k) submission concerning a device like a shunt system, the "acceptance criteria" are implied by the performance characteristics of predicate devices and consensus standards for medical devices. The manufacturer's goal is to demonstrate that their new device performs at least as well as and is as safe and effective as the predicate device. The text states "The Burr Hole Valve and Shunts have been tested for pressure/flow, leakage, catheter elongation and bending, markings visual inspection, pull testing and radiopacity," and concludes that the modified device is "substantially equivalent" and "do not raise new issues of safety and effectiveness." This implicitly means the results of these tests met the necessary standards for safety and function.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details about the sample size for the test set or the data provenance (country of origin, retrospective/prospective) for the physical and functional tests described. The tests mentioned (pressure/flow, leakage, etc.) are bench-top or mechanical tests, not clinical studies involving patients or human expert analysis of data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. The "test set" in this context refers to the manufactured devices undergoing engineering and functional verification, not clinical data requiring expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical data or imaging that required expert adjudication. The tests were objective measurements of physical properties.

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

Not applicable. This device is a hydrocephalus shunt system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study or AI component is mentioned.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the physical and functional tests was based on engineering specifications and established performance standards for hydrocephalus shunt systems. For example, a leakage test would have a "ground truth" of "no leakage" or "leakage within acceptable predefined limits."

8. The Sample Size for the Training Set

Not applicable. There is no AI or machine learning component mentioned that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an algorithm, there is no corresponding ground truth establishment method for it.

Summary

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Contidential

04020/

Burr Hole Valve and Shunt System 510(k) SUMMARY

Submitter's name and address:

Integra NeuroSciences Implants SA 2905 Route des Dolines 06921 Sophia Antipolis Cedex, France

Contact person and telephone number:

Valérie Gabert Regulatory Affairs Specialist +33 (0) 4 93 95 5626 Telephone: Facsimile: +33 (0) 4 93 65 4030

Date summary was prepared:

January 20, 2004

Name of the device:

Proprietary Name:	Burr Hole Valve and Shunt System
Common Name:	Hydrocephalus Shunt Systems and Components
Classification Name:	Central Nervous System Shunt and Components JXG

Substantial Equivalence:

The Burr Hole Valve and Shunt System is substantially equivalent in function and intended use to the currently marketed unmodified Burr Hole and Shunt System and the unmodified Burr Hole™ Valve and Shunt System which has been cleared to market under Premarket Notification 510(k) K970578.

Intended use:

The Burr Hole Valve and Shunt System is indicated for use in the treatment of patients with hydrocephalus. The Burr Hole Valve is a component of a system designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity.

Device Description:

The Burr Hole valve is available in two sizes designed to fit a 12mm or 16mm formal burr Both sizes are available in three (3) pressure/Now characteristics ranges: low, hole. medium, and high.

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Safety

The Burr Hole Valve and Shunt Systems are provided sterile and non-pyrogenic. The Burr The Dat Hole Valve and Shants bave been tested for pressure/flow, leakage, catheter elongation and bending, markings visual inspection, pull testing and radiopacity.

Conclusion

The modified Burr Hole Valve and Shunt System is substantially equivalent to the unmodified Burr Hole Valve and Shunt System. The modifications do not affect the intended u se, the fundamental s cientific technology of the device, and do not raise new issues of safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 26 2004

Integra NeuroSciences Implants SA c/o Ms. Judith E. O'Grady Senior Vice President Regulatory, Quality and Clinical Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K040201

Trade/Device Name: Burr Hole Valve and Shunt System Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: January 27, 2004 Received: January 29, 2004

Dear Ms. O'Grady::

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 l'ederal 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 sct 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.

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Pagc 2 - Ms. Judith E. O'Grady

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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Millican

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

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Indications for Use

K040201 510(k) Number (if known):

Device Name: Burr Hole Valve and Shunt System

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)Division of General, Restorative,and Neurological Devices
510(k) Number-	K040201

Page I of 1

Regulation Number and Section

§ 882.5550 Central nervous system fluid shunt and components.

(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).