The Integra NeuroSciences Contour-Flex Valve and Shunt System is used in treatment of patients with hydrocephalus. It 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 Contour-Flex™ Valve is a multi-function membrane valve with occluders and integral connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the bram. It incorporates a central reservoir for pumping and injection, proximal and distal occluders, and a fully flexible profile. The Contour-Flex Valve design includes a flat siliconc membrane, which provides resistance to CSF flow. The flat silicone membrane seats on a conical polypropylene base. This base is integral 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 Contour-Flex valve is available in two s izes: R egular a nd S mall. B oth s izes a re a vailable in 3 pressure/flow c haracteristics ranges: low, medium, and high

AI/ML Overview

This document (K033698) describes a 510(k) premarket notification for the Contour-Flex™ Valve and Shunt System, a medical device used in the treatment of hydrocephalus. The focus of this submission is on demonstrating substantial equivalence to a previously cleared device, rather than a clinical study evaluating novel performance against specific acceptance criteria in a clinical setting.

Therefore, many of the requested elements for a study that proves the device meets acceptance criteria are not directly applicable or available in this document. The "study" described here is primarily a series of engineering and performance tests to ensure the modified device functions similarly to its predicate.

Here's the information extracted from the provided text, addressing the points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria	Reported Device Performance
Safety	Provided sterile and non-pyrogenic.	"The Contour-Flex™ Valve and Shunt Systems are provided sterile and non-pyrogenic."
Pressure/Flow Characteristics	Not explicitly stated, but implied to be equivalent to the predicate device and within specified ranges (low, medium, high). The design "allows for accurate and precise regulation of CSF flow due to its structural integrity."	"The Contour-Flex™ Valve and Shunt Systems have been tested for pressure/flow..." (No specific quantitative results are provided, but the conclusion states "The modified Contour-Flex™ Valve and Shunt System is substantially equivalent...")
Leakage	Not explicitly stated, but implied to be acceptable and equivalent to the predicate. The flat silicone membrane "also prevents retrograde flow of CSF."	"...leakage..." (Tested against, but no specific results beyond stating it was tested.)
Anti-reflux	Not explicitly stated, but implied to function as intended to prevent retrograde flow.	"...antireflux..." (Tested against.) The flat silicone membrane "also prevents retrograde flow of CSF."
Flushing Capability	Not explicitly stated, but implied to function correctly.	"...flushing capability..." (Tested against.) The device incorporates "a central reservoir for pumping and injection."
Catheter Elongation	Not explicitly stated, but implied to meet durability and flexibility requirements.	"...catheter elongation..." (Tested against.)
Catheter Bending	Not explicitly stated, but implied to meet durability and flexibility requirements. The device features a "fully flexible profile."	"...and bending..." (Tested against.)
Markings	Visually clear and correct.	"...markings visual inspection..." (Tested against.)
Pull Testing	Not explicitly stated, but implied to demonstrate adequate strength and secure connections.	"...pull testing..." (Tested against.)
Radiopacity	Not explicitly stated, but implied to be radiopaque for visualization.	"...and radiopacity." (Tested against.)
Overall Equivalence	The modified device does not affect the intended use, the fundamental scientific technology, and does not raise new issues of safety and effectiveness compared to the predicate.	"The modified Contour-Flex™ Valve and Shunt System is substantially equivalent to the unmodified Contour-Flex Valve and Shunt System. The modifications do not affect the intended use, the fundamental scientific technology of the device, and do not raise new issues of safety and effectiveness."

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

Sample Size: Not specified in the provided text. The document refers to "systems" and individual "components" being tested but does not give specific numbers for how many units were subjected to each test.
Data Provenance: The tests are described as engineering/performance tests conducted on the device itself.
- Country of Origin: Integra NeuroSciences Implants SA is located in Sophia Antipolis Cedex, France. It's highly probable the testing was conducted at their facilities or by contracted labs, likely in Europe.
- Retrospective or Prospective: These are prospective tests performed on the manufactured device components to verify design specifications.

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

Not Applicable. For these engineering performance tests, "ground truth" is established by adherence to predefined engineering specifications and validated test methods, not by expert clinical review of test results in the same way it would be for a diagnostic AI device.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where multiple human readers assess cases and a consensus is needed for ground truth. For these performance tests, the outcome is typically pass/fail based on objective measurements against criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This document describes a 510(k) submission for a physical medical device (hydrocephalus shunt system), not a diagnostic AI algorithm. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not conducted or reported here.

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

No. This is not an AI algorithm.

7. The Type of Ground Truth Used

Engineering Specifications and Performance Standards: The "ground truth" for these tests is the pre-defined engineering specification or performance standard (e.g., a specific pressure/flow rate, acceptable leakage level, visual appearance criteria) that the device must meet.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI algorithm, so there is no "training set."

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

Not Applicable. There is no training set for an AI algorithm. The design and performance specifications would have been established through engineering design processes, previous device iterations (like the predicate device), industry standards, and regulatory requirements.

Summary

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K033698 1/2

Contour-Flex™ 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:

November 24, 2003

Name of the device:

Proprietary Name:	Contour-FlexTM Valve and Shunt System
Common Name:	Hydrocephalus Shunt Systems and Components
Classification Name:	Central Nervous System Shunt and Components JXG

Substantial Equivalence:

The Contour-Flex™ Valve and Shunt System is substantially equivalent in function and intended use to the currently marketed unmodified Contour-Flex and Shunt System and the unmodified Contour-Flex™ Valve and Shunt System which has been cleared to market under Premarket Notification 510(k) K954285.

Intended use:

The Contour-Flex™ Valve and Shunt System is indicated for use in the treatment of patients with hydrocephalus. The 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:

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Safety

The Contour-Flex™ Valve and Shunt Systems are provided sterile and non-pyrogenic. The Contour-Flex™ Valve and Shunt Systems have been tested for pressure/flow, leakage, antireflux, flushing capability, catheter elongation and bending, markings visual inspection, pull testing and radiopacity.

Conclusion

The modified Contour-Flex™ Valve and Shunt System is substantially equivalent to the unmodified Contour-Flex Valve and Shunt System. The modifications do not affect the intended u se, the fundamental s cientific technology of the device, a nd d o n ot raise n ew issues of safety and effectiveness.

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

DEC 1 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Integra Neurosciences Implants S.A. c/o Ms. Judith E. O'Grady Senior Vice President Regulatory, Quality and Clinical Affairs Integra Life Sciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K033698

Trade/Device Name: Contour-Flex™ 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: November 20, 2003 Received: November 26, 2003

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 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.

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Page 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 promarket notification" (21CFR Parl 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,

Miriam C. Provost

for 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

510(k) Number (if known): K033698

Device Name: Contour-Flex™ Valve and Shunt System

Indications For Use:

The Integra NeuroSciences Contour-Flex Valve and Shunt System is used in treatment The Integra Nodivere with hydrocephalus. It is a component of a system designed to shunt of patients with mydrooophialaer it to af the brain to an appropriate drainage site such as the atrium of the heart of to the peritoneal cavity.

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)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K633698

Page 1 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).