LPV II Valves and Kits
The Standard-LPV II and Mini-LPV II Valves, utilized in the treatment of hydrocephalic patients in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneum. The Mini-LPV II Valve can be used in (but is not restricted to) situations where skin erosion may be a problem, as with older patients.

Novus Valves and Kits
The Novus and Novus Mini Valves, utilized in the treatment of hydrocephalic patients, are components in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the right atrium of the heart or the peritoneum. The Novus Mini Valve can be used in (but is not restricted to) situations where skin erosion may be a problem, as with older patients. Valves with a Physiological Flow Device are intended to reduce the hazard of negative intraventricular pressure (with respect to atmospheric pressure) when the patient is sitting, standing or semi-recumbent.

Multi-Purpose Valve
The Multi-Purpose Valve, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the perioneum. Valves with an Anti-Siphon Device are intended to reduce the hazard of negative intraventricular pressure when the patient is sitting, semi-recumbent or standing.

Mishler Dual Chamber Valve with Integral Connectors
The Mishler Dual Chamber Flushing Valve, Flat Bottom Design, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum. Valves with an Anti-Siphon Device are intended to reduce the hazard of negative intraventricular pressure when the patient is sitting, semi-recumbent or standing.

Pudenz Flushing Valve with Integral Connectors
The Pudenz Flushing Valve, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneum. Valves with an Anti-Siphon Device are intended to reduce the intraventricular pressure when the patient is sitting, semi-recumbent or standing.

Ultra VS In-Line Valve System
The Ultra VS In-Line Valves, utilized in the treatment of hydrocephalic patients, are components in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles into either the peritoneal cavity or the right atrium of the heart. The in-line and burr-hole systems are designed to shunt cerebrospinal fluid from the lateral ventricles into the peritoneal cavity. A ventriculoperitoneal shunting system may be indicated to avoid the cardiovascular complications of an atrial shunt or for a hydrocephalic patient in whom an atrial shunt is contraindicated. The Small and Neonate Models can be used in (but are not restricted to) situations where skin erosion may be a problem, as with premature infants, pediatric patients and older patients.

Pudenz Cardiac and Infant Catheter
The Pudenz Cardiac Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the right atrium of the heart. The Infant Cardiac Catheter is utilized when the common facial and/or internal jugular veins are too small to accommodate the larger cardiac catheter.

Pudenz Ventricular Catheter
The Pudenz Ventricular Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the right atrium of the heart or the peritoneum.

Pudenz Peritoneal Catheter
The Pudenz Peritoneal Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventriculoperitoneum. A ventriculoperitoneal shunting system may be indicated to avoid the cardiovascular complications of an atrial shunt or for a hydrocephalic patient in whom an atrial shunt is contraindicated.

Peritoneal Reflux Control Catheter and Peritoneal Open-Ended Catheter With Slits
The Peritoneal Reflux Control Catheter and Peritoneal Open-Ended Catheter with Slits, utilized in the treatment of hydrocephalic patients, are components for systems designed to shunt cerebrospinal fluid from the lateral ventricles into the peritoneum. A ventriculoperitoneal shunting system may be indicated to avoid the cardiovascular complications of an atrial shunt or for a hydrocephalic patient in whom an atrial shunt is contraindicated.

Portnoy Ventricular Catheter
The Portnoy Ventricular Catheter, utilized in the treatments, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum.

Neuroview Endoscopic Ventricular Catheter
The Neuroview Ventricular Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum.

Integra CSF Reservoir with Integral Connectors
The Integra CSF Reservoir provides access to the lateral cerebral ventricles via hypodermic puncture for sampling and/or injection of fluids. It is useful in obtaining CSF samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The Convertible Integra CSF Reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart or the peritoneum.

Essential Shunt Kit Burr Hole Design
The CSF Control Valve, utilized in the treatments, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the right atrium of the heart or the peritoneum.

Essential Shunt Kit Flat Bottom Design
The Essential Shunt Kit – Flat Bottom Design, utilized in the treatment of hydrocephalic patients, is designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum. The Essential Shunt Kit – Flat Bottom Design, can be used in (but is not restricted to) situations where skin erosion may be a problem, as with older patients.

Connectors for Neurosurgical Use
Integra connectors are utilized principally in the treatment of hydrocephalic patients, as components in systems designed to shunt cerebrospinal fluid from the lateral cerebral ventricles of the right atrium of the heart or the peritoneum.

On-Off Flushing Reservoirs
The On-Off Flushing Reservoir, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the peritoneum. Reservoirs with an Anti-Siphon Device are intended to reduce the hazard of negative intraventricular pressure when the patient is sitting, semi-recumbent or standing.

Braden Flushing Reservoir
The Braden Flushing Reservoir, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum.

Foltz Flushing Reservoir
The Foltz Flushing Reservoir, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum.

Anti-Siphon Device
The Anti-Siphon Device, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the right atrium of the heart or the heart or the peritoneum. The device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when the patient is in a sitting, standing or erect position.

Device Description

Integra Neurological Shunts and Accessories are used in the treatment of hydrocephalus. Hydrocephalus is commonly treated by creating a CSF flow pathway from a cerebral ventricle to the peritoneal spaces in the abdomen or to the right atrium of the heart. This is commonly referred to as "shunting". Integra markets a full line of products for CSF shunting procedures including catheters, valves, reservoir devices, connectors and accessories to aid in implantation.

A shunt system may comprise of a catheter, valve, reservoir and connectors, depending on clinician preference and use. In practice, a catheter is implanted into the space where CSF drainage is necessary (ventricles of the brain or lumbar subarachnoid space) and connected to a valve. The valve is used to control the CSF drainage rate. The other side of the valve is connected to a catheter which is placed to allow drainage to the desired site, typically the right atrium of the heart or the peritoneal cavity. As needed, a clinician may also incorporate a reservoir, for a closed ventricular access site, and/or additional connectors into the shunt system.

Catheters are silicone elastomer and some models are made from high durometer silicone elastomer. Valve mechanisms are categorized as diaphragm and miter. For diaphragm valves, the mechanism is an umbrella shaped component oriented at right angles to the flow path. Miter valves incorporates two silicone flaps in the shape of a duckbill. The flaps part in response to a pressure differential to allow flow. Some vales are available with low, medium or high closing pressure ranges and some contain an anti-siphon component. Reservoirs are available as standard or side-inlet or convertible and in various sizes; some have an on-off flushing feature. A variety of connectors, made of nylon or silicone elastomer material, are also available.

AI/ML Overview

The provided text describes a 510(k) summary for Integra Neurological Shunts and Accessories. The summary focuses on establishing substantial equivalence to previously marketed devices, particularly regarding the addition of MRI safety information.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Focus of the Study: MRI Safety Information

The key aspect of the study described is the demonstration of MRI safety for the Integra Neurological Shunts and Accessories. The acceptance criteria and testing are designed to support an "MR Conditional" claim on the device labeling.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Magnetically Induced Displacement Force (ASTM F2052-06e1): Amount of magnetically induced force on the device is less than or equal to the force on the device due to gravity.	The magnetically induced force for the devices was considered to meet the acceptance criteria in both 1.5T and 3.0T MR environments, thus supporting the MR Conditional claim. The maximum acceptable spatial gradient was determined on the basis of the component with the largest deflection, and is listed in the labeling.
Magnetically Induced Torque Test (ASTM F2213-06): Amount of magnetically induced torque on the device is less than or equal to the gravitational torque.	The magnetically induced torque for the devices was considered to meet the acceptance criteria in both 1.5T and 3.0T MR environments, thus supporting the MR Conditional claim.
RF Heating Test (ASTM F2182-09): No portion of the implanted device exhibits an increase in temperature of more than 2℃ at a whole body averaged specific absorption rate (SAR) of 2W/kg and head average SAR of 3.2 W/kg (Normal Operating Mode).	All tested implants met this acceptance criterion. The labeling includes a statement that the expected temperature rise is less than 0.4℃ after 15 minutes of continuous scanning (in both 1.5 T and 3.0 T MR environments).

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

The text does not specify a numerical "sample size" in terms of number of individual devices tested. It refers to "the devices" or "all tested implants" for the RF Heating Test, implying that representative samples of the various Integra Neurological Shunts and Accessories products listed were tested. The data provenance is described as non-clinical testing performed by the applicant, Integra LifeSciences Corporation, in a laboratory setting to demonstrate MRI compatibility. There is no mention of country of origin of data or retrospective/prospective clinical data for these specific tests, as they are engineering/physical property tests.

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

This type of information is not applicable to the non-clinical engineering tests performed for MRI safety. Ground truth in this context is established by the physical laws and measurement protocols defined by the ASTM standards.

4. Adjudication Method for the Test Set

This is not applicable. The data from these tests are quantitative measurements against predefined criteria, not subjective assessments requiring adjudication.

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

This is not applicable. The document describes non-clinical engineering tests related to MRI safety, not a clinical study involving human readers or AI.

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

This is not applicable. The device is a physical medical device (shunts and accessories), not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used

The ground truth for these non-clinical tests is based on:

ASTM Standard Operating Procedures and Definitions: For displacement force (ASTM F2052-06e1), torque (ASTM F2213-06), and RF heating (ASTM F2182-09). These standards define how the measurements are taken and what constitutes safe limits.
Physical Properties: The inherent physical response of the device materials to magnetic fields and radiofrequency energy.

There is no "expert consensus," "pathology," or "outcomes data" used as ground truth for these MRI safety tests.

8. The Sample Size for the Training Set

This is not applicable. There is no training set mentioned or implied, as the described tests are non-clinical hardware evaluation, not a machine learning model development.

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

This is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing to the right, arranged in a way that they resemble a bird-like shape. The profiles are black, and they are positioned within a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W 066-G609 Silver Spring, MD 20993-0002

March 24, 2016

Integra LifeSciences Corporation Mr. Timothy Connors Senior Regulatory Affairs Specialist 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K153041

Trade/Device Name: Integra Neurological Shunts and Accessories Products (LPV II Valves and Kits, Novus Valves and Kits, Multi-Purpose Valve, Mishler Dual Chamber Valve with Integral Connectors, Pudenz Flushing Valve with Integral Connectors, Ultra VS In-Line Valve System, Pudenz Cardiac and Infant Catheter, Pudenz Ventricular Catheter, Pudenz Peritoneal Catheter, Peritoneal Reflux Control Catheter and Peritoneal Open-Ended Catheter With Slits, Portnoy Ventricular Catheter, Neuroview Endoscopic Ventricular Catheter, Integra CSF Reservoir with Integral Connectors, Essential Shunt Kit Burr Hole Design, Essential Shunt Kit Flat Bottom Design. Connectors for Neurosurgical Use, On-Off Flushing Reservoirs, Braden Flushing Reservoir, Foltz Flushing Reservoir, Anti-Siphon Device) Regulation Number: 21 CFR 882.5550

Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: December 14, 2015 Received: December 15, 2015

Dear Mr. Connors:

This letter corrects our substantially equivalent letter of March 14, 2016.

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 Actinclude 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.

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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153041

Device Name

Integra Neurological Shunts and Accessories Products

Indications for Use (Describe)

LPV II Valves and Kits

The Standard-LPV II and Mini-LPV II Valves, utilized in the treatment of hydrocephalic patients in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneum. The Mini-LPV II Valve can be used in (but is not restricted to) situations where skin erosion may be a problem, as with older patients.

Novus Valves and Kits

The Novus and Novus Mini Valves, utilized in the treatment of hydrocephalic patients, are components in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the right atrium of the heart or the peritoneum. The Novus Mini Valve can be used in (but is not restricted to) situations where skin erosion may be a problem, as with older patients. Valves with a Physiological Flow Device are intended to reduce the hazard of negative intraventricular pressure (with respect to atmospheric pressure) when the patient is sitting, standing or semi-recumbent.

Multi-Purpose Valve

The Multi-Purpose Valve, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the perioneum. Valves with an Anti-Siphon Device are intended to reduce the hazard of negative intraventricular pressure when the patient is sitting, semi-recumbent or standing.

Mishler Dual Chamber Valve with Integral Connectors

The Mishler Dual Chamber Flushing Valve, Flat Bottom Design, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum. Valves with an Anti-Siphon Device are intended to reduce the hazard of negative intraventricular pressure when the patient is sitting, semi-recumbent or standing.

Pudenz Flushing Valve with Integral Connectors

The Pudenz Flushing Valve, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneum. Valves with an Anti-Siphon Device are intended to reduce the intraventricular pressure when the patient is sitting, semi-recumbent or standing.

Ultra VS In-Line Valve System

The Ultra VS In-Line Valves, utilized in the treatment of hydrocephalic patients, are components in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles into either the peritoneal cavity or the right atrium of the heart. The in-line and burr-hole systems are designed to shunt cerebrospinal fluid from the lateral ventricles into the peritoneal cavity. A ventriculoperitoneal shunting system may be indicated to avoid the cardiovascular complications of an atrial shunt or for a hydrocephalic patient in whom an atrial shunt is contraindicated. The Small and Neonate Models can be used in (but are not restricted to) situations where skin erosion may be a problem, as with premature infants, pediatric patients and older patients.

Pudenz Cardiac and Infant Catheter

The Pudenz Cardiac Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the right atrium of the heart. The Infant Cardiac

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Catheter is utilized when the common facial and/or internal jugular veins are too small to accommodate the larger cardiac catheter.

Pudenz Ventricular Catheter

The Pudenz Ventricular Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the right atrium of the heart or the peritoneum.

Pudenz Peritoneal Catheter

The Pudenz Peritoneal Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventriculoperitoneum. A ventriculoperitoneal shunting system may be indicated to avoid the cardiovascular complications of an atrial shunt or for a hydrocephalic patient in whom an atrial shunt is contraindicated.

Peritoneal Reflux Control Catheter and Peritoneal Open-Ended Catheter With Slits

The Peritoneal Reflux Control Catheter and Peritoneal Open-Ended Catheter with Slits, utilized in the treatment of hydrocephalic patients, are components for systems designed to shunt cerebrospinal fluid from the lateral ventricles into the peritoneum. A ventriculoperitoneal shunting system may be indicated to avoid the cardiovascular complications of an atrial shunt or for a hydrocephalic patient in whom an atrial shunt is contraindicated.

Portnoy Ventricular Catheter

The Portnoy Ventricular Catheter, utilized in the treatments, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum.

Neuroview Endoscopic Ventricular Catheter

The Neuroview Ventricular Catheter, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum.

Integra CSF Reservoir with Integral Connectors

The Integra CSF Reservoir provides access to the lateral cerebral ventricles via hypodermic puncture for sampling and/or injection of fluids. It is useful in obtaining CSF samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The Convertible Integra CSF Reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart or the peritoneum.

Essential Shunt Kit Burr Hole Design

The CSF Control Valve, utilized in the treatments, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the right atrium of the heart or the peritoneum.

Essential Shunt Kit Flat Bottom Design

The Essential Shunt Kit – Flat Bottom Design, utilized in the treatment of hydrocephalic patients, is designed to shunt cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum. The Essential Shunt Kit – Flat Bottom Design, can be used in (but is not restricted to) situations where skin erosion may be a problem, as with older patients.

Connectors for Neurosurgical Use

Integra connectors are utilized principally in the treatment of hydrocephalic patients, as components in systems designed to shunt cerebrospinal fluid from the lateral cerebral ventricles of the right atrium of the heart or the peritoneum.

On-Off Flushing Reservoirs

The On-Off Flushing Reservoir, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the peritoneum. Reservoirs with an Anti-Siphon Device are intended to reduce the hazard of negative intraventricular pressure when the patient is sitting, semi-recumbent or standing.

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Braden Flushing Reservoir

The Braden Flushing Reservoir, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum.

Foltz Flushing Reservoir

The Foltz Flushing Reservoir, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into either the right atrium of the heart or the peritoneum.

Anti-Siphon Device

The Anti-Siphon Device, utilized in the treatment of hydrocephalic patients, is a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles of the right atrium of the heart or the heart or the peritoneum. The device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when the patient is in a sitting, standing or erect position.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

807.92(a)(1) – Submitter information
Name	Integra LifeSciences Corporation
Address	311 Enterprise DrivePlainsboro, New Jersey 08536
Phone Number	(609) 936-531
EstablishmentRegistration Number	9004007
Name of Contact Person	Timothy Connors
Date Prepared	October 16, 2015
807.92(a)(2) – Name of device
Trade or Propriety Names	Integra Neurological Shunts and Accessories Products(LPV II Valves and Kits, Novus Valves and Kits,Multi-Purpose Valve,Mishler Dual Chamber Valve with Integral Connectors,Pudenz Flushing Valve with Integral Connectors,Ultra VS In-Line Valve System,Pudenz Cardiac and Infant Catheter,Pudenz Ventricular Catheter,Pudenz Peritoneal Catheter,Peritoneal Reflux Control Catheter,Peritoneal Open-Ended Catheter With Slits,Portnoy Ventricular Catheter,Neuroview Endoscopic Ventricular Catheter,Integra CSF Reservoir with Integral Connectors,Essential Shunt Kit Burr Hole Design,Essential Shunt Kit Flat Bottom Design,Connectors for Neurosurgical Use,On-Off Flushing Reservoirs,Braden Flushing Reservoir,Foltz Flushing Reservoir,Anti-Siphon Device)
Common or Usual Name	Hydrocephalus Shunt Systems and Components
Classification Name	Central Nervous System Fluid Shunt and Components
Classification Panel	Neurology
Regulation	Class II, under 21 CFR 882.5550
Product Code(s)	JXG
807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed
Equivalence is claimed to current Integra Neurological Shunts and Accessories Products,as identified below:

LPV II Valves and Kits - K974708

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Novus Valves and Kits - K961859 Multi-Purpose Valve - Pre-amendment device Mishler Dual Chamber Valve with Integral Connectors - K760784 Pudenz Flushing Valve with Integral Connectors - K760501, K760502 Ultra VS In-Line Valve System - K894072 Pudenz Cardiac and Infant Catheter - Pre-amendment device Pudenz Ventricular Catheter - Pre-amendment device Pudenz Peritoneal Catheter - Pre-amendment device Peritoneal Reflux Control Catheter - K894072 Peritoneal Open-Ended Catheter With Slits – K894072 Portnoy Ventricular Catheter - Pre-amendment device Neuroview Endoscopic Ventricular Catheter - K971617 Integra CSF Reservoir with Integral Connectors - Pre-amendment device Essential Shunt Kit Burr Hole Design - K973525 Essential Shunt Kit Flat Bottom Design - K973525 Connectors for Neurosurgical Use - Pre-amendment device On-Off Flushing Reservoirs - Pre-amendment device Braden Flushing Reservoir - Pre-amendment device Foltz Flushing Reservoir - Pre-amendment device Anti-Siphon Device - K760785

807.92(a)(4) - Device description

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nylon or silicone elastomer material, are also available.
807.92(a)(5) – Intended use of the device
Indications for Use	LPV II Valves and Kits
	The Standard-LPV II and Mini-LPV II Valves, utilized inthe treatment of hydrocephalic patients, are components insystems designed to shunt cerebrospinal fluid from thelateral ventricles of the brain into either the right atrium ofthe heart or the peritoneum.
	The Mini-LPV II Valve can be used in (but is not restrictedto) situations where skin erosion may be a problem, as witholder patients.
	Novus Valves and Kits
	The Novus and Novus Mini Valves, utilized in the treatmentof hydrocephalic patients, are components in systemsdesigned to shunt cerebrospinal fluid from the lateralventricles of the brain into either the right atrium of the heartor the peritoneum.
	The Novus Mini Valve can be used in (but is not restrictedto) situations where skin erosion may be a problem, as witholder patients.
	Valves with a Physiological Flow Device are intended toreduce the hazard of negative intraventricular pressure (withrespect to atmospheric pressure) when the patient is sitting,standing or semi-recumbent.
	Multi-Purpose Valve
	The Multi-Purpose Valve, utilized in the treatment ofhydrocephalic patients, is a component in systems designedto shunt cerebrospinal fluid from the lateral ventricles intoeither the right atrium of the heart or the peritoneum.
	Valves with an Anti-Siphon Device are intended to reducethe hazard of negative intraventricular pressure when thepatient is sitting, semi-recumbent or standing.
	Mishler Dual Chamber Valve with Integral Connectors
	The Mishler Dual Chamber Flushing Valve, Flat BottomDesign, utilized in the treatment of hydrocephalic patients, isa component in systems designed to shunt cerebrospinalfluid from the lateral ventricles into either the right atrium ofthe heart or the peritoneum.
Valves with an Anti-Siphon Device are intended to reducethe hazard of negative intraventricular pressure when thepatient is sitting, semi-recumbent or standing.
Pudenz Flushing Valve with Integral ConnectorsThe Pudenz Flushing Valve, utilized in the treatment ofhydrocephalic patients, is a component in systems designedto shunt cerebrospinal fluid from the lateral ventricles of thebrain into either the right atrium of the heart or theperitoneum.
Valves with an Anti-Siphon Device are intended to reducethe hazard of negative intraventricular pressure when thepatient is sitting, semi-recumbent or standing.
Ultra VS In-Line Valve SystemThe Ultra VS In-Line Valves, utilized in the treatment ofhydrocephalic patients, are components in systems designedto shunt cerebrospinal fluid (CSF) from the lateral ventriclesinto either the peritoneal cavity or the right atrium of theheart. The in-line and burr-hole systems are designed toshunt cerebrospinal fluid from the lateral ventricles into theperitoneal cavity. A ventriculoperitoneal shunting systemmay be indicated to avoid the cardiovascular complicationsof an atrial shunt or for a hydrocephalic patient in whom anatrial shunt is contraindicated.
The Small and Neonate Models can be used in (but are notrestricted to) situations where skin erosion may be aproblem, as with premature infants, pediatric patients andolder patients.
Pudenz Cardiac and Infant CatheterThe Pudenz Cardiac Catheter, utilized in the treatment ofhydrocephalic patients, is a component in systems designedto shunt cerebrospinal fluid from the lateral ventricles of thebrain into the right atrium of the heart. The Infant CardiacCatheter is utilized when the common facial and/or internaljugular veins are too small to accommodate the largercardiac catheter.
Pudenz Ventricular CatheterThe Pudenz Ventricular Catheter, utilized in the treatment ofhydrocephalic patients, is a component in systems designedto shunt cerebrospinal fluid from the lateral ventricles of the
brain into either the right atrium of the heart or theperitoneum.
Pudenz Peritoneal CatheterThe Pudenz Peritoneal Catheter, utilized in the treatment ofhydrocephalic patients, is a component in systems designedto shunt cerebrospinal fluid from the lateral ventricles intothe peritoneum.
A ventriculoperitoneal shunting system may be indicated toavoid the cardio vascularcomplications of an atrial shunt or for a hydrocephalicpatient in whom an atrial shunt is contraindicated.
Peritoneal Reflux Control Catheter and PeritonealOpen-Ended Catheter With SlitsThe Peritoneal Reflux Control Catheter and PeritonealOpen-Ended Catheter with Slits, utilized in the treatment ofhydrocephalic patients, are components for systemsdesigned to shunt cerebrospinal fluid from the lateralventricles into the peritoneum.
A ventriculoperitoneal shunting system may be indicated toavoid the cardiovascular complications of an atrial shunt orfor a hydrocephalic patient in whom an atrial shunt iscontraindicated.
Portnoy Ventricular CatheterThe Portnoy Ventricular Catheter, utilized in the treatmentof hydrocephalic patients, is a component in systemsdesigned to shunt cerebrospinal fluid from the lateralventricles into either the right atrium of the heart or theperitoneum.
Neuroview Endoscopic Ventricular CatheterThe Neuroview Ventricular Catheter, utilized in thetreatment of hydrocephalic patients, is a component insystems designed to shunt cerebrospinal fluid from thelateral ventricles into either the right atrium of the heart orthe peritoneum.
Integra CSF Reservoir with Integral ConnectorsThe Integra CSF Reservoir provides access to the lateralcerebral ventricles via hypodermic puncture for samplingand/or injection of fluids. It is useful in obtaining CSFsamples for cytological and chemical studies, for monitoring
ventricular fluid pressure and for ventricular drainage.
The Convertible Integra CSF Reservoir may be utilized inhydrocephalic patients as a component in systems designedto shunt CSF from the lateral ventricles into either the rightatrium of the heart or the peritoneum.
Essential Shunt Kit Burr Hole DesignThe CSF Control Valve, utilized in the treatment ofhydrocephalic patients, is a component in systems designedto shunt cerebrospinal fluid from the lateral ventricles of thebrain into either the right atrium of the heart or theperitoneum.
Essential Shunt Kit Flat Bottom DesignThe Essential Shunt Kit - Flat Bottom Design, utilized in thetreatment of hydrocephalic patients, is designed to shuntcerebrospinal fluid from the lateral ventricles of the braininto the peritoneum.
The Essential Shunt Kit - Flat Bottom Design, can be usedin (but is not restricted to) situations where skin erosion maybe a problem, as with older patients.
Connectors for Neurosurgical UseIntegra connectors are utilized principally in the treatment ofhydrocephalic patients, as components in systems designedto shunt cerebrospinal fluid from the lateral cerebralventricles of the brain into either the right atrium of the heartor the peritoneum.
On-Off Flushing ReservoirsThe On-Off Flushing Reservoir, utilized in the treatment ofhydrocephalic patients, is a component in systems designedto shunt cerebrospinal fluid from the lateral ventricles intoeither the right atrium of the heart or the peritoneum.
Reservoirs with an Anti-Siphon Device are intended toreduce the hazard of negative intraventricular pressure whenthe patient is sitting, semi-recumbent or standing.
Braden Flushing ReservoirThe Braden Flushing Reservoir, utilized in the treatment ofhydrocephalic patients, is a component in systems designedto shunt cerebrospinal fluid from the lateral ventricles intoeither the right atrium of the heart or the peritoneum.
	Foltz Flushing ReservoirThe Foltz Flushing Reservoir, utilized in the treatment ofhydrocephalic patients, is a component in systems designedto shunt cerebrospinal fluid from the lateral ventricles intoeither the right atrium of the heart or the peritoneum.
	Anti-Siphon DeviceThe Anti-Siphon Device, utilized in the treatment ofhydrocephalic patients, is a component in systems designedto shunt cerebrospinal fluid from the lateral ventricles of thebrain into either the right atrium of the heart or theperitoneum. The device is designed to reduce the potentialhazards of excessive lowering of intraventricular pressure(with respect to atmospheric pressure) when the patient is ina sitting, standing or erect position.
007-024(c) Scope of the device includes prevention of the device over-drainage

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807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate

The proposed Integra Neurological Shunts and Accessories have the same technological characteristics compared to the predicate devices of the same name. The addition of MRI safety information to the labeling does not alter the intended use, materials of composition, manufacturing and sterilization process, or the fundamental scientific technology of the devices.

807.92(b)(1-2) - Nonclinical tests submitted

Non-clinical testing was performed to support MRI Labeling for Integra Neurological Shunts and Accessories, ensuring the safety and effectiveness was maintained following device modifications. Testing included:

. Magnetically Induced Displacement Force (ASTM F2052-06e1): This test assessed if the amount of magnetically induced force on the device is less than or equal to the force on the device due to gravity. The magnetically induced force for the devices was considered to meet the acceptance criteria in both 1.5T and 3.0T MR environment, thus supporting the MR Conditional claim. The maximum acceptable spatial gradient was determined on the basis of the component with the largest deflection, and is listed in our labeling.
Magnetically Induced Torque Test (ASTM F2213-06): This test assessed if the amount of magnetically induced torque on the device is less than or equal to the gravitational torque. The magnetically induced torque for the devices was considered to meet the acceptance criteria in both 1.5T and 3.0T MR environments, thus supporting the MR Conditional claim.
RF Heating Test: ASTM F2182-09: The acceptance criterion for this test was that ●

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no portion of the implanted device exhibits an increase in temperature of more than 2℃ at a whole body averaged specific absorption rate (SAR) of 2W/kg and head average SAR of 3.2 W/kg (Normal Operating Mode). All tested implants met this acceptance criterion, thus supporting the MR Conditional Claim. Our labeling includes a statement on RF heating that the expected temperature rise is less than 0.4℃ after 15 minutes of continuous scanning (in both 1.5 T and 3.0 T MR environments).

Image Artifact Test: ASTM F2119-07: Image Artifact information was collected for the devices in both 1.5T and 3.0T MR environments. For each device, scans were made in three planes (sagittal, coronal, and axial) for using both gradient and spin echo sequences. Our labeling lists the worst-case image artifact for gradient echo sequencing.
Functional testing before/after exposure to MR scanning conditions was not performed because:
The catheters in scope are single lumen tubing that would be not be affected by exposure to MR scanning conditions.
-The mechanisms of the valves in scope do not have any metallic components and therefore would not be affected by exposure to MR scanning conditions.

The results of this testing have demonstrated that the devices listed below are MR Conditional and support the conditions as defined within the labeling:

Integra Neurological Shunts and Accessories Products (LPV II Valves and Kits, Novus Valves and Kits, Multi-Purpose Valve. Mishler Dual Chamber Valve with Integral Connectors, Pudenz Flushing Valve with Integral Connectors, Ultra VS In-Line Valve System, Pudenz Cardiac and Infant Catheter. Pudenz Ventricular Catheter. Pudenz Peritoneal Catheter. Peritoneal Reflux Control Catheter and Peritoneal Open-Ended Catheter With Slits, Portnoy Ventricular Catheter. Neuroview Endoscopic Ventricular Catheter, Integra CSF Reservoir with Integral Connectors, Essential Shunt Kit Burr Hole Design, Essential Shunt Kit Flat Bottom Design, Connectors for Neurosurgical Use. On-Off Flushing Reservoirs. Braden Flushing Reservoir, Foltz Flushing Reservoir.

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Anti-Siphon Device)

807.92(b)(3) - Conclusions drawn from non-clinical data

The proposed Integra Neurological Shunts and Accessories, as identified within this submission, are substantially equivalent to the currently marketed Integra Neurological Shunts and Accessories, which were either previously cleared by the United States Food and Drug Administration (FDA) or were determined to be equivalent to a pre-amendment device, as outlined in the "Legally marketed device(s) to which equivalence is claimed" section of this 510(k) summary.

The addition of MRI safety information to the labeling does not alter the indications for use, intended use, materials of composition, manufacturing and sterilization process, or the fundamental scientific technology of the devices. The non-clinical testing has demonstrated the devices listed below are MR Conditional; a patient with these devices can be safely scanned in an MR system meeting the conditions defined within the labeling:

Integra Neurological Shunts and Accessories Products (LPV II Valves and Kits. Novus Valves and Kits, Multi-Purpose Valve, Mishler Dual Chamber Valve with Integral Connectors, Pudenz Flushing Valve with Integral Connectors, Ultra VS In-Line Valve System, Pudenz Cardiac and Infant Catheter. Pudenz Ventricular Catheter, Pudenz Peritoneal Catheter, Peritoneal Reflux Control Catheter and Peritoneal Open-Ended Catheter With Slits, Portnoy Ventricular Catheter. Neuroview Endoscopic Ventricular Catheter, Integra CSF Reservoir with Integral Connectors, Essential Shunt Kit Burr Hole Design, Essential Shunt Kit Flat Bottom Design, Connectors for Neurosurgical Use, On-Off Flushing Reservoirs. Braden Flushing Reservoir, Foltz Flushing Reservoir, Anti-Siphon Device)

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).