Horizontal-Vertical Lumbar Valve Systems are implantable devices used in the treatment of patients with communicating hydrocephalus to shunt cerebrospinal fluid (CSF) from the lumbar subarachnoid region to the peritoneal cavity. They provide controlled intraventricular pressure and CSF drainage in patients with hydrocephalus. The antechamber can be electively mounted in line with the Valve Unit to allow for CSF sampling or injections in the subarachnoid space.

Percutaneous lumbar peritoneal shunting may be utilized in the treatment of communicating hydrocephalus. It is designed to shunt CSF from the lumbar subarachnoid space to the peritoneal cavity.

The shunt may be used for diagnosis, evaluation or treatment of normal pressure communicating hydrocephalus.

A percutaneous lumbar peritoneal shunt is also useful in the management of persistent cerebrospinal fluid fistulas, bulging cranial and suboccipital decompressions and in transient CSF absorption defects, e.g. post-meningitic or post-hemorrhagic hydrocephalus.

The In-Line Valve, available as a separate component of the system, is indicated for use where added resistance is desired to alleviate symptoms of low pressure in the small percentage of patients who, after normal drainage and in the normal course of treatment, develop such symptoms.

Device Description

Horizontal-Vertical Lumbar Valve Systems: The Horizontal-Vertical Lumbar Valve System is an implantable device that provides controlled intraventricular pressure and cerebrospinal fluid (CSF) drainage from the lumbar subarachnoid region to the peritoneal cavity. The system minimizes overdrainage by automatically compensating for changes in CSF hydrostatic pressure when the patient changes from a recumbent to an upright position.

Spetzler Lumbar Peritoneal Shunt Systems: The Spetzler Lumbar Peritoneal Shunt Systems are designed to shunt cerebrospinal fluid (CSF) from the lumbar subarachnoid space to the peritoneum. Due to the small diameter of the catheter tubing, shunting may be accomplished by percutaneous techniques. The lumbar catheter is inserted into the lumbar subarachnoid space through a 8.89cm (3½-inch), 14- gauge Tuohy spinal needle with a Huber tip. A catheter passer and peritoneal trocar may be used to bring the peritoneal catheter section around the flank and into the peritoneal cavity.

A variety of devices are available: a one-piece model without a reservoir; separate large or small reservoirs that contain a one-way valve, which may be used when a flushing capability is required; and a separate miter valve, available in low, medium, or high pressure, which may be used when added resistance is desired.

AI/ML Overview

This document is a 510(k) premarket notification for the Integra LifeSciences Corporation's Horizontal-Vertical Lumbar Valve Systems and Spetzler Lumbar Peritoneal Shunt Systems. It claims substantial equivalence to previously marketed predicate devices (K101381 and K152897). The primary change in this submission is an update to the MRI safety information in the labeling.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it claims substantial equivalence to predicate devices. The "performance" assessment is based on the devices having "Same" performance specifications as the predicate, which means they meet the established performance of the legally marketed devices.

Feature	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Claimed)
Horizontal-Vertical Lumbar Valve Systems
Intended Use/Indications	Same as predicate (treatment of communicating hydrocephalus, controlled intraventricular pressure, CSF drainage from lumbar subarachnoid to peritoneal cavity, CSF sampling/injections)	Same
Product Classification	Class II	Same – Class II
Product Code	JXG	Same – JXG
Design	Differential pressure valve with two balls in cone valve mechanisms: a spring-actuated (lower) pressure mechanism and a gravity-actuated (higher) pressure mechanism.	Same
Performance Specifications	Six pressure ranges with closing pressures between 50 and 125 mmH2O in the horizontal position and between 170 and 445 mmH2O in the vertical position.	Same
MRI Status	MR Conditional (based on previous testing cleared under K101381, updated with K152897 calculations)	Same – MR Conditional
Sterilization	Ethylene Oxide/ SAL = 10-6	Same - Ethylene Oxide/ SAL = 10-6
Biocompatible	Yes	Same – Yes
Non-Pyrogenic	Yes	Same – Yes
Packaging	Sterile, double packaged system	Same – sterile, double packaged system
Spetzler Lumbar Peritoneal Shunt Systems
Intended Use/Indications	Same as predicate (shunting CSF from lumbar subarachnoid space to peritoneum for communicating hydrocephalus, diagnosis/treatment of NPH, management of CSF fistulas, etc.)	Same
Product Classification	Class II	Same – Class II
Product Code	JXG	Same – JXG
Design	Pressure control achieved through a combination of double slit valve at the peritoneal end and the small inner diameter catheter.	Same
Performance Specifications	Six systems with pressure ranges with closing pressures between 50 and 400 mmH2O.	Same
MRI Status	MR Conditional (based on previous testing cleared under K101381, updated with K152897 calculations)	Same – MR Conditional
Sterilization	Ethylene Oxide/ SAL = 10-6	Same - Ethylene Oxide/ SAL = 10-6
Biocompatible	Yes	Same – Yes
Non-Pyrogenic	Yes	Same – Yes
Packaging	Sterile, double packaged system	Same – sterile, double packaged system

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document explicitly states: "No additional non-clinical testing was performed for this submission."
The testing referenced was performed to support the initial MRI Labeling for Integra Shunts and Implanted Accessories (K101381) and subsequent updates (K152897). The details of the sample size for these tests, country of origin, or whether they were retrospective or prospective are not provided in this document.

The tests listed were:

Magnetically Induced Displacement Force and Torque Test
RF Heating Test
Image Artifact Test
Pressure Flow Test

These are all non-clinical (bench) tests, not clinical studies involving patient data. Therefore, concepts like "test set sample size" in the context of patient data, data provenance, or retrospective/prospective studies are not applicable directly to this submission.

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 as the document describes non-clinical (bench) testing, not studies that require expert-established ground truth from clinical cases.

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

This information is not applicable as the document describes non-clinical (bench) testing, not studies that require adjudication of clinical cases.

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 information is not applicable. The device described is a physical implantable medical device (CSF shunt system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant.

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

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

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

For the non-clinical tests mentioned (Magnetically Induced Displacement Force and Torque Test, RF Heating Test, Image Artifact Test, and Pressure Flow Test), the "ground truth" would be established by engineering standards, physical measurements, and calculations according to relevant ASTM standards (e.g., ASTM F2052-15 mentioned for MRI safety calculations). It is not based on expert consensus for clinical diagnosis, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable as the device is a physical medical device and does not involve machine learning or AI models that require a training set.

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

This information is not applicable as the device is a physical medical device and does not involve machine learning or AI models that require a training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 22, 2016

Integra LifeSciences Corporation Ms. Jennifer Siegel Senior Regulatory Affairs Specialist 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K161992

Trade/Device Name: Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: August 22, 2016 Received: August 23, 2016

Dear Ms. Siegel:

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. 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.

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

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the quality systems (OS) 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,

Carlos L. Pena -S 同公

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) K161992

Device Name

Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems

Indications for Use (Describe) Horizontal-Vertical Lumbar Valve Systems

Horizontal-Vertical Lumbar Valve Systems are implantable devices used in the treatment of patients with communicating hydrocephalus to shunt cerebrospinal fluid (CSF) from the lumbar subarachnoid region to the perioneal cavity. They provide controlled intraventricular pressure and CSF drainage in patients with hydrocephalus. The antechamber can be electively mounted in line with the Valve Unit to allow for CSF sampling or injections in the subarachnoid space.

Spetzler Lumbar Peritoneal Shunt Systems

Percutaneous lumbar perioneal shunting may be utilized in the treatment of communicating hydrocephalus. It is designed to shunt CSF from the lumbar subarachnoid space to the peritoneal cavity.

The shunt may be used for diagnosis, evaluation or treatment of normal pressure communicating hydrocephalus.

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

A summary of 510(k) substantial equivalence information in accordance with the requirements of 21 CFR 807.92

807.92(a)(1) – Submitter information
Name	Integra LifeSciences Corporation
Address	311 Enterprise Drive Plainsboro, NJ 08536 USA
Phone Number	1-609-275-0500
Fax Number	1-609-275-5363
Establishment RegistrationNumber	3003418325
Name of Contact Person	Jennifer Siegel
Date Prepared	July 18, 2016
807.92(a)(2) – Name of device
Trade or Propriety Name	Horizontal-Vertical Lumbar Valve SystemsSpetzler Lumbar Peritoneal Shunt Systems
Common or Usual Name	Hydrocephalus Shunts
Classification Name	Shunt, Central Nervous System 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

Predicate device: Horizontal-Ventricular Lumbar Valves and Spetzler Lumbar Peritoneal Shunt Systems; K101381

Reference device: Integra DP Valve Systems (Including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory; K152897

807.92(a)(4) - Device description

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Horizontal-Vertical Lumbar Valve Systems

The Horizontal-Vertical Lumbar Valve System is an implantable device that provides controlled intraventricular pressure and cerebrospinal fluid (CSF) drainage from the lumbar subarachnoid region to the peritoneal cavity. The system minimizes overdrainage by automatically compensating for changes in CSF hydrostatic pressure when the patient changes from a recumbent to an upright position.

Spetzler Lumbar Peritoneal Shunt Systems

The Spetzler Lumbar Peritoneal Shunt Systems are designed to shunt cerebrospinal fluid (CSF) from the lumbar subarachnoid space to the peritoneum. Due to the small diameter of the catheter tubing, shunting may be accomplished by percutaneous techniques. The lumbar catheter is inserted into the lumbar subarachnoid space through a 8.89cm (3½-inch), 14- gauge Tuohy spinal needle with a Huber tip. A catheter passer and peritoneal trocar may be used to bring the peritoneal catheter section around the flank and into the peritoneal cavity.

807.92(a)(5) - Intended use of the device

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Indications for Use	Horizontal-Vertical Lumbar Valve Systems
	Horizontal-Vertical Lumbar Valve Systems are implantabledevices used in the treatment of patients with communicatinghydrocephalus to shunt cerebrospinal fluid (CSF) from thelumbar subarachnoid region to the peritoneal cavity. Theyprovide controlled intraventricular pressure and CSF drainagein patients with hydrocephalus. The antechamber can beelectively mounted in line with the Valve Unit to allow forCSF sampling or injections in the subarachnoid space.
	Spetzler Lumbar Peritoneal Shunt Systems
	Percutaneous lumbar peritoneal shunting may be utilized in thetreatment of communicating hydrocephalus. It is designed toshunt CSF from the lumbar subarachnoid space to theperitoneal cavity.
	The shunt may be used for diagnosis, evaluation or treatmentof normal pressure communicating hydrocephalus.
	A percutaneous lumbar peritoneal shunt is also useful in themanagement of persistent cerebrospinal fluid fistulas, bulgingcranial and suboccipital decompressions and in transient CSFabsorption defects, e.g. post-meningitic or post-hemorrhagichydrocephalus.
	The In-Line Valve, available as a separate component of thesystem, is indicated for use where added resistance is desired toalleviate symptoms of low pressure in the small percentage ofpatients who, after normal drainage and in the normal course oftreatment, develop such symptoms.
807.92(a)(6) Summary of the technological characteristics of the device compared to thepredicate

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The proposed Horizontal-Vertical Lumbar Valve Systems and Spetzler Lumbar Peritoneal Shunt Systems have the same technological characteristics compared to the predicate devices of the same name (K101381) as shown in the table below. The update of the MRI safety information in the labeling to increase the maximum spatial gradient and to align with the FDA's guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment 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. This update to the labeling is consistent with that cleared under K152897, which serves as a reference device for this submission.

Feature	Technological Characteristics as Compared to Predicate of Same NameHorizontal-Vertical LumbarValve Systems	Spetzler Lumbar PeritonealShunt Systems
Intended Use/Indications for Use	Same – see 807.92(a)(5)	Same – see 807.92(a)(5)
Product Classification	Same – Class II	Same – Class II
Product Code	Same – JXG	Same – JXG
Design	Same – Differential pressurevalve with two balls in conevalve mechanisms: a spring-actuated (lower) pressuremechanism and a gravity-actuated (higher) pressuremechanism.	Same – Pressure control isachieved through acombination of double slitvalve at the peritoneal endand the small inner diametercatheter
Performance Specifications	Same – Six pressure rangeswith closing pressuresbetween 50 and 125 mmH2Oin the horizontal position andbetween 170 and 445mmH2O in the verticalposition.	Same – Six systems withpressure ranges with closingpressures between 50 and400 mmH2O
MRI Status	Same – MR Conditional	Same – MR Conditional
Sterilization	Same - Ethylene Oxide/ SAL= 10-6	Same - Ethylene Oxide/ SAL= 10-6
Biocompatible	Same – Yes	Same – Yes
Non-Pyrogenic	Same – Yes	Same – Yes
Packaging	Same – sterile, doublepackaged system	Same – sterile, doublepackaged system

Technological Characteristics as Compared to Predicate of Same Name

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No additional non-clinical testing was performed for this submission. Non-clinical testing was performed to support the initial MRI Labeling for Integra Shunts and Implanted Accessories, which was cleared under K101381. Testing included:

Magnetically Induced Displacement Force and Torque Test ●
. RF Heating Test
Image Artifact Test ●
Pressure Flow Test ●

The non-clinical testing has since been amended to include updated calculations for the maximum spatial gradient based on ASTM F2052-15 and clinical injury threshold considerations, which were cleared under K152897.

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

The proposed Horizontal-Vertical Lumbar Valve Systems and Spetzler Lumbar Peritoneal Shunt Systems are substantially equivalent to the currently marketed Horizontal-Vertical Lumbar Valve Systems and Spetzler Lumbar Peritoneal Shunt Systems which were previously cleared to market by the United States Food and Drug Administration (FDA) on July 7, 2011 under K101381.

The update of the 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.

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).