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

{0}------------------------------------------------ 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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. 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-memingitic 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. Type of Use (Select one or both, as applicable) | <div> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </div> | |---------------------------------------------------------------------------| | <div> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 Registration<br>Number | 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 Systems<br>Spetzler 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 {4}------------------------------------------------ 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. ## 807.92(a)(5) - Intended use of the device {5}------------------------------------------------ | Indications for Use | Horizontal-Vertical Lumbar Valve Systems | |------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Horizontal-Vertical Lumbar Valve Systems are implantable<br>devices used in the treatment of patients with communicating<br>hydrocephalus to shunt cerebrospinal fluid (CSF) from the<br>lumbar subarachnoid region to the peritoneal cavity. They<br>provide controlled intraventricular pressure and CSF drainage<br>in patients with hydrocephalus. The antechamber can be<br>electively mounted in line with the Valve Unit to allow for<br>CSF sampling or injections in the subarachnoid space. | | | Spetzler Lumbar Peritoneal Shunt Systems | | | Percutaneous lumbar peritoneal shunting may be utilized in the<br>treatment of communicating hydrocephalus. It is designed to<br>shunt CSF from the lumbar subarachnoid space to the<br>peritoneal cavity. | | | The shunt may be used for diagnosis, evaluation or treatment<br>of normal pressure communicating hydrocephalus. | | | A percutaneous lumbar peritoneal shunt is also useful in the<br>management of persistent cerebrospinal fluid fistulas, bulging<br>cranial and suboccipital decompressions and in transient CSF<br>absorption defects, e.g. post-meningitic or post-hemorrhagic<br>hydrocephalus. | | | The In-Line Valve, available as a separate component of the<br>system, is indicated for use where added resistance is desired to<br>alleviate symptoms of low pressure in the small percentage of<br>patients who, after normal drainage and in the normal course of<br>treatment, develop such symptoms. | | 807.92(a)(6) Summary of the technological characteristics of the device compared to the<br>predicate | | {6}------------------------------------------------ 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 Name<br>Horizontal-Vertical Lumbar<br>Valve Systems | Spetzler Lumbar Peritoneal<br>Shunt Systems | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/<br>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 pressure<br>valve with two balls in cone<br>valve mechanisms: a spring-<br>actuated (lower) pressure<br>mechanism and a gravity-<br>actuated (higher) pressure<br>mechanism. | Same – Pressure control is<br>achieved through a<br>combination of double slit<br>valve at the peritoneal end<br>and the small inner diameter<br>catheter | | Performance Specifications | Same – Six pressure ranges<br>with closing pressures<br>between 50 and 125 mmH2O<br>in the horizontal position and<br>between 170 and 445<br>mmH2O in the vertical<br>position. | Same – Six systems with<br>pressure ranges with closing<br>pressures between 50 and<br>400 mmH2O | | MRI Status | Same – MR Conditional | Same – MR Conditional | | Sterilization | Same - Ethylene Oxide/ SAL<br>= 10-6 | Same - Ethylene Oxide/ SAL<br>= 10-6 | | Biocompatible | Same – Yes | Same – Yes | | Non-Pyrogenic | Same – Yes | Same – Yes | | Packaging | Same – sterile, double<br>packaged system | Same – sterile, double<br>packaged system | Technological Characteristics as Compared to Predicate of Same Name {7}------------------------------------------------ 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.