Cranial COVER

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 12, 2016 Neos Surgery S.L. % Mr. Marcos Velez-Duran President M Squared Associates, Inc. 575 Eighth Avenue, Suite 1212 New York. New York 10018 Re: K160739 Trade/Device Name: Cranial COVER Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR Dated: March 16, 2016 Received: March 17, 2016 Dear Mr. Velez-Duran: 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 yours, Carlos L. Pena -\$ D/A 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) K160739 Device Name Cranial COVER Indications for Use (Describe) The Cranial COVER is intended for use to cover burr holes resulting from cranial surgery. With the available sizes, burr holes with an epicranial diameter between 10 and 14 mm, made with standard perforators or with spherical drills, can be covered. | 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) #### 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 The following information is provided as required by 21 CFR § 807.87 for the Cranial COVER Cranial Burr Hole Cover System 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based. - Sponsor: Neos Surgery S.L. Parc Tecnològic del Vallès C/Ceramistes, 2 (08290) Cerdanyola del Vallès Barcelona, Spain - Contact: Marcos Velez-Duran M Squared Associates, Inc. 575 Eighth Avenue, Suite 1212 New York, NY 10018 Ph: 703-562-9800 Ext 206 Fax: 702-562-9797 Email: MVelez-Duran@MSquaredAssociates,com Date of Submission: March 16, 2016 | Proprietary Name: | Cranial COVER, Cranial Burr Hole Cover System | |-----------------------|-----------------------------------------------| | Common Name: | Burr hole cover | | Regulatory Class: | 882.5250 Burr hole cover | | Classification Panel: | Neurology | | Product Codes: | GXR | | Predicate Device(s): | Leibinger Burr Hole Covers – K983885 | Neuropace Burr Hole Cover - K123163 Cranial LOOP XL - K132044 ### Device Description The Cranial COVER is a postoperative biocompatible cranial burr hole cover system. It fits into most common cranial burr holes, and its upper platform is in contact with the skull surface. It {4}------------------------------------------------ avoids the anti-cosmetic postoperative skin concavities. It does not require any specific surgical instrument for its handling or implantation. It is provided sterile, for a single use. Two different sizes are presented: - . FC050300, large size, for the most common burr holes, made with standard perforators (diameters 14/11 mm or 13/9 mm1). - . FC050400, small size, for small burr holes (diameters from 12 mm to 10 mm), made with spherical drills. The device functions like a clamp. An upper (epicranial) and a lower (subcranial) platform, joined by two cable ties, are tightened together with the help of non-implantable elements (handle and applier) and cover the burr hole. ## Indications for Use The Cranial COVER is intended for use to cover burr holes resulting from cranial surgery. With the available sizes, burr holes with an epicranial diameter between 10 and 14 mm, made with standard perforators or with spherical drills, can be covered. ### Technological characteristics and comparison to predicate devices The Cranial COVER is substantially equivalent in its indications for use and anatomical implantation site to the Leibinger Burr Hole Covers (K983885), the NeuroPace Burr Hole Cover (K123163) and the Cranial LOOP XL (included in K132044). More specifically: - · The Cranial COVER has the same indications for use as the primary indications for use of the Leibinger Burr Hole Covers and the NeuroPace Burr Hole Cover. - · A part of the indications for use of the Cranial LOOP XL is the same indications for use of the Cranial COVER (covering burr holes resulting from cranial surgery). ¹ In burr holes made with perforators, epicranial and subcranial diameters are different. For instance, the 14/1 mm perforator generates burr holes with epicranial diameter 14 mm and subcranial diameter 11 mm. {5}------------------------------------------------ Additionally, Cranial COVER is substantially equivalent in its technology to the Cranial LOOP XL, as their design features and manner of implantation are the same: they are both clamp-like devices. Finally, the material of the implanted parts of the Cranial COVER is the same as the material of the implanted part of the Cranial LOOP XL and the NeuroPace Burr Hole Cover (PEEK). | Device | Cranial COVER<br>(FC050300 /<br>FC050400) | Cranial LOOP XL<br>(FC050200) | NeuroPace Burr Hole<br>Cover (model 8110) | Leibinger Burr Hole<br>Covers | | | | | | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | Company | Neos Surgery S.L. | Neos Surgery S.L. | NeuroPace<br>Inc. | Howmedica, Inc. | | covers the burr hole<br>like a plug. | intended use by fixing<br>the bone flap to the<br>cranial bone and by<br>covering the burr hole. | | | | 510(k) No. | Present submission | K132044 | K123163 | K983885 | Applier<br>Instrument | Not necessary | Not necessary | Screwdriver<br>(minimum) | Screwdriver<br>(minimum) | | Product Code | GXR - burr hole cover | GXR - burr hole cover | GXR - burr hole cover | GXR - burr hole cover | Material<br>Composition | Platforms and ties<br>(implantable parts) -<br>PEEK<br>Handle and applier-<br>biocompatible polymer | Platforms and ties<br>(implantable parts) -<br>PEEK<br>Handle and applier-<br>biocompatible polymer | Synthetic polymer<br>(PEEK according to<br>the IFUs) and<br>silicone. | Titanium | | Indications<br>for Use | The Cranial COVER is<br>intended for use to<br>cover burr holes<br>resulting from cranial<br>surgery. With the<br>available sizes, burr<br>holes with an epicranial<br>diameter between 10<br>and 14 mm, made with<br>standard perforators or<br>with spherical drills,<br>can be covered. | The Cranial LOOP<br>Cranial Bone Fixation<br>Systems: Cranial<br>LOOP, Cranial LOOP<br>(L) and Cranial LOOP<br>(XL), are long-term<br>implantable devices<br>indicated for post-<br>craniotomy bone flap<br>fixation.<br>(...) The Cranial<br>LOOP (XL)<br>(FC050200) is to be<br>used for covering a<br>standard 14 mm<br>cranial burr hole only. | The NeuroPace®<br>Burr Hole Cover is<br>intended for use<br>following cranial<br>surgery to cover a 14<br>mm burr hole.<br>Secondarily, the<br>NeuroPace Burr Hole<br>Cover also can be used<br>to support a 1.3 mm<br>indwelling lead. | The Leibinger Burr<br>Hole Covers are<br>designed to be used<br>with fixation screws to<br>cover burr holes of<br>various diameters in<br>the craniofacial<br>skeleton in order to<br>provide good cosmetic<br>results and protection<br>of the underlying soft<br>tissues and brain. This<br>device can also be used<br>to secure cranial bone<br>flaps. | Sizes | - FC050300: for burr<br>holes of diameter 14/11<br>mm and 13/9 mm<br>- FC050400: for burr<br>holes of diameter from<br>10 to 12 mm | FC050200, only size<br>applicable in burr holes. | One size (14 mm). | Four different<br>configurations.<br>(According to the<br>Intended Use: to cover<br>burr holes of various<br>diameters) | | Device<br>Design | Two platforms linked<br>by two adjustable cable<br>ties, which are joined to<br>the lower platform and<br>have a locking system<br>that allows movement<br>of the upper platform<br>towards the lower<br>platform but impedes<br>backward movements.<br>The surgeon tightens<br>the upper platform to<br>the bone by gently<br>pressing with the<br>applier and pulling on<br>the handle. The device<br>remains adjusted to the<br>bone thickness and | Two platforms linked<br>by two adjustable cable<br>ties, which are joined to<br>the lower platform and<br>have a locking system<br>that allows movement<br>of the upper platform<br>towards the lower<br>platform but impedes<br>backward movements.<br>The surgeon tightens<br>the lower platform to<br>the bone and bone flap<br>by gently pressing with<br>the applier and pulling<br>on the handle. The<br>device remains adjusted<br>to the bone thickness<br>and it achieves its | The NeuroPace® Burr<br>Hole Cover (model<br>8110) includes a base<br>that<br>is screwed to the<br>cranium (skull) using<br>bone screws.<br>The cap is an assembly<br>comprised of a cap and<br>a gasket. The cap is<br>pressed into the base<br>covering the opening in<br>the base and securing a<br>single 1.3 mm lead. The<br>Burr Hole Cover<br>requires three bone<br>screws (1.5 to 1.8 mm). | The Burr Hole Cover<br>has a segmented plate-<br>like structure. These<br>Burr Hole Covers are<br>0.5 rnm thick and are<br>comprised of four<br>different configurations | Implant life | Long-term implant | Long-term implant | Long-term implant | Long-term implant | | Biocompa-<br>tible | Yes | Yes | Yes | Yes | | | | | | | Provided<br>Sterile | Yes | Yes | Yes | No | | | | | | | MRI<br>Compatibility | MR Safe | MR Safe | MR compatible | MR compatible<br>(although no data is<br>available in the IFUs or<br>510k summary). | | | | | | | Method of<br>Fixation to<br>Cranium | Like a clamp | Like a clamp | Titanium Screws | Titanium Screws | | | | | | A side-by-side comparison of the Cranial COVER to the predicate devices follows: {6}------------------------------------------------ Some differences exist in the diameters of the holes that the predicate devices are able to cover. Despite these differences, it is important to consider that burr holes made with a 14/11 mm standard perforator are the ones most commonly used in cranial surgery, and these burr holes can be covered with all the mentioned devices. Additionally, for both Cranial COVER and Leibinger Burr Hole Covers different sizes of the device are available, to cover different diameters. Once implanted, and despite being based in essentially two basic designs to keep their position (clamp-like in the case of Cranial COVER and Cranial LOOP XL; screwed to the bone in the case of NeuroPace and Leibinger Burr Hole Covers), all these devices remain adjusted on the burr holes and cover them properly in the long-term. #### Sterility The sterilization method of the device does not differ from that of the Cranial LOOP XL predicate device (included in K132044). The sterilization process specification validation method and the bioburden limits are the same for this product and the predicate device Cranial LOOP XL. The results for the Cranial COVER are comparable to those obtained with Cranial LOOP XL. {7}------------------------------------------------ ### Biocompatibility With respect to the materials used in their manufacturing, all devices are made of biocompatible materials. The Cranial COVER, as well as the predicate devices Cranial LOOP XL and NeuroPace Burr Hole Cover, are made of PEEK (this makes them radiolucent and prevents interference with CT scanning and MRI systems). The Leibinger Burr Hole Covers are made of titanium. The implantable parts of the Cranial COVER are the upper and lower platforms, as well as the ties, all of which are made of PEEK. As already mentioned, this is the same material used in the same parts of the predicate device Cranial LOOP XL (K132044). PEEK is well established as an implantable thermoplastic material. The Cranial COVER handle and applier (the non-implantable parts of the device) are made of biocompatible polymers. Letters of Authorization to Masters Files for these polymers have been provided. ### Discussion of mechanical and performance testing Mechanical and performance testing confirms that Cranial COVER performs as intended and that it is substantially equivalent to the predicate devices. Performance testing has demonstrated that the technological characteristics of Cranial COVER do not raise any new safety or effectiveness issues. A summary of the tests performed, including a discussion of the relevance of their results to determine the substantial equivalence of Cranial COVER to the predicate devices, follows: | Test | Test Method Summary | Results and Conclusion | |-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | A. Functional testing | | | | A.1. Functionality<br>of implantable<br>parts | Goal: Determine the breaking force of the<br>ratchet mechanism of the device's upper<br>platform. | All tested samples meet the<br>specifications. Functionality of<br>the devices is demonstrated. | | | Method: Fully assembled devices were tested.<br>A calibrated dynamometer was used to apply a<br>traction force on the upper platform until its<br>ratchets broke. | Results are comparable to the<br>Cranial LOOP XL predicate<br>device. | | A.2. Functionality<br>of the handle | Goal: Determine the breaking force of the<br>ratchet mechanism between the handle and the<br>lower platform (and cable ties). | | | | Method: Fully assembled devices were tested.<br>A calibrated dynamometer was used to apply a<br>traction force on the handle until its ratchets | | | | broke. | | | B. Biomechanical testing | | | | B.1. Push-in | Goal: Simulate patient's pressure on the device<br>and determine the force required to sink the<br>devices up to a maximum of 2 mm.<br>Method: Fully assembled devices were tested<br>in holes equivalent to those in which they will<br>be implanted. The implanted devices were<br>placed under a calibrated dynamometer and a<br>cylindrical tool used to apply force on the<br>upper platform. | All tested samples meet the<br>specifications. The devices<br>have an adequate<br>biomechanical behavior at<br>push-in and pull-out.<br>Results are better than those<br>obtained with the Cranial<br>LOOP XL predicate device.<br>Both devices must be able to<br>resist pull-out and push-in<br>forces appropriately. However,<br>the use of Cranial LOOP XL<br>as a fixation element for the<br>bone flap causes that these<br>devices are subject to different<br>force intensities. In general, it<br>is reasonable to say that the<br>Cranial COVER is subject to a<br>less demanding situation than<br>Cranial LOOP XL; the results<br>obtained confirm this point. | | B.2. Pull-out | Goal: Simulate pulling forces during<br>implantation or caused by increased ICP, to<br>determine the maximum force that 1) the<br>device can withstand before sliding out from<br>the burr hole, or 2) the handle can withstand<br>before breaking.<br>Method: Fully assembled devices were tested<br>in holes equivalent to those in which they will<br>be implanted. A calibrated dynamometer was<br>used to apply a traction force on the handle<br>until the lower platform slid out from the hole<br>or the handle broke. | | | C. Cadaver testing | Goal: Evaluation of the devices when<br>simulating their implantation on the skull of<br>patients in a clinical environment, following<br>the procedures described in the products'<br>Instructions for Use.<br>Method: The test was performed on a<br>cadaveric specimen with fully assembled<br>devices. Some of the most relevant aspects<br>analyzed include:<br>- availability of space to place and position the<br>device<br>- absence of danger for the surgeon<br>- fast and instrument-free implantation<br>- epicranial and subcranial profiles<br>- lateral and axial stability when the device is<br>moved<br>- completeness of burr hole covering<br>- ease of device removal | Correct implantation is<br>verified in a simulated real-life<br>situation. The devices show<br>adequate performance and<br>safety.<br>The results demonstrate that<br>the Cranial COVER is<br>equivalent, in terms of<br>performance and safety and to<br>the relevant extent, to the<br>predicate device Cranial<br>LOOP XL. | {8}------------------------------------------------ All the setups applied in the tests simulate clinical service conditions and, in some cases, the worst case scenario. The results of the testing confirmed that both sizes of the Cranial COVER will {9}------------------------------------------------ perform as intended in the clinical setting, and that they are comparable to the predicate devices particularly to the Cranial LOOP XL (included in K132044). The following standards are applicable to the design and performance of the Cranial COVER: - · Recognition number 14-428: ISO 11137-1:2006, "Sterilization of health care products -Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013)]" - · Recognition number 14-409: ISO 11137-2:2013, "Sterilization of health care products -Radiation - Part 2: Establishing the sterilization dose" - · Recognition number 14-407: ISO 11737-1:2006, "Sterilization of medical devices --Microbiological methods -- Part 1: Determination of a population of microorganisms on products [Including: Technical Corrigendum 1 (2007)]'' - · Recognition number 14-327: ISO 11737-2:2009, "Sterilization of medical devices --Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process" - · Recognition number 2-220: ISO 10993-1:2009, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)]" ## Discussion of clinical testing No clinical testing was deemed necessary to support substantial equivalence to predicate devices. ### Conclusion Based on the design features, the use of established well-known biocompatible materials, technological characteristics comparison, indications for use, and results of the mechanical and performance testing, the subject device has demonstrated substantial equivalence to the identified legally marketed predicate devices.