BrightMatter Guide with BrightMatter Pointer

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three figures intertwined to represent people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 24, 2016 Synaptive Medical Inc. % Allison Komiyama, PhD, RAC Principal Consultant AcKnowledge Regulatory Strategies 2834 Hawthorn Street San Diego. California 92104 Re: K160523 Trade/Device Name: BrightMatter Guide with BrightMatter Pointer Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: May 26, 2016 Received: May 27, 2016 Dear Dr. Allison Komiyama: 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. Isting 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) K160523 Device Name BrightMatter Guide with BrightMatter Pointer #### Indications for Use (Describe) BrightMatter Guide is intended as a planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures where the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The user should consult the "Accuracy Characterization" section of the User Manual to assess if the accuracy of the system is suitable for their needs. The BrightMatter Pointer is intended to be used for anatomy palpation and as a pointing tool to enable spatial localization and identification by BrightMatter Guide navigational systems. The system should be operated only by trained personnel such as surgeons and other clinic staff. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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 K160523 #### DATE PREPARED June 23, 2016 #### MANUFACTURER AND 510(k) OWNER Synaptive Medical, Inc. 101 College Street, Suite 200, Toronto, Ontario M5G 1L7, Canada Telephone: (416) 673-6679 Fax: (888) 650-5230 Official Contact: Cameron Piron, President #### REPRESENTATIVE/CONSULTANT Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies Telephone: akomiyama@acknowledge-rs.com Email: #### PROPRIETARY NAME OF SUBJECT DEVICE BrightMatter Guide with BrightMatter Pointer #### COMMON NAME Neurological stereotaxic instrument ## DEVICE CLASSIFICATION Stereotaxic instrument (21 CFR 882.4560, Product Code HAW, Class II) ## PREMARKET REVIEW ODE/DNPMD/NNDB Neurology Panel #### PURPOSE OF SUBMISSION The purpose of this submission is to introduce a titanium version of the Pointer tool. ## INDICATIONS FOR USE BrightMatter Guide is intended as a planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures where the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The user should consult the {4}------------------------------------------------ "Accuracy Characterization" section of the User Manual to assess if the accuracy of the system is suitable for their needs. The BrightMatter Pointer is intended to be used for anatomy palpation and as a pointing tool to enable spatial localization and identification by BrightMatter Guide navigational systems. The system should be operated only by trained personnel such as surgeons and other clinic staff. # DEVICE DESCRIPTION BrightMatter Guide is a planning and image guided surgical system that enables computer assisted surgery where use of stereotactic image guidance may be considered appropriate. The BrightMatter Pointer is a handheld passive instrument which can be used for anatomy palpation using its tip. This tool can be tracked using passive reflective markers in order for BrightMatter Guide to identify and spatially track its location. There are rigid features on the subject device where the markers (passive spheres) that reflect infrared (IR) signals can be attached. The markers are arranged in a unique pattern on the device so that the BrightMatter Guide can differentiate it from other instruments. The Pointer portion of the device is provided non sterile and requires steam sterilization before use. The passive reflective markers are single-use. The BrightMatter Pointer is made of either titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) or 17-4 stainless steel conforming to ASTM A564 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes. | The BrightMatter Pointer is substantially equivalent to the following predicates: | | | |-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|----------------------| | 510(k)<br>Number | Predicate Device Name / Manufacturer | Primary<br>Predicate | | K142024 | BrightMatter Navigation System v1.0 / Synaptive, Inc. | ✓ | | K153281 | BrightMatter Guide with Surface Trace Registration /<br>Synaptive, Inc. | | | K142344 | Disposable Passive Accessory for Medtronic StealthStation<br>System / IZI Medical Products LLC | | | K080450 | Stryker Power Tool Navigator / Stryker Instruments | | ## PREDICATE DEVICE IDENTIFICATION The BrightMatter Pointer is substantially equivalent to the following predicates: {5}------------------------------------------------ #### SUMMARY OF NON-CLINICAL TESTING No FDA performance standards have been established for the BrightMatter Guide with BrightMatter Pointer. The following tests were performed to demonstrate substantial equivalence between the subject and predicate devices. | Test | Purpose | Results | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | Dimensional<br>analysis | Comparison of measured dimensions to<br>ensure tolerances are within acceptable<br>limits. | Measurements found within<br>acceptable tolerances. If outside<br>tolerance, navigational accuracy<br>testing was performed. | | Navigational<br>accuracy | Accuracy of navigational components<br>evaluated to ensure performance of the<br>system. | Accuracy testing demonstrated<br>the subject device was as accurate<br>as the predicate device. | | Cytotoxicity | Cytotoxicity of the device evaluated to<br>demonstrate biocompatibility. | Testing demonstrated the device<br>is not cytotoxic. | | Sensitization | Sensitization of the device evaluated to<br>demonstrate biocompatibility. | Testing demonstrated the device<br>is not sensitizing. | | Irritation | Irritation of the device evaluated to<br>demonstrate biocompatibility. | Testing demonstrated the device<br>is not an irritant. | | Pyrogenicity | Material mediated pyrogenicity<br>evaluated to demonstrate the absence<br>of a febrile response in an <i>in vivo</i> model. | Testing demonstrated the device<br>is non-pyrogenic. | | Endotoxin<br>(LAL test) | Amount of gram negative bacteria<br>evaluated to demonstrate endotoxin<br>units are within acceptable limits. | Endotoxin units were found to be<br><0.333, lower than the acceptable<br>limit. | ## EQUIVALENCE TO PREDICATE DEVICES The subject device has a similar design and dimensions as the device originally cleared in K142024 and similar tracking mechanisms (i.e. passive spheres) as the devices cleared in K142024, K153281, and K142344. The position of the passive spheres for the subject device are identical to the device cleared in K142024. The subject device has similar indications to the devices cleared in K142024, K153281, K142344, and K080450. The subject device is reusable and has similar reprocessing procedures as those cleared in K142024 and K080450. This submission does not include any changes to the previously cleared components of the BrightMatter navigational systems except the Pointer tool. Synaptive is currently unaware of another Pointer tool on the market that is made of titanium alloy. Therefore, complete biocompatibility testing has been performed to demonstrate substantial equivalence of the new material. Synaptive Medical, Inc. believes that the BrightMatter Pointer is substantially equivalent to the predicate devices based on the information summarized in the table below. {6}------------------------------------------------ # CONCLUSION The proposed BrightMatter Guide with BrightMatter Pointer is considered substantially equivalent to the predicate devices based on the testing performed, the similar indications for use, and similar technological characteristics. {7}------------------------------------------------ | | Subject Device | Predicate Device | | | |---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Synaptive Medical, Inc. | Synaptive Medical, Inc. | IZI Medical Products<br>LLC | Stryker<br>Instruments | | | BrightMatter Guide with BrightMatter<br>Pointer | BrightMatter Navigation System v1.0 /<br>BrightMatter Guide with SurfaceTrace Registration | Disposable Passive<br>Accessory for<br>Medtronic<br>StealthStation System | Stryker Power<br>Tool Navigator | | | K160523 | K142024 / K153281 | K142344 | K080450 | | Indications for<br>Use | BrightMatter Guide is intended as a<br>planning and intraoperative guidance<br>system to enable open and percutaneous<br>computer assisted surgery. The system is<br>indicated for medical conditions requiring<br>neurosurgical cranial procedures where<br>the use of computer assisted planning<br>and surgery may be appropriate. The<br>system can be used for intraoperative<br>guidance where a reference to a rigid<br>anatomical structure can be identified.<br>The user should consult the "Accuracy<br>Characterization" section of the User<br>Manual to assess if the accuracy of the<br>system is suitable for their needs.<br>The BrightMatter Pointer is intended to<br>be used for anatomy palpation and as a<br>pointing tool to enable spatial localization<br>and identification by BrightMatter Guide<br>navigational systems.<br>The system should be operated only by<br>trained personnel such as surgeons and<br>other clinic staff. | K142024: BrightMatter Navigation System is intended as a<br>planning and intraoperative guidance system to enable<br>open and percutaneous computer assisted surgery. The<br>system is indicated for medical conditions requiring<br>neurosurgical cranial procedures where the use of<br>computer assisted planning and surgery may be<br>appropriate. The system can be used for intra-operative<br>guidance where a reference to a rigid anatomical structure<br>can be identified.<br>The system should be operated only by trained personnel<br>such as surgeons and other clinic staff.<br>K153281: BrightMatter Guide with SurfaceTrace<br>Registration is intended as a planning and intraoperative<br>guidance system to enable open and percutaneous<br>computer assisted surgery. The system is indicated for<br>medical conditions requiring neurosurgical cranial<br>procedures where the use of computer assisted planning<br>and surgery may be appropriate. The system can be used<br>for intraoperative guidance where a reference to a rigid<br>anatomical structure can be identified. The user should<br>consult the "Accuracy Characterization" section of the User<br>Manual to assess if the accuracy of the system is suitable<br>for their needs.<br>The system should be operated only by trained personnel<br>such as surgeons and other clinic staff. | The Disposable<br>Passive Accessory is<br>intended to be used<br>for anatomy palpation<br>and registration in<br>image guided<br>surgeries with<br>Medtronic<br>StealthStation®<br>System. The device is<br>sterile and designed<br>for single use. | The Stryker®<br>Power Tool<br>Navigator<br>attachment is<br>intended to<br>enable spatial<br>localization and<br>identification of<br>Stryker Power<br>Tools by the<br>Stryker®<br>Navigation<br>System. | | ProCodes / Reg # | HAW /<br>21 CFR 882.4560 | HAW /<br>21 CFR 882.4560 | HAW /<br>21 CFR 882.4560 | HAW /<br>21 CFR 882.4560 | | | Subject Device | Predicate Device | | | | | Synaptive Medical, Inc. | Synaptive Medical, Inc. | IZI Medical Products LLC | Stryker Instruments | | | BrightMatter Guide with<br>BrightMatter Pointer | BrightMatter Navigation System v1.0 /<br>BrightMatter Guide with SurfaceTrace Registration | Disposable Passive Accessory<br>for Medtronic StealthStation<br>System | Stryker Power Tool Navigator | | | K160523 | K142024 / K153281 | K142344 | K080450 | | Technological characteristics | | | | | | Design | Pointer tool that features<br>four passive reflective<br>markers to enable spatial<br>localization and<br>identification by Synaptive<br>BrightMatter systems | Pointer tool that features four passive reflective<br>markers to enable spatial localization and<br>identification by Synaptive BrightMatter systems | Disposable passive probe<br>where five passive reflective<br>markers are mounted to allow<br>the probe to be recognized<br>and registered by the<br>StealthStation system | Tracking device designed an<br>optical surgical navigation<br>tracker that attaches to a<br>power tool, allowing that<br>tool to be tracked by the<br>Stryker Navigation System | | Pointer Material | Titanium alloy | Stainless steel 17-4 | Stainless steel 303 | Unknown | | Tracking<br>mechanism | Passive spheres | Passive spheres | Passive spheres | Optical IR LEDs | | Passive or Active<br>tracking | Passive | Passive | Passive | Active | | Single use or<br>Reusable | Reusable | Reusable | Single use | Reusable | | Provided Sterile<br>or Non sterile | Non sterile | Non sterile | Sterile | Unknown | | Customized<br>sterilizable tray | Yes | Yes | Unknown | Unknown | | Customized<br>sterilizable tray<br>material | Anodized aluminum | Anodized aluminum | Unknown | Unknown | | Calibration block | Yes | Yes | Unknown | Unknown | | Calibration block<br>material | Stainless steel 17-4 | Stainless steel 17-4 | Unknown | Unknown | {8}------------------------------------------------