NAV PAK Needle, NIM NAV PAK Needle

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. April 10, 2019 Boston Endo Surgical Tech Mr. James Rogers Director, Regulatory Affairs, Safety and Environment Division of Lacey Manufacturing Co., LLC 1146 Barnum Ave Bridgeport, Connecticut 06610 Re: K182662 Trade/Device Name: NAV PAK Needle, NIM NAV PAK Needle Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, PDQ, HAW Dated: Undated Received: March 11, 2019 Dear Mr. Rogers: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Matthew C. Krueger -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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182662 Device Name BE-ST Navigated PAK and Navigated NIM® PAK Indications for Use (Describe) The BE-ST NAV PAK is indicated for navigated pedicle pilot hole preparation. The BE-ST NAV PAK should only be used with a compatible Medtronic StealthStation® System. The BE-ST NAV NIM® PAK is indicated for navigated pedicle pilot hole preparation, locating, and identifying nerves during surgery, including spinal nerve roots. The BE-ST NAV NIM® PAK should only be used with compatible Medtronic StealthStation® and Medtronic NIM® Systems. | Type of Use (Select one or both, as applicable) | |------------------------------------------------------------------------------------| | <span style="font-size:10pt">✓</span> Prescription Use (Part 21 CFR 801 Subpart D) | | <span style="font-size:10pt">❍</span> 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 ## I. SUBMITTER Boston-Endo Surgical Technologies, Division of Lacey Manufacturing Company, LLC 1146 Barnum Avenue Bridgeport, CT 06610 (203) 336-7453 Prepared by: James Rogers Director of Regulatory Affairs, Environment and Safety Email: jim.rogers@nninc.com Phone: (203)336-7453 Date Prepared: September 18, 2018 #### II. DEVICE | Name of Device: | BE-ST Navigated PAK Needles | |----------------------|------------------------------------------------------------------------------------------------| | 510(k) Number: | K182662 | | Common Name: | Nerve Stimulator/Locator | | Classification Name: | 21 CFR 882.4560, Stereotaxic instrument<br>21 CFR 874.1820, Surgical nerve, stimulator/locator | | Review Panel | Neurology | | Regulatory Class: | II | | Product Code: | OLO, PDO | #### III. IDENTIFICATION OF LEGALLY MARKETED DEVICES (PREDICATE DEVICES) #### Predicate Device | K180542 | BE-ST NIM PAK Needle, Blunt, and Pedicle Probe | |---------|----------------------------------------------------| | K170011 | Medtronic StealthStation® S8 Spine Software v1.0.0 | | K050438 | Medtronic StealthStation® System Update | #### IV. DEVICE DESCRIPTION The BE-ST Navigated PAK Needles are single use surgical instruments composed of stainless steel and plastic. They are sterile packaged. The devices are comprised of three main components: the cannula, stylet assembly, and tracker subassembly. There are two devices in the family: the BE-ST Navigated NIM® PAK Needle and the BE-ST Navigated PAK Needle. The BE-ST Navigated NIM® PAK Needle is an accessory to the Medtronic StealthStation® System and is intended for use as a stimulating accessory to the Medtronic NIM® System. The BE-ST Navigated PAK Needle is an accessory to the Medtronic StealthStation® System. {4}------------------------------------------------ The only significant differences between the two subject devices are the electrical insulation on the cannula and the connection to the NIM® System. The BE-ST Navigated PAK device has the same basic function and navigational capabilities as the BE-ST Navigated NIM® PAK device but is not an accessory to the Medtronic NIM® system and therefore cannot be used for nerve monitoring. The Medtronic StealthStation® System and Medtronic NIM® System are not included in the scope of this premarket notification. # V. INDICATIONS FOR USE The BE-ST NAV PAK is indicated for navigated pedicle pilot hole preparation. The BE-ST NAV PAK should only be used with a compatible Medtronic StealthStation® System. The BE-ST NAV NIM® PAK is indicated for navigated pedicle pilot hole preparation, locating, and identifying nerves during surgery, including spinal nerve roots. The BE-ST NAV NIM® PAK should only be used with compatible Medtronic StealthStation® and Medtronic NIM® Systems. ## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The BE-ST Navigated NIM® PAK device is based on the predicate Medtronic Navigated NIM-SPINE® PAK Needle. The BE-ST Navigated NIM® PAK device is similar to the BE-ST NIM® PAK device with the addition of a tracker assembly which allows the device to be used with the Medtronic StealthStation® System. The subject device and the BE-ST NIM® PAK device have the same technological features, the same basic geometry, and are manufactured from the same materials, with the exception that the subject device has a tracker assembly which is substantially equivalent to the tracker assembly on the Medtronic predicate device. The BE-ST Navigated PAK device has the same basic function and navigational capabilities as the BE-ST Navigated NIM® PAK device but does not have neural integrity monitoring capabilities. | Comparison of Subject and Predicate Devices | | | | | |---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | Characteristic | Subject Device | Predicate Device | Predicate | Reference Predicate | | | BE-ST Navigated NIM® PAK<br>Needle | StealthStation System<br>Update | BE-ST NIM® PAK<br>Needle | StealthStation S8<br>Spine Software v1.0.0 | | Manufacturer | Boston-Endo Surgical<br>Technologies | Medtronic Navigation | Boston-Endo Surgical<br>Technologies | Medtronic Navigation | | 510(k) | K182662 | K050438 | K180542 | K170011 | | Indications for<br>Use | The BE-ST NAV PAK is<br>indicated for navigated pedicle<br>pilot hole preparation. The BE-<br>ST NAV PAK should only be<br>used with a compatible | [...] is indicated for any<br>medical condition in<br>which the use of<br>stereotactic surgery<br>may be appropriate, | [...] is indicated for<br>pedicle pilot hole<br>preparation, locating,<br>and identifying cranial<br>and peripheral motor | [...] is indicated for<br>any medical condition<br>in which the use of<br>stereotactic surgery<br>may be appropriate, | The tables below compare the subject and predicate devices. {5}------------------------------------------------ | Medtronic StealthStation® System. | and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. | nerves during surgery, including spinal nerve roots. | and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy. | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | The BE-ST NAV NIM® PAK is indicated for navigated pedicle pilot hole preparation, locating, and identifying nerves during surgery, including spinal nerve roots. The BE-ST NAV NIM® PAK should only be used with compatible Medtronic StealthStation® and Medtronic NIM® Systems | | | | | Technological Comparison of Subject and Predicate Devices | | | | |-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | Characteristic | BE-ST Navigated NIM® PAK Needle | Medtronic Navigated NIM-SPINE® PAK Needle | BE-ST NIM® PAK Needle | | Manufacturer | Boston-Endo Surgical Technologies | Medtronic Navigation | Boston-Endo Surgical Technologies | | Accessory to Medtronic StealthStation® System | Yes | Yes | No | | Accessory to Medtronic NIM® System | Yes | Yes | Yes | | Technological features | Same as predicate | Same as subject | Same as subject with exception of tracker assembly used for navigation | | Construction Materials | Stainless steel - stylet, cannula, self-tapping screws, and posts<br>Polymer - stylet handle, cannula hub, and tracker assembly<br>Polyester – cannula electrical insulation | Stainless steel – stylet, cannula, self-tapping screw, and posts<br>Polymer - stylet handle, locking ring, cannula hub, and tracker assembly<br>Nylon - cannula electrical insulation | Stainless steel – stylet and cannula<br>Polymer - stylet handle, cannula hub<br>Polyester - cannula electrical insulation | | Electrical insulation | On all cannula surfaces not intended to provide electrical contact with the patient. | On all cannula surfaces not intended to provide electrical contact with the patient. | On all cannula surfaces not intended to provide electrical contact with the patient. | | Distal tip | Same as predicate | Same as subject | Same as subject | | Stylet handle/cannula Hub connection | Overmolded stylet handle that locks to overmolded cannula hub | Removable handle with a locking ring the locks the handle to the cannula and/or stylet. | Overmolded stylet handle that locks to overmolded cannula hub | | Biocompatible | Yes | Yes | Yes | {6}------------------------------------------------ | Single Use | Yes | Yes | Yes | |-------------------------|----------------|----------------|-----------------| | Sterilization Method(s) | Sterile (ETO) | Sterile (ETO) | Sterile (gamma) | | Environment of Use | Intraoperative | Intraoperative | Intraoperative | | Duration of Use | < 24 hours | < 24 hours | < 24 hours | The subject device was shown to be substantially equivalent to the predicate devices through dimensional and functional testing. #### VII. PERFORMANCE DATA The subject device conforms to the following standards: - · ANSI/AAMI ST72:2011/(R) 2016, Bacterial endotoxins: Test methods, routine monitoring, and alternatives to batch testing. - ASTM A313, Standard Specification for Stainless Steel Spring Wire . (2017) - · ASTM A269, Standard Specification for Seamless and Welded Austenitic Stainless Steel Tubing (2015a) - · ISO 10993-4:2017, Biological Evaluation of Medical Devices: Tests for interactions with blood - · ISO 10993-5:2009, Biological Evaluation of Medical Devices: Tests for in vitro cytotoxicity. - ISO 10993-10:2010, Biological Evaluation of Medical Devices: Tests for irritation and sensitization. - ISO 10993-11:2017, Biological Evaluation of Medical Devices: Tests for . systemic toxicity. - · ISO 11135:2014, Sterilization of health-care products Ethylene oxide -Requirements for the development, validation, and routine control of a sterilization process for medical devices. - · ISO 11607-1:2006, Packaging for terminally sterilized medical devices: Requirements for materials, sterile barrier systems and packaging systems. - · ISO 11607-2:2006, Packaging for terminally sterilized medical devices: Validation requirements for forming, sealing andassembly processes. - · ISO 11737-1:2018, Sterilization of medical devices Microbiological methods: Determination of a population of microorganisms on products. - · ISO 11737-2:2009, Sterilization of medical devices Microbiological methods: Tests of sterility performed in the definition, validation and maintenance of a sterilization process. - · USP <85>, Bacterial Endotoxins Test. - · USP <151>, Rabbit Pyrogen Test - · USP <161>, Medical Devices: Bacterial Endotoxin and Pyrogen Tests The table below summarizes the testing which was performed on the subject devices to show substantial equivalence to the predicate devices. {7}------------------------------------------------ | Test | Test Method Summary | Results | |--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| | Functional use and<br>reliability testing | The following functional use tests were performed on the<br>subject devices and the predicate devices. For all tests, the<br>results were compared to verify substantial equivalence.<br>• Impact testing into simulated bone with snap lock testing of<br>cannula and stylet handles<br>• Hipot testing, continuity testing, and visual analysis following<br>impact testing<br>• Instron insertion and removal testing in simulated bone | Devices passed all<br>functional use and<br>reliability testing | | Biocompatibility<br>testing | Biocompatibility testing conducted on ETO sterilized, finished<br>devices per ISO 10993.<br>• Cytotoxicity: MEM Elution testing<br>• Sensitization: Magnusson-Kligman Method<br>• Irritation: Intracutaneous Toxicity<br>• Systemic Toxicity: Systemic Injection Test<br>• Material Mediated Pyrogen test: Rabbit Pyrogen Test<br>• Hemolysis: Extract method test | Devices passed<br>biocompatibility testing | | ETO sterilization<br>validation | ETO sterilization validation per ISO 11135. Validation achieved<br>a SAL of 10-6. The residual ETO limit for the devices is<br><4mg/device EO and <9mg/device ECH per ISO 10993-7.<br>Following validation, routine bioburden testing will be<br>performed on the devices. | ETO sterilization<br>validation completed<br>successfully | | Packaging<br>durability testing | Ship testing on final finished, packaged, sterilized, devices. The<br>ship testing was comprised of the following steps:<br>• ISTA 1C Test<br>o Environmental pre-conditioning<br>o Compression test<br>o Vibration test – fixed vibration<br>o Vibration test - random vibration<br>o Drop testing – corner, edge, and face drop<br>• Visual analysis of outer packaging, inner and outer blisters,<br>and device<br>• Inner and outer blister seal integrity testing via dye injection | Devices passed ship<br>testing | | Packaging process<br>validation | Packaging heat sealing process validation<br>• Heat sealing OQ<br>o Seal width verification<br>o Visual inspection<br>o Seal strength process capability analysis<br>• Heat sealing PQ conducted at nominal heat sealing parameters | Packaging process<br>validation completed<br>successfully | | | | | | Age testing<br>(device and<br>packaging) | 36 month accelerated aging on packaging and devices followed<br>by functional use testing and packaging integrity testing.<br>Accelerated aging to 36 months Device Functional use testing of devices including impact testing Visual, Hipot, and conductivity verification is conducted before and after impact testing. Snap lock testing of cannula and stylet handles Packaging Seal integrity testing using dye penetration method Seal strength testing | Devices and packaging<br>passed age testing. | | Surface area<br>validation | Performed dimensional analysis | Surface area found to be<br>substantially equivalent. | | Device<br>navigational<br>accuracy and<br>compatibility with<br>Medtronic<br>StealthStation®<br>System | Accuracy and compatibility testing with Medtronic<br>StealthStation® System. Testing conducted by Medtronic Devices registered by the StealthStation® System Devices tested to the accuracy criteria for the StealthStation® System | Devices passed accuracy<br>testing, meeting the<br>confidence/reliability<br>tolerance interval<br>requirement. | {8}------------------------------------------------ ## VIII. CONCLUSIONS The Navigated NIM® PAK Needle and the Navigated PAK Needle are intended for use as accessories to the Medtronic StealthStation® System. The Navigated NIM® PAK Needle is additionally intended for use as a stimulating accessory to the Medtronic NIM® System. As confirmed through bench testing; the subject devices have the same safety and effectiveness profile as the predicate devices.