Instrument Clamps Electromagnetic

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October 9, 2020 Stryker Corporation Maya Schiel Staff Regulatory Affairs Specialist Boetzinger Strasse 41 Freiburg, Baden-Wuerttemberg D-79111 Germany Re: K202609 Trade/Device Name: Instrument Clamps Electromagnetic Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: September 3, 2020 Received: September 9, 2020 Dear Maya Schiel: 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). 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Sincerely, for Malvina Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K202609 Device Name Instrument Clamps Electromagnetic #### Indications for Use (Describe) The Instrument Clamp Electromagnetic Sphere and Instrument Clamp Electromagnetic Universal are accessories to the Electromagnetic Navigation Unit and are intended for navigating conventional surgical instruments. The Stryker ENT Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy. Example procedures include, but are not limited to the following ENT procedures: - Transphenoidal access procedures: - Intranasal procedures; - Sinus procedures, such as Maxillary antrostomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies; - ENT related anterior skull based procedures. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> | |----------------------------------------------|-------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <input type="checkbox"/> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 Special 510(k): Instrument Clamps Electromagnetic ## Submitter Information | 510(k) Submitter | Stryker Leibinger GmbH & Co. KG<br>Boetzinger Strasse 41<br>79111 Freiburg, Germany | |-----------------------------|-----------------------------------------------------------------------------------------------------------------| | FDA Establishment Number | 8010177 | | Contact Person | Maya Schiel<br>Staff Regulatory Affairs Specialist<br>Phone: +49 30 311 911 89<br>Mail: maya.schiel@stryker.com | | Date Submitted | September 3, 2020 | | Subject Device | | | Trade / Proprietary Name | Instrument Clamps Electromagnetic | | Common Name | Ear, Nose, And Throat Stereotaxic Instrument | | Classification | Class II | | Classification Product Code | PGW | | Classification Name | Stereotaxic Instrument | | Classification Regulation | 21 CFR 882.4560 | st ## Legally Marketed Predicate Device | Predicate Device Name | Scopis Extended Instrument Set EM | |--------------------------------|-----------------------------------| | | Instrument Clamps | | | Universal Tracker Electromagnetic | | Predicate Device 510(k) Number | K171661 | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are black and the background is white. The word is all lowercase. The Scopis Extended Instrument Set EM was cleared under K171661 by Scopis GmbH in September 2017. This submission was an extension to the previously cleared Scopis Hybrid Navigation System (K161491). Scopis GmbH was acquired by Stryker in November 2017. In July 2018, the legal manufacturer for the devices was changed to Stryker Leibinger GmbH & Co. KG. Since October 2019, the devices have also been also physically manufactured in Freiburg under the Stryker Leibinger Quality Management System. The 510(k) ownership was also transferred from Scopis GmbH. As part of the post-acquisition integration the Scopis name of the system was changed from Scopis Hybrid Navigation System to Stryker ENT Navigation System. The cleared instrument set contains instrument clamps and an electromagnetic tracker, which needs to be mounted on top of a clamp to enable tracking of conventional surgical instruments. Since the Instrument Clamps Electromagnetic are a combination of these devices, they are viewed as variants of the predicate device. The Instrument Clamps Electromagnetic themselves have the same intended purpose and indications and are therefore considered line extensions. #### Device Description The Instrument Clamps Electromagnetic are part of the Stryker ENT Navigation System. The basic principle of this system is the generation of an electromagnetic (EM) field with an EMemitter (Field Generator). The EM devices have sensor coils that transform the detected EM field into an analogue signal is transmitted via cable to the Electromagnetic Navigation Unit. The signal is then evaluated, and the tracking data is transmitted to the platform. This technology allows tracking instruments without a line-of-sight requirement. The Instrument Clamps Electromagnetic are to be used for localizing surgical instruments in a dedicated working volume. They are intended to be mounted on suitable surgical rigid instruments. The body of the clamp incorporates the required sensor coils, which enables tracking of conventional instruments. For accurate navigation, the instrument with the attached electromagnetic clamp needs to be calibrated prior to use. Two electromagnetic clamps are in scope of this submission: - Instrument Clamp Electromagnetic Sphere: Clamping interface optimized for tracking instruments with a circular cross-section between 2.0 mm and 4.6 mm in diameter (inclusive) - . Instrument Clamp Electromagnetic Universal: Clamping interface optimized for tracking instruments with angular cross-section (e.g. forceps) between 3.0 mm and 6.0 mm in diameter (inclusive) The subject devices are not intended to have patient contact. Their bodies are made of PEEK and the clamps and screws are manufactured from titanium. They are reusable devices that need to be reprocessed prior to first use. They are limited to 10 uses. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase and black. The background is white. ## Intended Use and Indications The Instrument Clamp Electromagnetic Sphere and Instrument Clamp Electromagnetic Universal are accessories to the Electromagnetic Navigation Unit and are intended for navigating conventional surgical instruments. The Stryker ENT Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy. Example procedures include, but are not limited to the following ENT procedures: - -Transsphenoidal access procedures; - -Intranasal procedures; - Sinus procedures, such as Maxillary antrostomies. Ethmoidectomies, -Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies; - ENT related anterior skull-based procedures. - #### Comparison of Technological Characteristics This submission is about the modification of combining two products (clamp and electromagnetic tracker) into one (electromagnetic clamp). The combination was achieved by integrating the electromagnetic sensor coil into the body of the clamp, as opposed to an EM tracker unit that must be separately attached, resulting in a smaller and lighter device. The one-piece electromagnetic clamp requires one step less of preparation and post-processing in the OR, since the devices do not need to be assembled or disassembled. The Instrument Clamps Electromagnetic are attached to conventional surgical instruments the same way as the predicate clamps. The step of attaching a separate electromagnetic tracker (as in predicate) is not required, as it is already incorporated into the subject device. The subject and predicate devices are identical in the following characteristics: - . 510(k) holder - FDA product codes and regulation ● - Intended Use - . Indications for Use - Application Area ● - Type of Use - Type of Patient Contact ● - Tracking Technology - Usage - Material ● - Packaging ● - Fixation ● - Calibration ● - Compatibility {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "Stryker" in a bold, sans-serif font. The letters are black and the background is white. The word is horizontally oriented and appears to be a logo or brand name. The subject and predicate devices differ in the following ways: The key requirements of the Instruments Clamps Electromagnetic are to be smaller and lighter, but with the same functionalities as the variants of the predicate. This requires a design that allows the device to be both clamp and tracker in one device. Therefore, the same type of electromagnetic sensor coil used in the predicate is directly incorporated into the body of the subject device in a more compact form. #### Performance Data #### Non-Clinical Testing A risk analysis was completed for subject devices in compliance with ISO 14971 to identify required verification and validation activities in order to evaluate the impact of the device modification and to mitigate potential risks. This submission includes appropriate supporting data to show the safety and effectiveness of the Instrument Clamps Electromagnetic. The following bench testing was performed to evaluate performance (accuracy), reprocessing, and electrical safety. Table 1: Performance Data | Scientific discipline | Test summary | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance - Accuracy | To ensure accuracy, subject devices are tested in accordance<br>with ASTM F2554. The devices meet state-of-the-art<br>acceptance criteria for point accuracy, precision and distance<br>accuracy. | | Reprocessing | Subject devices are reusable instruments and were therefore<br>validated in compliance with the respective FDA guidance for<br>reprocessing medical devices including respective TIRs.<br>The steam sterilization was also conducted in compliance<br>with ISO 17665-1 and ANSI/AAMI ST79.<br>The respective instructions follow ISO 17664. | | Electrical Safety | The devices are used as parts of the Stryker ENT Navigation<br>System, which is defined as ME Equipment. Therefore, devices<br>were checked and certified for compliance with ANSI/AAMI<br>ES 60601-1 as accessories to a ME Equipment. | All cited standards are FDA-recognized consensus standards #### Clinical Testing No clinical testing was deemed necessary for this 510(k) submission. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the word "Stryker" in a bold, sans-serif font. The letters are black and the background is white. The word is the logo for Stryker Corporation, a medical technology company. ### Conclusion The intended use and fundamental scientific technologies of subject devices and their predicate are identical. The subject devices are line extensions to the variants of the predicate and are therefore part of the same ENT Navigation System, following the same operating principles and conditions. The change of combining two devices into one does not affect the indications for use, tracking technology, calibration or other basic features. The device modifications do not raise different questions of safety and effectiveness than the predicate device. Risk management was conducted in accordance with ISO 14971 and does not show any unacceptable risk or new risks when compared to the predicate. Verification testing demonstrates that the subject devices are at least as safe and effective as the predicate. In conclusion, the information provided demonstrates that the Instrument Clamps Electromagnetic are at least as safe and effective as their predicate (K171661) and do not introduce different questions of safety or effectiveness, and therefore supports a determination of substantial equivalence.