neuromate Gen III

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized depiction of a human figure, while the FDA part includes the acronym "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. April 24, 2018 Renishaw Mayfield Sarl Stéphane Vinot Quality Assurance & Regulatory Affairs Manager 31. Rue Ampère Chassieu, 69680 Fr #### Re: K180206 Trade/Device Name: neuromate Gen III Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: January 4, 2018 Received: January 24, 2018 Dear Stéphane Vinot: 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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. {1}------------------------------------------------ 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. For comprehensive regulatory information about medical devices and radiation-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, ### Michael J. Hoffmann -S for 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) K180206 Device Name neuromate Gen III Indications for Use (Describe) Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments. neuromate Gen III has been validated with the Leksell Stereotactic System Type G (comprising of head frame and CT Localizer). | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------|------------------------------------------------------------------------------| | <div> <span> </span> Prescription Use (Part 21 CEB 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CER 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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SUBMITTER: RENISHAW mayfield S.A.R.L. 31, rue Ampère 69680 Chassieu FRANCE 011-33 4 37 23 89 00 Phone: 011-33 4 78 90 75 22 Fax: Contact person: Stéphane Vinot Quality Assurance & Regulatory affairs Manager quality@renishawmayfield.com Preparation date: January 4th, 2018 #### 2. DEVICE NAME: | Trade name: | neuromate® Gen III | |------------------|---------------------------------------------| | Common name: | neuromate Gen III stereotactic system | | Classification : | Regulation: 882.4560 Stereotaxic Instrument | | Product Code: | HAW - Neurological Stereotaxic Instrument | #### 3. PREDICATE DEVICE(s): K132755 - neuromate Frameless Gen II - RENISHAW Mayfield S.A.R.L. #### 4. REFERENCE DEVICE: K163666 - neuro | inspire™ - Renishaw plc. #### Renishaw Mayfield sarl 31 rue ampère F-69680 Chassieu - France Téléphone +33 (0) 4 37 23 89 00 +33 (0) 4 78 90 75 22 Fax RCS Lyon 480 820 307 SIRET 48082030700027 APE 3250A Nº identification TVA FR26 480 820 307 Capital : 250 000 € Société Générale Lyon République Code Banque 30003 Code guichet 01200 Nº compte 00020839167 Clé 57 IBAN FR76 30003 01200 00020839167 57 BIC SOGEFRPP {4}------------------------------------------------ #### 5. DEVICE DESCRIPTION: A stereotactic system with an electromechanical, multi jointed arm for spatial positioning and orientation of an instrument holder or tool-guide. Guidance is based on a preoperative plan developed with three-dimensional imaging software. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. #### 6. INDICATION FOR USE: Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments. neuromate Gen III has been validated with the Leksell Stereotactic System Type G (comprising of head frame and CT Localizer). #### 7. COMPARISON WITH PREDICATE DEVICE: The neuromate Gen III system (this submission) has the same intended use and the same fundamental scientific technology as the predicate device cleared under K132755. The differences between the two devices are about the use of a new planning software named neuro|inspire (reference device K163666). - . Substitution of neuro|inspire planning software in the system: The predicate device used a software package called VoXim as the planning software application. The neuromate Gen III (this submission) uses a planning software package called neuro|inspire (replacing Voxim). neuro|inspire contains a subset of functionalities of Voxim. Moreover, the PC provided with the workstation has been changed to support the neuro|inspire software. #### The proposed neuromate Gen III (this submission) is identical in design, intended use, construction and operation to the predicate K132755. The itemised comparison between the device and its predicate is provided in the following paragraph 7 (Substantial Equivalence Summary) of this document. {5}------------------------------------------------ | Device | neuromate Gen III (this<br>submission) | neuromate Frameless Gen II<br>(510(k) K132755) | SE | |--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | Manufacturer | RENISHAW mayfield | RENISHAW mayfield | Same | | | Intended Use | | | | Intended Use | Stereotactic spatial<br>positioning and orientation of<br>an instrument holder or tool<br>guide to be used by a<br>surgeon to manually guide<br>standard neurosurgical<br>instruments. | Stereotactic spatial positioning<br>and orientation of an instrument<br>holder or tool guide to be used<br>by a surgeon to manually guide<br>standard neurosurgical<br>instruments. | Same | | Indication for use | | | | | Indication<br>for use | Stereotactic spatial<br>positioning and orientation of<br>an instrument holder or tool<br>guide to be used by a<br>surgeon to manually guide<br>standard neurosurgical<br>instruments.<br>neuromate Gen III has been<br>validated with the Leksell<br>Stereotactic System Type G<br>(comprising of head frame<br>and CT Localizer). | Stereotactic spatial positioning<br>and orientation of an instrument<br>holder or tool guide to be used<br>by a surgeon to manually guide<br>standard neurosurgical<br>instruments. | SE | | Clinical<br>application | Neurological surgery | Neurological surgery | Same | | Sites of use | Operating rooms | Operating rooms | Same | | User | Neurosurgeon | Neurosurgeon | Same | | Anatomical<br>site | Head | Head | Same | | Principle of<br>operation | Patient imaging data is<br>visualized on the supplied<br>workstation running<br>neuro inspire software. It is<br>the surgeon who chooses the<br>tool, trajectory, point of<br>access and orientation.<br>The data is communicated to<br>the robot which located the<br>tool holder accordingly and<br>accurately.<br>The surgeon performs the<br>procedure by inserting tools<br>though the tool-holder, the<br>robot ensures the continued<br>stability of the position. | Patient imaging data is<br>visualized on the supplied<br>workstation running the VoXim<br>software. It is the surgeon who<br>chooses the tool, trajectory,<br>point of access and orientation.<br>The data is communicated to<br>the robot which located the tool<br>holder accordingly and<br>accurately.<br>The surgeon performs the<br>procedure by inserting tools<br>though the tool-holder, the robot<br>ensures the continued stability<br>of the position. | SE | | Registration<br>methods | Framebased mode: the<br>patient wears a stereotactic<br>frame and the frame is<br>attached to the robot<br> | Framebased mode: the patient<br>wears a stereotactic frame and<br>the frame is attached to the<br>robot (mechanical registration)<br>Frameless mode: The patient<br>wears a light-weight microphone<br>frame and the registration is<br>made by ultrasound. | SE | | Frame type<br>indicated | Leksell Stereotactic<br>System Type G (head ring<br>and CT localizer). | Leksell Stereotactic System<br>Type G (head ring, CT and<br>MRI localizers from Elekta)<br>+ CRW (head ring with MRI<br>and CT localizers from<br>Integra)<br>+ Fischer (head ring with CT<br>localizer from Inomed) | SE | | <b>Technical Characteristics</b> | | | | | General<br>device<br>description | Computer-controlled<br>electromechanical multi-<br>jointed arm | Computer-controlled<br>electromechanical multi-jointed<br>arm | Same | | System | • A robot, made of a<br>computer-controlled | • A robot, made of a computer-<br>controlled articulated | Same | | Architecture | articulated motorized arm<br>and the base that supports<br>it and contains the control<br>electronics;<br>• A workstation on which<br>runs software for scanned<br>image processing,<br>procedure planning, robot<br>configuration, robot control<br>and system diagnostic;<br>• A series of attachments to<br>connect the robot to the<br>patient, to perform patient<br>registration and to support<br>the tools used by the<br>surgeon. | motorized arm and the base<br>that supports it and contains<br>the control electronics;<br>• A workstation on which runs<br>software for scanned image<br>processing, procedure<br>planning, robot configuration,<br>robot control and system<br>diagnostic;<br>• A series of attachments to<br>connect the robot to the<br>patient, to perform patient<br>registration and to support the<br>tools used by the surgeon. | | | Axis control<br>technology | Incremental digital encoders<br>Absolute digital encoders | Incremental digital encoders<br>Absolute digital encoders | Same | | Compliance<br>with<br>voluntary<br>standards | Yes<br>IEC 60601-1: 2005 + AC1 +<br>AC2 + A1: 2012<br>IEC 60601-1-2: 2007<br>ISO 14971: 2007<br>IEC 62304: 2006<br>IEC 62366: 2007<br>ISO 17665-1: 2006<br>DICOM 3 | Yes<br>IEC 60601-1: 2005 + AC1 +<br>AC2 + A1: 2012<br>IEC 60601-1-2: 2007<br>IEC 60601-1-4: 2000<br>ISO 14971: 2007<br>IEC 62304: 2006<br>IEC 62366: 2007<br>ISO 17665-1: 2006<br>DICOM 3 | SE | | Maximum<br>instrument<br>payload | Maximum useful load: 5 kg<br>(11 lb)<br>1 kg (2.2 lb) for maximum<br>accuracy | Maximum useful load: 5 kg (11<br>lb)<br>1 kg (2.2 lb) for maximum<br>accuracy | Same | | Working<br>volume<br>(subset of the<br>above in<br>which the<br>positioning<br>accuracy is<br>achived) | 20 cm (~8") long, 18 cm (7")<br>diameter horizontal cylinder<br>oriented<br>along the robot axis and with<br>its<br>centre 81 cm (~32") from the<br>base. | 20 cm (~8") long, 18 cm (7")<br>diameter horizontal cylinder<br>oriented<br>along the robot axis and with its<br>centre 81 cm (~32") from the<br>base. | Same | | Overall<br>positioning<br>accuracy<br>(including<br>imaging) | In Frame-based mode: $< 2 mm (5/64")$ .<br>maximum error: $2 mm (0.079")$ and $2°$ between the<br>position reached by the<br>instrument carried by the arm<br>and the actual target. | In Frame-based mode: $< 2 mm (5/64")$ .<br>In Frameless mode: $< 3 mm (1/8")$ | SE | #### 8. SUBSTANTIAL EQUIVALENCE SUMMARY: {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ #### 9. NO CLINICAL TESTING | Software<br>Verification<br>and<br>Validation | The neuromate Gen III software including neuro inspire planning were<br>designed, verified and validated in accordance with IEC 62304: 2006<br>and General Principles of Software Validation; Final Guidance for<br>Industry and FDA Staff. | |-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Verification and validation confirmed that the neuromate Gen III<br>software are safe and effective. | | Electrical<br>Safety<br>Verification | The neuromate Gen III system was tested in accordance with IEC<br>60601-1:2005 + AC1 + AC2 + A1: 2012. | | | Test results confirmed that the neuromate Gen III complies with this<br>standard. | | Performance<br>Validation | The neuromate Gen III system was validated with the Leksell<br>Stereotactic System Type G (comprising of head frame and CT<br>Localizer). | | | The result of this validation confirmed that the accuracy of the system<br>complies with its claimed performances and is equivalent to those of<br>the predicate system. | | Usability<br>Validation | The neuromate Gen III interface including neuroinspire was validated<br>in accordance with Usability Engineering standard IEC 62366: 2007. | | | This validation confirmed that the use of the neuromate Gen III does<br>not pose an unacceptable risk. | #### 10. CONCLUSIONS FROM TESTING Verification and validation activities were conducted to establish the performance and safety characteristics of the neuromate Gen III system. {9}------------------------------------------------ The results of these activities demonstrate that the neuromate Gen III is safe and effective and performs at least as safely and effectively as the predicate marketed device. Therefore, the neuromate Gen III is considered substantially equivalent to the predicate device.