NEUROMATE FRAMELESS GEN II

{0}------------------------------------------------ # RENISHAW mayfie ## 510(k) SUMMARY APR 2 9 2014 - 1. SUBMITTER: . Renishaw Mayfield sarl 31. rue Ampère 69680 Chassieu FRANCE 011-33 4 37 23 89 00 Phone: Fax: 011-33 4 78 90 75 22 Contact person: Stéphane Vinot Quality Assurance & Regulatory affairs Manager stephane.vinot@renishawmayfield.com Preparation date: July 11, 2013 #### 2. DEVICE NAME: | Trade name: | neuromate Frameless Gen II | |----------------------|----------------------------------| | Common name: | Stereotactic neurological system | | Classification name: | Stereotaxic Instrument (HAW) | #### 3. PREDICATE DEVICE(s): K991081 - Frameless Neuromate - Integrated Surgical Systems Inc #### DEVICE DESCRIPTION: 4. 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 and utilizes ultrasonic registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. #### 5. INTENDED 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. 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 quichet 01200 N° compte 00020839167 Clé 57 IBAN FR76 30003 01200 00020839167 BIC SOGEFRPP {1}------------------------------------------------ #### 6. COMPARISON TO PREDICATE DEVICE: ## 6.1 Similarities The neuromate system is a technical update of the cleared Frameless NeuroMate. It has the same intend and is similar in all the following respects: - the patient benefits . - the architecture of the product . - the materials and components used . - . the construction and method of manufacture - . the embedded software - . the planning and imaging software - the operational modes offered ● - . the attachments used ## 6.2 Differences The only areas of difference between the neuromate and the cleared Frameless NeuroMate are: - a. The new neuromate system is type BF applied part while the cleared Frameless NeuroMate is type B applied part. - Note: The terms "Type BF applied part" and "Type B applied part" are used in the IEC60601-1 standard (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) to define the level of electrical isolation of an electrical medical equipment that has a part(s) in contact with a patient under normal use. The electrical isolation is between the patient and an external electrical source. In the IEC60601-1 standard, a "Type BF applied part" has a higher degree of electrical isolation compared to a "Type B applied part". - b. The neuromate system uses absolute digital encoders to control the position of the axis of the robot arm of the system while the cleared Frameless NeuroMate uses analogical ones. - c. The image-feedback sensor has been removed from the standard tool-holder, thereby removing the image-feedback functionality of the system ## 6.3 Conclusion ## Except for the above stated changes, the proposed Neuromate is identical in design, intended use, construction and operation to the predicate K991081. The itemised comparison between the device and its predicate is provided in paragraph 10 (Substantial Equivalence Summary) of this document. {2}------------------------------------------------ ## 7. NONCLINICAL DATA: Bench and performance testing showed that neuromate performed as designed and intended. The neuromate was tested to and found compliant with the requirements of IEC 60601-1 and IEC 60601-1-2. Software was developed in compliance with FDA software guidance and IEC 62304. #### CLINICAL DATA: 8. No clinical data are submitted. #### CONCLUSIONS DRAWN FROM TESTING: 9. Øi The testing showed that the neuromate performs as designed and intended, and is equivalent in design and performance to the predicate device. ## 10. SUBSTANTIAL EQUIVALENCE SUMMARY | Device | neuromate Frameless Gen II<br>(this submission) | Frameless Neuromate<br>(510(k) K991081) | SE | | |--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|--| | Manufacturer | Renishaw Mayfield | Integrated Surgical Systems Inc | SE | | | | Intended Use/Indications for Use | | | | | Intended Use | Stereotactic spatial positioning and<br>orientation of an instrument holder or<br>tool quide to be used by a surgeon<br>to manually guide standard<br>neurosurgical instruments. | Stereotactic spatial positioning and<br>orientation of an instrument holder or<br>tool quide to be used by a surgeon<br>to manually guide standard<br>neurosurgical instruments. | Same | | | Clinical<br>application | Neurological surgery | Neurological surgery | Same | | | Sites of use | Operating rooms | Operating rooms | Same | | | User | Neurosurgeon | Neurosurgeon | Same | | | Anatomical site | Head | Head | Same | | | Technical Characteristics | | | | | | General device<br>description | Computer-controlled<br>electromechanical multi-jointed arm | Computer-controlled<br>electromechanical multi-jointed arm | Same | | | Principle of<br>Operation | Patient imaging data is visualized<br>on the supplied workstation running<br>the VoXim software. It is the<br>surgeon who chooses the tool,<br>trajectory, point of access and<br>orientation.<br>The data is communicated to the<br>robot which locates the tool holder<br>accordingly and accurately. | Patient imaging data is visualized<br>on the supplied workstation running<br>the VoXim software. It is the<br>surgeon who chooses the tool,<br>trajectory, point of access and<br>orientation.<br>The data is communicated to the<br>robot which locates the tool holder<br>accordingly and accurately. | Same | | | Device | neuromate Frameless Gen II<br>(this submission) | Frameless Neuromate<br>(510(k) K991081) | SE | | | | The surgeon performs the<br>procedure by inserting tools through<br>the tool-holder, the robot ensuring<br>the continued stability of the<br>position. | The surgeon performs the<br>procedure by inserting tools through<br>the tool-holder, the robot ensuring<br>the continued stability of the<br>position. | | | | | Patient registration uses an<br>ultrasound system. | Patient registration uses an<br>ultrasound system. | | | | May be used in<br>frame-based<br>mode | Yes: the patient wears a stereotactic<br>frame and the frame is attached to<br>the robot (mechanical registration) | Yes: the patient wears a<br>stereotactic frame and the frame is<br>attached to the robot (mechanical<br>registration) | Same | | | May be used in<br>frameless mode | Yes: the patient wears a light-weight<br>microphone frame and the<br>registration is made by ultrasound. | Yes: the patient wears a light-<br>weight microphone frame and the<br>registration is made by ultrasound. | Same | | | Image feedback | No: the surgeon controls the depth<br>of insertion of a biopsy needle<br>through the rule on the cannula. | Yes: the position of the tool's<br>extremity is shown superposed to<br>the brain scan image. | | | | | | However, the surgeon is advised<br>not to use this information to control<br>tool depth (use instead the rule on<br>the cannula) | SE | | | System<br>Architecture | • a robot, made of a computer-<br>controlled articulated motorized<br>arm and the base that supports it<br>and contains the control<br>electronics;<br>• a workstation on which runs<br>software for scanned image<br>processing, procedure planning,<br>robot configuration, robot control<br>and system diagnostic;<br>• a series of attachments to connect<br>the robot to the patient, to perform<br>patient registration and to support<br>the tools used by the surgeon | • a robot, made of a computer-<br>controlled articulated motorized<br>arm and the base that supports it<br>and contains the control<br>electronics;<br>• a workstation on which runs<br>software for scanned image<br>processing, procedure planning,<br>robot configuration, robot control<br>and system diagnostic;<br>a series of attachments to<br>connect the robot to the patient, to<br>perform patient registration and to<br>support the tools used by the<br>surgeon | Same | | | Attachments | • remote control handset<br>• standard tool-holder<br>• tool laser holder<br>• frame adapter<br>• head-holder<br>• ultrasound tool-holder<br>• microphone frame<br>• temporary implant insert<br>• CT image localizer<br>• MRI image localizer<br>• angiographic module localizer | • remote control handset<br>• standard tool-holder<br>• tool laser holder<br>• frame adapter<br>• head-holder<br>• ultrasound tool-holder<br>• microphone frame<br>• temporary implant insert<br>• CT image localizer<br>• MRI image localizer<br>• angiographic module localizer | Same | | | Device | neuromate Frameless Gen II<br>(this submission) | Frameless Neuromate<br>(510(k) K991081) | SE | | | Construction | • Mechanical arm in four parts with<br>5 joints (5 degrees of freedom)<br>• Rigid fixation between the<br>stereotactic ring attachment or<br>head holder attachment and the<br>neuromate robot<br>• Each arm joint is an electrome-<br>chanical subassembly composed<br>of a motor; planetary reducer;<br>gear reducer; and worm-wheel<br>adjustment system with variable<br>backlash, providing non-reversible<br>motion and guaranteeing rigid<br>position locking. | • Mechanical arm in four parts with<br>5 joints (5 degrees of freedom)<br>• Rigid fixation between the<br>stereotactic ring attachment or<br>head holder attachment and the<br>neuromate robot<br>• Each arm joint is an electrome-<br>chanical subassembly composed<br>of a motor; planetary reducer;<br>gear reducer; and worm-wheel<br>adjustment system with variable<br>backlash, providing non-reversible<br>motion and guaranteeing rigid<br>position locking. | Same | | | Axis control<br>technology | Incremental digital encoders<br>Absolute digital encoders | Incremental digital encoder<br>Absolute analogical encoder | SE | | | Software/firmware<br>/ microprocessor<br>control | Yes | Yes | Same | | | Controller S/W | Main Controller | Main Controller | Same | | | Planning S/W | VoXim neuromate 6.4 | VoXim 1.0 | SE | | | Imaging S/W | VoXim neuromate 6.4 | VoXim 1.0 | SE | | | Compliance with<br>voluntary<br>standards | Yes<br>IEC 60601-1:2005 + AC1 + AC2<br>IEC 60601-1-2:2007<br>IEC 60601-1-4:2000<br>IEC 62366: 2007<br>ISO 14971: 2007<br>IEC 62304: 2006<br>DICOM 3<br>ISO 17665-1:2006 | Yes<br>EN 55011, Group 1, Class B<br>EN 50082-1 (IEC 801-2)<br>EN 50082-1 (IEC 801-3)<br>EN 50082-1 (IEC 801-4)<br>IEC 601.1 | SE | | {3}------------------------------------------------ ・ - . : {4}------------------------------------------------ : : : . . {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 29, 2014 Renishaw Mayfield Sarl Mr. Stephane Vinot Quality Assurance & Regulatory Affairs Manager 31 Rue Ampere Chassieu. France 69680 Re: K132755 Trade/Device Name: Neuromate Frameless Gen II Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: January 21, 2014 Received: January 29, 2014 Dear Mr. 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 fray of subject to additions, 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 that I DA has made a dolor regulations administered by other Federal agencies. You must {6}------------------------------------------------ Page 2 – Mr. Stephane Vinot 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Safetw/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, ## Felipe Aquel -S Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K132755 ### Device Name Neuromate Frameless Gen II 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. 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) ## PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY :54 : 1 . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) ## Date: 2014.04.2 18:06:23 -04'00' FORM FDA 3881 (1/14) PSC Publishing Services (301) 443-6740 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. {8}------------------------------------------------ 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. 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