Micromate™ Navi+

K230130 · Isys Medizintechnik GmbH · JAK · Oct 10, 2023 · Radiology

Device Facts

Record IDK230130
Device NameMicromate™ Navi+
ApplicantIsys Medizintechnik GmbH
Product CodeJAK · Radiology
Decision DateOct 10, 2023
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.1750
Device ClassClass 2

Intended Use

The intended use of the Micromate™ Navi+ device is to function as a remote-operated positioning and guidance system for needle placement during interventional procedures. Positioning is done in a remote-controlled manner; planning of the position/angulation is done based on 2D/3D patient data (CT) using an internal image-guided planning and navigation system. The verification of the correct position and orientation of the tool prior to/during/after the intervention is done by means of external imaging devices. The Micromate™ Navi+ system is then acting as a guideway during the manual insertion of the interventional tool - usually a needle type device, and the like- through a third-party needle guide, manufactured by Exact Medical Manufacturing Inc. (K101689): P/N E2178 (Micromate Needle Guide, 8-11G), P/N E2183 (Micromate Needle Guide, 10-14G) and P/N E2184 (Micromate Needle Guide, 15-21G). During operation, the device is covered with a sterile drape, which is part of the P/N2178, P/N E2183 and E2184. An additional third-party Control Unit Drape is available, also manufactured by Exact Medical Manufacturing Inc. (K101689): P/N 11718EU (Micromate Control Unit Drape), tracker frame P/N: E6842, and tracker spheres P/N: 2010 (K022074). Micromate Navi+ is Intended only for adult use.

Device Story

Micromate™ Navi+ is a robotic positioning unit for percutaneous needle-based interventions (biopsy, tumor ablation). Input: 2D/3D CT images. Operation: User defines surgical plan via MicroNav software; system aligns robotic arm to trajectory; user performs manual needle advancement. Used in OR; operated by physician. System includes targeting platform, control unit, positioning arm, and optical tracking camera. Output: Visual guidance on navigation station. Benefits: Improved precision in needle placement; reduced manual adjustment. Safety: User verifies position via external imaging (scout scans/fluoroscopy) before/during/after intervention. Device is non-patient contacting; sterile drapes used.

Clinical Evidence

Bench testing validated navigation accuracy per ASTM F2554-18 (95% CI <2mm/2°). Simulated use accuracy: 1.04 ± 0.60mm lateral, 0.75 ± 0.47° angular. Clinical guidance accuracy validated in 54 interventions (19 abdominal, 19 thoracic, 16 musculoskeletal): overall 1.33 ± 1.13mm lateral, 1.02 ± 0.83° angular deviation. Worst-case clinical accuracy estimated at 6.40mm overall.

Technological Characteristics

Electromechanical robotic arm; metal/plastic/electronic construction. Optical tracking via stereo camera and disposable marker spheres. Connectivity: Point-to-point to navigation station. Software: MicroNav planning/navigation. Sterilization: Sterile drapes for non-patient contacting components. Standards: IEC 60601-1 (electrical), IEC 60601-1-2 (EMC), ASTM F2554-18 (accuracy).

Indications for Use

Indicated for adult patients to assist in the positioning of 8-19 gauge needles in the chest, abdomen, and musculoskeletal structures when CT optical navigation is used for target trajectory planning and intra-operative tracking. The needle is manually advanced by the user.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ October 10, 2023 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health and Human Services logo, which features an abstract image of a human figure. To the right of this is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue font. The word "FDA" is in a larger, bolder font than the rest of the text. ISYS Medizintechnik GMBH % Pedro Costa Bergwerksweg 21, Salzburg Kitzbuehel, AT 6370 AUSTRIA Re: K230130 Trade/Device Name: Micromate™ Navi+ Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: September 8, 2023 Received: September 8, 2023 Dear Pedro Costa: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Lu Jiang Lu Jiang, Ph. D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230130 Device Name Micromate™ Navi+ #### Indications for Use (Describe) The Micromate™ Navi+ device is a user-controlled electromechanical arm with a needle guide. It is intended to assist the user in the positioning of 8-19 gauge needles in the chest, abdomen and musculoskeletal structures when computed tomography (CT) optical navigation can be used for target trajectory planning and intra-operative tracking. The needle is then manually advanced by the user. Trajectory planning is made with software that is a part of the Micromate™ Navi+ device. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;"> </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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Interventional Systems. The logo consists of a blue icon on the left and the words "INTERVENTIONAL SYSTEMS" on the right. The icon is a stylized representation of three curved lines that converge at the bottom. The text is in a bold, sans-serif font and is also blue. # 510(k) Summary (K230130) - 1. Applicant: iSYS Medizintechnik GmbH - 2. Address: Berawerkswea 21 6370 KITZBÜHEL / AUSTRIA - Pedro Costa 3. Contact Person: Tel. +351 919 073 292 e-mail: Pedro.Costa@interventional-systems.com - 4. Preparation Date: December 2022. - Micromate™ Navi+ Trade Name: 5. - 6. Common Name: Robotic Positioning Unit - Classification 7. Computed tomography x-ray system Name: Product Code JAK, Reg.No. 892.1750 - Substantial Equiva-Micromate™ Navi+ is substantially equivalent to the following legally mar-8. keted devices: lence: ### Predicate Device: Micromate™ (iSYS Medizintechnik GmbH), K203720 Product Code JAK, Reg. No. 892.1750 ### Reference Device: Excelsius GPS System (Globus Medical Inc), K171651 Product Code OLO, Reg. No. 882.4560 - 9. Purpose The purpose of this submission is clearance of Micromate™ Navi+ as a new version of previously cleared Micromate™ (K203720) device that is complemented with additional/changed accessories and components, aimed to improve device performance by supporting and augmenting the already existing features as well as to expand its capabilities to Optical Navigation workflow. The characteristics of Micromate™ Navi+ device are equivalent to those of the predicate and/or reference device identified on the comparison table, which is provided with the premarket notification submission. It is our opinion that Micromate™ Navi+ system does not have technological characteristics that raise additional questions related to terms of safety and effectiveness. - 10. Device Description: The Micromate™ Navi+ system allows the percutaneous execution of a surgical intervention by providing instrument guidance according to one or more pre-operative plans defined by an internal planning and navigation software (MicroNav). The alignment to the surgical plan is performed through a manual gross-positioning using a Positioning Arm, followed by automatic or joystick-controlled movement with image guidance, such as optical CT navigation (tracked by camera). After alignment, the advancement of surgical instruments and delivery of therapy is performed manually by the user, while the position is retained by the targeting platform of {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains a logo for Interventional Systems. The logo consists of a blue icon on the left and the text "INTERVENTIONAL SYSTEMS" on the right. The icon is a stylized representation of three curved lines, resembling a hand or a wave. The text is in a bold, sans-serif font, with "INTERVENTIONAL" on the top line and "SYSTEMS" on the bottom line. Micromate™ Navi+, relying on the displayed navigation information or real-time images from third party imaging device. The Micromate Navi+ device is intended for biopsy and percutaneous tumor ablation procedures, in the abdomen, thorax and musculoskeletal tissue. The Micromate™ Navi+ system comprises the following main components: - . Targeting Platform, a robotic positioning unit that aligns to the surgical plan and holds the surgical instruments through an end-effector acting as a tool-guide adapter, - . Control Unit, device that allows the automatic or manual control of the Targeting Platform movement and can communicate with an internal planning and navigation station, - . Positioning Arm, a multi-functional arm that is used to gross-position the Targeting Platform in such a way the traiectory is reachable. - . Strain Relief Box, which distributes power and data through the Micromate™ system, - . Power and Network Unit, which connects the system to power and allows an optional direct point-to-point connection to an internal planning and navigation station for input of real-time navigation data, - . Connecting Cables. and following Accessories: - Sterile Drapes for the Control Unit and Targeting Platform, . - Needle guides for instrument guidance, packaged together with a . drape for the sterile covering of the Targeting Platform, - Sterile Tracker, to which off-the-shelf mounting spheres can be at-● tached, to enable optical tracking for the localization of the Targeting Platform in space, - A trolley for transport and storage, . - . Medical grade PC, - . Camera tracking system, - Planning and navigation software (MicroNav). . For listed accessories following table is the proposal of classification according to Title 21 of the Code of Federal Requlations (CFR), Parts 862-892: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains a logo for a company called Interventional Systems. The logo consists of a stylized blue hand-like symbol on the left, followed by the words "INTERVENTIONAL" and "SYSTEMS" stacked on top of each other in blue. The hand-like symbol is made up of four curved lines that converge at the bottom. | Accessory: | Is intended for use with one or more parent devices? | Is intended to support, supplement, and/or augment the performance of one or more parent devices? | Proposed accessory classification | Comment | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | MicroNav (planning and navigation software) | Yes, according to MicroNav intended use: | The MicroNav is intended to support the alignment of an external targeting platform (such as Micromate ™) to a plan defined pre- or intra-operatively by the user, in image-guided procedures. | Inclusion in the same classification as the parent device.<br>Regulation No. 892.1750<br>System, X-ray, Tomography, computed.<br>Product Code: JAK<br>Class II | | | Medical grade PC | Yes, Cybermed S24 Medical grade PC is intended to support Micromate™ by providing PC hardware environment for proper operation of MicroNav software and necessary communication/data transfer to other accessories or components of the system, temporary storage of provided data, conversion, and display of provided DICOM images.<br>Intended use: CyberMed S series products are designed for general pc application in the health care environment. It can be used for Radiology, PACS (Picture Archiving Communication Systems),LIS (Lab Information Systems), COW (Computer on Wheels), and Electronic Medical Record purposes. It shall not be used for life-supporting systems. | | Inclusion in the same classification as the parent device.<br>Regulation No. 892.1750<br>System, X-ray, Tomography, computed<br>Product Code JAK<br>Class II | Medical grade PC used as component in already 510(k) cleared device<br>Device name: Practical Navigation Surgical Guidance System (PNSGS)<br>Applicant: Practical Navigation, LLC (K202184) | | Atracsys camera | Yes, the SpryTrack sTk180 Optical Tracking System is a flexible, real-time tracking technology based on a stereo camera approach intended to support and augment Micromate™ during the navigated workflow procedure. | | Inclusion in the same classification as the parent device.<br>Regulation No. 892.1750<br>System, X-ray, Tomography, computed<br>Product Code JAK<br>Class II | / | | Trolley<br>(Supplier: ITD GmbH) | Yes: Third party trolley manufactured by ITD GmbH (FDA registration number 3007713438). The uni-cart single-column cart is small, manoeuvrable and ideal for space-saving, mobile use. It offers a high degree of stability for the integration of small medical devices and monitors for patient monitoring intended to support Micromate™ by providing a platform for storage and transport of device components and accessories. | | FDA listed device:<br>Device name: Uni-cart<br>Registered Establishment Name: ITD GMBH<br>Regulation No. 868.6175<br>Class I<br>510(k) exempt | / | | Optical tracker | Yes, according to intended use: Optical tracker is a rigid frame intended to provide necessary position in space of tracking spheres in accordance to Micromate end-effector. | | Already 510(k) cleared:<br>EXACT MEDICAL MANUFACTURING, INC (K101689) | / | | Tracking spheres | Yes, disposable Tracking spheres is intended to be used for patient referencing and tool registration in image guided surgeries.<br>Indications for use: For use as a stereotactic system accessory to aid in auto-registration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgery. It is indicated for any medical condition in which the use of sterotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure can be identified relative to a CT or MB-based model of the anatomy | | Already 510(k) cleared: I.Z.I. CORP. (K022074) | / | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Interventional Systems. The logo consists of a blue icon on the left and the words "INTERVENTIONAL SYSTEMS" on the right. The icon is a stylized representation of three curved lines that resemble fingers or a hand. The words "INTERVENTIONAL SYSTEMS" are stacked on top of each other, with "INTERVENTIONAL" on the top line and "SYSTEMS" on the bottom line. The system can be mounted to different bed/table through a specific adapter for each type of table. Third-party sterile instruments, tool guides and optical tracker (with spheres) are connected over the sterile drape to the Targeting Platform end-effector. Micromate™ Navi+ is not patient contacting. The intended use of the Micromate™ Navi+ device is to function as a re-11. Intended Use: mote-operated positioning and guidance system for needle placement during interventional procedures. Positioning is done in a remote-controlled manner; planning of the position/anqulation is done based on 2D/3D patient data (CT) using an internal image-guided planning and navigation system. The verification of the correct position and orientation of the tool prior to/during/after the intervention is done by means of external imaging devices. The Micromate™ Navi+ system is then acting as a guideway during the manual insertion of the interventional tool - usually a needle type device, and the like- through a third-party needle guide, manufactured by Exact Medical Manufacturing Inc. (K101689): P/N E2178 (Micromate Needle Guide, 8-11G), P/N E2183 (Micromate Needle Guide, 10-14G) and P/N E2184 (Micromate Needle Guide, 15-21G). During operation, the device is covered with a sterile drape, which is part of the P/N2178, P/N E2183 and E2184. An additional third-party Control Unit Drape is available, also manufactured by Exact Medical Manufacturing Inc. (K101689): P/N 11718EU (Micromate Control Unit Drape), tracker frame P/N: E6842, and tracker spheres P/N: 2010 (K022074). Micromate Navi+ is Intended only for adult use. - Indications for use: The Micromate™ Navi+ device is a user-controlled electromechanical arm 12. with a needle quide. It is intended to assist the user in the positioning of 8-19 gauge needles in the chest, abdomen and musculoskeletal structures when computed tomography (CT) optical navigation can be used for target trajectory planning and intra-operative tracking. The needle is then manually advanced by the user. Trajectory planning is made with software that is a part of the Micromate™ Navi+ device. ### 13. Clinical use # Preparing the system: After bringing sterile disposables into the operating room, bring the Micromate™ to the vicinity of the operating table, outside of the sterile field. Position the image-guided panning and navigation station. Prepare the patient according to hospital procedure by placing it in the appropriate position on the OR table. - Mounting the system on OR environment O {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Interventional Systems. The logo consists of a blue abstract graphic on the left and the words "INTERVENTIONAL SYSTEMS" in blue on the right. The word "INTERVENTIONAL" is above the word "SYSTEMS". - The Targeting Platform is affixed to the OR Table using a multi-functional mechanical O support arm, ensuring that the Targeting Platform has sufficient range of motion to be placed over the surgical site - Inserting the adequate end-effector type as per selected workflow in predicted slot on O targeting platform - Connecting cables between system components O - Draping the system with third-party sterile drape cover (sterile barrier to isolate non-sterile O system components) - The compact tracking Camera is rigidly affixed to the OR table using a multifunctional O mechanical support arm in the appropriate position to track the surgical site (option for navigated workflow) - Perform image recording according to CT navigation workflow. On an external CT sys- O tem perform a volume scan. - Bring the targeting platform to HOME position. O # CT Navigated workflow: Prerequisites: - The tracker camera is mounted. o - Tracker with tracking spheres is mounted on the Micromate Targeting Platform end effec-O tor - Both positioning arms, for camera and Micromate Targeting Platform are locked. o Workflow steps: - o Load the study (image data) into a planning and navigation from a PACS query, direct Communication with the CT or by data on USB flash drive - The software detects the position of the targeting platform in medical images, in relation O to the surgical anatomy based on fiducial markers on the targeting platform - The system optically tracks its position in real-time, using a peripheral tracking camera. O and transmits that information to the software - Confirmation of the valid RMS registration assessment (green mark) is done by navigation O station for both for the Camera and for the Tracker - Select the instrument type and size and confirm O - O Define single plan or multiple plans of intervention - Perform the gross-positioning of targeting platform by adjusting the positioning arm o - Using the available tools on the external modality, check validity of the trajectory (entry O and target point) and confirm - Perform the intervention (manual insertion of guided instrument performed by the user). o - 14. Biocompatibility The Micromate™ Navi+ is not in contact with the patient. At any time, when in use, a third-party sterile drape is to be placed between the patient and the system. No biocompatibility studies were considered necessary for this device. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Interventional Systems. The logo consists of a blue graphic on the left and the words "INTERVENTIONAL SYSTEMS" on the right. The graphic is a stylized representation of three curved lines. The text is in a bold, sans-serif font and is also blue. ### Device comparison summary | Reference | Micromate™<br>(predicate device)<br>K203720 | Micromate™ Navi+<br>(subject device)<br>K230130 | Excelsius GPS™<br>(reference device)<br>K171651 | | 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| 510(k) Number | K203720 | K230130 | K171651 | | | Manufacturer | iSYS Medizintechnik<br>GmbH Bergwerksweg 21 6370<br>Kitzbühel Austria | iSYS Medizintechnik<br>GmbH Bergwerksweg 21 6370<br>Kitzbühel Austria | Globus Medical Inc.<br>2560 General Armistead Ave.<br>Audubon, PA 19403<br>610-930-1800 | | | | DESIGN | | | | | General Device<br>Description | Computer controlled electrome-<br>chanical multi-jointed arm indi-<br>cated for both stereotactic and<br>non-stereotactic invasive<br>procdures.<br>The Micromate™ system allows<br>the percutaneous execution of a<br>surgical intervention by providing<br>instrument guidance according<br>to one or more pre-operative<br>plans defined in an external<br>planning or navigation station.<br>The alignment to the surgical<br>plan is performed through a<br>manual gross positioning using a<br>Positioning Arm, followed by au-<br>tomatic or joystick-controlled<br>movement with image guidance,<br>such as CT and fluoroscopic im-<br>age. | Computer controlled electrome-<br>chanical multi-jointed arm indi-<br>cated for both stereotactic and<br>non-stereotactic invasive<br>procedures.<br>The Micromate™ Navi+ system<br>allows the percutaneous execu-<br>tion of a surgical intervention by<br>providing instrument guidance<br>according to one or more pre-op-<br>erative plans defined in planning<br>or navigation station.<br>The alignment to the surgical<br>plan is performed through a man-<br>ual gross positioning using a Po-<br>sitioning Arm, followed by auto-<br>matic or joystick-controlled<br>movement with image guidance,<br>such as CT. | The EXCELSIUS GPS™ is a<br>Robotic Positioning System<br>that includes a<br>computer controlled robotic<br>arm, hardware, and software<br>that enables real time<br>surgical navigation and robotic<br>guidance using radiological pa-<br>tient images<br>(preoperative CT, intraopera-<br>tive CT and fluoroscopy), using<br>a dynamic reference<br>base and positioning camera | | | Localization<br>Method | Optical system (infrared<br>camera) | Optical system (infrared<br>camera) | Optical system (infrared<br>camera) | | | Planning soft-<br>ware | Third-party | Yes (MicroNav) | Yes (EXCELSIUS™ GPS<br>Planning and Navigation<br>Application software) | | | Registration<br>method | By navigation/imaging software<br>during intervention | By navigation/imaging software<br>during intervention. Registration<br>fixture during 3D intraoperative<br>images is part of the Targeting<br>Platform's end-effector. | Registration fixture during 3D<br>intraoperative images. Fluoro-<br>scopic merge to pre-op CT<br>Registration fixture in place<br>during fluoroscopy | | | Instrumentation | Tool Guides P/N: 11718EU<br>(Sterile Drapes Manufacturer:<br>Exact MM (K101689), P/N<br>E2178 (Micromate Needle Guide<br>Set, 8-11G), P/N E2183 (Micro-<br>mate Needle Guide Set, 10-14G)<br>and P/N E2184 (Micromate Nee-<br>dle Guide Set, 15-21G). During<br>operation, the device is covered<br>with a sterile drape, which is part<br>of the P/N2178, P/N E2183 and<br>E2184. An additional third-party<br>Control Unit Drape is available, | Tool Guides P/N: 11718EU<br>(Sterile Drapes Manufacturer:<br>Exact Medical Manufacturing Inc.<br>(K101689), P/N E2178 (Micro-<br>mate Needle Guide, 8-11G), P/N<br>E2183 (Micromate Needle<br>Guide,10-14G) and P/N E2184<br>(Micromate Needle Guide, 15-<br>21G). During operation, the de-<br>vice is covered with a sterile<br>drape, which is part of the<br>P/N2178, P/N E2183 and E2184.<br>An additional third-party Control<br>Unit Drape is available, also<br>manufactured by Exact Medical | N/A | | | | | | | | | | also manufactured by Exact MM<br>(K101689): P/N 11718EU (Mi-<br>cromate Control Unit Drape | Manufacturing Inc. (K101689):<br>P/N 11718EU (Micromate Con-<br>trol Unit Drape | | | | Instrument<br>Fixation and<br>Instrument<br>Guide<br>Position<br>Adjustment | Special tool holders for different<br>applications mounted to the<br>device<br>Trajectory and location set by<br>the robot. Instruments are manu-<br>ally positioned by the user<br>through the needle guides on the<br>robotic arm. | Special tool holders for different<br>applications mounted to the<br>device<br>Trajectory and location set by the<br>robot. Instruments are manually<br>positioned by the user through<br>the needle guides on the robotic<br>arm. | Trajectory and location set by<br>the robotic arm. Instruments<br>are manually positioned by the<br>user through the Guide Tube<br>on the robotic arm. | | | | System Operation | | | | | Principles of<br>operation | Positioning and guidance system<br>intended for the spatial position-<br>ing and orientation of instrument<br>holders or tool guides to be used<br>to hold and guide standard in-<br>struments, based on a pre-oper-<br>ative, operative (real time) plan<br>or feedback from an image-<br>guided navigation system or tra-<br>jectory planning station with two-<br>dimensional or three-dimen-<br>sional imaging software.<br>• Provide a mechanical connec-<br>tion to positioning devices on in-<br>terventional tables.<br>• Align to an active surgical plan<br>in a planning or navigation sys-<br>tem.<br>• Provide manual or automatic<br>motion control.<br>• Support the insertion and re-<br>lease of instrumentation, through<br>an accessory end-effector. | Positioning and guidance system<br>intended for the spatial position-<br>ing and orientation of instrument<br>holders or tool guides to be used<br>to hold and guide standard in-<br>struments, based on a pre-oper-<br>ative, operative (real time) plan<br>or feedback from an image-<br>guided navigation system or tra-<br>jectory planning station with two-<br>dimensional or three-dimensional<br>imaging software.<br>• Provide a mechanical connec-<br>tion to positioning devices on in-<br>terventional tables.<br>• Align to an active surgical plan<br>in a planning or navigation sys-<br>tem.<br>• Provide manual or automatic<br>motion control.<br>• Support the insertion and re-<br>lease of instrumentation, through<br>an accessory end-effector. | Intraoperative<br>preoperative images<br>Patient registration<br>Surgical planning<br>Real-time tracking of navigated<br>instruments<br>Guidance of instruments | | | Input Images | N/A | 3D Pre-operative images<br>3D Intraoperative images<br>2D Intraoperative images | 3D Pre-operative images<br>3D Intraoperative images<br>2D Intraoperative images | | | Trajectory<br>planning<br>parameters | N/A | Entry point, target point, length of<br>the trajectory, diameter of the in-<br>strument | Entry point, target point, length<br>of the instrument, diameter | | | Camera system | N/A | Stereo | Stereo | | | Image-guided | YES…
Innolitics
510(k) Summary
Decision Summary
Classification Order
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