MICROMATE

{0}------------------------------------------------ June 22, 2021 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. ISYS Medizintechnik GMBH % Cornelia Damsky President CDI Regulatory Consultants 6552 Hermosa Beach Lane DELRAY BEACH FL 33446 Re: K203720 Trade/Device Name: Micromate™ Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: May 24, 2021 Received: May 26, 2021 Dear Cornelia Damsky: 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 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 {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 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 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 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. For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203720 Device Name Micromate™ #### Indications for Use (Describe) The Micromate™ device is a user-controlled electromechanical arm with a needle guide. It is intended to assist the surgeon in the positioning of a needle or instrument where both comography (CT) and fluoroscopic imaging can be used for target trajectory planning and intraoperative tracking. The needle or electrode is then manually advanced by the surgeon. Trajectory planning is made with software that is not part of the Micromate™ device Type of Use (Select one or both, as applicable): | <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="color: #000000;"> <span style="font-weight: bold;"> <span style="font-style: normal;"> <span style="text-decoration: none;"> </span> </span> </span> </span> </span> </span> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="color: #000000;"> <span style="font-weight: normal;"> <span style="font-style: normal;"> <span style="text-decoration: none;"> </span> </span> </span> </span> </span> </span> <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="color: #000000;"> <span style="font-weight: normal;"> <span style="font-style: normal;"> <span style="text-decoration: none;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> </span> </span> </span> | <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="color: #000000;"> <span style="font-weight: normal;"> <span style="font-style: normal;"> <span style="text-decoration: none;"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> </span> </span> </span> | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| ### 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Interventional Systems. The logo features a stylized "i" with a blue dot above a black vertical line, next to the word "INTERVENTIONAL" in bold, black letters. Below "INTERVENTIONAL" is the word "systems" in a smaller, teal font. # 005 510(k) Summary K203720 - 1. Applicant: iSYS Medizintechnik GmbH - Address: Bergwerksweg 21 2. - 6370 Kitzbuehel / Austria - Dr. Michael Vogele 3. Contact Person: - Tel. +43 (0) 664 2411140 - January 19, 2021 4. Preparation Date: - 5. Trade Name: Micromate TM - Common Name: 6. Robotic Positioning Unit - Classification 7. System, X-ray, Tomography, computed Name: Product Code JAK, Reg. No. 892.1750 - 8. Substantial The Micromate™ is substantially equivalent to the following legally mar-Equivalence: keted devices: ## Predicate Device: iSYS1 (iSYS Medizintechnik GmbH), K131433 Product Code JAK, Reg. No. 892.1750 # Reference Device: Stealth Autoguide™ System (Medtronic Navigation Inc.), K191597 Product Code HAW, Reg. No. 882.4560 The characteristics of this device are similar to those of the predicate devices identified on the comparison chart, which is provided with the premarket notification submission. It is our opinion that the Micromate™ system does not have technological characteristics that raise additional types of questions related to terms of safety and effectiveness. - 9. Device The Micromate™ system allows the percutaneous execution of a surgical Description: intervention by providing instrument guidance according to one or more pre-operative plans defined in an external planning or navigation station. The alignment to the surgical plan is performed through a manual grosspositioning using a Positioning Arm, followed by automatic or joystick-controlled movement with image guidance, such as CT and fluoroscopic image. After alignment, the advancement of surgical instruments and delivery of therapy is performed manually by the surgeon, while the position is retained by the system and relying on the displayed navigation information or realtime images. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Interventional Systems. The logo features a stylized "i" with a blue dot above a black vertical line. To the right of the "i" are the words "INTERVENTIONAL" in bold, black letters, with the word "systems" in a smaller font and a lighter color below it. The system comprises the following main components: - . Tarqeting 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, a handheld device that allows the automatic or manual control of the Targeting Platform movement and can communicate with an external planning and navigation station. - . Positioning Arm, a multi-functional arm that is used to gross-position the Targeting Platform in such a way the trajectory 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 external planning and navigation station for input of real-time navigation data. - . Sterile Drapes for the Control Unit and Targeting Platform (this one containing also needle guides) for instrument guidance. - . Connecting Cables - A cart for transport and storage . The system can be mounted to different bed/table through specific adapter accessories and all components are covered with a sterile drape during use. Third-party needle or tool guides are connected to the Targeting Platform end-effector through a customized mechanical interface that preserves the sterile barrier. Micromate™ is not patient contacting. - The intended use of the Micromate™ device is to function as a remote-10. Intended Use: operated positioning and quidance system 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, cone-beam CT, fluoroscopy) by external planning software - for example using an external navigation system, or planning software coming with the used imaging device. Also, verification of the correct position and orientation of the tool prior to/during/after the intervention is done by means of these external devices. The Micromate™ 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 MM (K101689): P/N E2183 (Device Cover with 11G-14G needle guide) or P/N E2184 (Device Cover with 15G-21G needle guide). During operation, the device is covered with a sterile drape, which is part of the P/N E2183 and {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Interventional Systems. The logo features a stylized "i" with a blue circle above a black vertical line. To the right of the "i" is the text "INTERVENTIONAL" in black, with "systems" in a smaller, light blue font below it. The logo is simple and modern, using a clean font and a limited color palette. E2184. An additional third-party Control Unit Drape is available, also manufactured by Exact MM (K101689): P/N 11718EU (Handheld Device Cover). Applications include, but are not limited to, interventions like biopsy procedures, tumor ablation, nerve blocking, electrode placement, etc. - 11. Indications for use: The Micromate™ device is a user-controlled electromechanical arm with a needle guide. It is intended to assist the surgeon in the positioning of a needle or electrode where both computed tomography (CT) and fluoroscopic imaging can be used for target trajectory planning and intraoperative tracking. The needle or electrode is then manually advanced by the surgeon. Trajectory planning is made with software that is not part of the Micromate™ device - 12. Clinical Use: Depending on the used operating table, the user selects a specific table adapter and attaches it to the table (a Table Top Adapter for C-arm couchtops, a Standard Baseplate and respective adapters for a CT-table or Fluoro-CT table, Side-Rail Adapters for side-rails on any table). All adapters are equipped with a starburst connector, to which the multi-functional Positioning Arm is connected. The Positioning Arm is equipped with one starburst adapter at the bottom and a spoon adapter at the top, to which the Targeting Platform is connected with a counterpart. A Strain Relief Box (for power distribution and cable management) and the Control Unit for handheld remote control of the Targeting Platform are connected to a siderail. Both the Targeting Platform and the Control unit are connected to the Strain Relief Box with cables. The Strain Relief Box is then connected to a Power and Network Unit, responsible for the power and data input into the system, respectively through a power cord that is connected to the mains outlet and a network cable that can be plugged into an external planning or navigation station. An end-effector is connected to the Targeting Platform and the assembly (comprised of the Targeting Platform carrying and Endeffector and the Positioning Arm) are covered with a sterile drape. A sterile disposable needle guide is connected to the End-effector interface with the sterile drape in place. The Control Unit can optionally be covered with the respective sterile drape. The Targeting Platform is gross-positioning within the region of interest, by locking the Positioning Arm when the Targeting Platform is in the desired position. Planning of the tool position/orientation as well as validation of the correctness of the tool position must be performed with an external planning or navigation station. The Targeting Platform is remotely controlled using the Control Unit for fine positioning and to align the needle guide axis to the surgical plan. The surgical instruments are then inserted manually by the user into the needle guide and advanced to the planned target. For procedures requiring the placement of multiple instruments, each instrument can be released from the needle guide after placement and the alignment to additional planned surgical trajectories performed similarly. iSYS Medizintechnik GmbH, Bergwerksweg 21, 6370 Kitzbühel, Austria, Geschäftsführer: Dr. Michael Vogele, Thomas Pfeifer Firmensitz: Kitzbühel, Firmenbuchgericht: LG Innsbuchn: 348982 i, UID-Nr.: ATU65852918, St.Nr.: 103/0640 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Interventional Systems. The logo features a stylized letter "i" in black, with a blue dot above it. To the right of the "i" are the words "INTERVENTIONAL" in bold black letters, with the word "systems" in a smaller, lighter blue font below it. - Biocompatibility: The Micromate™ is not in contact with the patient. At any time, when in 13. 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. - 14. Performance Data: Operating conditions: 10-30°C (50-86°F), 30-70% RH, non-condensing, 0.689 bar-1.019 bar, altitude up to 3000m (9842 ft). Shipping conditions: 0-40°C (32–104°F), 20–80% RH, non-condensing, 0.689 bar–1.019 bar. Storage conditions: 0–30°C (32–86°F), 20–80% RH, non-condensing, 0.689 bar–1.019 bar. Power supply: 30VA, 100-240 VAC, 50/60 Hz. Sterilization of the sterile accessories has been validated by Exact Medical Manufacturing (K101689), the legal manufacturer of the sterile drapes and needle quides compatible with the Micromate™. The accuracy of the intervention is adjunct to the capabilities of the operator and depends on the resolution of the imaging device or software, among other factors. As calculated from actual clinical data, the 95% confidence interval (CI) accuracy of Micromate™ in clinical use is between 0.00 mm to 1.14 mm and 0.25 degrees to 1.70 degrees from the surgical plan. This corresponds to an average accuracy of alignment to the trajectory on Entry Point view of 0.43 ± 0.5mm, and an average angular deviation of the needle when being inserted along the trajectory of 0.79 ± 0.41 degrees. Micromate™ has no influence on the accuracy of the needle placement on target in terms of depth, as the instrument is manually delivered and advanced by the physician, under live imaging. All results were obtained in combination with the Philips Allura Xper FD20 X-ray system. The mechanical accuracy of the Micromate™ system itself is below 1 mm (relative mechanical accuracy 0.03 mm and absolute mechanical accuracy 0.2 mm), as measured by commanding the Targeting Platform to a predetermined location in air. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Interventional Systems. The logo features a stylized "i" with a blue dot above a black vertical line. To the right of the "i" is the text "INTERVENTIONAL" in bold, black letters, with "systems" in a smaller, lighter blue font directly below. ### Device comparison summary | Reference | iSYS1<br>(predicate device) | Stealth Autoguide™<br>System<br>(reference device) | Micromate™<br>(subject device) | Equivalence?¹ | 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| 510(k)-Number | K131433 | K191597 | K203720 | YES | | Manufacturer | iSYS Medizintechnik GmbH<br>Bergwerksweg 21<br>6370 Kitzbühel<br>Austria | Medtronic Navigation, Inc.<br>826 Coal Creek Circle<br>Louisville, Colorado 80027<br>United States | iSYS Medizintechnik GmbH<br>Bergwerksweg 21<br>6370 Kitzbühel<br>Austria | | | | | DESIGN | | | | General Device<br>Description | Computer controlled electro-<br>mechanical multi-jointed arm<br>indicated for invasive proce-<br>dures | Computer controlled elec-<br>tromechanical multi-joined<br>arm indicated for use as a<br>stereotactic instrument | Computer controlled electro-<br>mechanical multi-jointed arm<br>indicated for both stereotac-<br>tic and non-stereotactic inva-<br>sive procedures | YES (4) | | Localization<br>Means | Fiducial markers on tool<br>holder | Optical markers on tool<br>holder | Fiducial markers on tool<br>holder | YES (7) | | Image-guided | Yes | Yes | Yes | YES (1,3,11) | | Planning software | Third-party | Yes (StealthStation) | Third-party | YES (1) | | Registration<br>method | By navigation/imaging soft-<br>ware during intervention | By navigation/imaging<br>software during interven-<br>tion | By navigation/imaging soft-<br>ware during intervention | YES (4,7) | | Instrumentation | Marker<br>Tool Holder<br>Sterile Covers (third-party) | Reusable surgical instru-<br>ments<br>Navigated Trajectory<br>Guide, Tool Holders, Drill<br>Guides, Cranial reducing<br>Tubes, Height Guides and<br>Tapping Tube<br>(K162604) | Tool Guides<br>Sterile Drapes<br>Manufacturer: Exact MM<br>(K101689)<br>Device Cover with 11G-14G<br>needle guide, P/N E2183<br>Device Cover with 15G-21G<br>needle guide, P/N E2184<br>Handheld Device Cover, P/N<br>11718EU | YES (13) | | Instrument<br>Fixation | Special tool holders for dif-<br>ferent applications mounted<br>to the device | Special tool holders for dif-<br>ferent applications<br>mounted to the Stealth Au-<br>toguide™ | Special tool holders for dif-<br>ferent applications mounted<br>to the device | YES (9) | | Instrument<br>Calibration | Intra-operative | Intra-operative | Intra-operative | YES (8) | | Planning and Navigation Software | | | | | | N/A | | | | | | System Operation | | | | | | Fiducial markers<br>with registration<br>with pointer probe | No | No | No | YES (14) | | Optical<br>Registration | No | Yes | No | Yes (15) | | Ultrasound<br>Registration | No | No | No | YES (16) | | Accuracy<br>Verification | Yes, performed by user | Yes, performed by user | Yes, performed by user…