CUVIS-spine

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 7, 2022 Curexo, Inc. % Do Kim CEO BT Solutions, Inc. Unit 904, Eonju-ro 68-gil 5, Gangnam-gu Seoul, 06210 Korea, South Re: K222698 Trade/Device Name: CUVIS-spine Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 5, 2022 Received: September 7, 2022 #### Dear Do Kim: 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/cdrl/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. {1}------------------------------------------------ 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 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 medical devices and radiation -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. Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K222698 Device Name CUVIS-spine (Model name: CS100) #### Indications for Use (Describe) CUVIS-spine is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of guide bush to be used by surgeons for navigating compatible surgical instruments in open or percutaneous surgical procedures provided that the required markers and rigid patient anatomy can be identified on O-arm or C-arm. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ # CUVIS-spine 510(k) Summary K222698 # 5. 510(k) Summary # 5.1. General Information | Applicant/Submitter: | CUREXO, INC. | |----------------------|----------------------------------------------------------------------------------------------------------------------| | Address: | 577, Gangnam-Daero, Seocho-Gu<br>Seoul, 06530, Republic of Korea<br>Tel: +82-31-788-7935 | | Contact Person: | Do Hyun Kim | | Address: | Unit 904, Eonju-ro 86gil 5, Gangnam-gu<br>Seoul 06210, Korea.<br>Tel: +82-2-538-9140<br>Email: ceo@btsolutions.co.kr | | Preparation Date: | September 5, 2022 | # 5.2. Device Name and Code | Device Trade Name: | CUVIS-spine | |----------------------|----------------------------| | Model Name: | CS100 | | Common Name: | Pedicle Screw Guide System | | Classification Name: | Stereotaxic instrument | | Product Code: | OLO | | Regulation Number: | 21 CFR 882.4560 | | Classification: | II | | Review Panel: | Orthopedic | # 5.3. Predicate Device CUVIS-spine is substantially equivalent to the following legally marketed predicate devices Table 1 Primary Predicate device | Applicant | Device Name | 510(k) Number | |-------------|-------------|---------------| | CUREXO, INC | CUVIS-spine | K201569 | # 5.4. Device Description The CUVIS-spine is a mobile system mainly comprising the robotic arm, the main console and {4}------------------------------------------------ #### CUVIS-spine K22698 the staff console as an option. The robotic arm is positioned on the floor near the side of the surgical table. The location of the main console or the staff console is appropriately determined considering the user preference and the environments. CUVIS-spine is a pedicle screw guide system which consists of Robotic Arm, Main Console, Staff Console, Guide bush, Source Calibrator, Registration Tool, Registration Tool Adapter, Robotic Arm Drape, Tool Drape, Detector Drape, Marker Ball, Patient Marker, Marker Driver, Detector Calibrator, Dilator, Serration-tip Dilator, Drill Bit, Tapper, Stylet Tapper, Screwdriver, Instrument Container. ### 5.5. Indications / Intended Use CUVIS-spine is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of guide bush to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous surgical procedures provided that the required markers and rigid patient anatomy can be identified on O-arm or Carm. #### 5.6. Technical Characteristics in Comparison to Predicate Devices CUVIS-spine is substantially equivalent to the following legally marketed predicate devices | | Proposed Device | Predicate Device | |-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | CUVIS-spine | CUVIS-spine | | | | (K201569) | | Device description and indications for use | | | | Manufacturer | CUREXO, INC | CUREXO, INC | | Classification | Class II | Class II | | Product Code | OLO | OLO | | Regulation No. | 882.4560 | 882.4560 | | General Device description | The CUVIS-spine is a mobile<br>system mainly comprising the<br>robotic arm, the main console and<br>the staff console as an option. The<br>robotic arm is positioned on the<br>floor near the side of the surgical | The CUVIS-spine is a mobile<br>system mainly comprising the<br>robotic arm, the main console and<br>the staff console as an option. The<br>robotic arm is positioned on the<br>floor near the side of the surgical | | | Proposed Device | Predicate Device | | Device | CUVIS-spine | CUVIS-spine<br>(K201569) | | | table. The location of the main<br>console or the staff console is<br>appropriately determined<br>considering the user preference<br>and the environments. | table. The location of the main<br>console or the staff console is<br>appropriately determined<br>considering the user preference<br>and the environments | | | CUVIS-spine is intended for use<br>as an aid for precisely locating<br>anatomical structures and for the<br>spatial positioning and orientation | CUVIS-spine is intended for use<br>as an aid for precisely locating<br>anatomical structures and for the<br>spatial positioning and orientation | | | of guide bush to be used by<br>surgeons for navigating and/or | of guide bush to be used by<br>surgeons for navigating and/or | | Indications<br>for use | guiding compatible surgical<br>instruments in open or | guiding compatible surgical<br>instruments in open or | | | percutaneous surgical procedures<br>if the required markers and rigid | percutaneous surgical procedures<br>if the required markers and rigid | | | patient anatomy can be identified<br>on O-arm or C-arm. | patient anatomy can be identified<br>on O-arm or C-arm. | | Technical Characteristics | | | | | - Intraoperative images | - Intraoperative images | | | - Patient registration | - Patient registration | | Principle of<br>operation | - Surgical planning | - Surgical planning | | | - Real-time tracking of navigated<br>instruments | - Real-time tracking of<br>navigated instruments | | | - Guidance of instruments | - Guidance of instruments | | Image | O-arm, C-arm | O-arm, C-arm | | Input Images | - 3D intra-operative exam | - 3D intra-operative exam | | | - 2D intra-operative exam | - 2D intra-operative exam | | Tracker | Optical Tracking System | Optical Tracking System | | Guide | Dilator and Tapper | Dilator and Tapper | | Target<br>Tracking | YES | YES | | Software<br>Information | - SRC (Control Software)<br>- SPN (Planner Software) | - SRC (Control Software)<br>- SPN (Planner Software) | | Save/load<br>Planning | YES | YES | | Merge images | YES | YES | | | Proposed Device | Predicate Device | | Device | CUVIS-spine | CUVIS-spine<br>(K201569) | | functionality | | | | Trajectory planning<br>parameters | - Entry point | - Entry point | | | - Target point | - Target point | | | - Instrument length/diameter | - Instrument length/diameter | | Localization means | Optical system (infrared camera) | Optical system (infrared camera) | | Image-guided | YES | YES | | Controller | Forced-controlled movement | Forced-controlled movement | | | allowing robot arm positioning | allowing robot arm positioning | | | (called hand guide function) | (called hand guide function) | | Patient registration<br>method | - Intra-op CT : Registration tool<br>- Fluoroscopy : Source calibrator | - Intra-op CT : Registration tool<br>- Fluoroscopy : Source calibrator | | Real time display of<br>instrument position | YES | YES | | Accessories | - Registration instruments<br>(Guide bush, Source calibrator,<br>Registration tool, Registration<br>tool adapter, Detector<br>calibrator) | - Registration instruments<br>(Guide bush, Source calibrator,<br>Registration tool, Registration<br>tool adapter, Detector<br>calibrator) | | | - Patient reference instruments<br>(Patient marker, Clamp, Pin,<br>Marker ball, Adapter, Pin Vise,<br>Slide Hammer, Probe) | - Patient reference instruments<br>(Patient marker, Clamp,<br>Marker ball) | | | - Surgical instruments<br>(Marker Driver, Dilator,<br>Serration-tip dilator, Bur, Stylet<br>tapper, Tapper, Screwdriver,<br>Robotic arm drape, Tool drape,<br>Detector drape, Instrument<br>Container) | - Surgical instruments<br>(Marker Driver, Dilator,<br>Serration-tip dilator, Bur,<br>Stylet tapper, Tapper,<br>Screwdriver, Robotic arm<br>drape, Tool drape, Detector<br>drape, Instrument Container) | | Electrical Safety and<br>Electromagentic<br>compatibility | - IEC60601-1<br>- IEC60601-1-2 | - IEC60601-1<br>- IEC60601-1-2 | | Accuracy | Yes | Yes | | | Proposed Device | Predicate Device | | Device | CUVIS-spine | CUVIS-spine<br>(K201569) | | verification on<br>anatomical<br>landmarks | | | | Bio-compatibility | The biocompatibility evaluation<br>for the patient marker has been<br>conducted in accordance with EN<br>ISO 10993 standards. | The biocompatibility evaluation<br>for the patient marker has been<br>conducted in accordance with EN<br>ISO 10993 standards. | | Parts of<br>Contact with<br>Patient | Patient marker | Patient marker, Clamp* | | Nature of<br>Body Contact | Implant device / bone | Implant device / bone | | Patient Fixation | Reference is fixed to patient's<br>bony structure for tracking system | Reference is fixed to patient's<br>bony structure for tracking system | {5}------------------------------------------------ ## CUVIS-spine K222698 {6}------------------------------------------------ ## CUVIS-spine K222696 {7}------------------------------------------------ *For Clamp corresponds to the Body of the Patient Marker of the initial approved device. The structure of Patient Marker, the initial approved device, of the Maker Frame and Body were disassembled, and the name was changed for each structure. This change was documented on August 14, 2021. # 5.7. Performance Data Non-clinical tests: Pose accuracy and Repeatability of the CUVIS-spine were tested and validated. A cadaveric study of the proposed device had been performed for the robotic-assisted pedicle screw placement. Biocompatibility were tested using following consensus standards: - Tests for in vitro cytotoxicity were tested and evaluated according to the FDA-recognized consensus standard, ISO 10993-5. - -Tests for irritation, skin sensitization and intracutaneous reactivity were tested and evaluated according to the FDA-recognized consensus standard, ISO 10993-10. Electromagnetic compatibility and electrical safety, etc, were tested using following consensus standards: - Basic safety and essential performance of the CUVIS-spine is tested and evaluated - {8}------------------------------------------------ according to the FDA-recognized consensus standard, ES 60601-1. - Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2. - Risk management was recorded by referring to ISO 14971. - - Usability was documented by referring to IEC 60601-1-6. - #### 5.8. Substantial Equivalence CUVIS-spine is not based on a new technology. The predicate device is already available in the US market. There is a slight difference between CUVIS-spine and the predicate device. However, it does not affect the technical, clinical and biological aspects. It can be claimed that CUVIS-spine is substantially equivalent to the predicate device. ### 5.9. Conclusions On the basis of the information provided in this Summary, CUREXO, INC. believes that CUVIS-spine is substantially equivalent to legally commercialized predicate device for the purposes of this 510 (k) submission.