CUVIS-spine
Device Facts
| Record ID | K223558 |
|---|---|
| Device Name | CUVIS-spine |
| Applicant | Curexo, Inc. |
| Product Code | OLO · Neurology |
| Decision Date | Jun 22, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
Indications for 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 pedicle screw placement provided that the required markers and rigid patient anatomy can be identified on 3D or 2D image.
Device Story
Mobile robotic system comprising robotic arm, main console, and optional staff console; used in surgical settings for pedicle screw placement. Inputs include preoperative/intraoperative 3D CT or 2D fluoroscopic images. System performs patient registration, surgical planning, and real-time tracking of navigated instruments via optical infrared camera. Robotic arm provides force-controlled guidance for instrument positioning (hand-guide function). Surgeon uses system to align guide bush for surgical instruments; output includes real-time display of instrument position relative to anatomy. Benefits include precise anatomical localization and guidance for spinal procedures.
Clinical Evidence
Non-clinical bench testing included pose accuracy and repeatability validation. Clinical evidence consists of a cadaveric study for robotic-assisted pedicle screw placement. Biocompatibility (ISO 10993-5, 10993-10), electrical safety (ES 60601-1), and EMC (IEC 60601-1-2) testing were performed.
Technological Characteristics
Mobile robotic arm with optical infrared tracking system. Materials evaluated per ISO 10993. Connectivity includes network protocols and firewall control. Software is Major level of concern. Force-controlled movement for robotic arm positioning. Compatible with O-arm, C-arm, and CT imaging.
Indications for Use
Indicated for surgeons performing open or percutaneous pedicle screw placement in patients where rigid anatomy and markers are identifiable on 3D or 2D imaging.
Regulatory Classification
Identification
A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
Predicate Devices
Submission Summary (Full Text)
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June 22, 2023
Sujin Yang RA Staff 577, Gangnam-Daero, Seocho-Gu Seoul, 06530 Korea. South
Re: K223558
Trade/Device Name: CUVIS-spine Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 23, 2023 Received: November 28, 2022
Dear Sujin Yang:
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
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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 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,
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Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K223558
Device Name CUVIS-spine
Indications for Use (Describe)
CUVIS-spine is intended for use as an aid for precisely locating anatomical structures and for the spationing and orientation of guide bush to be used by surgeons for navigating compatible surgical instruments in open or percutaneous pedicle screw placement provided that the required markers and rigid patient anatomy can be identified on 3D or 2D image.
Type of Use (Select one or both, as applicable)
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 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: +82-31-788-7938 |
| | Jungeun PARK<br>Quality Management Representative<br>Email: jepark@curexo.com |
| Contact Person: | Su Jin Yang |
| Address: | 4-5, Yanghyeon-ro 405beon-gil, Jungwon-gu,<br>Seongnam-si, Gyeonggi-do, Republic of Korea<br>Tel: +82-31-788-7938 |
| | Email: sjyang@curexo.com |
| Preparation Date: | November 25, 2022 |
## 5.2. Device Name and Code
| Device Trade Name: | CUVIS-spine |
|----------------------|-----------------------------------|
| Model Name: | CS200 |
| Common Name: | Pedicle Screw Guide System |
| Classification Name: | Orthopedic Stereotaxic instrument |
| Product Code: | OLO |
| Regulation Number: | 21 CFR 882.4560 |
| Classification: | II |
| Review Panel: | Orthopedic |
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#### 510(k) Summary
## 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 |
Table 2 Other predicate device
| Applicant | Device Name | 510(k) Number |
|---------------------|-----------------|---------------|
| Globus Medical Inc. | Excelsius GPSTM | K171651 |
### 5.4. Device Description
The CUVIS-spine is a mobile system mainly comprising the robotic arm, the main console and 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, Drape, Marker Ball, Patient Marker, Clamp, Adapter, Pin, Pin vise, Slide Hammer, Marker Driver, Detector calibrator, Dilator, Serration-tip dilator, Bur, Awl, Probe, Lenke probe, 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 pedicle screw placement provided that the required markers and rigid patient anatomy can be identified on 3D or 2D image.
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## 5.6.Technical Characteristics in Comparison to Predicate Devices
CUVIS-spine is substantially equivalent to the following legally marketed predicate devices
| | Subject Device | Primary predicate<br>Device | Other predicate Device |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | CUVIS-spine | CUVIS-spine<br>(K201569) | Excelsius GPS™<br>(K171651) |
| | Device Description and indications for use | | |
| Manufacturer | CUREXO, INC. | CUREXO, INC. | Globus Medical Inc. |
| Classification | Class II | Class II | Class II |
| Product Code | OLO | OLO | OLO |
| Regulation<br>No. | 882.4560 | 882.4560 | 882.4560 |
| General<br>Device<br>description | The CUVIS-spine is a<br>mobile system mainly<br>comprising the robotic<br>arm, the main console<br>and the staff console as<br>an option. The robotic<br>arm is positioned on the<br>floor near the side of the<br>surgical table. The<br>location of the main<br>console or the staff<br>console is appropriately<br>determined considering<br>the user preference and<br>the environments. | The CUVIS-spine is a<br>mobile system mainly<br>comprising the robotic<br>arm, the main console<br>and the staff console as<br>an option. The robotic<br>arm is positioned on the<br>floor near the side of the<br>surgical table. The<br>location of the main<br>console or the staff<br>console is appropriately<br>determined considering<br>the user preference and<br>the environments. | The EXCELSIUS<br>GPS™ is a Robotic<br>Positioning System that<br>includes a computer<br>controlled robotic arm,<br>hardware, and software<br>that enables real time<br>surgical navigation and<br>robotic guidance using<br>radiological patient<br>images(preoperative CT,<br>intraoperative CT and<br>fluoroscopy), using a<br>dynamic reference base<br>and positioning camera. |
| Indications<br>for use | CUVIS-spine is<br>intended for use as an<br>aid for precisely<br>locating anatomical<br>structures and for the<br>spatial positioning and<br>orientation of guide<br>bush to be used by<br>surgeons for<br>navigating and/or<br>guiding compatible | CUVIS-spine is intended<br>for use as an aid for<br>precisely locating<br>anatomical structures<br>and for the spatial<br>positioning and<br>orientation of guide bush<br>to be used by surgeons<br>for navigating and/or<br>guiding compatible | The EXCELSIUS<br>GPS™ is intended for<br>use as an aid for<br>precisely locating<br>anatomical structures<br>and for the spatial<br>positioning and<br>orientation of an<br>instrument holder or<br>guide tube to be used by |
| | Subject Device | Primary predicate<br>Device | Other predicate Device |
| Device | CUVIS-spine | CUVIS-spine<br>(K201569) | Excelsius GPSTM<br>(K171651) |
| | surgical instruments in<br>open or percutaneous<br>pedicle screw<br>placement provided that<br>the required markers and<br>rigid patient anatomy<br>can be identified on 3D<br>or 2D image. | surgical instruments in<br>open or percutaneous<br>surgical procedures if<br>the required markers and<br>rigid patient anatomy<br>can be identified on O-<br>arm or C-arm. | surgeons for navigating<br>and/or guiding<br>compatible surgical<br>instruments in open or<br>percutaneous procedures<br>provided that the<br>required fiducial markers<br>and rigid patient<br>anatomy can be<br>identified on CT scans or<br>fluoroscopy. The system<br>is indicated for the<br>placement of spinal and<br>orthopaedic bone<br>screws. |
| Technical Characteristics | | | |
| Principle of<br>operation | -Preoperative images<br>-Intraoperative images<br>-Patient registration<br>-Surgical planning<br>Real-time tracking<br>of<br>navigated instruments<br>-Guidance of instruments | -Intraoperative images<br>-Patient registration<br>-Surgical planning<br>-Real-time tracking<br>of<br>navigated instruments<br>-Guidance of instruments | -Intraoperative/<br>preoperative images<br>-Patient registration<br>-Surgical planning<br>-Real-time tracking<br>of<br>navigated instruments<br>-Guidance of instruments |
| Image | O-arm, C-arm, CT | O-arm, C-arm | O-arm, C-arm, CT |
| Input Images | -3D pre-operative exam<br>-3D intra-operative exam<br>-2D intra-operative exam | -3D intra-operative exam<br>-2D intra-operative exam | -3D pre-operative exam<br>-3D intra-operative exam<br>-2D intra-operative exam |
| Tracker | Optical Tracking System | Optical Tracking System | Optical Tracking System |
| Guide | Dilator and Tapper | Dilator and Tapper | Dilator and Tapper |
| Target<br>Tracking | YES | YES | YES |
| Integrated<br>Planning | - SRC<br>(Control Software) | - SRC<br>(Control Software) | Excelsius GPS Planning<br>and Navigation |
| | Subject Device | Primary predicate<br>Device | Other predicate Device |
| Device | CUVIS-spine | CUVIS-spine<br>(K201569) | Excelsius GPSTM<br>(K171651) |
| Software | SPNe<br>(Planner Software) | - SPN<br>(Planner Software) | Application Software |
| Save/load<br>Planning | YES | YES | YES |
| Merge images<br>functionality | YES | YES | YES |
| Trajectory<br>planning<br>parameters | - Entry point<br>- Target point<br>- Instrument<br>length/diameter | - Entry point<br>- Target point<br>- Instrument<br>length/diameter | - Entry point<br>- Target point<br>- Instrument<br>length/diameter |
| Localization<br>means | Optical system (infrared<br>camera) | Optical system (infrared<br>camera) | Optical system (infrared<br>camera) |
| Image-guided | YES | YES | YES |
| Controller | Forced-controlled<br>movement allowing<br>robot arm positioning<br>(called hand guide<br>function) | Forced-controlled<br>movement allowing<br>robot arm positioning<br>(called hand guide<br>function) | Force-controlled<br>movement allowing<br>robotic arm positioning |
| Patient<br>registration<br>method | - Pre-op CT :<br>Fluoroscopic to pre-<br>op CT merge<br>- Intra-op CT :<br>Registration tool<br>- Fluoroscopy : Source<br>calibrator | - Intra-op CT :<br>Registration tool<br>- Fluoroscopy :<br>Source calibrator | - Pre-op CT :<br>Fluoroscopic to pre-op<br>CT merge<br>- Intra-op CT :<br>Registration fixture<br>- Fluoroscopy :<br>Registration fixture |
| Real time<br>display of<br>instrument<br>position | YES | YES | YES |
| Accessories | - Registration<br>instruments<br>(Guide bush,<br>Source calibrator,<br>Registration tool,<br>Registration tool<br>adapter, Detector<br>calibrator) | - Registration<br>instruments<br>(Guide bush,<br>Source calibrator,<br>Registration tool,<br>Registration tool<br>adapter, Detector<br>calibrator) | - Registration<br>instruments |
| | Subject Device | Primary predicate<br>Device | Other predicate Device |
| Device | CUVIS-spine | CUVIS-spine<br>(K201569) | Excelsius GPS TM<br>(K171651) |
| | - Patient reference<br>instruments<br>(Patient marker,<br>Clamp, Pin, Marker<br>ball, Adapter, Pin<br>Vise, Slide<br>Hammer, Probe,<br>Awl, Lenke probe) | - Patient reference<br>instruments<br>(Patient marker, Clamp,<br>Marker ball) | - Patient reference<br>instruments |
| | - Surgical instruments<br>(Marker Driver,<br>Dilator, Serration-tip<br>dilator, Bur, Stylet<br>tapper, Tapper,<br>Screwdriver,<br>Robotic<br>arm drape, Tool drape,<br>Detector drape,<br>Instrument Container) | - Surgical instruments<br>(Marker Driver, Dilator,<br>Serration-tip dilator, Bur,<br>Stylet tapper, Tapper,<br>Screwdriver, Robotic<br>arm drape, Tool drape,<br>Detector drape,<br>Instrument Container) | - Surgical<br>instruments |
| | | | - End effector |
| Cybersecurity | - Industry standard<br>protocols<br>- User access<br>control(admin)<br>- Network protocols and<br>Firewall control<br>- Data cryptography<br>(binary, registry, CSP)<br>- Core resource files are<br>regenerated as new type<br>of files<br>- Event logging<br>- software<br>update(only admin) | - Industry standard<br>protocols<br>- User access<br>control(admin)<br>- Network protocols and<br>Firewall control<br>- Data cryptography<br>(binary, registry)<br>- Core resource files are<br>regenerated as new type<br>of files<br>- Event logging<br>- software update(only<br>admin) | N/A |
| Performance data | | | |
| | Subject Device | Primary predicate<br>Device | Other predicate Device |
| Device | CUVIS-spine | CUVIS-spine<br>(K201569) | Excelsius GPSTM<br>(K171651) |
| Electrical<br>Safety and<br>Electromagnetic<br>compatibility | - IEC60601-1<br>- IEC60601-1-2 | - IEC60601-1<br>- IEC60601-1-2 | - IEC60601-1<br>- IEC60601-1-2 |
| Accuracy<br>verification<br>on anatomical<br>landmarks | Yes | Yes | Yes |
| Bio-<br>compatibility | The biocompatibility<br>evaluation for the patient<br>marker has been<br>conducted in accordance<br>with EN ISO 10993<br>standards. | The biocompatibility<br>evaluation for the patient<br>marker has been<br>conducted in accordance<br>with EN ISO 10993<br>standards. | The biocompatibility<br>evaluation for<br>EXCELSIUS GPSTM has<br>been conducted in<br>accordance with ISO<br>10993 standards. |
| | Parts of<br>Contact with<br>Patient | Patient marker<br>(Clamp type, Pin type) | Patient marker |
| Nature of<br>Body Contact | Implant device / bone | Implant device / bone | Implant device / bone |
| Patient<br>Fixation | Reference is fixed to<br>patient's body structure<br>for tracking system | Reference is fixed to<br>patient's body structure<br>for tracking system | Reference is fixed to<br>patient's body structure<br>for tracking system |
Table 3 Technical Characteristics in Comparison to Predicate Devices
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## 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 -
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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 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. -
Software validation and verification testing was performed in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). The software for this device is considered a "MAJOR" level of concern. Cybersecurity was verified Cybersecurity control and management as recommended in FDA.
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## 5.8. Substantial Equivalence
CUVIS-spine, a proposed device, is equivalent to CUVIS-spine(K201569) as a whole, and some characteristics are equivalent to Excelsius GPSTM(K171651).
CUVIS-spine is not based on a new technology. The differences between CUVIS-spine and the predicate device would not affect the safety, effectiveness, and essential performance. Thus, subject device CUVIS-spine is concluded to be 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 devices for the purposes of this 510 (k) submission.
