(342 days)
Not Found
No
The summary describes a robotic system for surgical guidance but does not mention any AI or ML components in its description, intended use, or performance studies.
No
The device is an aid for precisely locating anatomical structures and for spatial positioning and orientation during pedicle screw placement, not directly treating a disease or condition.
No
The device is described as a "pedicle screw guide system" that aids surgeons in "navigating compatible surgical instruments in open or percutaneous pedicle screw placement." Its primary function is to provide spatial positioning and orientation, not to diagnose a medical condition or disease.
No
The device description explicitly lists multiple hardware components including a robotic arm, main console, staff console, and various surgical instruments.
Based on the provided information, the CUVIS-spine is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- CUVIS-spine Function: The CUVIS-spine is a robotic surgical assistance system. Its intended use is to aid surgeons in precisely locating anatomical structures and guiding surgical instruments during pedicle screw placement. It works by using imaging modalities (O-arm, C-arm) and robotic technology to assist in a surgical procedure performed on the patient's body, not by analyzing samples from the patient's body.
The description clearly indicates a surgical navigation and guidance system, which falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / 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 compatible surgical instruments in open or percutaneous pedicle screw placement provided that the required markers and rigid patient anatomy can be identified on O-arm or C-arm.
Product codes
OLO
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.
The 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
- 3D intra-operative exam
- 2D intra-operative exam
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons / open or percutaneous pedicle screw placement
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 FDArecognized 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 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. -
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).
0
May 19, 2021
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: the Department of Health & 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.
Curexo, Inc. % Do Hyun Kim CEO BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul, 06210 Republic of Korea
Re: K201569
Trade/Device Name: CUVIS-spine Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 16, 2021 Received: April 19, 2021
Dear Do Hyun 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/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
1
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 (OS) 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: 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201569
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 spatial positioning 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 O-arm or C-arm.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------------------- |
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3
510(k) Summary
| Submitter/Applicant: | CUREXO, INC. |
|---|---|
| Address: | 577, Gangnam-Daero, Seocho-Gu |
| Seoul, 06530, Republic of Korea | |
| Tel: +82-31-788-7935 | |
| Jungeun PARK | |
| Quality Management Representative | |
| Email: jepark@curexo.com | |
| Applicant correspondent: | Do Hyun Kim, BT Solutions, Inc. |
| Address: | Unit 904, Eonju-ro 86gil 5, Gangnam-gu |
| Seoul 06210, Korea. | |
| Tel: +82-2-538-9140 | |
| Email: ceo@btsolutions.co.kr | |
| Preparation Date: | May 20, 2021 |
Device Name and Code
| Device Trade Name: | CUVIS-spine |
|---|---|
| Common Name: | Pedicle Screw Guide System |
| Classification Name: | Stereotaxic instrument |
| Product Code: | OLO |
| Regulation Number: | 21 CFR 882.4560 |
| Classification: | II |
| Review Panel: | Orthopedic |
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 |
|---|---|---|
| Globus Medical Inc. | Excelsius GPSTM | K171651 |
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.
The 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.
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 O-arm or C-arm.
Technical Characteristics in Comparison to Predicate Devices
| Subject Device | Predicate Device | |
|---|---|---|
| CUVIS-spine(K201569) | Excelsius GPSTM (K171651) | |
| Manufacturer | CUREXO, INC. | Globus Medical Inc. |
| Classification | Class II | Class II |
| Product Code | OLO | OLO |
| Regulation No. | 882.4560 | 882.4560 |
| Subject Device | Predicate Device | |
| CUVIS-spine(K201569) | Excelsius GPSTM (K171651) | |
| General 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. | The EXCELSIUS GPSTM is a | |
| Robotic Positioning System that | ||
| includes a computer controlled | ||
| robotic arm, hardware, and software | ||
| that enables real time surgical | ||
| navigation and robotic guidance | ||
| using radiological patient | ||
| images(preoperative CT, | ||
| intraoperative CT and fluoroscopy), | ||
| using a dynamic reference base and | ||
| positioning camera. | ||
| 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 | ||
| O-arm or C-arm. | The EXCELSIUS GPSTM is | |
| intended for use as an aid for | ||
| precisely locating anatomical | ||
| structures and for the spatial | ||
| positioning and orientation of an | ||
| instrument holder or guide tube to | ||
| be used by surgeons for navigating | ||
| and/or guiding compatible surgical | ||
| instruments in open or percutaneous | ||
| procedures provided that the | ||
| required fiducial markers and rigid | ||
| patient anatomy can be identified on | ||
| CT scans or fluoroscopy. The | ||
| system is indicated for the | ||
| placement of spinal and orthopaedic | ||
| bone screws. | ||
| Technical Characteristics | ||
| Principle of | ||
| operation | - Intraoperative images |
- Patient registration
- Surgical planning
- Real-time tracking of navigated
instruments - Guidance of instruments | - Intraoperative/preoperative
images - Patient registration
- Surgical planning
- Real-time tracking of navigated
instruments - Guidance of instruments |
| Image | O-arm, C-arm | O-arm, C-arm, CT |
| | Subject Device | Predicate Device |
| | CUVIS-spine(K201569) | Excelsius GPS TM (K171651) |
| Input Images | - 3D intra-operative exam - 2D intra-operative exam | - 3D pre-operative exam
- 3D intra-operative exam
- 2D intra-operative exam |
| Tracker | Optical Tracking System | Optical Tracking System |
| Guide | Dilator and Tapper | Dilator and Tapper |
| Target
Tracking | YES | YES |
| Integrated
Software | - SRC (Control Software) - SPN (Planner Software) | Excelsius GPS Planning and
Navigation Application Software |
| Save/load
Planning | YES | YES |
| Merge images
functionality | YES | YES |
| Trajectory
planning
parameters | - Entry point - Target point
- Instrument length/diameter | - Entry point
- Target point
- Instrument length/diameter |
| Localization
means | Optical system (infrared camera) | Optical system (infrared camera) |
| Image-guided | YES | YES |
| Controller | Forced-controlled movement
allowing robot arm positioning
(called hand guide function) | Force-controlled movement
allowing robotic arm positioning |
| Patient
registration
method | - Intra-op CT: Registration tool - Fluoroscopy: Source calibrator | - Pre-op CT: Fluoroscopic to pre-op
CT merge - Intra-op CT: Registration fixture
- Fluoroscopy: Registration fixture |
| Real time
display of
instrument
position | YES | YES |
| Accessories | - Registration instruments - Patient reference instruments
- Surgical instruments | - Registration instruments
- Patient reference instruments
- Surgical instruments
- End effector |
| Performance data | | |
| Electrical
Safety and
Electromagenti | - IEC60601-1 - IEC60601-1-2 | - IEC60601-1
- IEC60601-1-2 |
| | Subject Device | Predicate Device |
| | CUVIS-spine(K201569) | Excelsius GPS TM (K171651) |
| c compatibility
Accuracy
verification on
anatomical
landmarks | Yes | Yes |
| Biocompatibility | The biocompatibility evaluation for
the patient marker has been
conducted in accordance with EN
ISO 10993 standards. | The biocompatibility evaluation for
EXCELSIUS GPSTM has been
conducted in accordance with ISO
10993 standards. |
| Parts of
Contact with
Patient | Patient marker | Patient reference instruments
(Patient marker) |
| Nature of
Body Contact | Implant device / bone | Implant device / bone |
| Patient Fixation | Reference is fixed to patient's bony
structure for tracking system | Reference is fixed to patient's bony
structure for tracking system |
CUVIS-spine is substantially equivalent to the following legally marketed predicate devices
5
6
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 FDArecognized 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 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. -
8
- -Usability was documented by referring to IEC 60601-1-6.
Substantial Equivalence
CUVIS-spine is not based on a new technology. The technological characteristics of the subject device is comparable to the predicate device for comparable indications for use. Thus, subject device CUVIS-spine is concluded to be substantially equivalent to the predicate device.
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.