(206 days)
Not Found
No
The summary describes a robotic surgical guidance system that uses imaging and markers for navigation, but there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as an aid for precisely locating anatomical structures and for guiding surgical instruments and is a pedicle screw guide system. It facilitates surgical procedures but does not directly treat a disease or condition itself.
No
Explanation: The device is intended for surgical navigation and guidance (locating anatomical structures, spationing, and orientation of guide bush) during pedicle screw placement. It does not perform a diagnostic function such as identifying a disease or condition.
No
The device description explicitly lists numerous hardware components, including a robotic arm, consoles, guide bush, and various surgical instruments. This indicates it is a hardware-based system with software control, not a software-only medical device.
Based on the provided information, the CUVIS-spine device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used as an aid for precisely locating anatomical structures and guiding surgical instruments during surgery (pedicle screw placement). This is an in vivo application, meaning it is used within a living organism.
- Device Description: The description details a robotic system, consoles, and surgical instruments. These are tools used directly on or within the patient during a surgical procedure.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health status, diagnose conditions, or monitor treatment. The CUVIS-spine does not perform any such analysis of biological samples.
The CUVIS-spine is a surgical navigation and robotic assistance system, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
O-arm, C-arm, CT
-3D pre-operative exam
-3D intra-operative exam
-2D intra-operative exam
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol of the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
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
1
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,
Image /page/1/Picture/5 description: The image shows the name "Shumaya Ali-S" in a simple, sans-serif font. The text is black against a white background, making it easily readable. The name appears to be a signature or label, possibly indicating ownership or authorship. The overall impression is clean and straightforward, with a focus on clarity.
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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| 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
5. 510(k) Summary
5.1. General Information
| Applicant/Submitter: | CUREXO, INC. |
|---|---|
| Address: | 577, Gangnam-Daero, Seocho-Gu |
| Seoul, 06530, Republic of Korea | |
| Tel: +82-31-788-7938 | |
| Jungeun PARK | |
| Quality Management Representative | |
| Email: jepark@curexo.com | |
| Contact Person: | Su Jin Yang |
| Address: | 4-5, Yanghyeon-ro 405beon-gil, Jungwon-gu, |
| Seongnam-si, Gyeonggi-do, Republic of Korea | |
| 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 |
4
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.
5
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
Device | Other predicate Device |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | CUVIS-spine | CUVIS-spine
(K201569) | Excelsius GPS™
(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
No. | 882.4560 | 882.4560 | 882.4560 |
| 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 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
GPS™ 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 | 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 | The EXCELSIUS
GPS™ 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 |
| | Subject Device | Primary predicate
Device | Other predicate Device |
| Device | CUVIS-spine | CUVIS-spine
(K201569) | Excelsius GPSTM
(K171651) |
| | 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. | surgical instruments in
open or percutaneous
surgical procedures if
the required markers and
rigid patient anatomy
can be identified on O-
arm or C-arm. | 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 | -Preoperative images
-Intraoperative images
-Patient registration
-Surgical planning
Real-time tracking
of
navigated instruments
-Guidance of instruments | -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, CT | O-arm, C-arm | O-arm, C-arm, CT |
| Input Images | -3D pre-operative exam
-3D intra-operative exam
-2D intra-operative exam | -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 | Optical Tracking System |
| Guide | Dilator and Tapper | Dilator and Tapper | Dilator and Tapper |
| Target
Tracking | YES | YES | YES |
| Integrated
Planning | - SRC
(Control Software) | - SRC
(Control Software) | Excelsius GPS Planning
and Navigation |
| | Subject Device | Primary predicate
Device | Other predicate Device |
| Device | CUVIS-spine | CUVIS-spine
(K201569) | Excelsius GPSTM
(K171651) |
| Software | SPNe
(Planner Software) | - SPN
(Planner Software) | Application Software |
| Save/load
Planning | YES | YES | YES |
| Merge images
functionality | YES | YES | YES |
| Trajectory
planning
parameters | - Entry point
- Target point
- Instrument
length/diameter | - Entry point - Target point
- Instrument
length/diameter | - Entry point - Target point
- Instrument
length/diameter |
| Localization
means | Optical system (infrared
camera) | Optical system (infrared
camera) | Optical system (infrared
camera) |
| Image-guided | YES | YES | YES |
| Controller | Forced-controlled
movement allowing
robot arm positioning
(called hand guide
function) | Forced-controlled
movement allowing
robot arm positioning
(called hand guide
function) | Force-controlled
movement allowing
robotic arm positioning |
| Patient
registration
method | - Pre-op CT :
Fluoroscopic to pre-
op CT merge - Intra-op CT :
Registration tool - Fluoroscopy : Source
calibrator | - 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 | YES |
| Accessories | - Registration
instruments
(Guide bush,
Source calibrator,
Registration tool,
Registration tool
adapter, Detector
calibrator) | - Registration
instruments
(Guide bush,
Source calibrator,
Registration tool,
Registration tool
adapter, Detector
calibrator) | - Registration
instruments |
| | Subject Device | Primary predicate
Device | Other predicate Device |
| Device | CUVIS-spine | CUVIS-spine
(K201569) | Excelsius GPS TM
(K171651) |
| | - Patient reference
instruments
(Patient marker,
Clamp, Pin, Marker
ball, Adapter, Pin
Vise, Slide
Hammer, Probe,
Awl, Lenke probe) | - Patient reference
instruments
(Patient marker, Clamp,
Marker ball) | - Patient reference
instruments |
| | - Surgical instruments
(Marker Driver,
Dilator, Serration-tip
dilator, Bur, Stylet
tapper, Tapper,
Screwdriver,
Robotic
arm drape, Tool drape,
Detector drape,
Instrument Container) | - Surgical instruments
(Marker Driver, Dilator,
Serration-tip dilator, Bur,
Stylet tapper, Tapper,
Screwdriver, Robotic
arm drape, Tool drape,
Detector drape,
Instrument Container) | - Surgical
instruments |
| | | | - End effector |
| Cybersecurity | - Industry standard
protocols - User access
control(admin) - Network protocols and
Firewall control - Data cryptography
(binary, registry, CSP) - Core resource files are
regenerated as new type
of files - Event logging
- software
update(only admin) | - Industry standard
protocols - User access
control(admin) - Network protocols and
Firewall control - Data cryptography
(binary, registry) - Core resource files are
regenerated as new type
of files - Event logging
- software update(only
admin) | N/A |
| Performance data | | | |
| | Subject Device | Primary predicate
Device | Other predicate Device |
| Device | CUVIS-spine | CUVIS-spine
(K201569) | Excelsius GPSTM
(K171651) |
| Electrical
Safety and
Electromagnetic
compatibility | - IEC60601-1 - IEC60601-1-2 | - IEC60601-1
- IEC60601-1-2 | - IEC60601-1
- IEC60601-1-2 |
| Accuracy
verification
on anatomical
landmarks | Yes | Yes | Yes |
| Bio-
compatibility | The biocompatibility
evaluation for the patient
marker has been
conducted in accordance
with EN ISO 10993
standards. | 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
(Clamp type, Pin type) | Patient marker |
| Nature of
Body Contact | Implant device / bone | Implant device / bone | Implant device / bone |
| Patient
Fixation | Reference is fixed to
patient's body structure
for tracking system | Reference is fixed to
patient's body structure
for tracking system | Reference is fixed to
patient's body structure
for tracking system |
Table 3 Technical Characteristics in Comparison to Predicate Devices
6
7
8
9
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 -
10
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.
11
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.