(206 days)
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.
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.
The provided text describes the CUVIS-spine device, a robotic-assisted pedicle screw placement system. However, it does not contain specific acceptance criteria or details of a study demonstrating that the device meets those criteria, particularly regarding clinical performance metrics like accuracy measurements, clinical outcomes, or human reader effectiveness.
The document primarily focuses on:
- Substantial Equivalence: Comparing the CUVIS-spine to predicate devices (CUVIS-spine K201569 and Excelsius GPS™ K171651) based on technical characteristics, indications for use, and general device descriptions.
- Non-Clinical Tests: Mentioning that pose accuracy and repeatability were tested, and a cadaveric study was performed. It also lists the consensus standards used for biocompatibility, electrical safety, electromagnetic compatibility, risk management, usability, and software validation (including cybersecurity).
Therefore, I cannot populate the table or provide detailed answers to most of your questions based on the input text. The information needed to describe acceptance criteria and a study proving the device meets them (e.g., specific accuracy metrics, clinical data, sample sizes for test sets, ground truth establishment, or human reader improvement) is not present.
Here's what can be inferred or stated based on the given text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Specific metrics are NOT provided in the document) | Reported Device Performance (Specific metrics are NOT provided in the document) |
|---|---|
| Accuracy verification on anatomical landmarks: (No specific metric, e.g., ±X mm deviation, is stated) | "Yes" (Indicates that accuracy verification was performed, but no quantitative results are given.) |
| Pose accuracy: (No specific metric is stated) | "tested and validated" (No quantitative results are given.) |
| Repeatability: (No specific metric is stated) | "tested and validated" (No quantitative results are given.) |
| Biocompatibility: (No specific metric is stated beyond adherence to standards) | "evaluated according to the FDA-recognized consensus standard, ISO 10993-5" "evaluated according to the FDA-recognized consensus standard, ISO 10993-10" |
| Basic safety and essential performance: (No specific metric is stated beyond adherence to standards) | "tested and evaluated according to the FDA-recognized consensus standard, ES 60601-1" |
| Effect to the device by electromagnetic disturbances: (No specific metric is stated beyond adherence to standards) | "tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2" |
| Software validation (Level of Concern): Functionality, Cybersecurity | "MAJOR" level of concern, "verified Cybersecurity control and management as recommended in FDA." |
Missing Information for a Comprehensive Answer:
- Quantitative Acceptance Criteria: The document states that accuracy, pose accuracy, and repeatability were tested, but it does not define the specific numerical thresholds for these criteria (e.g., "accuracy must be within 1.0 mm").
- Quantitative Device Performance: Similarly, it does not report the actual measured performance values for accuracy, pose accuracy, or repeatability. It only states they were "tested and validated."
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document mentions a "cadaveric study" for the proposed device but does not state the sample size (e.g., number of cadavers, number of pedicles analyzed).
- Data Provenance: The document does not specify the country of origin of the cadaveric study or any other test data. It indicates the study was "cadaveric," implying it's a prospective experimental study, but details are lacking.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document.
4. Adjudication method for the test set
- This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- A MRMC comparative effectiveness study is not mentioned in the document. The device is a robotic-assisted surgical system, not an AI diagnostic imaging tool that typically involves human reader performance studies in that context. The focus is on the robot's ability to aid surgeons in instrument placement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The document implies that "Pose accuracy and Repeatability of the CUVIS-spine were tested and validated," which would constitute standalone technical performance testing of the robotic system itself, independent of a human surgeon's real-time interaction beyond initial setup and guidance. However, no specific details or results are provided to elaborate on this.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the cadaveric study, the "ground truth" for pedicle screw placement accuracy would typically be established through post-procedure imaging (e.g., CT scans) quantitatively analyzed against the planned trajectory or anatomical landmarks. However, the document does not explicitly state how ground truth was established for the cadaveric study or the accuracy verification.
8. The sample size for the training set
- This information is not provided in the document. The document describes a robotic system, not a machine learning model, so a "training set" in the typical ML sense might not be applicable or explicitly mentioned here.
9. How the ground truth for the training set was established
- This information is not provided in the document, as it does not discuss a training set.
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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,
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
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| 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-GuSeoul, 06530, Republic of KoreaTel: +82-31-788-7938 |
| Jungeun PARKQuality Management RepresentativeEmail: jepark@curexo.com | |
| Contact Person: | Su Jin Yang |
| Address: | 4-5, Yanghyeon-ro 405beon-gil, Jungwon-gu,Seongnam-si, Gyeonggi-do, Republic of KoreaTel: +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 predicateDevice | 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 |
| RegulationNo. | 882.4560 | 882.4560 | 882.4560 |
| GeneralDevicedescription | The CUVIS-spine is amobile system mainlycomprising the roboticarm, the main consoleand the staff console asan option. The roboticarm is positioned on thefloor near the side of thesurgical table. Thelocation of the mainconsole or the staffconsole is appropriatelydetermined consideringthe user preference andthe environments. | The CUVIS-spine is amobile system mainlycomprising the roboticarm, the main consoleand the staff console asan option. The roboticarm is positioned on thefloor near the side of thesurgical table. Thelocation of the mainconsole or the staffconsole is appropriatelydetermined consideringthe user preference andthe environments. | The EXCELSIUSGPS™ is a RoboticPositioning System thatincludes a computercontrolled robotic arm,hardware, and softwarethat enables real timesurgical navigation androbotic guidance usingradiological patientimages(preoperative CT,intraoperative CT andfluoroscopy), using adynamic reference baseand positioning camera. |
| Indicationsfor use | CUVIS-spine isintended for use as anaid for preciselylocating anatomicalstructures and for thespatial positioning andorientation of guidebush to be used bysurgeons fornavigating and/orguiding compatible | CUVIS-spine is intendedfor use as an aid forprecisely locatinganatomical structuresand for the spatialpositioning andorientation of guide bushto be used by surgeonsfor navigating and/orguiding compatible | The EXCELSIUSGPS™ is intended foruse as an aid forprecisely locatinganatomical structuresand for the spatialpositioning andorientation of aninstrument holder orguide tube to be used by |
| Subject Device | Primary predicateDevice | Other predicate Device | |
| Device | CUVIS-spine | CUVIS-spine(K201569) | Excelsius GPSTM(K171651) |
| surgical instruments inopen or percutaneouspedicle screwplacement provided thatthe required markers andrigid patient anatomycan be identified on 3Dor 2D image. | surgical instruments inopen or percutaneoussurgical procedures ifthe required markers andrigid patient anatomycan be identified on O-arm or C-arm. | surgeons for navigatingand/or guidingcompatible surgicalinstruments in open orpercutaneous proceduresprovided that therequired fiducial markersand rigid patientanatomy can beidentified on CT scans orfluoroscopy. The systemis indicated for theplacement of spinal andorthopaedic bonescrews. | |
| Technical Characteristics | |||
| Principle ofoperation | -Preoperative images-Intraoperative images-Patient registration-Surgical planningReal-time trackingofnavigated instruments-Guidance of instruments | -Intraoperative images-Patient registration-Surgical planning-Real-time trackingofnavigated instruments-Guidance of instruments | -Intraoperative/preoperative images-Patient registration-Surgical planning-Real-time trackingofnavigated 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 |
| TargetTracking | YES | YES | YES |
| IntegratedPlanning | - SRC(Control Software) | - SRC(Control Software) | Excelsius GPS Planningand Navigation |
| Subject Device | Primary predicateDevice | Other predicate Device | |
| Device | CUVIS-spine | CUVIS-spine(K201569) | Excelsius GPSTM(K171651) |
| Software | SPNe(Planner Software) | - SPN(Planner Software) | Application Software |
| Save/loadPlanning | YES | YES | YES |
| Merge imagesfunctionality | YES | YES | YES |
| Trajectoryplanningparameters | - Entry point- Target point- Instrumentlength/diameter | - Entry point- Target point- Instrumentlength/diameter | - Entry point- Target point- Instrumentlength/diameter |
| Localizationmeans | Optical system (infraredcamera) | Optical system (infraredcamera) | Optical system (infraredcamera) |
| Image-guided | YES | YES | YES |
| Controller | Forced-controlledmovement allowingrobot arm positioning(called hand guidefunction) | Forced-controlledmovement allowingrobot arm positioning(called hand guidefunction) | Force-controlledmovement allowingrobotic arm positioning |
| Patientregistrationmethod | - Pre-op CT :Fluoroscopic to pre-op CT merge- Intra-op CT :Registration tool- Fluoroscopy : Sourcecalibrator | - Intra-op CT :Registration tool- Fluoroscopy :Source calibrator | - Pre-op CT :Fluoroscopic to pre-opCT merge- Intra-op CT :Registration fixture- Fluoroscopy :Registration fixture |
| Real timedisplay ofinstrumentposition | YES | YES | YES |
| Accessories | - Registrationinstruments(Guide bush,Source calibrator,Registration tool,Registration tooladapter, Detectorcalibrator) | - Registrationinstruments(Guide bush,Source calibrator,Registration tool,Registration tooladapter, Detectorcalibrator) | - Registrationinstruments |
| Subject Device | Primary predicateDevice | Other predicate Device | |
| Device | CUVIS-spine | CUVIS-spine(K201569) | Excelsius GPS TM(K171651) |
| - Patient referenceinstruments(Patient marker,Clamp, Pin, Markerball, Adapter, PinVise, SlideHammer, Probe,Awl, Lenke probe) | - Patient referenceinstruments(Patient marker, Clamp,Marker ball) | - Patient referenceinstruments | |
| - Surgical instruments(Marker Driver,Dilator, Serration-tipdilator, Bur, Stylettapper, Tapper,Screwdriver,Roboticarm drape, Tool drape,Detector drape,Instrument Container) | - Surgical instruments(Marker Driver, Dilator,Serration-tip dilator, Bur,Stylet tapper, Tapper,Screwdriver, Roboticarm drape, Tool drape,Detector drape,Instrument Container) | - Surgicalinstruments | |
| - End effector | |||
| Cybersecurity | - Industry standardprotocols- User accesscontrol(admin)- Network protocols andFirewall control- Data cryptography(binary, registry, CSP)- Core resource files areregenerated as new typeof files- Event logging- softwareupdate(only admin) | - Industry standardprotocols- User accesscontrol(admin)- Network protocols andFirewall control- Data cryptography(binary, registry)- Core resource files areregenerated as new typeof files- Event logging- software update(onlyadmin) | N/A |
| Performance data | |||
| Subject Device | Primary predicateDevice | Other predicate Device | |
| Device | CUVIS-spine | CUVIS-spine(K201569) | Excelsius GPSTM(K171651) |
| ElectricalSafety andElectromagneticcompatibility | - IEC60601-1- IEC60601-1-2 | - IEC60601-1- IEC60601-1-2 | - IEC60601-1- IEC60601-1-2 |
| Accuracyverificationon anatomicallandmarks | Yes | Yes | Yes |
| Bio-compatibility | The biocompatibilityevaluation for the patientmarker has beenconducted in accordancewith EN ISO 10993standards. | The biocompatibilityevaluation for the patientmarker has beenconducted in accordancewith EN ISO 10993standards. | The biocompatibilityevaluation forEXCELSIUS GPSTM hasbeen conducted inaccordance with ISO10993 standards. |
| Parts ofContact withPatient | Patient marker(Clamp type, Pin type) | Patient marker | |
| Nature ofBody Contact | Implant device / bone | Implant device / bone | Implant device / bone |
| PatientFixation | Reference is fixed topatient's body structurefor tracking system | Reference is fixed topatient's body structurefor tracking system | Reference is fixed topatient's body structurefor 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.
§ 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).