(260 days)
Not Found
No
The document describes a standard optical tracking navigation and robotic-assisted system based on established techniques, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device provides navigation and guidance for surgeons to place surgical instruments; it does not directly treat or cure any condition.
No
Explanation: This device is for surgical guidance and robotic assistance during spine surgeries, not for diagnosing medical conditions. It assists surgeons in instrument placement and preparation based on existing 3D image volumes.
No
The device description explicitly lists hardware components such as a Navigation Station, Robotic-Assisted Station, Camera Station, and Integrated Guiding System components (arrays, fixation solutions). It also mentions utilizing optical position determination technology with an infra-red camera.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a Spine Navigation and Robotic-Assistance Device. Its purpose is to provide spatial positioning and orientation of surgical instruments during spine surgeries. It uses imaging data (CT or CBCT) to guide the surgeon and/or a robotic arm.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is entirely focused on surgical guidance based on anatomical imaging.
Therefore, this device falls under the category of surgical navigation and robotic-assistance systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Spine Navigation and Robotic-Assistance Device is indicated for the spatial positioning and orientation of compatible surgical instruments, used by surgeons in Freehand Navigation Mode and/ or in Robotic-Assisted Guidance Mode. Spine Navigation and Robotic-Assistance Device is used for spine surgeries, in open or percutaneous procedures, with patient in prone or in lateral position. Freehand Navigation Mode and Robotic-Assisted Guidance Mode are based on a three-dimensional image volume (3D CT or CBCT image), on which the surgeon may perform the Intraoperative Surgical Planning.
Spine Navigation and Robotic-Assistance Device is indicated to provide quidance for the placement of spinal bone screws relative to bony structures of the spine, in Freehand Navigation Mode and/or in Robotic-Assisted Guidance Mode, and for intervertebral disc access and preparation, including discectomy and bony resection, in Freehand Navigation Mode.
Product codes
OLO
Device Description
The Spine Navigation and Robotic-Assistance Device is a medical device that provides stereotaxic quidance for spinal surgery. The Subject Device assists the surgeon to quide and position surgical instruments through two modes: Freehand Navigation and Robotic-Assisted Guidance.
The Subject Device includes:
- A Navigation Station
- A Robotic-Assisted Station
- A Camera Station
- Embedded Software
- Integrated Guiding System components, composed of single use items, such as navigation Arrays, and reusable items, such as Patient Array fixation solutions.
The navigation of the instruments is based on the standard and established techniques of navigation systems utilizing optical position determination technology. As currently marketed optical tracking navigation systems, the operating principle of the navigation feature is based on the use of an infra-red camera allowing to determine a 3D position of markers, either passive reflective markers or active LED markers. This allows real-time tracking of the navigated instruments.
The Subject Device is compatible with:
-
Specific Instruments of DePuy Synthes, a Johnson & Johnson company. These Instruments are aimed to be quided with Robotic-Assisted Guidance Mode and/or with Freehand Navigation Mode.
-
Several third-partv 3D Imaging Systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D CT or CBCT image
Anatomical Site
Spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons / Not explicitly stated, but implied to be a surgical setting.
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: Design verification, Electrical safety and electromagnetic compatibility (EMC), Usability, Safety and performance, Software Verification and Validation Testing, Mechanical Testing, Sterilization & Shelf-life Testing, Reprocessing validation, Biocompatibility Testing, Packaging validation.
Sample Size: Not provided.
AUC: Not provided.
MRMC: Not provided.
Standalone Performance: Not provided.
Key Results: All test requirements were met, no new issues of safety or effectiveness were raised, and substantial equivalence was demonstrated. Performance and Safety Testing activities have demonstrated that the Spine Navigation and Robotic-Assistance Device does not raise any concern of safety or effectiveness.
Key Metrics
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
June 14, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ecential Robotics Amanie Yazidi Quality and Regulatory Affairs Manager 2 Avenue de Vignate Zone Mayencin II, Parc Equation - Batiment 1 Gieres. 38610 France
Re: K233228
Trade/Device Name: Spine Navigation and Robotic-Assistance Device Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: June 4, 2024 Received: June 4, 2024
Dear Amanie Yazidi:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Digitally signed by Jesse Muir Jesse Muir -S -၃ Date: 2024.06.14 18:53:48 -04'00' 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
2
Indications for Use
Submission Number (if known)
Device Name
Spine Navigation and Robotic-Assistance Device
Indications for Use (Describe)
Spine Navigation and Robotic-Assistance Device is indicated for the spatial positioning and orientation of compatible surgical instruments, used by surgeons in Freehand Navigation Mode and/ or in Robotic-Assisted Guidance Mode. Spine Navigation and Robotic-Assistance Device is used for spine surgeries, in open or percutaneous procedures, with patient in prone or in lateral position. Freehand Navigation Mode and Robotic-Assisted Guidance Mode are based on a three-dimensional image volume (3D CT or CBCT image), on which the surgeon may perform the Intraoperative Surgical Planning.
Spine Navigation and Robotic-Assistance Device is indicated to provide quidance for the placement of spinal bone screws relative to bony structures of the spine, in Freehand Navigation Mode and/or in Robotic-Assisted Guidance Mode, and for intervertebral disc access and preparation, including discectomy and bony resection, in Freehand Navigation Mode.
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
Address:
Fax:
Email:
Administrative Information
ECENTIAL ROBOTICS 510(k) Applicant: 2 avenue de Vignate Zone Mayencin II, Parc Equation – Bâtiment 1 38610 GIERES, France Company Contact Person: Amanie YAZIDI Phone: +33 (0)4 58 00 35 80 N/A amanie.yazidi@ecential-robotics.com Date Prepared: June 4th, 2024
Device Information
| Device Common Name: | Orthopedic Stereotaxic Instrument |
|---|---|
| Device trade or proprietary name: | Spine Navigation and Robotic-Assistance Device |
| Classification Name: | Stereotaxic Instrument |
| Classification Regulation: | 21 CFR §882.4560 |
| Device Classification: | Class II |
| Device Panel: | Orthopedic |
| Device Product Code: | OLO |
| Predicate 510(k): | K231886 (Primary) |
| K191100 |
4
Device Description
The Spine Navigation and Robotic-Assistance Device is a medical device that provides stereotaxic quidance for spinal surgery. The Subject Device assists the surgeon to quide and position surgical instruments through two modes: Freehand Navigation and Robotic-Assisted Guidance.
The Subject Device includes:
-
A Navigation Station
-
A Robotic-Assisted Station
-
A Camera Station
-
Embedded Software
-
Integrated Guiding System components, composed of single use items, such as navigation Arrays, and reusable items, such as Patient Array fixation solutions.
The navigation of the instruments is based on the standard and established techniques of navigation systems utilizing optical position determination technology. As currently marketed optical tracking navigation systems, the operating principle of the navigation feature is based on the use of an infra-red camera allowing to determine a 3D position of markers, either passive reflective markers or active LED markers. This allows real-time tracking of the navigated instruments.
The Subject Device is compatible with:
-
Specific Instruments of DePuy Synthes, a Johnson & Johnson company. These Instruments are aimed to be quided with Robotic-Assisted Guidance Mode and/or with Freehand Navigation Mode.
-
Several third-partv 3D Imaging Systems.
Indications For Use
Spine Navigation and Robotic-Assistance Device is indicated for the spatial positioning and orientation of compatible surgical instruments, used by surgeons in Freehand Navigation Mode and/or in Robotic-Assisted Guidance Mode. Spine Navigation and Robotic-Assistance Device is used for spine surgeries, in open or percutaneous procedures, with patient in prone or in lateral position.
Freehand Navigation Mode and Robotic-Assisted Guidance Mode are based on a threedimensional image volume (3D CT or CBCT imaqe), on which the surgeon may perform the Intraoperative Surgical Planning.
Spine Navigation and Robotic-Assistance Device is indicated to provide guidance for the placement of spinal bone screws relative to bony structures of the spine, in Freehand Navigation Mode and/or in Robotic-Assisted Guidance Mode, and for intervertebral disc access and preparation, including discectomy and bony resection, in Freehand Navigation Mode.
5
omparison of Technological Characteristics with the predicate devic
summary of principal similaties and differences betwen the Spine Navigation and Robel (16 SURGIVISO
231886 – Manufacturer: eCential Robotics), as Primary Predicate, and the
| Intended Use | Indications For Use | TECHNOLOGICAL
CHARACTERISTICS | Discussion on the equivalence |
|--------------|---------------------|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | SUBSTANTIALLY EQUIVALENT to both predicates,
The Subject Device and its predicates are intended:
- to position and orientate surgical instruments
- to be used in Freehand Navigation Guidance Mode and Robotic-Assisted Guidance mode. |
| | | | SUBSTANTIALLY EQUIVALENT to both predicates,
The Subject Device and its predicates are indicated: - for open or percutaneous spinal procedures.
- for a use based on the identification of the bony structure of the spine.
- to be used by surgeons.
- for the placement of spinal implants.
- The Subject Device and its predicates share equivalent contraindications, environment of use and users. |
| | | | SUBSTANTIALLY EQUIVALENT to ExcelsiusGPS® Spine 1.1 Interbody Module,
The Subject Device and ExcelsiusGPS® Spine 1.1 Interbody Module share equivalent Anatomical site and Patient Population. |
| | | | SUBSTANTIALLY EQUIVALENT to both predicates,
The Subject Device and its predicates are substantially equivalent in terms of: - General technology description.
- Principles of operation of the Robotic-Assisted Guidance Mode.
- Principles of operation of the Freehand Navigation Mode.
- Operation Principles (SURGIVISIO Device allows to navigate targeting needles.)
- Surgical workflow in Freehand Navigation.
- Surgical workflow in Robotic-Assisted Guidance.
- DICOM compatibility.
- User's Control.
- Graphical User Interface. |
| | | | SUBSTANTIALLY EQUIVALENT to SURGIVISIO Device,
The Subject Device and SURGIVISIO Device are substantially equivalent in terms of: - Registration Method.
- Supported Image type.
- Robotic Arm Dynamic Compensation feature.
- Device Accuracy in Freehand Navigation.
- Device Accuracy in Robotic-Assisted Guidance. |
6
| | SUBSTANTIALLY EQUIVALENT to both predicates,
The Subject Device and its predicates are substantially equivalent in terms of:
- Main System Components.
- Camera Station.
- Dedicated Software.
- Dedicated Tracking System (Patient reference, Patient Array, Phantom), except for the Surveillance Marker
(SUBSTANTIALLY EQUIVALENT to ExcelsiusGPS® Spine 1.1 Interbody Module). | |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SYSTEM COMPONENTS | SUBSTANTIALLY EQUIVALENT to SURGIVISIO Device,
The Subject Device and SURGIVISIO Device are substantially equivalent in terms of: - Navigation Station (Note: SURGIVISIO Device embeds two monitors, one is being dedicated to the SURGIVISIO 3D imaging device).
- Robotic-Assisted Station, except for:
- the presence of a monitor on Subject Device Robotic-Assisted Station
- power supply: the Subject Device Robotic-Assisted Station is not directly linked to the power supply. Power supply is provided through Navigation Station. This difference does not raise any question of safety or effectiveness as power supply will be part of the Performance and Safety Testing activities.
- Robotic Arm. | |
| | SUBSTANTIALLY EQUIVALENT to ExcelsiusGPS® Spine 1.1 Interbody Module,
The Subject device and ExcelsiusGPS® Spine 1.1 Interbody Module are substantially equivalent in terms of: - Presence of a monitor on the Robotic-Assisted Station. The Subject Device does not include any tablet. However, the Device includes two duplicated touchscreen monitors, one on the Navigation Station and the other one on the Robotic-Assisted Station, which allows to have two touchscreen user interfaces, as the secondary predicate which has a monitor and a tablet.
- Optical Localizer and tracking system. | |
| | PERFORMANCE AND
SAFETY TESTING | SUBSTANTIALLY EQUIVALENT to both predicates,
The Subject Device and its predicates are substantially equivalent in terms of Performance & Safety Testing. |
| | | SUBSTANTIALLY EQUIVALENT to SURGIVISIO Device,
The Subject Device and SURGIVISIO Device are substantially equivalent in terms of Packaging Labeling and Sterilization. |
ecential robotics
7
| CS | ||
|---|---|---|
| 4: | ر | |
| bot | ||
| ( | ||
| - | ||
| ecential | ||
following table summarizes how the Best practices for selecting a Predicate devices used to support the 510(k The
| A – Well-established methods | B – Meets or exceeds expected predicate performance | C – Unmitigated use-related or design-related safety issues | D – Associated design-related recall | |
|---|---|---|---|---|
| SURGIVISIO Device | Performance testing: Used updated methods from current FDA guidance document. | |||
| Biocompatibility and Software verification and validation testing: Used outdated methods in a subsequently superseded FDA guidance document. | No record was found. | No known unmitigated use-related or design-related safety issues. | No design-related recall identified. | |
| EXCELSIUS GPS® | Performance testing: No information available. | |||
| Biocompatibility and Software verification and validation testing: Used outdated methods in a subsequently superseded FDA guidance document. | Expected frequency of reported adverse events. | No known unmitigated use-related or design-related safety issues (for the last three years). | No design-related recall identified. |
8
PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Design verification
Design verification tests were performed based on risk management activities (conducted in accordance with ISO 14971 Third Edition 2019-12: Medical Devices - Application of risk management to medical devices) and product requirements.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and electromagnetic compatibility (EMC) testing were conducted in accordance with:
IEC 60601-1 Edition 3.2 2020-08 consolidated version: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; and
IEC 60601-1-2 Edition 4.1 2020-09 consolidated version: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Usabilitv
Usability was evaluated in accordance with:
IEC 60601-1-6 Edition 3.2 2020-07 consolidated version: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usabilitv:
IEC 62366-1 Edition 1.1 2020-06 consolidated version: Medical devices - Part 1: Application of usability engineering to medical device and FDA guidance.
Safety and performance
Safety and performance tests were performed in accordance with:
IEC 80601-2-77 Edition 1.0 2019-07: Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT.
Software Verification and Validation Testing
Software development and testing activities were conducted in accordance with:
IEC 62304 Edition 1.1 2015-06 Consolidated version: Medical device software - Life cycle processes and FDA guidances.
Mechanical Testing
Bench testings were conducted in accordance with:
ASTM F2554-22: Standard Practice for Measurement of Positional Accuracy of Compunter Assisted Surqical Systems
Sterilization & Shelf-life Testing
Sterilization testing activities were conducted in accordance with:
ISO 11137-1 First edition 2006-04-15: Sterilization of health care products - Radiation - Part 1: Requirements for development validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)];
ISO 11137-2 Third edition 2013-06 Amendment 1 2022: Sterilization of health care products -Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)]; and
9
ISO 17665-1 First edition 2006-08-15: Sterilization of health care products - Moist Head - Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices.
Reprocessing validation activities were evaluated and testing in accordance with:
ANSI AAMI ST98:2022: Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices and FDA guidance.
Biocompatibility Testing
Biological evaluation was evaluated and testing in accordance with:
ISO 10993-1 Fifth edition 2018-08: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process;
ISO 10993-5 Third edition 2009-06-01: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity;
ISO 10993-10 Fourth edition 2021-11: Biological evaluation of medical devices - Part 5: Tests for in vitro cvtotoxicity:
ISO 10993-11 Third edition 2017-09: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity;
ISO 10993-17 First edition 2002-12-01: Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances:
ISO 10993-17 Second edition 2023-09: Biological evaluation of medical devices - Part 17:
Toxicological risk assessment of medical device constituents
ISO 10993-18 Second edition 2020-01 Amendment 1 2022: Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)]; and
ISO 10993-23 First edition 2021-01: Biological evaluation of medical devices - Part 23: Tests for irritation
Packaging validation
Packaging validation tests were performed in accordance with:
ISO 11607-1 second edition 2019-02: Packaging for terminally sterilized medical devices – Part 1: Requirements for materials sterile barrier systems and packaging systems; and
ISO 11607-2 second edition 2019-02: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming sealing and assembly processes.
Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the Device.
Clinical Test
Clinical testing was not required to demonstrate the safety and effectiveness of the Device.
All test requirements were met, no new issues of safety or effectiveness were raised, and substantial equivalence was demonstrated.
10
CONCLUSION
Reqarding the Indications For Use, Spine Navigation and Robotic-Assistance Device and the SURGIVISIO Device (K231886) are substantially equivalent, except for the following characteristics for which Spine Navigation and Robotic-Assistance Device is substantially equivalent with ExcelsiusGPS® Spine 1.1 Interbody Module (K191100):
- -Anatomical sites
- -Patient population
Reqarding the technological characteristics, Spine Navigation and Robotic-Assistance Device and the SURGIVISIO Device are substantially equivalent.
Regarding the System components, Spine Navigation and Robotic-Assistance Device and the SURGIVISIO Device are substantially equivalent except for the following components for which the Subject Device is substantially equivalent to the ExcelsiusGPS® Spine 1.1 Interbody Module:
- Tracking system including a surveillance marker. ।
- -Monitor on the Robotic-Assisted Station
- -Optical localization based on both passive and active markers.
Spine Navigation and Robotic-Assistance Device has two minor differences with the two predicates:
- । power supply of the Robotic-Assisted Station
- । no remote panel
These differences do not impact Performance or Safety of Spine Navigation and Robotic-Assistance Device.
Regarding the Performance and Safety testing, Spine Navigation and Robotic-Assistance Device and the SURGIVISIO Device are substantially equivalent.
Performance and Safety Testing activities have demonstrated that the Spine Navigation and Robotic-Assistance Device does not raise any concern of safety or effectiveness.