Predicate Devices

Reference Devices

GE OEC 9900 Elite 9" Image Intensifier (K122234)

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the system and its operation does not mention any AI/ML components.

Therapeutic

No.
The device is a surgical navigation system that aids surgeons in precisely locating anatomical structures and guiding surgical instruments; it does not directly treat or prevent a disease or condition.

Diagnostic

No

The Remi Robotic Navigation System is intended for surgical navigation and assistance in placing pedicle screws, not for diagnosing medical conditions. It aids in precisely locating anatomical structures and guiding surgical instruments during procedures.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system is comprised of a computer workstation, software, a trajectory system (including a targeting platform), a camera, and various image guided instruments, indicating it includes significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Remi Robotic Navigation System is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the system is used to aid surgeons in precisely locating anatomical structures and positioning surgical tools during open or percutaneous spinal procedures. This is an in vivo application, meaning it is used within a living organism.
Device Description: The description reinforces that it's an image-guided system used to assist surgeons in placing screws in the lumbar spine. This is a surgical assistance tool, not a device that analyzes biological samples.
Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Remi system does not perform any such analysis of biological samples.

The system utilizes imaging modalities and image processing, but this is for the purpose of guiding surgical procedures, not for analyzing biological samples for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Remi Robotic Navigation System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan or 2D fluoroscopic images. The Remi Robotic Navigation System is indicated for assisting the surgeon in placing pedicle screws in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the prone position and is compatible with the Accelus LineSider Spinal System.

Product codes

OLO

Device Description

The Remi Robotic Navigation System (Remi) is an image guided system primarily comprised of a computer workstation, software, a trajectory system, including a targeting platform, a camera, and various image guided instruments intended for assisting the surgeon in placing screws in the pedicles of the lumbar spine. The system operates in a similar manner to other optical-based image systems:

1. The patient is placed in the appropriate position on the OR table.
1. The compact tracking Camera is rigidly affixed to the OR table using a multi-functional mechanical support arm in the appropriate position to track the surgical site.
1. The Camera is also affixed to a pin placed in the patient's iliac to provide a fixed location relative to the patient's spinal anatomy.
1. The Targeting Platform is affixed to the OR Table using a multi-functional mechanical support arm, ensuring that the Targeting Platform has sufficient range of motion to be placed over the surgical site.
1. If a 3D imaging system is being used, the Registration Array is affixed to the Targeting Platform and positioned over the planned surgical site.
1. If 2D fluoroscopic system is being used, the C-Arm Grid Plate, 9900 9" is installed onto the fluoroscopic imaging system.
1. The appropriate area of spine (L1-S1) is Imaged with a validated imaging system.
1. The images are transferred to the Remi system workstation, which reconstructs the images and uses the registration array images) or the C-Arm Grid Plate Tracker image (for 2D fluoroscopic Images) to register the patient's spine relative to the Camera location.
1. The registration is confirmed by placing an image guided instrument with an Instrument Tracker at various points in the surgical field.
1. The surgical paths are then planned. If the procedure is using 3D images, this is done on the workstation. If the procedure is using 2D fluoroscopic images, the Planning Probe and workstation are utilized to capture the desired position for target pedicle screw placement.
1. The Targeting Platform is gross positioned manually close to the first surgical plan location.
1. The Targeting Platform is activated to set the fine location and the trajectory based on the surgical plan.
1. Instruments with tracking arrays can now be used through the tool guide of the Targeting Platform to prepare the pedicle and place a pedicle screw.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

3D Intraoperative images; 2D Fluoroscopic Images

Anatomical Site

posterior lumbar region (L1-S1)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

surgeons; OR table

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)

Performance Testing - Bench:

Navigation Accuracy Verification
System Accuracy Validation
Software System Test
ASTM F2554 Accuracy Test
Software Unit and Integration Tests

Testing was done to demonstrate that the updated requirement for this change was met and to ensure the risk profile of Remi was maintained. The testing shows that the use of the 2D fluoroscopic images with the Remi system is equivalent to the use of the validated 3D imaging systems.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Positioning accuracy (bench): $0.74 \pm 0.36$ mm (worst case), 95% CI: 1.46mm (worst case)

Predicate Device(s)

Remi Robotic Navigation System (K223070), EXCELSIUS GPS (K171651)

Reference Device(s)

GE OEC 9900 Elite 9" Image Intensifier (K122234)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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Fusion Robotics, LLC % Sarah Braun Senior Regulatory Affairs Specialist Integrity Implants Inc. dba Accelus 354 Hiatt Drive Palm Beach Gardens, Florida 33418

Re: K223350

Trade/Device Name: Remi Robotic Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 22, 2022 Received: November 23, 2022

Dear Sarah Braun:

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.

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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 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 medical devices and radiation-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.

Jesse Muir -S

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

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Indications for Use

510(k) Number (if known) K223350

Device Name Remi Robotic Navigation System

Indications for Use (Describe)

The Remi Robotic Navigation System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan or 2D fluoroscopic images. The Remi Robotic Navigation System is indicated for assisting the surgeon in placing pedicle screws in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the prone position and is compatible with the Accelus LineSider Spinal System.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

| 510(k) Owner | Fusion Robotics, LLC
168 Centennial Parkway, Unit 170
Louisville, CO 80027 USA |
|--------------------------|----------------------------------------------------------------------------------------------------------|
| Contact Person | Sarah Braun
Senior Regulatory Affairs Specialist
Tel: 423-838-4454
Email: sbraun@accelusinc.com |
| Date Prepared | 11/22/2022 |
| Classification Reference | 21 CFR 882.4560 |
| Product Code | OLO |
| Common/Usual Name | Stereotaxic Instrument |
| Trade/Proprietary Name | Remi Robotic Navigation System |
| Predicate Device(s) | Remi Robotic Navigation System (K223070)
EXCELSIUS GPS (K171651) |

The Remi Robotic Navigation System (Remi) is an image guided system primarily comprised of a computer workstation, software, a trajectory system, including a targeting platform, a camera, and various image guided instruments intended for assisting the surgeon in placing screws in the pedicles of the lumbar spine. The system operates in a similar manner to other optical-based image y systems:

1. The patient is placed in the appropriate position on the OR table.
1. The compact tracking Camera is rigidly affixed to the OR table using a multi-functional mechanical support arm in the appropriate position to track the surgical site.
1. The Camera is also affixed to a pin placed in the patient's iliac to provide a fixed location relative to the patient's spinal anatomy.
1. The Targeting Platform is affixed to the OR Table using a multi-functional mechanical support arm, ensuring that the Targeting Platform has sufficient range of motion to be placed over the surgical site.

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1. If a 3D imaging system is being used, the Registration Array is affixed to the Targeting Platform and positioned over the planned surgical site.
1. If 2D fluoroscopic system is being used, the C-Arm Grid Plate, 9900 9" is installed onto the fluoroscopic imaging system.
1. The appropriate area of spine (L1-S1) is Imaged with a validated imaging system.
1. The images are transferred to the Remi system workstation, which reconstructs the images and uses the registration array images) or the C-Arm Grid Plate Tracker image (for 2D fluoroscopic Images) to register the patient's spine relative to the Camera location.
1. The registration is confirmed by placing an image guided instrument with an Instrument Tracker at various points in the surgical field.
1. The surgical paths are then planned. If the procedure is using 3D images, this is done on the workstation. If the procedure is using 2D fluoroscopic images, the Planning Probe and workstation are utilized to capture the desired position for target pedicle screw placement.
1. The Targeting Platform is gross positioned manually close to the first surgical plan location.
1. The Targeting Platform is activated to set the fine location and the trajectory based on the surgical plan.
1. Instruments with tracking arrays can now be used through the tool guide of the Targeting Platform to prepare the pedicle and place a pedicle screw.

Intended Use/Indications for Use

The Remi Robotic Navigation System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan or 2D fluoroscopic images. The Remi Robotic Navigation System is indicated for assisting the surgeon in placing pedicle screws in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the prone position and is compatible with the Accelus LineSider Spinal System.

Substantial Equivalence

The proposed Remi Robotic Navigation System (Remi) allows the use of a 2D fluoroscopic Imaging system. The system validated for this submission is the GE OEC 9900 Elite 9" Image Intensifier (K122234). The indications for use has been updated to add 2D fluoroscopic images for use with the Remi system. Four instruments were added: Long Reference Arm (PN1075), Planning Probe (PN1115), C-

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Arm Grid Plate, 9900 9" (PN1138), C-Arm Grid Plate Tracker (PN1139). The software was updated to support the use of 2D fluoroscopic images. Changes include compatibility with the new instruments and an algorithm which corrects the distortion of the 2D fluoroscopic image.

Performance Testing - Bench

The following tests were performed to support the substantial equivalence of the subject Remi Robotic Navigation System (Remi) to its predicates:

Navigation Accuracy Verification
. System Accuracy Validation
Software System Test
ASTM F2554 Accuracy Test
Software Unit and Integration Tests

Testing was done to demonstrate that the updated requirement for this change was met and to ensure the risk profile of Remi was maintained. The testing shows that the use of the 2D fluoroscopic images with the Remi system is equivalent to the use of the validated 3D imaging systems.

Devices	Subject Device	Primary Predicate Device	Secondary Predicate Device
	Remi Robotic Navigation
System	Remi Robotic Navigation
System [K223070]	EXCELSIUS GPS
[K171651]
Indications for
Use	The Remi Robotic Navigation
System is intended for use as
an aid for precisely locating
anatomical structures and for
the spatial positioning and
orientation of a tool holder or
guide tube to be used by
surgeons for navigating
and/or guiding compatible
surgical instruments in open
or percutaneous spinal
procedures in reference to
rigid patient anatomy and
fiducials that can be identified
on a 3D imaging scan or 2D
fluoroscopic images. The Remi
Robotic Navigation System is
indicated for assisting the
surgeon in placing pedicle
screws in vertebrae in the
posterior lumbar region (L1-
S1). The system is designed
for lumbar pedicle screw
placement with the patient in	The Remi Robotic Navigation
System is intended for use as an
aid for precisely locating
anatomical structures and for
the spatial positioning and
orientation of a tool holder or
Guide Tube to be used by
surgeons for navigating and/or
guiding compatible surgical
instruments in open or
percutaneous spinal procedures
in reference to rigid patient
anatomy and fiducials that can
be identified on a 3D Imaging
scan. The Remi Robotic
Navigation System is indicated
for assisting the surgeon in
placing pedicle screws in
vertebrae in the posterior
lumbar region (L1-S1). The
system is designed for lumbar
pedicle screw placement with
the patient in the prone position	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 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 orthopedic bone
screws.
	the prone position and is compatible with the Accelus
LineSider Spinal System.	and is compatible with the Accelus LineSider Spinal System.	and is compatible with the Accelus LineSider Spinal System.
Product Code	OLO	OLO	OLO
Principles of
Operation	Same as Predicates.	Intraoperative/preoperative 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
Input Images	3D Intraoperative images Medtronic O-arm GE OEC 3D Ziehm-Vision RFD 3D Stryker Airo TruCT 2D Fluoroscopic Images GE OEC 9900 Elite 9" Image Intensifier (K122234)	3D Intraoperative images Medtronic O-arm GE OEC 3D Ziehm-Vision RFD 3D Stryker Airo TruCT	3D pre-operative images
3D intra-operative images
2D intra-operative images
Trajectory
planning
parameters	Same as Primary Predicate.	Entry point, target point, length of the instrument, diameter	Unknown
Localization
method	Same as Primary Predicate	Optical System (infrared Camera)	Unknown
Camera system	Same as Primary Predicate	Monocular	Unknown
Controller	Same as Primary Predicate	Manual macro adjustments
Force-controlled movement of Targeting platform	Unknown
Patient
Registration
Method	Same as Primary Predicate	Registration fixture in place during 3D
intraoperative images	Intra-op CT: Registration fixture
Pre-op CT: Fluoroscopic to pre-op CT merge
Fluoroscopy: Registration fixture
Accuracy
verification on
anatomical
landmarks	Same as Predicates.	Yes	Yes
Real time
display of
instrument
position	Same as Predicates.	Yes	Yes
Instrument
Guidance	Same as Primary Predicate.	Trajectory and location set by
Targeting platform. Instruments
are manually positioned by the
surgeon through the guide tube
on the Targeting Platform.	Yes, instruments are used
through the guide tube on
the robotic arm or are
manually positioned by the
surgeon.
Patient fixation	Same as Primary Predicate.	Tracking Camera is fixed to OR
table and the patient's iliac
crest.	Reference is fixed to
patient's bony structure
such as a long bone, iliac
crest, spinous process,
vertebra, etc. for tracking
system
Positioning
accuracy
(bench	Same as Primary Predicate.	$0.74 \pm 0.36$ mm (worst case)
95% CI: 1.46mm (worst case)	Unknown
Robot collision
avoidance/det
ection	Same as Primary Predicate.	Manual movement of Trajectory
Platform to gross location. Small
fine tuning of Trajectory
Platform location is automatic
but is currently limited to cease
when platform encounters a
force greater than 9lbs.	Unknown

Substantial equivalence analysis for Remi

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Conclusions

The subject device, Remi Robotic Navigation System, described in this submission shares a majority of the same technological characteristics as the primary predicate device, Remi Robotic Navigation System (K223070). The primary difference between the subject device and the primary predicate is the addition of validated 2D fluoroscopic imaging systems and the subsequent modification of the wording of the indications for use. Like the subject device, the secondary predicate, EXCELSIUS GPS (K171651) has the capability to rely on 2D intra-operative exam as the Input Images for the stereotaxic navigation of pedicle screw placement.

The verification and validation testing demonstrated that the characteristics of the subject Remi device are substantially equivalent to the predicate device. The subject device continues

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to meet design requirements, is as safe and effective as the predicate device, and performs according to its intended use. The information presented in this 510(k) premarket notification demonstrates that the subject device is substantially equivalent to the predicate devices.