The use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy.

This can include spinal procedures, where the target point for the access to the access to the area of interest, is a rigid landmark, such as:

· Transforaminal procedure

• Interlaminar procedure

Device Description

The RIWOtrack Navigation System is an image guided surgery system, visualizing instrument positions on intraoperative fluoroscopy images (AP and LAT) utilizing electromagnetic tracking technology. The positions of the instrument and of the patient localizer, both equipped with sensors, are localized within an electromagnetic field, generated by a field generator, called navigation sensor. The principle of navigation is based on electromagnetic spatial measuring of localizer element in a generated electromagnetic field. The display of navigation information requires an image-to-patient registration procedure. During registration procedure, the Navigation System determines the coordinate transformation between the physical position of the patient and the position of the patient in intraoperative scans by means of autodetection of x-ray marker of a device called MapperBridge. Thereafter, the spatial position of the instrument is displayed superimposed to the image data. The navigation information is updated with a rate of 15 to 45 Hz.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the RIWOtrack Navigation System, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Mean system level accuracy: Position error	< 2mm
Mean system level accuracy: Angular error	< 2°
Electrical safety	Met all specified criteria (according to IEC 60601-1)
Electromagnetic compliance	Met all specified criteria (according to IEC 60601-1-2)
Software verification and validation	Met all specified criteria
Cleaning validation	Met all specified criteria
Sterilization validation	Met all specified criteria
Biocompatibility validation	Met all specified criteria

Study Details for Accuracy Bench Testing

The document mentions "Accuracy bench testing for each instrument probe and localizer" as a performance test. While it confirms the device met the specified criteria of "Position error < 2mm" and "Angular error < 2°", the detailed information regarding the test set, ground truth, and training set is not explicitly provided in this 510(k) summary.

Based on the information available:

Sample size used for the test set and data provenance: Not explicitly stated. The description refers to "each instrument probe and localizer," suggesting multiple tests for different components, but specific quantities or origin (e.g., country, retrospective/prospective) are not provided.
Number of experts used to establish the ground truth for the test set and their qualifications: Not explicitly stated. For bench testing, ground truth is typically established through precise measurement devices rather than expert human interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for a bench test where objective measurements are taken against a known standard.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. The tests performed were primarily technical performance assessments.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the accuracy bench testing assessed the system's performance directly, independent of human interaction during the measurement process, to determine its inherent accuracy in tracking position and orientation.
The type of ground truth used: For accuracy bench testing, the ground truth would be established by highly precise measurement systems or calibrated references (e.g., optical trackers, coordinate measuring machines) against which the device's electromagnetic tracking measurements are compared. The document does not specify the exact method but implies a highly accurate reference.
The sample size for the training set: Not applicable for this type of bench testing. The device is a navigation system that localizes physical objects using electromagnetic tracking, not a machine learning model that requires a training set for pattern recognition.
How the ground truth for the training set was established: Not applicable, as there is no mention of a training set for this type of performance evaluation.

Summary

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November 20, 2023

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.

Fiagon GmbH Dirk Mucha Chief Technology Officer Neuendorfstr. 23b Hennigsdorf, Brandenburg 16761 Germany

Re: K230700

Trade/Device Name: RIWOtrack Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: November 20, 2023 Received: November 20, 2023

Dear Dirk Mucha:

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).

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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 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,

Shumaya Ali-S

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

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Indications for Use

510(k) Number (if known) K230700

Device Name RIWOtrack Navigation System

Indications for Use (Describe)

This can include spinal procedures, where the target point for the access to the access to the area of interest, is a rigid landmark, such as:

· Transforaminal procedure

• Interlaminar procedure

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 K230700

1. Submitter Information

Submitter:	Fiagon GmbH
Address:	Neuendorfstr. 23b16761 Hennigsdorf, Germany
Telephone:	+49 3302 201 21 10
Telefax:	+49 3302 201 21 15
Contact:	Dirk MuchaChief Technology Officer

2. Device Information

Trade Name:	RIWOtrack Navigation System
Common Name:	Image guided surgery system
Classification:	Class II per 21 CFR 882.4560
Classification Name:	Orthopedic Stereotaxic Instrument
Product Code:	OLO

3. Predicate Device Information

joimax® Intracs® em System (K192663) Predicate device:

4. Device Description

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by a field generator, called navigation sensor. The principle of navigation is based on electromagnetic spatial measuring of localizer element in a generated electromagnetic field. The display of navigation information requires an image-to-patient registration procedure. During registration procedure, the Navigation System determines the coordinate transformation between the physical position of the patient and the position of the patient in intraoperative scans by means of autodetection of x-ray marker of a device called MapperBridge. Thereafter, the spatial position of the instrument is displayed superimposed to the image data. The navigation information is updated with a rate of 15 to 45 Hz.

5. Intended Use

Device	Indications for Use
RIWOtrackNavigationSystem	The RIWOtrack Navigation System is intended to continuously display theposition and orientation of RIWOspine surgical instruments relative to theanatomy in medical image data in either open or minimal invasive orthopedicprocedures.The use is indicated for any medical condition in which the use of stereotacticsurgery may be appropriate, and where reference to a rigid anatomical structure,such as the spine or pelvis, can be identified relative to images of the anatomy.This can include spinal procedures, where the target point for the procedureitself or for the access to the area of interest,is a rigid landmark, such as:• Transforaminal procedure• Interlaminar procedure
Joimax IntracsSystem(K192663)	The joimax® Intracs® em Navigation System is intended to continuously displaythe position and orientation of joimax® surgical instruments relative to theanatomy in medical image data in either open or minimal invasive orthopedicprocedures.The use is indicated for any medical condition in which the use of stereotacticsurgery may be appropriate, and where reference to a rigid anatomical structure,such as the spine or pelvis, can be identified relative to images of the anatomy.This can include spinal procedures, where the target point for the procedureitself or for the access to the area of interest,is a rigid landmark, such as:• Transforaminal procedure• Interlaminar procedure

Device

Indications for Use

RIWOtrackNavigationSystem

The RIWOtrack Navigation System is intended to continuously display theposition and orientation of RIWOspine surgical instruments relative to theanatomy in medical image data in either open or minimal invasive orthopedicprocedures.The use is indicated for any medical condition in which the use of stereotacticsurgery may be appropriate, and where reference to a rigid anatomical structure,such as the spine or pelvis, can be identified relative to images of the anatomy.This can include spinal procedures, where the target point for the procedureitself or for the access to the area of interest,is a rigid landmark, such as:• Transforaminal procedure• Interlaminar procedure

Joimax IntracsSystem(K192663)

The joimax® Intracs® em Navigation System is intended to continuously displaythe position and orientation of joimax® surgical instruments relative to theanatomy in medical image data in either open or minimal invasive orthopedicprocedures.The use is indicated for any medical condition in which the use of stereotacticsurgery may be appropriate, and where reference to a rigid anatomical structure,such as the spine or pelvis, can be identified relative to images of the anatomy.This can include spinal procedures, where the target point for the procedureitself or for the access to the area of interest,is a rigid landmark, such as:• Transforaminal procedure• Interlaminar procedure

	Indications for Use RIWOtrack Navigation System and Predicate Devices

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6. Comparison of Technological Characteristics

At a high level, the RIWOtrack Navigation System is based on the same technological elements as the joimax® Intracs® em System. Both systems deploy the same electromagnetic technology, have NDI technology installed in their components and are run by a navigation software. The systems are designed to facilitate spinal surgical procedures by localization of surgical instruments and patient anatomy.

The RIWOtrack System has the same technological characteristics as the predicate device including design, intended use, major system components, principle of operation and imageto-patient registration method. The similarities and differences are summarized in the table below:

Feature	RIWOtrack Navigation System	Joimax® Intracs® em [K192663]
Class	Class II21 CFR 882.4560Product code: OLO	Class II21 CFR 882.4560Product code: OLO
Indications for Use	(see above)	(see above)
Anatomic site	Spine	Spine
Tracking Method	Electromagnetic	Electromagnetic
Computer	Intel-based PC	Intel-based PC
Principle ofOperation	Localization of sensors attached toinstruments within a definedelectromagnetic field	Localization of sensors attached toinstruments within a definedelectromagnetic field
Image modality	x-ray (fluoroscopy)	x-ray (fluoroscopy)
View	AP and Lateral View, Video Input	AP and Lateral View, Video Input
Field generator	NDI Navigation senor AuroraMounted to articulating metal arm	NDI Navigation senor AuroraMounted to articulating metal arm
EMinstrumentation	RIWOtrack instruments aretracked by electromagnetic sensorswhich can be attached toRIWOspine surgical instruments	joimax® instruments are tracked byelectromagnetic sensors which canbeattached to the joimax® surgicalinstrument
Method ofregistration	Autodetection of x-ray markers ofa reference device in intraoperativefluoroscopy images	Autodetection of x-ray markers of areference device in intraoperativefluoroscopy images
Systemaccuracy	Mean system level accuracy:Position error < 2mmAngular error < 2º	Mean system level accuracy:Position error ≤ 2mmAngular error ≤ 2º

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7. Performance Data

The following tests were performed to substantiate the performance claims and to support substantial equivalence to the predicate device:

Electrical safety according to IEC 60601-1 .
. Electromagnetic compliance according to IEC 60601-1-2
Accuracy bench testing for each instrument probe and localizer. ●
Software verification and validation .
Cleaning validation .
Sterilization validation .
Biocompatibility validation .

The RIWOtrack Navigation System met all specified criteria. and did not raise new safety or performance concerns. Based on the performance testing, it was found that the RIWOtrack Navigation System has a similar safety and effectiveness profile to the predicate device.

8. Conclusion

Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate device, the RIWOtrack Navigation System demonstrates to be substantially equivalent to the predicate device identified in this submission and it does not present any new issues of safety or effectiveness.

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).