Spine & Trauma Navigation is intended as an intraoperative image-guided localization system to enable open and minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data.

Spine & Trauma Navigation enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system. The software offers screw and interbody device planning and navigation with surgical instruments.

The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 3D fluoroscopic image reconstruction or 2D fluoroscopic image) and/or an image databased model of the anatomy.

Device Description

The Spine & Trauma Navigation is an image quided surgery system for navigated treatments in the fields of spine and trauma surgery, whereas the user may use image data based on CT, MR, 3D fluoroscopic image reconstruction (cone beam CT) or 2D fluoroscopic images. It offers different patient image registration methods and instrument calibrations to allow surgical navigation by using optical tracking technology. To fulfil this purpose, it consists of software, Image Guided Surgery platforms and surgical instruments.

Modified Drill Guides and Drill Bits have been introduced as part of the Subject Device. The Drill Guide instruments are navigated instruments which support the surgeon in guiding drill bits and K-wires during spinal procedures. They consist of a guide tube, a trocar insert (both available in five different diameters), a body with two available handles, an array and a depth control (available in two different sizes for various drilling depths). The Drill Guide Tubes and Drill Guide Trocar Inserts have patient contact. All instruments are delivered unsterile and require end user sterilization.

The Drill Bits are used for drilling of bone. They are made of stainless steel and are delivered non-sterile. They require steam sterilization onsite before use. There are several variants in terms of diameter, length, and presence of a depth stop feature.

AI/ML Overview

The provided text describes the regulatory clearance for the Brainlab AG Drill Guide, Drill Bit, and Spine & Trauma Navigation system. Here's a summary of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature	Acceptance Criteria (Subject Device)	Reported Device Performance
Navigation Accuracy	Mean Positional Error of the placed instrument's tip ≤ 2 mm	Accuracy testing: Tip position deviation equal to or below 1.7 mm (95th percentile).
	Mean Angular Error of the placed instrument's axis ≤ 2°	Accuracy testing: Angular deviation equal to or below 1.7° (95th percentile).
Assembly Stability	Withstand unintended loads without losing accuracy or function.	The Drill Guide was able to withstand forces without losing accuracy or function.
Lifecycle Assessment	Maintain accuracy and label readability throughout product lifetime.	Accuracy as well as label readability requirements were met.
Skiving	Provide a stable hold.	The modified Drill Guide provides a more stable hold with the improved teeth design compared to the predicate Guide Tubes.
Handling and Interface	Acceptance criteria met for depth control and array attachment.	Acceptance criteria were met in all cases.
Usability	Safe and effective for use in defined scenarios.	The final design was proven safe and effective for use in the defined use scenarios.
Mechanical Failure	Strong enough to withstand expected torques and possible bending.	The new worst case drill bit (diameter 2 mm) was tested under different scenarios in order to ensure it is strong enough to withstand the expected torques and possible bending under worst case conditions.
Biocompatibility	Compliance with ISO 10993-1:2018.	Was evaluated according to ISO 10993-1:2018 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process."
Reprocessing Validation	Compliance with ISO 11737-1:2018, ANSI/AAMI ST98:2022, ISO 15883-5:2021-07.	Was evaluated according to ISO 11737-1:2018, ANSI/AAMI ST98:2022 and ISO 15883-5:2021-07.

2. Sample Size Used for the Test Set and Data Provenance:

The document doesn't explicitly state sample sizes for all test sets.

Usability Testing: 15 representative users.
Other Testing (Accuracy, Assembly Stability, Lifecyle assessment, Skiving, Handling and interface analysis, Mechanical failure testing, Biocompatibility, Reprocessing validation): Sample sizes are not specified in the provided text.
Data Provenance: Not specified, but generally, these types of performance tests are conducted in a controlled laboratory environment. The document does not mention the country of origin of data or whether it was retrospective or prospective, as clinical data was not required.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The performance tests described (e.g., accuracy, mechanical failure) are typically assessed against engineering specifications rather than expert consensus on medical images or diagnoses.
For usability testing, the 15 "representative users" likely served as the evaluators, but their specific qualifications beyond being "representative" are not detailed.

4. Adjudication Method for the Test Set:

An adjudication method (like 2+1, 3+1) is not applicable for the reported performance testing, as these are engineering and functional tests.
For usability testing, the document states "The final design was proven safe and effective," implying an overall assessment rather than a specific multi-reader adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

No MRMC comparative effectiveness study was done. This device is a navigation system and surgical instruments, not an AI diagnostic or assistive tool that would typically be evaluated in an MRMC study comparing human reader performance with and without AI.
The document explicitly states: "No clinical testing was required for the subject device."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The "Spine & Trauma Navigation" system is an image-guided surgery system that inherently involves a human surgeon in the loop. The performance tests (e.g., navigation accuracy) evaluate the system's ability to accurately guide instruments, which is a standalone function of the technology when used by a surgeon. It's not an "algorithm-only" performance in the sense of a fully automated diagnostic or interpretive AI.

7. The Type of Ground Truth Used:

The ground truth for most of the performance tests (e.g., accuracy, mechanical failure, stability) is based on engineering specifications and metrology (precise measurements against known values).
For biocompatibility and reprocessing, the ground truth is established by adherence to international standards (ISO 10993-1:2018, ISO 11737-1:2018, ANSI/AAMI ST98:2022, ISO 15883-5:2021-07).
For usability, the ground truth is the satisfaction of predefined acceptance criteria by the representative users in a simulated scenario.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. The device is an image-guided surgery system and newly modified instruments, not a machine learning or AI model trained on data in the traditional sense that would have a "training set." The development of such physical devices and software systems involves rigorous engineering design, verification, and validation, but not typically a "training set" like that seen in deep learning applications.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable, as there is no mention of a "training set" for an AI model.

Summary

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May 23, 2024

Image /page/0/Picture/1 description: The image shows 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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Brainlab AG Esther Moreno Garcia Manager Regulatory Affairs Olof-Palme-Str. 9 Munich, 81829 Germany

Re: K240701

Trade/Device Name: Drill Guide; Drill Bit; Spine & Trauma Navigation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 14, 2024 Received: April 23, 2024

Dear Esther Moreno Garcia:

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 (QS) 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,

Tejen D. Soni -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

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Indications for Use

510(k) Number (if known) K240701

Device Name Drill Guide; Drill Bit; Spine & Trauma Navigation

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized pink brain icon on the left, followed by the word "BRAINLAB" in pink, uppercase letters. The brain icon appears to be made up of several curved lines, giving it a modern and abstract look.

510(k) Summary

March 14th, 2024

General Information
Manufacturer	Brainlab AG; Olof-Palme-Str.9, 81829, Munich, Germany
Establishment Registration	8043933
Trade Name	Drill GuideDrill BitSpine & Trauma Navigation
Classification Name	Orthopedic Stereotaxic Instrument
Product Code	OLO
Regulation Number	882.4560
Regulatory Class	II
Panel	Orthopedic
Predicate Device(s)	K221618 - Spine & Trauma Navigation
Contact Information
Primary Contact	Alternate Contact
Esther Moreno GarciaManager Regulatory AffairsPhone: +49 89 99 15 68 0Email: regulatory.affairs@brainlab.com	Chiara CunicoPhone: +49 89 99 15 68 0Fax: +49 89 99 15 68 5033Email: chiara.cunico@brainlab.com

1. Indications for Use

2. Device Description

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Image /page/4/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized pink symbol on the left, resembling a brain or a network, followed by the word "BRAINLAB" in pink, block letters. The overall design is clean and modern, suggesting a focus on technology and innovation in the field of neuroscience or medical technology.

3. Substantial Equivalence

For the Substantial Equivalence determination, comparison of the Subject Device features with the following predicate device(s) was carried out:

K221618 - Spine & Trauma Navigation (product code: OLO)

The predicate device was chosen since it's the predecessor device and therefore very similar to the subject device w.r.t the indications for use, technological characteristics and use cases.

The main difference compared to the predicate device are modified instruments.

Feature	Predicate Device K221618	Subject Device
Indicationsfor use	Spine & Trauma Navigation isintended as an intraoperative image-guided localization system to enableopen and minimally invasive surgery.It links a freehand probe, tracked bya passive marker sensor system tovirtual computer image space on apatient's preoperative orintraoperative 2D or 3D image data.Spine & Trauma Navigation enablescomputer-assisted navigation ofmedical image data, which can either	Spine & Trauma Navigation isintended as an intraoperative image-guided localization system to enableopen and minimally invasive surgery.It links a freehand probe, tracked bya passive marker sensor system tovirtual computer image space on apatient's preoperative orintraoperative 2D or 3D image data.Spine & Trauma Navigation enablescomputer-assisted navigation ofmedical image data, which can either
Feature	Predicate Device K221618	Subject Device
	be acquired preoperatively orintraoperatively by an appropriateimage acquisition system. Thesoftware offers screw and interbodydevice planning and navigation withsurgical instruments.	be acquired preoperatively orintraoperatively by an appropriateimage acquisition system. Thesoftware offers screw and interbodydevice planning and navigation withsurgical instruments.
	The system is indicated for anymedical condition in which the use ofstereotactic surgery may beappropriate and where a reference toa rigid anatomical structure, such asthe skull, the pelvis, a long bone orvertebra can be identified relative tothe acquired image (CT, MR, 3Dfluoroscopic image reconstruction or2D fluoroscopic image) and/or animage databased model of theanatomy.	The system is indicated for anymedical condition in which the useof stereotactic surgery may beappropriate and where a referenceto a rigid anatomical structure, suchas the skull, the pelvis, a long boneor vertebra can be identified relativeto the acquired image (CT, MR, 3Dfluoroscopic image reconstruction or2D fluoroscopic image) and/or animage databased model of theanatomy.
Navigationaccuracy	Mean Positional Error of the placedinstrument's tip ≤ 2 mmMean Angular Error of the placedinstrument's axis ≤ 2°	Mean Positional Error of the placedinstrument's tip ≤ 2 mmMean Angular Error of the placedinstrument's axis ≤ 2°
Trackingtechnology	Optical tracking	Optical tracking
Drill guidecomponents	-Drill Guide Handles-Drill Guide Compact Handle-Drill Guide Tubes-Drill Guide Trocars-Tissue Protection Sleeve-Drill Guide Depth Controls	-Drill Guide Handle-Drill Guide Handle Compact-Drill Guide Tubes-Drill Guide Trocar Inserts-Drill Guide Depth Controls-Drill Guide Array
Adjustmentandhandlingfeatures ofDrill Guides	• Adjusting position of handlerequires loosening of thecounter nut.• Array is fixed to the handle body• The guide tubes are attached tothe main drill guide body bymeans of a left-handed thread.• Depth control is attached to drill	• Rotatable handle allows toadjust position relative to arraywithout loosening any fixationelements.• Detachable array with integratedmagnet to prevent it fromdropping.
Feature	Predicate Device K221618	Subject Device
	depth setting is secured with acounter nut.	The Guide Tube is attached tothe Handle by simple linearinsertion and held in place by aclick interface. Depth control is attached anddepth setting is secured with asnapping mechanism.
Drill Bits	Drill bits with diameters between2.4mm to 4.5mm.	Four new drill bits are introduced,three within the same range ofdiameters (3.2 and 4.5mm). A newworst case drill bit with a diameter of2mm.
Cleaningandsterilization	Automated cleaning and automatedthermal disinfectionSteam sterilization	Automated cleaning and automatedthermal disinfectionSteam sterilization

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Image /page/5/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized pink brain icon on the left, followed by the word "BRAINLAB" in pink, sans-serif capital letters. The brain icon is abstract and appears to be made up of several curved lines.

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Image /page/6/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized brain icon on the left and the word "BRAINLAB" in capital letters on the right. The color of the logo is pink.

4. Performance Data

The following testing was conducted on the Subject Device to establish substantial equivalence with the predicate device:

Assembly stability: In order to verify that the stiffness and fixation of the instruments can resist unintended loads. The Drill Guide was able to withstand the forces without losing accuracy or function.
. Accuracy: Accuracy testing was performed with acceptance criteria: tip position deviation must be equal or below 1.7 mm (95th percentile), and the angular deviation must be equal or below 1.7° (95th percentile). Testing showed the modified Drill Guide fulfills the same accuracy requirements as the predecessor one.
Lifecyle assessment: To evaluate the influence of wear, reprocessing and aging on . selected aspects of product performance throughout the product lifetime. Accuracy as well as label readability requirements were met.
. Skiving: Skiving testing showed the modified Drill Guide provides a more stable hold with the improved teeth design compared to the predicate Guide Tubes.
. Handling and interface analysis: The Drill Guide design changes in terms of depth control and array attachment concept were evaluated and acceptance criteria were met in all cases.
. Usability: Summative usability testing was performed in order to validate the changed design of the Drill Guides. The evaluation was conducted with 15 representative users

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Image /page/7/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized brain icon on the left and the word "BRAINLAB" in capital letters on the right. The color of the logo is pink.

which had to assemble and use the Drill Guide in a simulated scenario. The final design was proven safe and effective for use in the defined use scenarios.

. Mechanical failure testing: The new worst case drill bit (diameter 2 mm) was tested under different scenarios in order to ensure it is strong enough to withstand the expected torques and possible bending under worst case conditions.
. Biocompatibility: Was evaluated according to ISO 10993-1:2018 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
. Reprocessing validation: Was evaluated according to ISO 11737-1:2018, ANSI/AAMI ST98:2022 and ISO 15883-5:2021-07.

No clinical testing was required for the subject device.

5. Conclusion

The comparison of the Subject Device with the predicate device shows that the modified Spine & Trauma Navigation including modified instruments has similar functionality, intended use and technological characteristics as the predicate device. Based on the comparison to the predicate and the performance testing conducted, the Subject Device is considered substantially equivalent to the predicate device.

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).