May 23, 2024

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).

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.06.10
Silver Spring, MD 20993
www.fda.gov
K240701 - Esther Moreno Garcia Page 2

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 (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-reporting-
combination-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-devices/medical-device-safety/medical-device-reporting-
mdr-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/medical-
devices/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-devices/device-advice-comprehensive-regulatory-
assistance/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

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
Indications for Use See PRA Statement below.

510(k) Number (if known)

K240701

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

Indications for Use (Describe)

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
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Office of Chief Information Officer
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“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
 510(k) Summary

March 14th, 2024

General Information
Manufacturer Brainlab AG; Olof-Palme-Str.9, 81829, Munich, Germany
Establishment Registration 8043933
Trade Name Drill Guide
Drill Bit
Spine & 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 Garcia Chiara Cunico
Manager Regulatory Affairs Phone: +49 89 99 15 68 0
Phone: +49 89 99 15 68 0 Fax: +49 89 99 15 68 5033
Email: regulatory.affairs@brainlab.com Email: chiara.cunico@brainlab.com

1. Indications for Use

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.

2. Device Description

K240701 Page 1 of 5
The Spine & Trauma Navigation is an image guided 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.

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

Indications Spine & Trauma Navigation is Spine & Trauma Navigation is

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

Spine & Trauma Navigation enables Spine & Trauma Navigation enables
computer-assisted navigation of computer-assisted navigation of
medical image data, which can either medical image data, which can either

K240701 Page 2 of 5
 Feature Predicate Device K221618 Subject Device

be acquired preoperatively or be acquired preoperatively or

intraoperatively by an appropriate intraoperatively by an appropriate
image acquisition system. The image acquisition system. The
software offers screw and interbody software offers screw and interbody
device planning and navigation with device planning and navigation with
surgical instruments. surgical instruments.

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

Navigation Mean Positional Error of the placed Mean Positional Error of the placed
accuracy instrument’s tip ≤ 2 mm instrument’s tip ≤ 2 mm

Mean Angular Error of the placed Mean Angular Error of the placed
instrument’s axis ≤ 2° instrument’s axis ≤ 2°

Tracking Optical tracking Optical tracking

technology

Drill guide -Drill Guide Handles -Drill Guide Handle

components -Drill Guide Compact Handle -Drill Guide Handle Compact
-Drill Guide Tubes -Drill Guide Tubes
-Drill Guide Trocars
-Drill Guide Trocar Inserts
-Tissue Protection Sleeve
-Drill Guide Depth Controls
-Drill Guide Depth Controls
-Drill Guide Array
Adjustment • Adjusting position of handle • Rotatable handle allows to
and requires loosening of the adjust position relative to array
handling counter nut. without loosening any fixation
features of • Array is fixed to the handle body elements.
Drill Guides • The guide tubes are attached to • Detachable array with integrated
the main drill guide body by magnet to prevent it from
means of a left-handed thread. dropping.
• Depth control is attached to drill
guide body by a thread and

K240701 Page 3 of 5
 Feature Predicate Device K221618 Subject Device

depth setting is secured with a • The Guide Tube is attached to

counter nut. the Handle by simple linear
insertion and held in place by a
click interface.
• Depth control is attached and
depth setting is secured with a
snapping mechanism.
Drill Bits Drill bits with diameters between Four new drill bits are introduced,
2.4mm to 4.5mm. three within the same range of
diameters (3.2 and 4.5mm). A new
worst case drill bit with a diameter of
2mm.
Cleaning Automated cleaning and automated Automated cleaning and automated
and thermal disinfection thermal disinfection
sterilization Steam sterilization Steam sterilization

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

K240701 Page 4 of 5
 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.

K240701 Page 5 of 5