Automatic Registration

K203679 · Brainlab AG · OLO · Mar 18, 2021 · Neurology

Device Facts

• Record ID: K203679
• Device Name: Automatic Registration
• Applicant: Brainlab AG
• Product Code: OLO · Neurology
• Decision Date: Mar 18, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Automatic Registration is a surgical device for image guided surgery intended to be used in combination with compatible Brainlab navigation systems. Automatic Registration provides an image registration for intraoperatively acquired 3D CT/ CBCT or fluoroscopic images. It consists of the software module Automatic Registration and hardware accessories.

Device Story

Automatic Registration is a software-based surgical accessory for image-guided surgery (IGS) systems. It processes intraoperatively acquired 3D CT, CBCT, or fluoroscopic images to perform image registration, correlating patient anatomy with the surgical environment. The system utilizes a 'Registration Matrix' (a reusable hardware accessory) placed within the scan volume to determine the spatial position of the patient relative to navigated instruments. Operated by surgical staff in an OR setting, the device provides registration data to Brainlab navigation platforms. Healthcare providers use this output to verify registration accuracy prior to navigation, ensuring precise instrument tracking during procedures such as spinal surgery. The device benefits patients by enabling accurate, real-time image-guided navigation, reducing the need for manual registration steps.

Clinical Evidence

Bench testing only. Registration accuracy was validated in a simulated test environment (n=228 navigation points, m=50 scans). Results showed a mean navigation accuracy of 0.93mm and a 95th percentile of 1.80mm, outperforming the predicate device's mean accuracy of 1.26mm. Testing confirmed consistency across the cervical spine.

Technological Characteristics

Software module with reusable hardware 'Registration Matrix'. Operates via spatial correlation of intraoperative 3D/2D images to navigation system coordinates. Connectivity via integration with Brainlab IGS platforms. Non-sterile delivery. Registration principle relies on geometric markers within the scan volume.

Indications for Use

Indicated for use in image-guided surgery to provide image registration for intraoperatively acquired 3D CT, CBCT, or fluoroscopic images in combination with compatible Brainlab navigation systems.

Regulatory Classification

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.

Predicate Devices

• Spine & Trauma Navigation System (K183605)

Submission Summary (Full Text)

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March 18, 2021

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 Chiara Cunico Manager Regulatory Affairs Olof-Palme-Str. 9 Munich, Bavaria 81829 Germany

# Re: K203679

Trade/Device Name: Automatic Registration Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: February 12, 2021 Received: February 16, 2021

# Dear Chiara Cunico:

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.

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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) K203679

Device Name Automatic Registration

#### Indications for Use (Describe)

Automatic Registration is a surgical device for image guided surgery intended to be used in combination with compatible Brainlab navigation systems. Automatic Registration provides an image registration for intraoperatively acquired 3D CT/ CBCT or fluoroscopic images. It consists of the software module Automatic Registration and hardware accessories.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| X Prescription Use (Part 21 CFR 801 Subnart D) | |

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Image /page/3/Picture/0 description: The image is an abstract design featuring a series of interconnected triangles. The triangles vary in size and shade, transitioning from a darker blue on the left to a lighter blue and white on the right. The triangles are separated by thin white lines, creating a fragmented, geometric pattern.

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# 510(k) Summary

March 17, 2021

| General Information | |
|-------------------------------|--------------------------------------------|
| Manufacturer | Brainlab AG |
| Establishment Registration | 8043933 |
| Device Name | Orthopedic Stereotaxic Instrument |
| Trade Name | Automatic Registration |
| Classification Name | Stereotaxic instrument |
| Product Code | OLO |
| Regulation Number | 882.4560 |
| Regulatory Class | II |
| Panel | Orthopedic |
| Predicate Device and K Number | Spine & Trauma Navigation System - K183605 |
| Manufacturer | Brainlab AG |

| Contact Information | |
|-----------------------------------|----------------------------------------|
| Primary Contact | Alternate Contact |
| Chiara Cunico | Regulatory Affairs Brainlab |
| Manager RA | Phone: [phone] |
| Phone: [phone] | Fax: [phone] |
| Email: [e-mail] | Email: [e-mail] |

# 1. Indications for Use

Automatic Registration is a surgical device for image guided surgery intended to be used in combination with compatible Brainlab navigation systems. Automatic Registration provides an image registration for intraoperatively acquired 3D CT/CBCT or fluoroscopic images. It consists of the software module Automatic Registration and hardware accessories.

#### 2. Device Description

The Subject Device is intended to be used in combination with compatible Brainlab navigation systems. Automatic Registration provides an image registration for intraoperatively acquired 3D CT/CBCT or fluoroscopic images. It consists of the software module Automatic Registration and hardware accessories.

K203679 510(k) Summary

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Image /page/4/Picture/0 description: The image is an abstract design featuring a series of triangles in varying shades of blue. The triangles are arranged in a pattern that creates a sense of movement and depth. The triangles on the left side of the image are a darker blue, while the triangles on the right side of the image are a lighter blue. The triangles are separated by white lines, which add to the overall visual interest of the design.

Image /page/4/Picture/1 description: The image shows the word "BRAINLAB" in all capital letters. To the left of the word is a logo that appears to be three curved lines stacked on top of each other. The logo and the word are both in black and the background is white.

Automatic Registration is a surgical device for image guided surgery intended to be used in combination with compatible Brainlab navigation systems. Automatic Registration provides an image registration for intraoperatively acquired 3D CT/CBCT or fluoroscopic images. It consists of the software module Automatic Registration and hardware accessories.

In a spinal context, Automatic Registration serves as accessory to the Spine & Trauma navigation system.

The Matrices are reusable devices delivered in non-sterile condition. The devices makes the Correlation ("Registration") of Intraoperative acquired patient data to the surgical environment possible by determining its position in relation to the patient and the navigated instruments.

### 3. Substantial Equivalence

| Devices | Name | K-Number | Manufacturer |
|------------------|-------------------------------------|----------|--------------|
| Subject Device | Automatic Registration | K203679 | Brainlab AG |
| Predicate Device | Spine & Trauma Navigation<br>System | K183605 | Brainlab AG |

| Feature / Topic | Area | Changes of Automatic Registration in relation to the<br>predicate device K183605 |
|--------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | General | Same as in predicate device; minor expansion for automatic<br>registration specific feature |
| Integration of<br>Brainlab IGS<br>(computer) platforms | Compatibilities<br>and Hardware<br>Components | Same basic functionality; added compatibility to a platform with<br>minor differences |
| Automatic Image<br>Registration | Compatibilities to<br>external imaging<br>devices | Same basic functionality; further compatibilities added with<br>minor differences |
| | | Compatibility was added for a new intraoperative 3D imaging<br>device for pre-calibration. |
| Instruments that can<br>be employed –<br>Navigation<br>Accessories | Compatible<br>Instruments and<br>software relevant<br>Hardware | Addition of hardware parts with minor differences.<br><br>Same principle in registration of 2D and 3D images.<br><br>Material and design adapted to fit requirements of Universal<br>AIR (Registration Matrix) |

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Image /page/5/Picture/0 description: The image is an abstract design featuring a series of interconnected triangles. The triangles vary in size and are arranged in a pattern that spans across the image. The color palette consists of shades of blue, with the intensity of the blue gradually decreasing from left to right, creating a gradient effect.

Image /page/5/Picture/1 description: The image shows the word "BRAINLAB" in all capital letters. To the left of the word is a logo that appears to be three curved lines stacked on top of each other. The text and logo are in black and the background is white.

| Feature / Topic | Area | Changes of Automatic Registration in relation to the<br>predicate device K183605 |
|-----------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Automatic patient<br>registration | Software relevant<br>behavior and<br>features | Same basic functionality; minor modifications in<br>GUI/functionality.<br>The main functionality components of the software system stay<br>the same.<br>Additional instructions were added for automatic patient<br>registration using Universal AIR.<br>Icons and graphical representations of scanner reference<br>arrays were added to visualize the additionally integrated<br>scanning devices.<br>The basic concept of verification of registration accuracy prior<br>to navigation remains unchanged. |

#### Non-Clinical Testing:

- 1. Registration Accuracy Test Test Result:
- Mean navigation accuracy: 0.93mm ●
- . 95th percentile of single navigation accuracy: 1.80mm
- Total number of navigation points n=228 .

Above listed non-clinical performance testing demonstrates the equivalence of the navigation registration accuracy of the subject device to the predicate device. It was performed in a simulated test environment which matches the test scenario of the cleared device, where a mean registration accuracy of 1.26mm was measured.

Minor modifications to the test setup were required due to the device change where a Registration Matrix within the scan volume is used for automatic registration instead of infrared scanner markers in combination with a navigation calibration as in the cleared device. The navigated region of interest and measurement methods were not changed since these parameters are not affected by the device change.

An additional performance test demonstrated that the registration method is also applicable for the cervical spine and navigation accuracy in this region is consistent with the initial results listed above.

K203679 510(k) Summary

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Image /page/6/Picture/0 description: The image is an abstract design featuring a series of interconnected triangles. The triangles are arranged in a pattern that creates a sense of depth and movement. The color palette consists of varying shades of blue, with the darker shades concentrated on the left side of the image and gradually transitioning to lighter shades on the right. The overall effect is modern and visually appealing.

Image /page/6/Picture/1 description: The image shows the word "BRAINLAB" in all capital letters. To the left of the word is a logo that appears to be three curved lines stacked on top of each other. The logo and the word are both in black and are set against a white background. The image is simple and clean, with a focus on the company name and logo.

Test results generated demonstrated better mean navigation accuracy and met stricter acceptance criteria (mean navigation accuracy: <= 1.5mm, 95th percentile of single navigation accuracy: <=2.5mm) compared to the predicate device (mean navigation accuracy: <=2.0mm; 95th percentile of single navigation accuracy: <=3.0mm). The total number of measured navigation points (n=228) and total number of scans used (m=50) were increased compared to performance testing of the predicate device (n=126; total number of scans used: m=32).

### Conclusion

The changes described above do not alter intended use or the fundamental scientific technology of the device because they do not change the operating principle. Non-clinical performance tests demonstrated that device changes do not negatively affect registration accuracy. The changes to the Subject Device do not present new issues of safety and effectiveness when compared to the predicate device while still providing the benefit of an equally accurate registration resulting in an unchanged risk benefit ratio. Therefore, the devices are substantially equivalent.