Who is the manufacturer of HOLO Portal Surgical Guidance System?

Surgalign Spine Technologies filed the 510(k) submission for HOLO Portal Surgical Guidance System (K231611).

What is the FDA product code for HOLO Portal Surgical Guidance System?

SBF. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for HOLO Portal Surgical Guidance System?

510(k) clearance (submission type: Traditional).

Does HOLO Portal Surgical Guidance System use AI or machine learning?

Yes. HOLO Portal Surgical Guidance System (K231611) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like HOLO Portal Surgical Guidance System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like HOLO Portal Surgical Guidance System get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

HOLO Portal Surgical Guidance System

Q: What are the predicate devices for HOLO Portal Surgical Guidance System?

ARAI Surgical Navigation System (K211254).

K231611 · Surgalign Spine Technologies · SBF · Aug 31, 2023 · Neurology

Device Facts

Record ID	K231611
Device Name	HOLO Portal Surgical Guidance System
Applicant	Surgalign Spine Technologies
Product Code	SBF · Neurology
Decision Date	Aug 31, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2
Attributes	AI/ML

Intended Use

The HOLO Portal™ Surgical Guidance System is indicated as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region. Their use is indicated for any medical condition of the lumbosacral spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the iliac crest, can be identified relative to intraoperative CT images of the anatomy. The HOLO Portal™ Surgical Guidance System simultaneously displays 2D stereotaxic data along with a 3D virtual anatomy model over the patient during surgery. The stereotaxic display is indicated for continuously tracking instrument position and orientation to the registered patient anatomy while the 3D display is indicated for localizing the virtual instrument to the virtual anatomy model over the patient during surgery. The 3D display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed 2D stereotaxic information.

Device Story

HOLO Portal™ is a surgical navigation system for lumbosacral spine procedures. It uses intraoperative CT images and optical tracking to provide real-time guidance. System components include a surgeon workstation (display/AR visor), control workstation (computer/optical tracker), and passive reflective markers. Infrared cameras triangulate 3D positions of instruments and patient anatomy. Software transforms DICOM CT data into 3D polygonal mesh models. The system displays 2D stereotaxic data and 3D virtual anatomy overlays via AR glasses or a display unit. Used in the operating room by orthopedic or neurosurgeons, the system aids in precise instrument positioning relative to patient anatomy. It benefits patients by providing visual guidance for surgical trajectories, potentially improving accuracy in pedicle screw placement. Surgeons use the output to verify instrument orientation; the 3D display is intended as an adjunct to 2D stereotaxic data.

Clinical Evidence

No clinical trials were performed. Evidence consists of non-clinical bench testing and surgical simulations. Cadaveric validation (n=not specified) measured 3D positional error (mean 2.37mm, 99% CI upper bound 2.69mm) and angular error (mean 1.40°, 99% CI upper bound 1.73°). Phantom verification testing measured 3D positional error (mean 1.54mm, 95% CI upper bound 1.75mm) and angular error (mean 1.50°, 95% CI upper bound 1.69°). Software validation included autonomous spine segmentation performance evaluated against manual segmentations using the Sørensen-Dice coefficient (DSC).

Technological Characteristics

Optical infrared 6-DOF tracking using NDI Polaris Vega XT or OptiTrack V120: Trio cameras. Components: AR glasses, software, passive reflective markers, rigid reference, reusable instrument arrays. Imaging: X-ray based (CT). Connectivity: Encrypted USB for DICOM. Software: Real-time spatial calculation and 3D mesh rendering. Standards: ASTM F2554-18 (subsystem testing), IEC 60601-1 (safety), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for patients undergoing open or percutaneous orthopedic procedures in the lumbosacral spine region where stereotactic surgery is appropriate and rigid anatomical reference (e.g., iliac crest) is identifiable via intraoperative CT.

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

ARAI Surgical Navigation System (K211254)

Reference Devices

Ziehm Vision RFD 3D Scanner (K202360)
GE OEC 3D Scanner (K203346)

Related Devices

K211254 — ARAI Surgical Navigation System · Surgalign Spine Technologies · Jan 14, 2022
K220146 — VisAR · Novarad Corporation · May 27, 2022
K233725 — Spine Navigation System · Medivis, Inc. · Jul 26, 2024
K241870 — OnPoint Augmented Reality Spine System · Onpoint Surgical, Inc. · Aug 19, 2024
K211188 — xvision Spine system (XVS) · Augmedics, Ltd. · Jul 19, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ August 31, 2023 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. Surgalign Spine Technologies Jeremy Markovich Senior Director, Regulatory Affairs 520 Lake Cook Road Suite 315 Deerfield, Illinois 60015 Re: K231611 Trade/Device Name: HOLO Portal™ Surgical Guidance System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: June 1, 2023 Received: June 2, 2023 Dear Jeremy Markovich: 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. {1}------------------------------------------------ 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. Image /page/1/Picture/5 description: The image contains the acronym "FDA" in a light blue color on the left side. To the right of the acronym, the text "Tejen D. Soni -S" is written in black. The text is arranged in two lines, with "Tejen D." on the first line and "Soni -S" on the second line. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231611 Device Name HOLO Portal™ Surgical Guidance System ### Indications for Use (Describe) The HOLO Portal™ Surgical Guidance System is indicated as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region. Their use is indicated for any medical condition of the lumbosacral spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the iliac crest, can be identified relative to intraoperative CT images of the anatomy. The HOLO Portal™ Surgical Guidance System simultaneously displays 2D stereotaxic data along with a 3D virtual anatomy model over the patient during surgery. The stereotaxic display is indicated for continuously tracking instrument position and orientation to the registered patient anatomy while the 3D display is indicated for localizing the virtual instrument to the virtual anatomy model over the patient during surgery. The 3D display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed 2D stereotaxic information. 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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ # K231611 # 510(k) Summary: HOLO Portal™ Surgical Guidance System | Company: | Surgalign Spine Technologies, Inc. | |--------------------|---------------------------------------------------------------------------------------------------------------------------| | Contact: | Alanna Joshi Surgalign Spine Technologies, Inc. 520 Lake Cook Road Suite 315 Deerfield, IL 60015 630-227-3809 | | Date Prepared: | August 31, 2023 | | Proprietary Name: | HOLO Portal™ Surgical Guidance System | | Common Name: | Stereotaxic Instrument | | Classification: | 21 CFR 882.4560 Product Code(s): OLO, LLZ Class II | | Primary Predicate: | ARAI Surgical Navigation System (K211254) | # Indications for Use: The HOLO Portal™ Surgical Guidance System is indicated as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region. Their use is indicated for any medical condition of the lumbosacral spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the iliac crest, can be identified relative to intraoperative CT images of the anatomy. The HOLO Portal™ Surgical Guidance System simultaneously displays 2D stereotaxic data along with a 3D virtual anatomy model over the patient during surgery. The stereotaxic display is indicated for continuously tracking instrument position and orientation to the registered patient anatomy while the 3D display is indicated for localizing the virtual instrument to the virtual anatomy model over the patient during surgery. The 3D display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed 2D stereotaxic information. # Device Description: The HOLO Portal™ System is a combination of hardware and software that provides visualization of the patient's internal anatomy and surgical guidance to the surgeon based on patientspecific digital imaging. HOLO Portal™ is a navigation system for surgical planning and/or intraoperative guidance during stereotactic surgical procedures. The HOLO Portal™ System consists of two mobile devices: 1) Page 1 of 7. {4}------------------------------------------------ the surgeon workstation, which includes the display unit and the augmented reality visor (optional), and 2) the control workstation, which houses the optical navigation tracker and the computer. The optical navigation tracker utilizes infrared cameras and active infrared lights to triangulate the 3D location of passive markers attached to each system component to determine their 3D positions and orientations in real time. Software algorithms combine tracking information and high-resolution 3D anatomical models to display representations of patient anatomy, compared to traditional two-dimensional (2D), displays during surgical procedures. The following modifications have been applied to the previously cleared ARAI Surgical Navigation System (K211254): Additional compatibility capabilities have been added to the system. Clearance of this 510(k) will allow the HOLO Portal System to be compatible with the following components: - Ziehm Vision RFD 3D Scanner (K202360) ● - . GE OEC 3D Scanner (K203346) - NDI Polaris Vega XT Camera . ### Summary of Technological Characteristics: The modified HOLO Portal™ Surgical Guidance System has the same technological characteristics as its predicate device, the cleared ARAI Surgical Navigation Systems have the same design, materials, performance characteristics, and the same or equivalent labeling. Both systems include very similar hardware and software components with the following basic components: software, optical tracking camera, single use passive reflective markers, rigid reference point, reusable instrument arrays, and 2D and 3D augmented reality (AR) display. The software in both systems is designed for real time calculation and display of spatial position of the tip of surgical instruments relative to patient's anatomy. The HOLO Portal™ is comparable to the predicate in terms of intended use, fundamental scientific technology, technological characteristics, and principle of operation. A table comparing the key features of the subject and predicate devices is provided below: {5}------------------------------------------------ # Comparison of the Principles of Operation and Technological Characteristics | Features | HOLO Portal™ System | ARAIT™ Surgical Navigation System | |------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | Subject Device | K211254 | | Product Code | OLO, LLZ | OLO, LLZ | | Indications for Use | The HOLO Portal™ Surgical Guidance System is indicated as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region. Their use is indicated for any medical condition of the lumbosacral spine in which the use of stereotactic surgery may be appropriate, an where reference to a rigid anatomical structure, such as the iliac crest, can be identified relative to intraoperative CT images of the anatomy. The HOLO Portal™ Surgical Guidance System simultaneously displays 2D stereotaxic data along with a 3D virtual anatomy model over the patient during surgery. The stereotaxic display is indicated for continuously tracking instrument position and orientation to the registered patient anatomy while the 3D display is indicated for localizing the virtual instrument to the virtual anatomy model over the patient during surgery. The 3D display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed 2D stereotaxic information. | The ARAI™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region. Their use is indicated for any medical condition of the lumbosacral spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the iliac crest, can be identified relative to intraoperative CT images of the anatomy. The ARAI System simultaneously displays 2D stereotaxic data along with a 3D virtual anatomy model over the patient during surgery. The stereotaxic display is indicated for continuously tracking instrument position and orientation to the registered patient anatomy while the 3D display is indicated for localizing the virtual instrument to the virtual anatomy model over the patient during surgery. The 3D display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed 2D stereotaxic information. | | User Population | Orthopedic surgeons or neurosurgeons | Orthopedic surgeons or neurosurgeons | | Intended Use Environment | Operating room | Operating room | | Main System Components | AR glasses Software application Tracking camera Single use passive reflective markers Rigid reference point Reusable instrument arrays 2D and 3D augmented reality display | AR glasses Software application Tracking camera Single use passive reflective markers Rigid reference point Reusable instrument arrays 2D and 3D augmented reality display | | Modes of Operation | Patient Preparation System Set-up Intraoperative Scan | Patient Preparation System Set-up Intraoperative Scan | | Features | HOLO Portal™ System | ARAI™ Surgical Navigation System | | | Scan Import | Scan Import | | | Patient Registration | Patient Registration | | | Navigation | Navigation | | | 2D axial, sagittal, and coronal | 2D axial, sagittal, and coronal | | | 3D anatomical model | 3D anatomical model | | | Mesh Mode | Mesh Mode | | | 3D, 2D anatomic orthogonal planes | 3D, 2D anatomic orthogonal planes | | | Trajectories | Trajectories | | | Trajectory guidance | Trajectory guidance | | View (Display Features) | Look Ahead | Look Ahead | | | Instrument's tip view | Instrument's tip view | | | Clipping tool | Clipping tool | | | Image Intensity | Image Intensity | | | 3D transparent | 3D transparent | | | User defined | User defined | | | Implant | Implant | | | AR OFF (3D OFF) | AR OFF (3D OFF) | | | The HOLO Portal™ Software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance. | The ARAI Software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance. | | Software operating principle | | | | Localization Technology and Tracker | Optical - infrared 6 DOF NDI Polaris Vega XT Camera OptiTrack V120: Trio…