(90 days)
ARAI Surgical Navigation System (K211254)
Yes
The summary mentions "autonomous spine segmentation process" and describes testing this process by comparing it to manual segmentations using the Sørensen-Dice coefficient, which is a common metric for evaluating segmentation algorithms, often including those based on ML. While "AI" or "ML" are not explicitly stated, "autonomous segmentation" in this context strongly suggests the use of such technologies.
No.
The device functions as a surgical guidance system by providing visualization and tracking of instruments, rather than directly treating a medical condition itself.
No
Explanation: The device is described as a surgical guidance system that aids in precisely locating anatomical structures and tracking instrument position during orthopedic procedures. It provides real-time visualization and navigation for surgeons, which falls under surgical planning and intraoperative guidance, not diagnosis of medical conditions.
No
The device description explicitly states that the HOLO Portal™ System is a "combination of hardware and software" and lists specific hardware components like the surgeon workstation (including display unit and optional augmented reality visor), control workstation, and optical navigation tracker.
Based on the provided information, the HOLO Portal™ Surgical Guidance System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- HOLO Portal™ Function: The HOLO Portal™ system is a surgical guidance system. It uses imaging data (CT scans) of the patient's anatomy to provide real-time visualization and navigation during surgical procedures. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it is an "aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region." This is a surgical guidance function, not an in vitro diagnostic function.
- Device Description: The description details a navigation system with hardware (workstations, tracker) and software for visualizing anatomy and guiding instruments. This aligns with surgical navigation, not IVD testing.
Therefore, the HOLO Portal™ Surgical Guidance System falls under the category of a surgical navigation or guidance system, not an In Vitro Diagnostic device.
No
The provided input states "Control Plan Authorized (PCCP) and relevant text: Not Found", which means there is no explicit mention of the FDA reviewing, approving, or clearing a PCCP for this device.
Intended Use / 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.
Product codes
OLO, LLZ
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 patient-specific 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) 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray Based Imaging
Anatomical Site
lumbosacral spine region, lumbosacral spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
User Population: Orthopedic surgeons or neurosurgeons
Intended Use Environment: Operating room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A set of test samples presenting lumbosacral spine, extracted from stationary and intraoperative Computed Tomography scans was subjected to the autonomous spine segmentation process performed by the HOLO Portal System. The quality of the autonomous anatomical segmentation applied by the HOLO Portal System was determined by comparing it with manual segmentations prepared by trained analysts based on mean Sørensen-Dice coefficient (DSC) calculations.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-clinical system, software, and instrument verification and validation, Surgical simulations (cadavers), Surgical simulations (rigid benchtop phantoms), Bench top testing (subsystem testing), Augmented Reality technical characteristics (display latency and framerate, stereoscopic crosstalk, and spatial accuracy).
Key Results - Cadaver Performance Validation (worst-case):
- Positional Error: Mean 2.37 mm, Standard Dev. 0.72 mm, 95% CI Upper Bound 2.58 mm, 99% CI Upper Bound 2.69 mm
- Angular Error: Mean 1.40 degrees, Standard Dev. 0.84 degrees, 95% CI Upper Bound 1.65 degrees, 99% CI Upper Bound 1.73 degrees
Key Results - Benchtop Phantom Performance Verification (worst-case):
- Positional Error: Mean 1.54 mm, Standard Dev. 0.74 mm, 95% CI Upper Bound 1.75 mm
- Angular Error: Mean 1.50 degrees, Standard Dev. 0.68 degrees, 95% CI Upper Bound 1.69 degrees
Additional Tests:
- Bench top testing included subsystem testing per ASTM F2554-18.
- Augmented Reality technical characteristics were demonstrated via performance testing of display latency and framerate, stereoscopic crosstalk, and spatial accuracy (a measurement of disparity between the visualization of a real and virtual objects) under varying user conditions.
- Compliance conformity assessments per IEC 60601-1 and IEC 60601-1-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ARAI Surgical Navigation System (K211254)
Reference Device(s)
Ziehm Vision RFD 3D Scanner (K202360), GE OEC 3D Scanner (K203346)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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August 31, 2023
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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.
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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) |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ----------------------------------------------- |
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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:
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:
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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 | Optical - infrared 6 DOF OptiTrack V120: Trio |
| | | |
| | | |
| | Automatic 3D Image Registration performed after placing a
positional reference over the patient's anatomy and scanning
the surgical field with an intraoperative scanner. | Automatic 3D Image Registration performed after placing a
positional reference over the patient's anatomy and scanning
the surgical field with an intraoperative scanner. |
| Registration features | | |
| Segmentation and 3D model
generation | Voxels of medical datasets (DICOM format) that correspond
to the spine are automatically segmented and converted to a
polygonal mesh for displaying purposes. | Voxels of medical datasets (DICOM format) that correspond
to the spine are automatically segmented and converted to a
polygonal mesh for displaying purposes. |
| | | |
| Medical imaging rendering | Polygonal mesh | Polygonal mesh |
| Features | HOLO Portal™ System | ARAI™ Surgical Navigation System |
| | | |
| Imaging Modality | X-Ray Based Imaging | X-Ray Based Imaging |
| Medical Device Interfaces | O-arm Imaging System Ziehm Vision RFD Scanner GE OEC 3D Scanner | O-arm Imaging System |
| Communication
between
Scanner and
platform/
computer | Encrypted USB for DICOM | Encrypted USB for DICOM import & export with Medtronic
O-arm |
| Display and Optics Technology | Augmented Reality using near eye see-through display; data
displayed on patient's anatomy | Augmented Reality using near eye see-through display; data
displayed on patient's anatomy |
Subiect Device and Predicate Comparison
6
HOLO Portali
7
Image /page/7/Picture/0 description: The image shows the logo for HOLO Portal. The logo is written in a sans-serif font and is a light blue color. The word "HOLO" is written in all capital letters, and the word "Portal" is written in a mix of upper and lower case letters. There is a trademark symbol to the right of the word Portal.
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Performance Testing:
Verification and validation testing was conducted on HOLO Portal™ Surgical Guidance System to confirm that the device meets performance requirements under the indications for use and to ensure equivalent safety and efficacy of the system to the cited predicate device: Non-clinical testing included system, software, and instrument verification and validation to demonstrate that the system can consistently meet the user needs, corresponding design inputs, and intended use:
- . Non-clinical system, software, and instrument verification and validation - demonstrated compliance with user needs and corresponding design inputs.
- Surgical simulations conducted on cadavers were performed for system validation. The . positional displacement is measured as the 3D (Euclidean) distance between the tips of the virtual and real implants, and the angular axis displacement is measured as the angle between the 3D trajectories of the virtual and real implants.
The worst-case 3D positional (measured in mm) and angular error (measured in degrees) between the real and virtual pedicle screws for performance validation is summarized below:
| Performance Validation | Mean | Standard
Dev. | 95% CI
Upper
Bound | 99% CI
Upper
Bound |
|-------------------------|------|------------------|--------------------------|--------------------------|
| Positional Error [mm] | 2.37 | 0.72 | 2.58 | 2.69 |
| Angular Error [degrees] | 1.40 | 0.84 | 1.65 | 1.73 |
- . Surgical simulations conducted on rigid benchtop phantoms were performed for system verification. Phantoms were scanned, registered, and screws were placed using standard clinical workflows to verify the system accuracy and precision by removing the variation due to anatomical movements relative to the reference fixation. The worst-case 3D positional (measured in mm) and angular error (measured in degrees) between the real and virtual pedicle screws for performance verification is summarized below:
| Performance Verification | Mean | Standard Dev. | 95% CI Upper
Bound |
|--------------------------|------|---------------|-----------------------|
| Positional Error [mm] | 1.54 | 0.74 | 1.75 |
| Angular Error [degrees] | 1.50 | 0.68 | 1.69 |
- Additionally, bench top testing included subsystem testing per ASTM F2554-18. ●
- Augmented Reality technical characteristics were demonstrated via performance testing of ● display latency and framerate, stereoscopic crosstalk, and spatial accuracy (a measurement of disparity between the visualization of a real and virtual objects) under varying user conditions.
- . Compliance conformity assessments per:
-
- IEC 60601-1 Medical electrical equipment. General requirements for basic safety and essential performance
-
- IEC 60601-1-2 Medical electrical equipment. General requirements for basic safety and essential performance – Electromagnetic disturbances
-
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Biocompatibility:
The biocompatibility evaluation for HOLO Portal™ Surgical Guidance System has been conducted in accordance with FDA Guidance for Industry and FDA Staff, "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process', " June 16, 2016. The evaluation confirms that HOLO Portal™ System meets biocompatibility requirements.
Electrical Safety and Electromagnetic Compatibility:
Testing was performed to assure compliance with recognized safety standard, IEC 60601-1:2005, AMD1:2012, AMD2:2020, and standard for electrical safety and electromagnetic compatibility, IEC 60601-1-2:2020 Ed 4.1.
Software Verification and Validation Testing:
Software validation and verification testing was performed in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).
A set of test samples presenting lumbosacral spine, extracted from stationary and intraoperative Computed Tomography scans was subjected to the autonomous spine segmentation process performed by the HOLO Portal System. The quality of the autonomous anatomical segmentation applied by the HOLO Portal System was determined by comparing it with manual segmentations prepared by trained analysts based on mean Sørensen-Dice coefficient (DSC) calculations.
Basis of Substantial Equivalence:
HOLO Portal™ System has been found to be substantially equivalent to the predicate device with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports the substantial equivalence to the cited predicate device.