nView s1 with nav option
Device Facts
| Record ID | K221344 |
|---|---|
| Device Name | nView s1 with nav option |
| Applicant | Nview Medical |
| Product Code | OWB · Radiology |
| Decision Date | Dec 28, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1650 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The nView s1 is intended as an imaging system to provide both 2D and 3D imaging of adult and pediatric populations over 6 years of age. The device is intended to provide fluoroscopic and tomographic imaging of patients during orthopedic surgical procedures where the clinician benefits from 3D visualization of complex anatomical structures, such as high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of the upper and lower extremities. The nView s1 is indicated to image human anatomy up to 30 cm thickness. The nView s1 is not indicated for mammographic or lung nodule applications. The nView s1 with navigation option is intended as a navigation system to localize anatomical structures in spine fusion procedures for tasks such as identifying vertebrae, and identifying entry points in the thoracic and lumbar spine regions; and for the task of pilot hole verification for pedicle screw placement of 4.5 mm screws in the thoracic and lumbar spine regions. The navigation option is indicated for posterior approach open spinal procedures in pediatric populations over 6 years of age in which the use of stereotactic surgery may be appropriate, and where reference to a rigid spinous process can be identified relative to nView s1 images of the anatomy.
Device Story
Mobile fluoroscopic C-arm system; provides 2D/3D X-ray imaging; includes monitor cart with GPU. Used in hospital/clinic settings by surgeons. Inputs: X-ray projections captured via C-arm gantry. Processing: Iterative reconstruction algorithm (positivity/denoising regularizers) transforms projections into 3D volumes. Navigation: Optical infrared camera tracks passive markers on surgical instruments and patient reference; registers anatomy to images via automatic or paired-point methods. Output: Real-time 2D/3D visualization on monitor cart; navigation guidance (crosshairs, trajectory) overlaid on images. Benefits: Enables precise localization of anatomical structures and surgical tools during spine fusion; improves accuracy of pedicle screw placement; reduces need for repeated imaging.
Clinical Evidence
No clinical trials; bench testing only. Performance validated using cadaveric specimens under worst-case configurations. Primary endpoints: 3D positional accuracy and trajectory angle accuracy. Results: Positional error < 2.0 mm and trajectory angle error < 2.0 degrees for both automatic and paired-point registration modes.
Technological Characteristics
Mobile C-arm with stationary reflective anode X-ray tube (0.6mm focal spot, 75kV/12mA/350W). CMOS digital detector (30x30cm, 1952x1952 resolution). Multi-arc source trajectory reconstruction. Optical infrared tracking for navigation. Connectivity via Ethernet. Software uses iterative reconstruction with positivity and denoising regularizers. Complies with IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-43, 60601-2-54, ISO 10993-1, ISO 17665-1, and ASTM F2554-18.
Indications for Use
Indicated for adult and pediatric patients >6 years old undergoing orthopedic surgery requiring 2D/3D imaging of complex anatomy (bones, joints, spine) up to 30 cm thickness. Navigation option indicated for posterior approach open spinal fusion in patients >6 years old for vertebra/entry point identification and pilot hole verification for 4.5 mm pedicle screws. Contraindicated for mammography and lung nodule applications.
Regulatory Classification
Identification
An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
- nView s1 with nav option (K211064)
Reference Devices
- Medtronic Navigation Inc - StealthStation™ S8 system (K162309)
Related Devices
- K211064 — nView s1 with nav option · Nview Medical · Oct 29, 2021
- K202547 — Surgivisio system · Surgivisio · Mar 26, 2021
- K190064 — nView system 1 · Nview Medical, Inc. · Jul 8, 2019
- K142740 — Ziehm Vision RFD 3D · Ziehm Imaging GmbH · Apr 6, 2015
- K231701 — Ziehm Vision RFD 3D · Ziehm Imaging GmbH · Jul 10, 2023
Submission Summary (Full Text)
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December 28, 2022
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
nView medical Lisa Last Chief Operating Officer 2681 E Parleys Way STE 107 SALT LAKE CITY, UT 84109
Re: K221344
Trade/Device Name: nView s1 with nav option Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, JAK, OXO, OLO Dated: November 28, 2022 Received: November 28, 2022
Dear Lisa Last:
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 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,
| Esther O. Akinnagbe- | Digitally signed by Esther O. |
|----------------------|-----------------------------------|
| zusterzeel -S | Akinnagbe-zusterzeel -S |
| | Date: 2022.12.28 13:14:15 -05'00' |
For Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health 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)
#### K221344
Device Name nView s1 with nav option
#### Indications for Use (Describe)
The nView s1 is intended as an imaging system to provide both 2D and 3D imaging of adult and pediations over 6 years of age. The device is intended to provide fluoroscopic and tomographic imaging of patients during orthopedic surgical procedures where the clinician benefits from 3D visualization of complex anatomical structures, such as high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of the upper and lower extremities.
The nView s1 is indicated to image human anatomy up to 30 cm thickness. The nView s1 is not indicated for mammographic or lung nodule applications.
The nView s1 with navigation option is intended as a navigation system to localize anatomical structures in spine fusion procedures for tasks such as identifying vertebrae, and identifying entry points in the thoracic and lumbar spine regions; and for the task of pilot hole verification for pedicle screw placement of 4.5 mm screws in the thoracic and lumbar spine regions. The navigation option is indicated for posterior approach open spinal procedures in pediations over 6 years of age in which the use of stereotactic surgery may be appropriate, and where reference to a rigid spinous process can be identified relative to nView s1 images of the anatomy.
| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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# 510(k) Summary for K221344
The following statement is being submitted in accordance with the requirements of 21 CFR 807.92.
## Submitter Information
- Submitter: nView medical, Inc. 2681 E. Parleys Way, Suite 107 Salt Lake City, Utah 84109
Contact: Ms. Lisa Last Chief Operating Officer/ Regulatory Affairs lisa.last@nviewmed.com T 617.283.7053
Preparation Date: November 28, 2022
# Subject Device Information
| Device Name: | nView s1 with nav option |
|----------------------------|---------------------------------------------|
| Common/Usual Name: | Mobile Fluoroscopic C-Arm |
| Primary Regulation Number: | CFR 892.1650 |
| Primary Regulation Name: | Image-intensified fluoroscopic x-ray system |
| Primary Regulatory Class: | II |
| Primary Product Code: | OWB |
| Secondary Product Codes: | OXO, JAA, JAK, OLO |
# Predicate Device Information
| Device Name (510(k) number): | nView s1 with nav option (K211064) |
|------------------------------|---------------------------------------------|
| Common/Usual Name: | Mobile Fluoroscopic C-Arm |
| Regulation Number: | CFR 892.1650 |
| Regulation Name: | Image-intensified fluoroscopic x-ray system |
| Regulatory Class: | II |
| Primary Product Code: | OWB |
| Secondary Product Codes: | OXO, JAA, JAK, OLO |
# Reference Device Information
| Device Name (510(k) number): | Medtronic Navigation Inc - StealthStation™ S8 system (K162309) |
|------------------------------|----------------------------------------------------------------|
| Common/Usual Name: | Neurological Stereotaxic Instrument |
| Regulation Number: | CFR 882.4560 |
| Regulation Name: | Stereotaxic Instrument |
| Regulatory Class: | II |
| Product Codes: | HAW, OLO, PGW |
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#### Device Description:
Device Identification: The nView s1 with nav option mobile fluoroscopic system is a cone beam computed fluoroscopic and tomographic X-ray system consisting of two mobile C-arm and a monitor cart. The mobile C-arm is comprised of a fixed anode X-ray tube with a high voltage generator, X-ray controls, markers for image registration during navigation, and a mechanical "C" shaped structure which supports the X-ray chain, the image receptor flat panel detector, and navigation tracking camera is rigidly attached to the operating table and connects to the C-arm via a cable.
The monitor cart is a mobile platform containing a flat panel display and a GPU computer that connects to the mobile C-arm by ethernet cable.
Navigation instrumentation consists of a navigated surgical probe and a patient reference.
Device Characteristics: The device contains software. The nav option tracks single-use sterile navigation instrumentation. It does not contain biologics, drugs, coatings, or additives.
Environment of Use: The device is intended to be used in a hospital facility immediately before, during, or after surgery.
Brief Written Description of the Device: The nView s1 with nav option employs X-rays as its imaging technology for visualizing human anatomy in both 2D and 3D. The X-ray tube powered by a generator produces X-rays, which image the patient under control of the user, at the direction of a physician. The images from the system assist the physicians in visualizing the patient's anatomy during surgical procedures. The device poth real-time image capture and post capture visualization suitable for use immediately before, during, or after surgery. The optional navigation feature uses optical camera technology to display a surgeon's probe on the image in real time during the surgery.
Key Performance Specifications/Characteristics of the device performs both 2D and 3D medical imaging generated by means of an iterative algorithm. The system uses of a scan captured with relation to a predefined scan reference frame to compute the three-dimensional representation of the imaged object. The images are displayed on the screen of the monitor cart. It is possible to display projection views as well as tomographic views. The navigation option utilizes optical camera technology to track the C-arm, the instruments, and the patient.
Changes to predicate: The changes to the currently cleared nView s1 with nav option are as follows:
- . a phrase change in the indications for use to modify the ordering of the navigation tasks indicated for the device
- . an additional navigation registration mode where the patient reference is attached to the the image and then a paired point registration is performed to register the imaging and navigation coordinate frames
#### Indications for Use:
The nView s1 is intended as an imaging system to provide both 2D and 3D imaging of adult and pediatric populations over 6 years of age. The device is intended to provide fluoroscopic and tomographic imaging of patients during orthopedic surgical procedures where the clinician benefits from 3D visualization of complex anatomical structures, such as high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of the upper and lower extremities.
The nView s1 is indicated to image human anatomy up to 30 cm thickness.
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The nView s1 is not indicated for mammographic or lung nodule applications.
The nView s1 with navigation option is intended as a navigation system to localize anatomical structures in spine fusion procedures for tasks such as identifying vertebrae, and identifying entry points in the thoracic and lumbar spine regions; and for the task of pilot hole verification for pedicle screw placement of 4.5 mm screws in the thoracic and lumbar spine regions. The navigation option is indicated for posterior approach open spinal procedures in pediatic populations over 6 years of age in which the use of stereotactic surgery may be appropriate, and where reference to a rigid spinous process can be identified relative to nView s1 images of the anatomy.
## Comparison of Technology with Predicate
#### Intended Use
| SUBJECT<br>DEVICE<br>nView s1 with nav<br>option | The nView s1 is intended as an imaging system to provide both 2D and 3D imaging of adult<br>and pediatric populations over 6 years of age. The device is intended to provide fluoroscopic<br>and tomographic imaging of patients during orthopedic surgical procedures where the<br>clinician benefits from 3D visualization of complex anatomical structures, such as high<br>contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint<br>fractures of the upper and lower extremities.<br><br>The nView s1 is indicated to image human anatomy up to 30 cm thickness.<br>The nView s1 is not indicated for mammographic or lung nodule applications.<br><br>The nView s1 with navigation option is intended as a navigation system to localize<br>anatomical structures in spine fusion procedures for tasks such as identifying vertebrae, and<br>identifying entry points in the thoracic and lumbar spine regions; and for the task of pilot hole<br>verification for pedicle screw placement of 4.5 mm screws in the thoracic and lumbar spine<br>regions. The navigation option is indicated for posterior approach open spinal procedures in<br>pediatric populations over 6 years of age in which the use of stereotactic surgery may be<br>appropriate, and where reference to a rigid spinous process can be identified relative to<br>nView s1 images of the anatomy. |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PREDICATE<br>DEVICE<br>nView s1 with nav<br>option (K211064) | The nView s1 is intended as an imaging system to provide both 2D and 3D imaging of adult<br>and pediatric populations over 6 years of age. The device is intended to provide fluoroscopic<br>and tomographic imaging of patients during orthopedic surgical procedures where the<br>clinician benefits from 3D visualization of complex anatomical structures, such as high<br>contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint<br>fractures of the upper and lower extremities.<br><br>The nView s1 is indicated to image human anatomy up to 30 cm thickness.<br>The nView s1 is not indicated for mammographic or lung nodule applications.<br><br>The nView s1 with navigation option is intended as a navigation system to aid in pilot hole<br>verification for pedicle screw placement of 4.5 mm screws in the thoracic and lumbar spine<br>regions. The navigation option is indicated for posterior approach open spinal procedures in<br>pediatric populations over 6 years of age in which the use of stereotactic surgery may be<br>appropriate, and where reference to a rigid spinous process can be identified relative to<br>nView s1 images of the anatomy. |
EQUIVALENT- nView's subject device has essentially the same indications as the predicate. Both devices are indicated for tasks in spine fusion procedures. The phrasing has been updated for formatting only. Both devices have the same patient population, the same reference to a rigid spinous process, and the same use of the nView s1 image.
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## Technological Characteristics
| ATTRIBUTE | SUBJECT DEVICE<br>nView s1 with nav option | PREDICATE DEVICE<br>nView s1 with nav option<br>(K211064) | REFERENCE DEVICE<br>Medtronic StealthStation<br>(K162309) | SUBSTANTIAL<br>EQUIVALENCE |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| target population | adult and pediatric<br>populations over 6 years of<br>age with imaged anatomy up<br>to 30 cm thickness (pediatric<br>only for the navigation<br>option) | adult and pediatric<br>populations over 6 years<br>of age with imaged<br>anatomy up to 30 cm<br>thickness (pediatric only<br>for the navigation option) | all adult and pediatric<br>populations | IDENTICAL to<br>predicate |
| anatomical site | high contrast bony anatomy<br>for imaging, thoracic and<br>lumbar spine for navigation | high contrast bony<br>anatomy for imaging,<br>thoracic and lumbar<br>spine for navigation | | IDENTICAL |
| where used | Hospital/ clinic | Hospital/ clinic | Hospital/ clinic | IDENTICAL |
| Input Power<br>(VAC) | 120 | 120 | 120 | IDENTICAL |
| Mobile Platform | Yes | Yes | Yes | IDENTICAL |
| Imaging Platform | | | | |
| C-arm Gantry | Yes | Yes | N/A | IDENTICAL |
| # of Axes | 6 axes of motion, 1<br>motorized, one tracked with<br>encoders | 6 axes of motion, 1<br>motorized, one tracked<br>with encoders | N/A | IDENTICAL |
| User Interface | Touch control | Touch control | N/A | IDENTICAL |
| Fluoroscopic | Yes - via real-time digital<br>projections | Yes - via real-time digital<br>projections | N/A | IDENTICAL |
| Tomographic | Yes | Yes | N/A | IDENTICAL |
| Tube Type | Stationary Reflective Anode | Stationary Reflective<br>Anode | N/A | IDENTICAL |
| Tube Focal Spot<br>Size | 0.6mm | 0.6 mm | N/A | IDENTICAL |
| X-Ray Tube Max<br>kV/ mA/ W | 75/12/350 | 75/12/350 | N/A | IDENTICAL |
| Detector Type | CMOS Digital Detector | CMOS Digital Detector | N/A | IDENTICAL |
| Detector Shape | Square | Square | N/A | IDENTICAL |
| Detector Size<br>(cm) | 30 cm x 30 cm | 30 cm x 30 cm | N/A | IDENTICAL |
| Detector<br>Resolution | 1952 x 1952 | 1952 x 1952 | N/A | IDENTICAL |
| Distortion Free<br>Imaging | Yes | Yes | N/A | IDENTICAL |
| Collimator/Beam<br>Limiter | Yes | Yes | N/A | IDENTICAL |
| Anatomy<br>Alignment | Physical Markers | Physical Markers | N/A | IDENTICAL |
| Reconstruction<br>Geometry | Multi Arc Source Trajectory | Multi Arc Source<br>Trajectory | N/A | IDENTICAL |
| Dataset<br>Capabilities | 2D and 3D | 2D and 3D | N/A | IDENTICAL |
| ATTRIBUTE | SUBJECT DEVICE<br>nView s1 with nav option | PREDICATE DEVICE<br>nView s1 with nav option<br>(K211064) | REFERENCE DEVICE<br>Medtronic StealthStation<br>(K162309) | SUBSTANTIAL<br>EQUIVALENCE |
| Acquisition time<br>(s) | 2, 4, 8 | 2, 4, 8 | N/A | IDENTICAL |
| Reconstruction<br>Time (s) | 1 to 30 | 1 to 30 | N/A | IDENTICAL |
| 3D resolution<br>(mm) | 0.721 x 0.721 x 0.721 | 0.721 x 0.721 x 0.721 | N/A | IDENTICAL |
| 3D<br>Reconstruction<br>Type (deg) | Maximum of 117 multi arc | Maximum of 117 multi<br>arc | N/A | IDENTICAL |
| 3D reconstruction<br>algorithm | Iterative reconstruction with<br>positivity, denoising<br>regularizers | Iterative reconstruction<br>with positivity,<br>denoising regularizers | N/A | IDENTICAL |
| Navigation Characteristics | | | | |
| Imaging<br>Modality | nView s1 images | nView s1 images | CT, MRI, or fluoro images | EQUIVALENT, the<br>subject and predicate<br>work on the same<br>nView s1 images, the<br>reference device<br>uses generic<br>third-party images. |
| Patient<br>Registration<br>Options | Automatic image<br>registration with patient<br>reference placed before<br>imaging, paired point<br>registration with patient<br>reference placed after<br>imaging | Automatic image<br>registration with patient<br>reference placed before<br>imaging | PointMerge® registration,<br>Tracer™<br>registration, Touch<br>registration,<br>StealthAiR® registration,<br>O-arm® registration,<br>Mechanical based<br>registrations | EQUIVALENT, the<br>subject device<br>supports the identical<br>Automatic<br>registration mode as<br>the predicate, and a<br>paired point<br>registration mode<br>that is equivalent to<br>the PointMerge<br>registration in the<br>reference device. |
| Tracking<br>Technology | Optical infrared Camera | Optical infrared<br>Camera | Optical infrared Camera | IDENTICAL |
| Instrument<br>Tracking Method | passive marker sensor<br>system | passive marker sensor<br>system | passive marker sensor<br>system | IDENTICAL |
| Patient Tracking<br>Method | Via patient reference | Via patient reference | Via patient reference | IDENTICAL |
| Registration<br>Accuracy | 3D positional accuracy with<br>a positional error < 2.0 mm<br>and trajectory angle<br>accuracy error < 2.0<br>degrees immediately after<br>automatic or paired point<br>registration | 3D positional accuracy<br>with a positional error <<br>2.0 mm and trajectory<br>angle accuracy error <<br>2.0 degrees<br>immediately after<br>automatic | Not stated | EQUIVALENT, The<br>subject and predicate<br>have the same<br>accuracy for all<br>supported<br>registration modes |
| Clinical<br>Accuracy | 3D positional accuracy with<br>a positional error ≤ 3.0 mm | 3D positional accuracy<br>with a positional error ≤ | 3D positional accuracy<br>with a mean error ≤ 2.0<br>mm and trajectory angle | EQUIVALENT, The<br>subject has the same<br>accuracy numbers as |
| ATTRIBUTE | SUBJECT DEVICE<br>nView s1 with nav option | PREDICATE DEVICE<br>nView s1 with nav option<br>(K211064) | REFERENCE DEVICE<br>Medtronic StealthStation<br>(K162309) | SUBSTANTIAL<br>EQUIVALENCE |
| | and trajectory angle<br>accuracy error ≤ 3.0<br>degrees with patient<br>reference for spine<br>applications | 3.0 mm and trajectory<br>angle accuracy error ≤<br>3.0 degrees with<br>patient reference for<br>spine applications | accuracy with a mean<br>error ≤ 2.0 degrees for<br>cranial applications | the predicate. The<br>subject and predicate<br>have narrower claims<br>of spine applications<br>only. The accuracy<br>numbers are<br>adjusted from the<br>reference device<br>based on the<br>reduced clinical<br>applications. |
| Visualization Characteristics | | | | |
| Visualization<br>Viewports | 3 user selectable<br>slice/projection viewports | 3 user selectable<br>slice/projection<br>viewports | N/A | IDENTICAL |
| Visualization<br>Crosshairs | 3 plane system with tick<br>marks, controlled by<br>navigated tool when<br>navigating. | 3 plane system with tick<br>marks, controlled by<br>navigated tool when<br>navigating. | N/A | IDENTICAL |
| Measurements | Euclidean distances and<br>angle measurements when<br>moving cross-hairs | Euclidean distances<br>and angle<br>measurements when<br>moving cross-hairs | N/A | IDENTICAL |
| Image scrolling | User driven based on<br>position of anatomy and<br>axis or by navigated tool<br>when navigating. | User driven based on<br>position of anatomy<br>and axis or by<br>navigated tool when<br>navigating. | N/A | IDENTICAL |
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# 13.2 Discussion of similarities and differences vs predicate/reference
#### 13.2.1 Intended Use
The indications for use for the subject and predicate are essentially the same in the subject device and the cleared nView medical nView s1 with nav option (K211064). Both devices are indicated for tasks in spine fusion procedures. The phrasing has been changed for formatting only as discussed in a pre-submission. Both devices have the same patient population, the same reference to a rigid spinous process, and the same use of the nView s1 image.
#### 13.2.2 Technological Characteristics
The technological characteristics governing how the device produces images of human anatomy are identical in the subject device and the predicate nView medical nView s1 with nav option (K211064) system. The technological characteristics governing how the device navigates a surgical tool on images of human anatomy are equivalent in the subject device and the predical nView s1 with nav option (K211064) system. Both systems use an optical tracker and reflective markers to dynamically display a tool on an image. Both systems use a patient reference to track patient motion. Both systems use an automatic registration when the patient reference is attached before the image is taken.
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The characteristics of the subject device paired point registration and the reference device (Medtronic Navigation Inc - StealthStation™ S8 system (K162309) PointMerge registration are technologically equivalent. This registration methodology allows for registration of images taken without a patient reference to register the image to the navigation coordinate system. The method is equivalent in that it uses points found in the image and the same points touched physically on the anatomy to register the image and navigation coordinate frames. The subject device requires the user to set a minimum of 10 points on the anatomy. The reference device allows the user to set a maximum of 4 points on the anatomy. More points will give equivalent or better registration accuracy. Both systems allow the position of the selected point to be refined in the viewer. Both systems register the two sets of points (image based and navigation based) using a point set registration method to find the spatial transformation (e.g.,rotation and translation) that aligns the two sets of points. The subject device uses divots in the bone of the spints. The reference device recommends using "an identifiable anatomical landmark or a fiducial on the skin". A well defined divot made with a specified tool of a fixed diameter and depth such as in the subject device should provide better registration accuracy than the user selecting an identifiable landmark without a defined size. The subject device has the points on the anatomy first, and then the navigation system places the crosshair of the point in the viewer for the user to manually refine. The reference device has the user find points in the image first, and them on the anatomy in order. The order in which the point sets are collected does not impact the registration accuracy. Both systems provide an accuracy verification method after completing the registration by touching one or more of the set points and confirming the crosshairs are centered on the set point in the image. The accuracy of the subject device is identical to the predicate device both with the cleared automatic registration mode, and with the proposed paired point registration mode.
#### Summary of non-clinical test data
The demonstration of substantial equivalence is based on a comparison of features to the predicate devices and on an assessment of non-clinical performance data.
The nView s1 with nav option complies with the mandatory and voluntary standards listed in Table 1 below. The nView s1 with nav option was developed in accordance with the FDA guidance documents listed in Table 2.
| Standards development<br>organization, reference number,<br>and date | Standard name |
|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 21 CFR 1020.30, 32 | Federal Performance Standard for Diagnostic X-ray Systems |
| ES60601-1:2005/(R)2012 and<br>A1:2012 | Medical electrical equipment - Part 1: General requirements for basic safety and<br>essential performance (IEC 60601-1:2005, MOD) |
| IEC 60601-1-2: Edition 4.0 2014-02 | Medical Electrical Equipment, General requirements for basic safety and essential<br>performance - Collateral Standard: Electromagnetic disturbances - Requirements<br>and tests |
| IEC 60601-1-3: Edition 2.1 2013-04 | Medical Electrical Equipment, General requirements for basic safety and essential<br>performance - Collateral Standard: Radiation protection in diagnostic X-ray<br>equipment |
| IEC 60601-1-6: Edition 3.1 2013-10 | Medical electrical equipment. General requirements for basic safety and essential<br>performance - Collateral standard: Usability |
Table 1 - Standards used in the development of nView s1 with nav option
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| Standards development<br>organization, reference number,<br>and date | Standard name |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-2-43: Edition 2.1<br>2017-05 | Medical electrical equipment, Particular requirements for the basic safety and<br>essential performance of X-ray equipment for interventional procedures |
| IEC 60601-2-54: Edition 1.2<br>2018-06 | Medical electrical equipment, Particular requirements for the basic safety and<br>essential performance of X-ray equipment for radiography and radioscopy |
| ISO 14971: Third Edition 2019-12 | Application of risk management to medical devices |
| ISO 10993-1:2018: Fifth edition<br>2018-08 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a<br>risk management process |
| ISO 17665-1:2006: First edition<br>2006-08-15 | Sterilization of health care products - Moist heat - Part 1: Requirements for the<br>development, validation and routine control of a sterilization process for medical<br>devices |
| ASTM F2554-18 | Standard Practice for Measurement of Positional Accuracy of Computer Assisted<br>Surgical Systems |
Table 2 - Guidance documents used in the development of nView s1 with nav option
| Guidance Document Name | Issue Date |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating<br>Substantial Equivalence in Premarket Notifications [510(k)] | July 28, 2014 |
| Guidance for Industry and FDA Staff: Guidance for the Submission Of 510(k)'s for Solid State<br>X-ray Imaging (SSXI) Devices | September 1, 2016 |
| Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submission for<br>Software in Medical Devices | May 11, 2005 |
| Guidance for Industry and FDA Staff: Applying Human Factors and Usability Engineering to<br>Medical Devices | February 3, 2016 |
| Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging Device Premarket<br>Notifications | November 28, 2017 |
| Guidance for Industry and FDA Staff: Content of Premarket Submissions for Management of<br>Cybersecurity in Medical devices | October 18, 2018 |
| Guidance for Industry and FDA Staff: Information to Support a Claim of Electromagnetic<br>Compatibility (EMC) of Electrically-Powered Medical Devices | July 11, 2016 |
| Guidance for Industry and Food and Drug Administration Staff: Medical X-Ray Imaging Devices<br>Conformance with IEC Standards | May 8, 2019 |
| Guidance for Industry and Food and Drug Administration Staff: Policy Clarification for Certain<br>Fluoroscopic Equipment Requirements | May 8, 2019 |
| Draft Guidance for Industry and Food and Drug Administration Staff: Remanufacturing of Medical<br>Devices | June 24, 2021 |
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#### Verification and Validation
Software Documentation for a Moderate Level of Concern software Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. Non-clinical tests were conducted on the subject device during product development.
The risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all requirements have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
Test protocols and quality controls ensure the subject device is safe and effective for intended users, uses and use environments through the design control verification and validation process. The human factor usability validation showed that human factors are addressed in the system in simulated clinical use tests.
Under representative worst-case configuration, the nView s1 with nav option has demonstrated 3D positional accuracy with a positional error < 2.0 mm and trajectory angle accuracy error < 2.0 degrees immediately after automatic or paired point registration. This performance was determined using a cadaveric specimen and utilizing a subset of system components and features that represent the worst-case combinations of all potential system components.
The subject device conforms to the cybersecurity requirementing a process of preventing unauthorized access, modifications, misuse or denial of use, or unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient.
#### Conclusion as to substantial equivalence
In summary, the subject device is substantially equivalent to the subject device has an intended use that is essentially the same as the predicate device and essentially the same technological characteristics as the predical nView s1 with nav option (K211064). The proposed additional registration method utilizes the same scientific methodology as the reference device Medtronic Navigation Inc StealthStation™ S8 system (K162309). Performance testing demonstrates the nView s1 with nav option performs as intended and demonstrates substantial equivalence to the predicate device. No new questions of safety and effectiveness are raised in the subject device.
