(203 days)
No
The summary describes image processing using an iterative algorithm for 3D reconstruction, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The focus is on traditional imaging and navigation technology.
No
The device is described as an "imaging system" used for "fluoroscopic and tomographic imaging" during orthopedic surgical procedures, and an optional "navigation system" to aid in pedicle screw placement. These functions are for visualization and guidance, not for treating a disease or condition.
No
The device is described as an "imaging system" and a "navigation system," intended to provide anatomical visualization during orthopedic surgical procedures. Its purpose is to assist clinicians in visualizing structures and aid in pilot hole verification. While imaging can be used for diagnosis, the explicit "Intended Use / Indications for Use" and "Device Description" sections focus on providing visual information for surgical guidance rather than making a medical diagnosis.
No
The device description explicitly states it consists of two mobile units: a mobile C-arm and a monitor cart, which are hardware components. It also mentions an X-ray tube, image receptor flat panel detector, tracking camera, and navigation instrumentation (surgical probe and patient reference). While it includes software for image processing and navigation, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the living body (in vitro).
- Device Function: The nView s1 is an imaging system that uses X-rays to visualize internal human anatomy within the living body (in vivo) during surgical procedures. It does not analyze samples taken from the patient.
The device is a medical imaging system used for diagnosis and guidance during surgery, which falls under a different regulatory category than IVDs.
N/A
Intended Use / 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. 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 aid in 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 population 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.
Product codes (comma separated list FDA assigned to the subject device)
OWB, OXO, JAA, JAK, OLO
Device Description
The nView s1 with nav option mobile fluoroscopic system is a cone beam computed fluoroscopic and tomographic X-ray system consisting of two mobile units: a 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 markers. The 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.
The device contains software. The nav option tracks single-use sterile navigation instrumentation. It does not contain biologics, drugs, coatings, or additives.
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 direction of a physician. The images from the system assist the physicians in visualizing the patient's anatomy during surgical procedures. The device provides both real-time image 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.
The device performs both 2D and 3D medical imaging generated by means of an iterative algorithm. The system uses the images 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of the upper and lower extremities. For navigation: thoracic and lumbar spine regions.
Indicated Patient Age Range
adult and pediatric populations over 6 years of age. For navigation: pediatric population over 6 years of age.
Intended User / Care Setting
Used in a hospital facility immediately before, during, or after surgery by a clinician/physician.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. The subject device conforms to the cybersecurity requirements by implementing 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The device achieved 3D positional accuracy with a positional error less than or equal to 3.0 mm and trajectory angle accuracy error less than or equal to 3.0 degrees with patient reference for spine applications. This is for the navigation option.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
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.(b)
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.
0
October 29, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
nView medical % Lisa Last Chief Operating Officer 2681 E Parleys Way STE 107 SALT LAKE CITY UT 84109
Re: K211064
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, OXO, OLO, JAK Dated: September 28, 2021 Received: September 29, 2021
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
1
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,
, for
Thalia Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211064
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 sl 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 aid in 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 (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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3
510(k) Summary for K211064
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: October 21, 2021
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 |
| Additional Product Codes: | OXO, JAA, JAK, OLO |
Primary Predicate Device Information
| Device Name (510(k) number): | nView medical - nView system 1 (K190064) |
|---|---|
| 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 |
| Additional Product Codes: | OXO, JAA, JAK |
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: | Stereotactic Instrument |
| Regulatory Class: | |
| Primary Product Code: | HAW |
| Additional Product Codes: | OLO, PGW |
4
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 units: a 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 markers. The 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 direction of a physician. The images from the system assist the physicians in visualizing the patient's anatomy during surgical procedures. The device provides both real-time image 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 the images 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.
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. 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 aid in 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 population 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.
5
Comparison of Technology with Predicate:
The technological principle of operation for both the primary predicate device is limited angle cone beam CT X-ray imaging. It is based on the collection of a series of projection images of the same anatomy, and applying iterative reconstruction techniques to generate a 3D tomographic reconstruction. The technological principle of operation for both the subject and the reference device is optical tracking technology using passive reflective markers. Table 2 compare the intended use and technological characteristics of the subject and predicate devices.
| Table 1 - Intended Use statements for the proposed device and predicate devices |
|---|
| PROPOSED
DEVICE
nView s1 with
nav option | 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 aid in
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. |
|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PRIMARY
PREDICATE
DEVICE
nView system 1
(K190064) | nView system 1 is intended 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 device is indicated to image human anatomy up to 30 cm thickness.
The device is not indicated for mammographic or lung nodule applications. |
| REFERENCE
DEVICE
Medtronic
Navigation Inc
StealthStation™
S8 system
(K162309) | The StealthStation™ System is intended as an aid for precisely locating anatomical
structures in either open or percutaneous surgical procedures. The
StealthStationTM System is indicated for any medical condition in which the use of
stereotactic surgery may be appropriate, and where reference to a rigid anatomical
structure, such as the skull, a long bone, or vertebra, can be identified relative to a
CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. |
EQUIVALENT - n\View's indications are a subset of the predicates, fully encompassed by the predicates indications. nView s1 with nav option intended use is limited to navigation during orthopedic procedures on the nView s1 images only.
6
| ATTRIBUTE | PROPOSED
DEVICE
nView s1 with nav
option | PRIMARY
PREDICATE
DEVICE
nView system 1
(K190064) | REFERENCE
DEVICE
Medtronic
Navigation Inc
StealthStation™
S8 system
(K162309) | SUBSTANTIAL
EQUIVALENCE
DISCUSSION | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| target
population | adult and pediatric
populations over 6
years of age with
imaged anatomy
up to 30 cm
thickness
(pediatric only for
the navigation
option) | adult and
pediatric
populations over
6 years of age
with imaged
anatomy up to
30 cm thickness | all adult and
pediatric
populations | EQUIVALENT
nView's target population is a
subset, fully encompassed
by the predicates. | |
| anatomical site | high contrast bony
anatomy for
imaging, thoracic
and lumbar spine
for navigation | high contrast
bony anatomy | rigid anatomy
such as the
skull, a long
bone, or
vertebra, | EQUIVALENT
nView's target population is
identical to the primary
predicate for imaging and is
a subset, fully encompassed
by the reference device for
navigation. | |
| where used | Hospital/ clinic | Hospital/ clinic | Hospital | IDENTICAL | |
| Input Power
(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
motorized, one
tracked with
encoders | 6 axes of
motion, 1
motorized | N/A | EQUIVALENT
The proposed device has the
same degrees of freedom,
with an added encoder for
one DOF. | |
| User Interface | Touch control | Touch control | N/A | IDENTICAL | |
| Fluoroscopic | Yes - via real-time
digital projections | Yes - via
real-time digital
projections | N/A | IDENTICAL | |
| Tomographic | Yes | Yes | N/A | IDENTICAL | |
| Tube Type | Stationary
Reflective Anode | Stationary
Reflective
Anode | N/A | IDENTICAL | |
| Tube Focal Spot
Size | 0.6mm | 0.6 mm | N/A | IDENTICAL | |
| X-Ray Tube
Max 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
(cm) | 30 cm x 30 cm | 30 cm x 30 cm | N/A | IDENTICAL | |
| Detector
Resolution | 1952 x 1952 | 1952 x 1952 | N/A | IDENTICAL | |
| Distortion Free
Imaging | Yes | Yes | N/A | IDENTICAL | |
| Collimator/Bea
m Limiter | Yes | Yes | N/A | IDENTICAL | |
| Anatomy
Alignment | Physical Markers | Physical
Markers | N/A | IDENTICAL | |
| Reconstruction
Geometry | Multi Arc Source
Trajectory | Multi Arc Source
Trajectory | N/A | IDENTICAL | |
| Dataset
Capabilities | 2D and 3D | 2D and 3D | N/A | IDENTICAL | |
| Acquisition time
(s) | 2, 4, 8 | 2 or 4 | N/A | EQUIVALENT
Both systems provide a
range of acquisition times
based on the clinical
scenario | |
| Reconstruction
Time (s) | 1 to 30 | 1 to 30 | N/A | IDENTICAL | |
| 3D resolution
(mm) | 0.721 x 0.721 x
0.721 | 1.00 x 1.00 x
1.00 | N/A | EQUIVALENT
The proposed device has
increased resolution | |
| 3D
Reconstruction
Type (deg) | Maximum of 117
multi arc | 117 multi arc | N/A | EQUIVALENT
Both systems predicated on
a limited angle reconstruction | |
| 3D
reconstruction
algorithm | Iterative
reconstruction
with positivity,
denoising
regularizers | Iterative
reconstruction
with positivity,
denoising
regularizers | N/A | IDENTICAL | |
| Navigation Characteristics | | | | | |
| Imaging
Modality | nView s1 images | N/A | X-Ray based,
MR based,
Nuclear
Medicine
based | EQUIVALENT
The proposed device works
only using nView s1 images,
instead of generic third-party
images. | |
| Patient
Registration
Options | Automatic image
registration with
patient reference | N/A | PointMerge®
registration,
Tracer™
registration.
Touch
registration,
StealthAiR®
registration,
O-arm®
registration,
Mechanical
based | EQUIVALENT
The proposed device uses
only one registration method,
a subset of the reference
device. | |
| | | | registrations | | |
| Tracking
Technology | Optical infrared
Camera | N/A | Optical infrared
Camera | IDENTICAL | |
| Instrument
Tracking
Method | passive marker
sensor system | N/A | passive marker
sensor system | IDENTICAL | |
| Patient
Tracking
Method | Via patient
reference | N/A | Via patient
reference | IDENTICAL | |
| Clinical
Accuracy | 3D positional
accuracy with a
positional error ≤
3.0 mm and
trajectory angle
accuracy error ≤
3.0 degrees with
patient reference
for spine
applications | N/A | 3D positional
accuracy with a
mean error ≤
2.0 mm and
trajectory angle
accuracy with a
mean error ≤
2.0 degrees for
cranial
applications | EQUIVALENT
The proposed has narrower
claims of spine applications
only. The accuracy numbers
are adjusted based on the
reduced clinical applications. | |
| | Visualization Characteristics | | | | |
| Visualization
Viewports | 3 user selectable
slice/projection
viewports | 3 slice
viewports, 3
projection
viewports | 2 or 4 user
configurable
slice viewports
with instrument
overlay. | EQUIVALENT
All devices have user
configurable viewports. | |
| Visualization
Crosshairs | 3 plane system
with tick marks,
controlled by
navigated tool
when navigating. | 3 plane system
with no tick
marks | Controlled by
navigated tool,
with or without
tick marks. | EQUIVALENT
The proposed device utilizes
the same crosshairs, but with
tick marks added and
controlled by navigated tool
when navigating. | |
| Measurements | Euclidean
distances and
angle
measurements
when moving
cross-hairs | N/A | Measurements
available based
on the type of
view the user
selects | EQUIVALENT
Both devices utilize
measurement features | |
| Image scrolling | User driven
based on position
of anatomy and
axis or by
navigated tool
when navigating. | User driven
based on
position of axis | User driven
based on
navigated tool | EQUIVALENT
Both imaging systems
display images and scrolling
with respect to the displayed
axises. The proposed device
can adjust the axis and
therefore scrolling of images
to align with anatomy. Both
navigation systems control | |
7
8
9
| navigated tool. |
|---|
| ----------------- |
Discussion of similarities and differences vs predicates
The proposed subject device has an intended use that, for imaging, is identical to the primary predicate device, nView medical nView system 1 (K190064) and, for navigation, a subset of the reference device, Medtronic Navigation Inc, StealthStation™ S8 System (K162309). The subject device's indications are a reduction of claims from the reference device (less clinical applications and smaller patient population) but are fully encompassed in the reference device indications. There are no new indications or claims for the subject device.
Intended Use
The intended use of the proposed device and the predicate devices are the same within the guidance of "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff. Document issued on: July 28, 2014". The intended use of the imaging portion is identical to the primary predicate device. For the navigation system, the proposed device has a narrow indication for verifying pilot holes when placing pedicle screws. This indication is within the broad indications of the reference device. Additionally, for navigation the proposed device has a narrow patient population, pediatrics over the age of six. This population is within the broad patient population of the reference device. The proposed device intended use is fully encompassed by the reference device and does not include any new indications. A reduction in the clinical applications and patient population does not result in a new intended use.
Technological Characteristics
The technological characteristics governing how the device produces images of human anatomy are the equivalent in the proposed device and the cleared nView s1 (K190064) system. Both systems use X-ray to image the anatomy. Both systems are used for fluoroscopic and tomographic imaging. The technological characteristics governing how the device navigates a surgical tool on images of human anatomy are the equivalent in the proposed device and the cleared Medtronic Navigation Inc, StealthStation™ S8 System (K162309) system. Both systems use an optical tracker and reflective markers on instruments to dynamically display a tool on an image.
Primary Predicate
Both systems display 2D fluoroscopic views in real-time via a digital projection through the 3D tomographic volume. Both systems result in real-time 2D fluoroscopic projection views displayed to the user.
Both systems reconstruct 3D images from a series of fluoroscopic images collected at different angles using the same reconstruction algorithms. The proposed system allows for easier positioning of the C-arm for stereotactic imaging by utilizing an encoder to measure the C-arm position instead of requiring the user to move the system exactly to -30 and + 30 degrees. The proposed device has additional imaging modes to better suit different anatomies.
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The proposed device has improved interaction with the images on the monitor. It utilizes the identical monitor and touchscreen, and a similar multi viewport viewer. It adds improved scrolling through images by adjusting the scrolling axis to align with the anatomy.
The proposed device has the ability to combine two adjacent images to create a longer view of the anatomy. This is done through the same acquisition and reconstruction process as a stereotactic image.
Reference Device
The subject device uses an equivalent optical camera and reflective spheres for navigation as the reference device. The subject uses the same methodology of tracking the C-arm and patient with passive markers. The subject device only navigates on the nView s1 images, the reference device navigates on several third-party imaging technologies such as CT, MRI, fluoroscopy, and an internal technology, the O-arm. The reference device offers several types of registration based on the clinical application and surgeon preference. The subject device utilizes one of those registration types, automatic registration. The subject device has accuracy requirements based on the clinical application of spine. The reference device has a more stringent accuracy requirement to support the additional claims in cranial and ENT procedures.
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 3 below. The nView s1 with nav option was developed in accordance with the FDA guidance documents listed in Table 4.
| Standards development
organization, reference
| number, and date | Standard name |
|---|---|
| 21 CFR 1020.30, 32 | Federal Performance Standard for Diagnostic X-ray Systems |
| ES60601-1:2005/(R)2012 | |
| and A1:2012 | Medical electrical equipment - Part 1: General requirements for |
| basic safety and 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 performance - Collateral Standard: Electromagnetic | |
| disturbances - Requirements and tests | |
| IEC 60601-1-3: Edition 2.1 | |
| 2013-04 | Medical Electrical Equipment, General requirements for basic safety |
| and essential performance - Collateral Standard: Radiation | |
| protection in diagnostic X-ray equipment | |
| IEC 60601-1-6: Edition 3.1 | |
| 2013-10 | Medical electrical equipment, General requirements for basic safety |
| and essential performance - Collateral standard: Usability | |
| IEC 60601-2-43: Edition 2.1 | |
| 2017-05 | Medical electrical equipment, Particular requirements for the basic |
| safety and essential performance of X-ray equipment for | |
| interventional procedures |
Table 3 - Standards used in the development of nView s1 with nav option
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| IEC 60601-2-54: Edition 1.2
2018-06 | Medical electrical equipment, Particular requirements for the basic
safety and 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 2018-08 | Biological evaluation of medical devices — Part 1: Evaluation and
testing within a risk management process |
| ISO 17665-1:2006: First
edition 2006-08-15 | Sterilization of health care products — Moist heat — Part 1:
Requirements for the development, validation and routine control of
a sterilization process for medical devices |
| ASTM F2554-18 | Standard Practice for Measurement of Positional Accuracy of
Computer Assisted Surgical Systems |
Table 4 - 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 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 X-ray Imaging (SSXI) Devices | September 1, |
| 2016 | |
| Guidance for Industry and FDA Staff: Guidance for the Content of Premarket | |
| Submission for Software in Medical Devices | May 11, 2005 |
| Guidance for Industry and FDA Staff: Applying Human Factors and Usability | |
| Engineering to Medical Devices | February 3, 2016 |
| Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging | |
| Device Premarket Notifications | November 28, |
| 2017 | |
| Guidance for Industry and FDA Staff: Content of Premarket Submissions for | |
| Management of Cybersecurity in Medical devices | October 18, 2018 |
| Guidance for Industry and FDA Staff: Information to Support a Claim of | |
| Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices | July 11, 2016 |
| Guidance for Industry and Food and Drug Administration Staff: Medical X-Ray | |
| Imaging Devices Conformance with IEC Standards | May 8, 2019 |
| Guidance for Industry and Food and Drug Administration Staff: Policy | |
| Clarification for Certain Fluoroscopic Equipment Requirements | May 8, 2019 |
| Draft Guidance for Industry and Food and Drug Administration Staff: | |
| Remanufacturing of Medical Devices | June 24, 2021 |
Verification and Validation
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document
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"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.
The subject device conforms to the cybersecurity requirements by implementing 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 primary and reference device. The subject device has, for imaging, an intended use that is identical to the primary predicate intended use and, for navigation, a narrow subset of the reference device intended use and essentially the same technological characteristics as the predicates nView system 1 (K190064) and Medtronic Navigation Inc StealthStation™ S8 system (K162309). Minor differences that do not impact the decision of substantial equivalency include: the subject device having additional imaging and dose modes, an integrated navigation option equivalent to the reference device, and improved image visualization.