(203 days)
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.
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 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 provided text does not contain detailed information about a study proving the device meets specific acceptance criteria in a quantitative manner (e.g., sensitivity, specificity, or specific error rates with confidence intervals). Instead, it discusses the device's conformance to various medical device standards and guidance documents, as well as a comparison to predicate devices, to demonstrate substantial equivalence.
However, based on the text, we can infer some "acceptance criteria" related to performance characteristics and the device's adherence to standards. The document primarily focuses on demonstrating substantial equivalence to predicate devices.
Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since specific quantitative performance acceptance criteria (e.g., accuracy thresholds for diagnostic tasks) and corresponding reported performance metrics (e.g., measured sensitivity, specificity) are not explicitly stated in the provided document, I will infer the "acceptance criteria" from the comparison attributes to predicate devices and the clinical accuracy stated for the navigation option. The "reported device performance" will be the values specified for the proposed device itself.
| Acceptance Criteria (Inferred from Predicate Comparison & Device Claims) | Reported Device Performance (as stated for nView s1 with nav option) |
|---|---|
| Imaging System Performance | |
| 2D and 3D imaging capability for adult and pediatric populations over 6 years of age | Provides both 2D and 3D imaging of adult and pediatric populations over 6 years of age. |
| Fluoroscopic and tomographic imaging for orthopedic surgical procedures, high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of upper/lower extremities | 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. |
| Image human anatomy up to 30 cm thickness | Indicated to image human anatomy up to 30 cm thickness. |
| Not indicated for mammographic or lung nodule applications | Not indicated for mammographic or lung nodule applications. |
| Imaging acquisition time comparable to predicate (e.g., 2 or 4 seconds) | 2, 4, 8 seconds |
| Reconstruction Time | 1 to 30 seconds |
| 3D resolution | 0.721 x 0.721 x 0.721 mm (Improved compared to primary predicate's 1.00 x 1.00 x 1.00 mm) |
| Navigation System Performance (for pilot hole verification of 4.5 mm pedicle screws in thoracic and lumbar spine) | |
| Aid in pilot hole verification for pedicle screw placement of 4.5 mm screws in thoracic and lumbar spine regions | 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. |
| Posterior approach open spinal procedures in pediatric populations over 6 years of age | 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. |
| 3D positional accuracy (for spine applications) | Positional error ≤ 3.0 mm |
| Trajectory angle accuracy (for spine applications) | Trajectory angle accuracy error ≤ 3.0 degrees |
| Adherence to relevant standards (e.g., electrical safety, EMC, radiation protection, risk management, usability) | Compliance with 21 CFR 1020.30, 32; ES60601-1; IEC 60601-1-2, -1-3, -1-6, -2-43, -2-54; ISO 14971; ISO 10993-1; ISO 17665-1; ASTM F2554-18, and FDA guidance documents. Risk analysis completed, risk controls implemented. Human factors usability validation performed. Cybersecurity requirements met. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any clinical test or test set, nor does it provide details on data provenance (e.g., country of origin, retrospective/prospective nature) for performance evaluation. The "Summary of non-clinical test data" mentions "Non-clinical tests were conducted on the subject device during product development" and "Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence." However, no numbers or details on the nature of these tests are provided.
3. Number of Experts Used to Establish Ground Truth & Qualifications
The document does not mention any details regarding experts used to establish ground truth or their qualifications. The evaluation of the device appears to be based on engineering verification and validation, and comparison to predicate devices, rather than a clinical study requiring expert ground truth for specific diagnostic or interventional tasks.
4. Adjudication Method
No information is provided regarding an adjudication method. This is expected given the lack of specific details about a clinical study involving human readers or expert panels.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it mention any effect size of human readers improving with AI vs. without AI assistance. The device is a navigation and imaging system, not an AI-assisted diagnostic tool in the sense that would typically warrant such a study.
6. Standalone Performance Study (Algorithm Only)
The document does not explicitly describe a standalone algorithm-only performance study. The core function of the device is to generate images and provide navigation guidance based on those images for human use during surgery. The performance metrics (e.g., 3D positional accuracy) are related to the system's ability to accurately localize, which is part of its integrated design.
7. Type of Ground Truth Used
Based on the nature of the device (imaging and navigation system for surgical procedures) and the limited information provided, the ground truth for the stated accuracy claims (positional and angular accuracy) would typically be established through phantom studies or cadaveric models using known, precise measurements as ground truth, validated against physical markers or reference systems. However, the document does not explicitly state the type of ground truth used for these specific measurements, only that "non-clinical tests were conducted" and "Testing for verification and validation for the device was found acceptable."
8. Sample Size for the Training Set
The document does not specify a training set sample size. This is not applicable in the context of the information provided, as the submission focuses on hardware and integrated software for imaging and navigation, not a machine learning model that would typically require a training set.
9. How Ground Truth for the Training Set Was Established
Since no training set is mentioned or implied for a machine learning model, this information is not applicable and therefore not provided in the document.
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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
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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,
, 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
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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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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 |
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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 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.
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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 |
|---|
| PROPOSEDDEVICEnView s1 withnav option | The nView s1 is intended as an imaging system to provide both 2D and 3D imagingof adult and pediatric populations over 6 years of age. The device is intended toprovide fluoroscopic and tomographic imaging of patients during orthopedicsurgical procedures where the clinician benefits from 3D visualization of complexanatomical structures, such as high contrast objects, bones, joints, cervical,thoracic, and lumbar regions of the spine, and joint fractures of the upper and lowerextremities.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 inpilot hole verification for pedicle screw placement of 4.5 mm screws in the thoracicand lumbar spine regions. The navigation option is indicated for posterior approachopen spinal procedures in pediatric populations over 6 years of age in which theuse of stereotactic surgery may be appropriate, and where reference to a rigidspinous process can be identified relative to nView s1 images of the anatomy. |
|---|---|
| PRIMARYPREDICATEDEVICEnView system 1(K190064) | nView system 1 is intended to provide both 2D and 3D imaging of adult andpediatric populations over 6 years of age. The device is intended to providefluoroscopic and tomographic imaging of patients during orthopedic surgicalprocedures where the clinician benefits from 3D visualization of complexanatomical structures, such as high contrast objects, bones, joints, cervical,thoracic, and lumbar regions of the spine, and joint fractures of the upper and lowerextremities.The device is indicated to image human anatomy up to 30 cm thickness.The device is not indicated for mammographic or lung nodule applications. |
| REFERENCEDEVICEMedtronicNavigation IncStealthStation™S8 system(K162309) | The StealthStation™ System is intended as an aid for precisely locating anatomicalstructures in either open or percutaneous surgical procedures. TheStealthStationTM System is indicated for any medical condition in which the use ofstereotactic surgery may be appropriate, and where reference to a rigid anatomicalstructure, such as the skull, a long bone, or vertebra, can be identified relative to aCT 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.
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| ATTRIBUTE | PROPOSEDDEVICEnView s1 with navoption | PRIMARYPREDICATEDEVICEnView system 1(K190064) | REFERENCEDEVICEMedtronicNavigation IncStealthStation™S8 system(K162309) | SUBSTANTIALEQUIVALENCEDISCUSSION | |
|---|---|---|---|---|---|
| targetpopulation | adult and pediatricpopulations over 6years of age withimaged anatomyup to 30 cmthickness(pediatric only forthe navigationoption) | adult andpediatricpopulations over6 years of agewith imagedanatomy up to30 cm thickness | all adult andpediatricpopulations | EQUIVALENTnView's target population is asubset, fully encompassedby the predicates. | |
| anatomical site | high contrast bonyanatomy forimaging, thoracicand lumbar spinefor navigation | high contrastbony anatomy | rigid anatomysuch as theskull, a longbone, orvertebra, | EQUIVALENTnView's target population isidentical to the primarypredicate for imaging and isa subset, fully encompassedby the reference device fornavigation. | |
| 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, 1motorized, onetracked withencoders | 6 axes ofmotion, 1motorized | N/A | EQUIVALENTThe proposed device has thesame degrees of freedom,with an added encoder forone DOF. | |
| User Interface | Touch control | Touch control | N/A | IDENTICAL | |
| Fluoroscopic | Yes - via real-timedigital projections | Yes - viareal-time digitalprojections | N/A | IDENTICAL | |
| Tomographic | Yes | Yes | N/A | IDENTICAL | |
| Tube Type | StationaryReflective Anode | StationaryReflectiveAnode | N/A | IDENTICAL | |
| Tube Focal SpotSize | 0.6mm | 0.6 mm | N/A | IDENTICAL | |
| X-Ray TubeMax kV/ mA/ W | 75/12/350 | 75/12/350 | N/A | IDENTICAL | |
| Detector Type | CMOS DigitalDetector | CMOS DigitalDetector | 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 | |
| DetectorResolution | 1952 x 1952 | 1952 x 1952 | N/A | IDENTICAL | |
| Distortion FreeImaging | Yes | Yes | N/A | IDENTICAL | |
| Collimator/Beam Limiter | Yes | Yes | N/A | IDENTICAL | |
| AnatomyAlignment | Physical Markers | PhysicalMarkers | N/A | IDENTICAL | |
| ReconstructionGeometry | Multi Arc SourceTrajectory | Multi Arc SourceTrajectory | N/A | IDENTICAL | |
| DatasetCapabilities | 2D and 3D | 2D and 3D | N/A | IDENTICAL | |
| Acquisition time(s) | 2, 4, 8 | 2 or 4 | N/A | EQUIVALENTBoth systems provide arange of acquisition timesbased on the clinicalscenario | |
| ReconstructionTime (s) | 1 to 30 | 1 to 30 | N/A | IDENTICAL | |
| 3D resolution(mm) | 0.721 x 0.721 x0.721 | 1.00 x 1.00 x1.00 | N/A | EQUIVALENTThe proposed device hasincreased resolution | |
| 3DReconstructionType (deg) | Maximum of 117multi arc | 117 multi arc | N/A | EQUIVALENTBoth systems predicated ona limited angle reconstruction | |
| 3Dreconstructionalgorithm | Iterativereconstructionwith positivity,denoisingregularizers | Iterativereconstructionwith positivity,denoisingregularizers | N/A | IDENTICAL | |
| Navigation Characteristics | |||||
| ImagingModality | nView s1 images | N/A | X-Ray based,MR based,NuclearMedicinebased | EQUIVALENTThe proposed device worksonly using nView s1 images,instead of generic third-partyimages. | |
| PatientRegistrationOptions | Automatic imageregistration withpatient reference | N/A | PointMerge®registration,Tracer™registration.Touchregistration,StealthAiR®registration,O-arm®registration,Mechanicalbased | EQUIVALENTThe proposed device usesonly one registration method,a subset of the referencedevice. | |
| registrations | |||||
| TrackingTechnology | Optical infraredCamera | N/A | Optical infraredCamera | IDENTICAL | |
| InstrumentTrackingMethod | passive markersensor system | N/A | passive markersensor system | IDENTICAL | |
| PatientTrackingMethod | Via patientreference | N/A | Via patientreference | IDENTICAL | |
| ClinicalAccuracy | 3D positionalaccuracy with apositional error ≤3.0 mm andtrajectory angleaccuracy error ≤3.0 degrees withpatient referencefor spineapplications | N/A | 3D positionalaccuracy with amean error ≤2.0 mm andtrajectory angleaccuracy with amean error ≤2.0 degrees forcranialapplications | EQUIVALENTThe proposed has narrowerclaims of spine applicationsonly. The accuracy numbersare adjusted based on thereduced clinical applications. | |
| Visualization Characteristics | |||||
| VisualizationViewports | 3 user selectableslice/projectionviewports | 3 sliceviewports, 3projectionviewports | 2 or 4 userconfigurableslice viewportswith instrumentoverlay. | EQUIVALENTAll devices have userconfigurable viewports. | |
| VisualizationCrosshairs | 3 plane systemwith tick marks,controlled bynavigated toolwhen navigating. | 3 plane systemwith no tickmarks | Controlled bynavigated tool,with or withouttick marks. | EQUIVALENTThe proposed device utilizesthe same crosshairs, but withtick marks added andcontrolled by navigated toolwhen navigating. | |
| Measurements | Euclideandistances andanglemeasurementswhen movingcross-hairs | N/A | Measurementsavailable basedon the type ofview the userselects | EQUIVALENTBoth devices utilizemeasurement features | |
| Image scrolling | User drivenbased on positionof anatomy andaxis or bynavigated toolwhen navigating. | User drivenbased onposition of axis | User drivenbased onnavigated tool | EQUIVALENTBoth imaging systemsdisplay images and scrollingwith respect to the displayedaxises. The proposed devicecan adjust the axis andtherefore scrolling of imagesto align with anatomy. Bothnavigation systems control |
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| 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 developmentorganization, referencenumber, and date | Standard name |
|---|---|
| 21 CFR 1020.30, 32 | Federal Performance Standard for Diagnostic X-ray Systems |
| ES60601-1:2005/(R)2012and A1:2012 | Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance (IEC 60601-1:2005, MOD) |
| IEC 60601-1-2: Edition 4.02014-02 | Medical Electrical Equipment, General requirements for basic safetyand essential performance - Collateral Standard: Electromagneticdisturbances - Requirements and tests |
| IEC 60601-1-3: Edition 2.12013-04 | Medical Electrical Equipment, General requirements for basic safetyand essential performance - Collateral Standard: Radiationprotection in diagnostic X-ray equipment |
| IEC 60601-1-6: Edition 3.12013-10 | Medical electrical equipment, General requirements for basic safetyand essential performance - Collateral standard: Usability |
| IEC 60601-2-43: Edition 2.12017-05 | Medical electrical equipment, Particular requirements for the basicsafety and essential performance of X-ray equipment forinterventional procedures |
Table 3 - Standards used in the development of nView s1 with nav option
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| IEC 60601-2-54: Edition 1.22018-06 | Medical electrical equipment, Particular requirements for the basicsafety and essential performance of X-ray equipment forradiography and radioscopy |
|---|---|
| ISO 14971: Third Edition2019-12 | Application of risk management to medical devices |
| ISO 10993-1:2018: Fifthedition 2018-08 | Biological evaluation of medical devices — Part 1: Evaluation andtesting within a risk management process |
| ISO 17665-1:2006: Firstedition 2006-08-15 | Sterilization of health care products — Moist heat — Part 1:Requirements for the development, validation and routine control ofa sterilization process for medical devices |
| ASTM F2554-18 | Standard Practice for Measurement of Positional Accuracy ofComputer 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)'sfor Solid State X-ray Imaging (SSXI) Devices | September 1,2016 |
| Guidance for Industry and FDA Staff: Guidance for the Content of PremarketSubmission for Software in Medical Devices | May 11, 2005 |
| Guidance for Industry and FDA Staff: Applying Human Factors and UsabilityEngineering to Medical Devices | February 3, 2016 |
| Guidance for Industry and FDA Staff: Pediatric Information for X-ray ImagingDevice Premarket Notifications | November 28,2017 |
| Guidance for Industry and FDA Staff: Content of Premarket Submissions forManagement of Cybersecurity in Medical devices | October 18, 2018 |
| Guidance for Industry and FDA Staff: Information to Support a Claim ofElectromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices | July 11, 2016 |
| Guidance for Industry and Food and Drug Administration Staff: Medical X-RayImaging Devices Conformance with IEC Standards | May 8, 2019 |
| Guidance for Industry and Food and Drug Administration Staff: PolicyClarification 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.
§ 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.