(174 days)
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.
The nView system 1 mobile fluoroscopic system is cone beam computed tomography X-ray system and a fluoroscopic X-ray imaging 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, a high voltage generator, X-ray controls, and a mechanical "C" shaped structure which supports the X-ray tube and generator and the image receptor flat panel detector.
The monitor cart is a mobile platform that connects to the mobile C-arm by USB and HDMI cables, and which integrates the flat panel display monitors and user controls.
The nView system 1 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 provides both real-time image capture visualization suitable for use both during surgery or immediately pre or post-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 orthogonal tomographic views.
Here's a breakdown of the acceptance criteria and study information for the nView system 1, based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state a table of acceptance criteria with specific numerical targets. Instead, it relies on demonstrating substantial equivalence to a predicate device (Ziehm Vision RFD 3D, K142740) and compliance with various standards and guidance documents. The primary acceptance criteria appear to be:
- Substantial Equivalence: The device's intended use and technological characteristics are substantially equivalent to the predicate.
- Safety and Effectiveness: The device is safe and effective for its intended users, uses, and use environments.
- Compliance with Standards: The device complies with mandatory and voluntary standards (e.g., 21 CFR 1020.30, ES60601-1, IEC 60601 series, ISO 14971).
- Clinically Acceptable Performance: Performance is clinically acceptable as determined by a qualified expert evaluation.
Based on the provided text, a table can be constructed to show how the nView system 1 aligns with the predicate, rather than explicit numerical acceptance criteria for performance metrics.
| Feature/Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported nView System 1 Performance |
|---|---|---|
| Intended Use | Similar to predicate: 2D and 3D imaging for adult and pediatric populations (all ages), fluoroscopic and tomographic imaging for various surgical procedures, visualization of complex anatomical structures, bones, joints, spine regions, and joint fractures, up to 30 cm thickness. | Subset of Predicate: 2D and 3D imaging of adult and pediatric populations over 6 years of age. Fluoroscopic and tomographic imaging during orthopedic surgical procedures for 3D visualization of complex anatomical structures (high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of the upper and lower extremities). Indicated to image human anatomy up to 30 cm thickness. Not indicated for mammographic or lung nodule applications. |
| Safety | Device is safe for intended users, uses, and environments (demonstrated via risk analysis, V&V, compliance with safety standards). | Risk analysis completed, risk control implemented. Testing results support all requirements met acceptance criteria. Subject device found safe for intended users, uses and use environments through design control V&V process. |
| Effectiveness | Device is effective for intended users, uses, and environments (demonstrated via clinical acceptability, V&V, compliance with performance standards). | Testing results support all requirements met acceptance criteria. Subject device found effective for intended users, uses and use environments through design control V&V process. Clinically acceptable performance per qualified expert evaluation. |
| Image Quality | Equivalent to predicate (Ziehm Vision RFD 3D) for the indicated uses, specifically for high-contrast bony anatomy. | Uses a CMOS Digital Detector (30 cm x 30 cm) with 1952 x 1952 resolution (used in binned mode to be equivalent to predicate resolution). Produces 2D and 3D image datasets. Claimed "clinically acceptable performance." |
| Radiation Dose | Acceptable radiation dose for diagnostic imaging. | Designed to operate at a lower radiation dose than the predicate. Shorter acquisition time (2 or 4 seconds vs. 48 seconds for predicate) reduces radiation and motion artifacts. |
| Technical Attributes | Similar technical characteristics to predicate (e.g., mobile C-arm, X-ray imaging, 3D reconstruction, user interface). | Mobile Fluoroscopic C-Arm, 2D and 3D imaging using X-rays, iterative algorithm for 3D reconstruction. Touch control interface. Utilizes a Multi Arc Source Trajectory for reconstruction geometry. Limited angle reconstruction (117-degree multi-arc scan). CMOS Digital Detector. |
Study Information
The document describes non-clinical testing for substantial equivalence, rather than a specific clinical study with detailed performance metrics.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify a sample size for a test set or the data provenance (country of origin, retrospective/prospective). It mentions "non-clinical tests were conducted on the subject device during product development" and "Additional engineering bench testing was performed including the clinical and non-clinical testing identified in the guidance for submission of 510(k) s for Solid State X-Ray Imaging Devices (SSXI); demonstration of system performance; and an imaging performance evaluation." This implies a series of technical and engineering tests rather than a clinical trial with a specific patient dataset. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
The document states: "It has been demonstrated that the subject device has clinically acceptable performance per a qualified expert evaluation."- Number of experts: Not specified.
- Qualifications: "Qualified expert" is mentioned, but specific qualifications (e.g., specialization, years of experience) are not detailed.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not specify any adjudication method for establishing ground truth or evaluating the device's performance in the described "qualified expert evaluation." -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
The document does not describe a multi-reader, multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The nView system 1 is described as an imaging device, and the AI component (iterative reconstruction algorithm) is integral to its image generation, not an assistive AI layer for human interpretation itself. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The document describes the performance of the "nView system 1," which includes the entire device (C-arm, software, imaging capabilities). The "iterative algorithm" is an intrinsic part of how the device generates its 3D images. Therefore, the standalone performance of the algorithm is the device's imaging performance, as the algorithm is embedded within the device for image reconstruction. The discussion around "clinically acceptable performance" refers to the output of this integrated system. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The document states "clinically acceptable performance per a qualified expert evaluation." This suggests that the "ground truth" for evaluating the clinical acceptability of the images produced by the device was based on expert assessment/consensus of the image quality and diagnostic utility for the stated indications. It does not mention pathology or outcomes data as primary ground truth for the device's imaging output. -
The sample size for the training set:
The document does not specify a training set sample size. While the device uses an "iterative algorithm" for 3D reconstruction, this typically refers to a mathematical process, not necessarily a machine learning algorithm that requires a "training set" in the conventional sense of supervised learning on a large dataset of patient images. If machine learning was involved, the details are not provided. -
How the ground truth for the training set was established:
As no explicit training set or machine learning model is detailed in the submission, the document does not describe how ground truth for a training set was established. The iterative reconstruction algorithm is a computational method for image formation, less dependent on a "ground truth" derived from expert annotations of a training set compared to, say, a CADe or CADx algorithm.
{0}------------------------------------------------
July 8, 2019
Image /page/0/Picture/1 description: The image contains the logos of the U.S. Food and Drug Administration (FDA) and the Department of Health & Human Services. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The Department of Health & Human Services logo is a symbol of three figures in profile, representing health, services, and people.
nView medical, Inc. % Ms. Lisa Last Regulatory Affairs Leader 2681 E. Parleys Way, Suite 107 SALT LAKE CITY UT 84109
Re: K190064
Trade/Device Name: nView system 1 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA, JAK Dated: June 7, 2019 Received: June 12, 2019
Dear Ms. 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/cfpmp/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 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
{1}------------------------------------------------
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. 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) K190064
Device Name nView system 1
Indications for Use (Describe)
n View system 1 is intended to provide both 2D and 3D imaging of adult and pediations over 6 years of age. The device is intended to provide fluoroscopic 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for nView medical. The "n" in nView is blue, while the rest of the letters are dark gray. There is a blue dot above the "i" in nView. Below nView, the word "medical" is written in a smaller font.
510(k) Summary
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: June 7, 2019
Subject Device Information
| Device Name: | nView system 1 |
|---|---|
| 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 |
Predicate Device Information
| Device Name (510(k) number): | Ziehm Vision RFD 3D (K142740) |
|---|---|
| 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 |
Device Description:
Device Identification: The nView system 1 mobile fluoroscopic system is cone beam computed tomography X-ray system and a fluoroscopic X-ray imaging 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, a high voltage generator, X-ray controls, and a mechanical "C" shaped structure which supports the X-ray tube 001 S001 to K190064 nViewSvstem1
{4}------------------------------------------------
S001 to K190064 - Attachment 1 - Updated 510(k) summary and generator and the image receptor flat panel detector.
The monitor cart is a mobile platform that connects to the mobile C-arm by USB and HDMI cables, and which integrates the flat panel display monitors and user controls.
Device Characteristics: The device contains software. It does not contain biologics, drugs, patient-contacting materials, coatings, additives, single-use, or sterile components.
Environment of Use: The device is intended to be used in a hospital facility during surgery.
Brief Written Description of the Device: The nView system 1 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 provides both real-time image capture visualization suitable for use both during surgery or immediately pre or post-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 orthogonal tomographic views.
Indications for Use:
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.
Comparison of Technology with Predicate:
The technological principle of operation for both the predicate devices 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 following tables compare the intended use and technological characteristics of the subject and predicate device.
{5}------------------------------------------------
| SUBJECTDEVICEnView system1 | 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 toprovide fluoroscopic and tomographic imaging of patients during orthopedicsurgical procedures where the clinician benefits from 3D visualization ofcomplex anatomical structures, such as high contrast objects, bones, joints,cervical, thoracic, and lumbar regions of the spine, and joint fractures of theupper 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. |
|---|---|
| PREDICATEDEVICEZiehm VisionRFD 3D(K142740) | The Ziehm Vision RFD 3D system is intended for use in providing both 2Dand 3D medical imaging for all adult and pediatric populations, using pulsedand continuous fluoroscopic imaging.The device provides 2D medical imaging for fluoroscopy, digital subtraction,and acquisition of cine loops during diagnostic interventional and surgicalprocedures where intraoperative imaging and visualization of complexanatomical structures of both lower and higher contrast density arerequired. Such procedures may include but are not limited to those ofinterventional cardiology, heart surgery, hybrid procedures, interventionalradiology, interventional angiography, electrophysiology, pediatrics,endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery,neurology, neurosurgery, critical care, emergency room procedures, andthose procedures visualizing structures of the cervical, thoracic, and lumbarregions of the spine and joint fractures of the upper and lower extremities,and where digital image data is required for Computer-Assisted Surgeryprocedures.The device is also intended to provide 3D medical imaging of patientsduring orthopedic, neurological, intraoperative surgical procedures andwhere the clinician benefits from 3D visualization of complex anatomicalstructures, such as but not limited to those of high contrast objects, bones,joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine,pelvis, acetabulum and joint fractures of the upper and lower extremities,and where digital image and C-arm positioning data is required forComputer-Assisted Surgery procedures.The visualization of such anatomical structures assists the clinician in theclinical outcome. At the discretion of a physician, the device may be usedfor other imaging applications. This device does not support directradiographic film exposures and is not intended for use in performingmammography. The system is not intended for use near MRI systems. |
EQUIVALENT - nView's indications are a subset of the predicate, fully encompassed by the predicate indications. nView system 1 intended use is limited to high contrast imaging only and applicable to a more restricted patient population.
Table 2 – Comparison of attributes for the subject device and predicate device
{6}------------------------------------------------
S001 to K190064 - Attachment 1 - Updated 510(k) summary
| ATTRIBUTE | SUBJECT DEVICEnView system 1 | PREDICATEDEVICEZiehm Vision RFD3D (K142740) | SUBSTANTIAL EQUIVALENCEDISCUSSION |
|---|---|---|---|
| target population | adult and pediatricpopulations over 6years of age withimaged anatomy upto 30 cm thickness | all adult and pediatricpopulations | SUBSTANTIALLYEQUIVALENTnView's target population is asubset, fully encompassed bythe predicate. |
| anatomical site | 2D and 3D imagingof high contrastbony anatomy | 2D imaging of highand lower contrastanatomy, 3D imagingof high contrast bonyanatomy. | SUBSTANTIALLYEQUIVALENTnView's target population is asubset, fully encompassed bythe predicate. |
| where used | Hospital/ clinic | Hospital/ clinic | IDENTICAL |
| Input Power(VAC) | 120 | 120 | IDENTICAL |
| X-Ray Tube MaxkV/ mA/ W | 75/12/350 | 120/250/25k | SUBSTANTIALLYEQUIVALENTThe subject device outputslower power X-ray to optimizeimage quality of thin patients atlower dose |
| Mobile Platform | Yes | Yes | IDENTICAL |
| C-arm Gantry | Yes | Yes | IDENTICAL |
| # of Axes | 6 axes of motion, 1motorized | 4 axes of motion, allmotorized | SUBSTANTIALLYEQUIVALENTThe subject device does notmove during acquisition so doesnot need motorized axes. |
| User Interface | Touch control | Touch control | IDENTICAL |
| Fluoroscopic | Yes - via digitalprojections | Yes - via physicalprojections | SUBSTANTIALLYEQUIVALENTBoth systems provide 2Dprojection visualization. |
| Temporalresolution | 0.5 fps | 25/30 fps standard | SUBSTANTIALLYEQUIVALENTThe predicate has a highertemporal resolution to allow forbroader clinical applicationssuch as interventionalcardiology, hybrid procedures,and interventional angiography.For the clinical applicationsindicated for the subject device, |
| S001 to K190064 - Attachment 1 - Updated"fluoro shots" are used in boththe predicate and subjectdevice. A temporal resolutionof 0.5 fps is consistent with thisclinical use. | |||
| Tomographic | Yes | Yes | IDENTICAL |
| Tube Type | Stationary Anode | Rotating Anode | SUBSTANTIALLYEQUIVALENTBoth systems utilize similarx-ray technology. The predicatehas a rotating anode to accountfor higher power output. |
| Tube Focal SpotSize | 0.6mm | 0.6 mm | IDENTICAL |
| Detector Type | CMOS DigitalDetector | CMOS DigitalDetector | IDENTICAL |
| Detector Shape | Square | Square | IDENTICAL |
| Detector Size(cm) | 30 cm x 30 cm | 20 cm x 20 cm30 cm x 30 cm | IDENTICAL (Predicate hasmultiple configurations) |
| DetectorResolution | 1952 x 1952 | 1024 x 10241536 x 1536 | SUBSTANTIALLYEQUIVALENTnView utilizes a detector withhigher resolution than thepredicate |
| Distortion FreeImaging | Yes | Yes | IDENTICAL |
| Collimator/BeamLimiter | Yes | Yes | IDENTICAL |
| ReconstructionGeometry | Multi Arc SourceTrajectory | Multi Arc SmartScantrajectory | SUBSTANTIALLYEQUIVALENTBoth systems utilize a multipositional scan to acquireimages |
| DatasetCapabilities | 2D and 3D | 2D and 3D | IDENTICAL |
| Acquisition time(s) | 2 or 4 | 48 | SUBSTANTIALLYEQUIVALENTnView utilizes a shorteracquisition time. Thischaracteristic reduces radiationand motion artifacts. |
| ReconstructionTime (s) | 1 to 30 | 8 to 18 | SUBSTANTIALLYEQUIVALENTBoth systems provide a range ofreconstruction time based onimaging parameters. |
| 3D resolution | 512 x 512 x 512 | 512 x 512 x 512 | IDENTICAL |
| 3DReconstructionType (deg) | 117 multi arc | 180 via SmartScanpredicated on 165 | SUBSTANTIALLYEQUIVALENTBoth systems predicated on alimited angle reconstruction |
| 3Dreconstructionalgorithm | Iterative | Iterative | IDENTICAL |
{7}------------------------------------------------
S001 to K190064 - Attachment 1 - Updated 510(k) summary
{8}------------------------------------------------
S001 to K190064 - Attachment 1 - Updated 510(k) summary
Discussion of similarities and differences vs predicate
The subject device has an intended use that is a subset of the predicate device, Ziehm Vision RFD 3D (K142740). Both systems are intended to be used to generate fluoroscopic and tomographic images of human anatomy. The subject device's indications are a reduction of claims from the predicate (less clinical applications and smaller patient population) but are fully encompassed in the predicate indications. There are no new indications or claims for the subject device.
Intended Use
The intended use of the subject device and the predicate device 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". Both systems are intended for 2D and 3D imaging of adult and pediatric populations. The subject device limits use in pediatric populations to patients over 6 years of age and imaged human anatomy up to 30 cm thickness. A reduction in patient population does not result in a new intended use. Both systems are indicated for orthopedic surgical procedures where the clinician benefits from 3D visualization of complex anatomical structures, such as those of high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of the upper and lower extremities. The predicate includes additional claims in the clinical procedures of cardiology, angiography, electrophysiology, urology, gastroenterology, etc. A reduction in the diseases a device is intended to treat do not result in a new intended use as they don't affect the safety and/or effectiveness of the new device.
Technological Characteristics
The technological characteristics governing how the device produces images of human anatomy are the equivalent in the subject device and the cleared Ziehm Vision RFD 3D (K142740) system. Both systems use X-ray to image the anatomy. Both systems are used for fluoroscopic and tomographic imaging.
The predicate displays 2D fluoroscopic views via real-time physical projection images. The subject device displays 2D fluoroscopic views via a digital projection through the 3D tomographic volume. Both systems result in 2D fluoroscopic projection views displayed to the user.
The predicate reconstructs 3D images from a series of X-ray images collected while the gantry is 001 S001 to K190064 nViewSystem1 Page 30
{9}------------------------------------------------
S001 to K190064 - Attachment 1 - Updated 510(k) summary moving around the patient. The subject device reconstructs tomographic images from a series of X-ray images collected while the gantry stays in a fixed position with respect to the patient, but while the X-ray tube rotates within the system. Therefore, motorized axes are not required as the gantry is stationary during acquisition. The predicate device reconstructs tomographic images from a series of X-ray images collected while the gantry rotates and shifts around the patient. Therefore, motorized axes were implemented to automatically move the gantry while acquisitions are occurring.
The Ziehm Vision RFD 3D (K142740) is based on a predicate limited angle device employing 135 degrees (+90 degrees and -45 degrees) of orbital rotation. The Ziehm Vision RFD 3D (K142740) employs a shift-scan-shift (SmartScan) motion of this predicate to increase relative coverage to 180 degrees. 3D images are generated from this shift-scan-shift dataset. The nView system 1 is a limited angle device utilizing a 117-degree multi-arc scan for 3D reconstruction. The images are acquired in two steps, first the gantry is rotated to +30 degrees, and images are collected as the tube rotates 360 degrees. Next, the gantry is rotated to -30 degrees, and images are collected as the tube rotates 360 degrees.
Both the subject device and the predicate device have a fluoroscopic mode. The predicate has a higher temporal resolution to allow for broader clinical applications such as interventional cardiology, hybrid procedures, and interventional angiography. For the clinical applications indicated for the subject device, "fluoro shots" are used in both the predicate and subject device. A temporal resolution of 0.5 fps is consistent with this clinical use.
Both the subject device and the predicate use a 30 cm CMOS detector. The subject device CMOS detector has a higher resolution but is used in a binned mode to be equivalent to the resolution of the predicate device detector. The subject device has a lower power x-ray tube with a fixed anode. A higher power x-ray tube with rotating anode is not required for the subject device with limitations on imaged anatomy thickness. The subject device is designed to operate at a lower radiation dose than the predicate.
The acquisition and reconstruction times for the subject device are faster than the predicate device. This allows the subject device to perform real-time fluoroscopic imaging via digital projections and faster 3D tomographic imaging and does not impact safety or efficacy of the device.
Summary of non-clinical test data
The demonstration of substantial equivalence is based on a comparison of features to the predicate device and on an assessment of non-clinical performance data.
The nView system 1 complies with the mandatory and voluntary standards listed in Table 3 below. The nView system 1 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) |
| Table 3 - Standards used in the development of nView system 1 | ||
|---|---|---|
{10}------------------------------------------------
S001 to K190064 - Attachment 1 -- Updated 510(k),summary
| IEC 60601-1-2: 2014 | Medical Electrical Equipment, General requirements for basic safetyand essential performance - Collateral Standard: Electromagneticdisturbances - Requirements and tests |
|---|---|
| IEC 60601-1-3:2008 +AMD1:2013 | Medical Electrical Equipment, General requirements for basic safetyand essential performance - Collateral Standard: Radiationprotection in diagnostic X-ray equipment |
| IEC 60601-1-6:2010 +AMD1:2013 | Medical electrical equipment, General requirements for basic safetyand essential performance - Collateral standard: Usability |
| IEC 60601-2-43:2010 | Medical electrical equipment, Particular requirements for the basicsafety and essential performance of X-ray equipment forinterventional procedures |
| IEC 60601-2-54:2009 +AMD1:2015 | Medical electrical equipment, Particular requirements for the basicsafety and essential performance of X-ray equipment forradiography and radioscopy |
| ISO 14971: 2007 | Application of risk management to medical devices |
| Table 4 - Guidance documents used in the development of nView system 1 | ||
|---|---|---|
| -- | ------------------------------------------------------------------------ | -- |
| 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 Of510(k)'s for 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 MedicalDevices | July 11, 2016 |
| Guidance for Industry and Food and Drug Administration Staff: MedicalX-Ray Imaging 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 |
Verification and Validation
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
Page 32
{11}------------------------------------------------
S001 to K190064 - Attachment 1 - Updated 510(k) summary 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.
The subject device was tested and found to be 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.
Additional engineering bench testing was performed including the clinical and non-clinical testing identified in the guidance for submission of 510(k) s for Solid State X-Ray Imaging Devices (SSXI); demonstration of system performance; and an imaging performance evaluation.
Conclusion as to substantial equivalence
In summary, the subject device has an intended use that is a subset of the predicate intended use and essentially the same technological characteristics as the predicate Ziehm Vision RFD 3D (K142740). Minor differences that do not impact the decision of substantial equivalency include: the subject device having lower temporal fluoroscopic views generated from tomographic reconstructions, a different acquisition geometry, a lower powered x-ray tube, and faster acquisition and reconstruction times. It has been demonstrated that the subject device has clinically acceptable performance per a qualified expert evaluation. The subject device does not have new functionalities when compared to the predicate device.
§ 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.