NuVasive NuvaLine
Device Facts
| Record ID | K192435 |
|---|---|
| Device Name | NuVasive NuvaLine |
| Applicant | Nu Vasive, Incorporated |
| Product Code | LLZ · Radiology |
| Decision Date | Sep 26, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, 3rd-Party Reviewed |
Indications for Use
NuVasive NuvaLine is a medical device software application intended to assist healthcare professionals in capturing, viewing, measuring, and storage and distribution of spinal alignment assessment images at various time points in patient care. Online synchronization of the database allows healthcare professionals and service providers to conveniently perform and review spinal alignment assessments of images by featuring measurement tools on various platforms. Clinical judgment and experience are required to properly use the software.
Device Story
NuVasive NuvaLine is a software application for spinal alignment assessment; inputs include spinal X-ray images transferred from PACS; software calculates spinal, pelvic, lumbar, thoracic, and cervical parameters; outputs include quantifiable measurements for pre-operative and post-operative assessment; used by healthcare professionals in clinical settings; operates on mobile devices (iOS) and web interfaces; cloud-based database synchronization allows multi-platform access and data storage; assists clinicians in evaluating spinal deformity and surgical correction; supports clinical decision-making by correlating measurements with health-related quality of life (HRQOL) scores.
Clinical Evidence
Bench testing only. No clinical data provided. Verification and validation testing performed according to software requirements, including cloud connectivity validation and measurement library verification. Measurement accuracy verified to be within ±3° for angles and ±1 cm for offsets.
Technological Characteristics
Software-based PACS application; web-based and mobile (iOS) platforms; cloud-synchronized database; supports DICOM image transfer (converted to JPEG for app use); utilizes measurement tools for spinal parameters; connectivity via HTTPS/VPN; system requirements include Windows 10, 3GHz processor, 8GB RAM, and HTML5.2/JavaScript ES7 compatible browsers.
Indications for Use
Indicated for healthcare professionals to capture, view, measure, store, and distribute spinal alignment assessment images for patient care. No specific age or gender restrictions; intended for use in spinal deformity assessment and correction monitoring.
Regulatory Classification
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Predicate Devices
- NuVasive NuvaLine Mobile App (K162647)
Reference Devices
- NuVasive NVM5 System (K152942)
- Nemaris Surgimap 2.0 (K141669)
- NucleusHealth Nucleus Image Management System (K171130)
Submission Summary (Full Text)
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September 26, 2019
Image /page/0/Picture/1 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
NuVasive, Incorporated % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive Suite 510k SAINT PAUL MN 55114
Re: K192435
Trade/Device Name: NuVasive® NuvaLine® Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: September 3, 2019 Received: September 5, 2019
Dear Mr. Job:
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 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
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# Indications for Use
510(k) Number (if known)
K192435
Device Name NuVasive® NuvaLine®
### Indications for Use (Describe)
Nu Vasive NuvaLine is a medical device software application intended to assist healthcare professionals in capturing, viewing, measuring, and storage and distribution of spinal alignment assessment images at various time points in patient care. Online synchronization of the database allows healthcare professionals and service providers to conveniently perform and review spinal alignment assessments of images by featuring measurement tools on various platforms. Clinical judgment and experience are required to properly use the software.
Type of Use (Select one or both, as applicable):
| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in gray letters to the right of the leaf. The leaf shape is purple on the top and gray on the bottom.
K192435
## 510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations. Part 807, and in particular 21 CFR \$807.92, the following summary of information is provided:
#### Submitted by: A.
Manthan Damani Lead Regulatory Affairs Specialist NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800 Date Prepared: September 25, 2019
#### B. Device Name
| Trade or Proprietary Name: | <i>NuVasive</i> ® <i>NuvaLine</i> ® |
|----------------------------|---------------------------------------------|
| Common or Usual Name: | Picture archiving and communications system |
| Classification Name: | Picture archiving and communications system |
| Device Class: | Class II |
| Classification: | §892.2050 |
| Product Code: | LLZ |
#### C. Predicate Devices
The subject NuVasive NuvaLine is substantially equivalent to the primary predicate NuVasive NuvaLine Mobile App (K162647) and additional reference devices NuVasive NVM5 System (K152942), Nemaris Surgimap 2.0 (K141669), and NucleusHealth Nucleus Image Mangement System (K171130).
#### D. Device Description
NuVasive NuvaLine is a medical device software application used to calculate the spinal pelvic, lumbar, thoracic, and cervical parameters for pre-operative and post-operative assessment of spinal x-ray images. These measured parameters provide a quantifiable way to assess a patient's spinal deformity and correction correlated to health related quality of life (HRQOL) scores.
The purpose of this premarket notification is to gain clearance of the previously cleared NuvaLine app to communicate with cloud server for online synchronization of database to transfer and store assessment data to allow for use of the NuvaLine app on different platforms (e.g.: mobile, web interface, desktop) by healthcare professionals and service providers.
NuVasive NuvaLine is designed per recommendations provided in the following FDA guidance documents:
- Guidance for the Content of Premarket Submissions for Software Contained in Medical ● Devices
- Off-The-Shelf Software Use in Medical Devices
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Image /page/4/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a purple and gray leaf-like shape on the left, followed by the word "NUVASIVE" in gray letters. The logo is simple and modern, and the colors are muted and professional.
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
#### E. Indications for Use
NuVasive NuvaLine is a medical device software application intended to assist healthcare professionals in capturing, viewing, measuring, and storage and distribution of spinal alignment assessment images at various time points in patient care. Online synchronization of the database allows healthcare professionals and service providers to conveniently perform and review spinal alignment assessments of images by featuring measurement tools on various platforms. Clinical judgment and experience are required to properly use the software.
#### F. Technological Characteristics
As was established in this submission, the subject NuvaLine is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, intended use, and functions.
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Image /page/5/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape in purple and gray, followed by the company name "NUVASIVE" in gray, sans-serif font. The leaf shape is split into two colors, with the left side in purple and the right side in gray.
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| Table 1 – Comparison of Technical Characteristics | | | | | |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Specification<br>/<br>Property | Predicate Device<br>NuVasive NuvaLine<br>Mobile App (K162647) | Reference Device<br>NucleusHealth Nucleus Image<br>Management System (K171130) | Nemaris Surgimap 2.0<br>(K141669) | Subject Device<br>NuVasive NuvaLine | Discussion |
| Intended Use<br>/ Indications<br>for Use | The NuVasive NuvaLine<br>Mobile App is a medical<br>device software mobile<br>application intended to<br>assist healthcare<br>professionals in<br>capturing, measuring,<br>and storing spinal<br>alignment assessment<br>images at various time<br>points in patient care.<br>The device allows the<br>healthcare professional<br>to conveniently perform<br>and review spinal<br>alignment assessments<br>of images by featuring<br>measurement tools on<br>their mobile device. | The Nucleus Image Management System<br>(Nucleus IMS) is a software based PACS, to<br>be used by radiologists and other medical<br>personnel. The Nucleus IMS is comprised of<br>software modules that provide image receipt,<br>diagnostic viewing, storage, distribution,<br>enhancement, sharing, manipulation, and<br>networking of medical 2D/3D images at<br>distributed locations. All modules of the<br>Nucleus IMS are web-based and can operate<br>on off-the-shelf hardware, as needed. The<br>Nucleus IMS consists of the following<br>primary components: Nucleus Viewer with<br>image streaming technology for use by<br>medical professionals for diagnostic and<br>clinical image review—Nucleus Image<br>Exchange (iX) for image acceptance, transfer,<br>and sharing with hospitals/clinics as well as<br>between facilities—and Nucleus Image Store<br>for secure cloud based image storage and<br>management through HIPAA compliant<br>encryption. Nucleus iX integrates with the<br>Nucleus Viewer and Nucleus Image Store.<br>Nucleus.io, a web based class I PaaS device,<br>provides the basis for the system and for<br>vendor neutral applications.<br>The Nucleus IMS interfaces with health<br>information systems (HIS) using industry-<br>standard image transfer and data exchange<br>protocols—such as DICOM, HL7, and<br>HTML—through web-based networked<br>gateways and local and wide area networks.<br>The Nucleus IMS is compatible with<br>modalities including: Computed Tomography<br>(CT), Magnetic Resonance Imaging (MR),<br>Ultrasound (US), Computed Radiography<br>(CR), Digital Radiography (DX), Nuclear | The Surgimap software assists<br>healthcare professionals in<br>viewing, storing, and measuring<br>images as well as planning<br>orthopedic surgeries. The device<br>allows service providers to<br>perform generic as well as<br>specialty measurements of the<br>images, and to plan surgical<br>procedures. The device also<br>includes tools for measuring<br>anatomical components for<br>placement of surgical implants,<br>and offer online synchronization of<br>the database with the possibility to<br>share data among Surgimap users.<br>Clinical judgment and experience<br>are required to properly use the<br>software. | NuVasive NuvaLine is a<br>medical device software<br>application intended to assist<br>healthcare professionals in<br>capturing, viewing, measuring,<br>and storage and distribution of<br>spinal alignment assessment<br>images at various time points in<br>patient care. Online<br>synchronization of the database<br>allows healthcare professionals<br>and service providers to<br>conveniently perform and<br>review spinal alignment<br>assessments of images by<br>featuring measurement tools on<br>various platforms. Clinical<br>judgment and experience are<br>required to properly use the<br>software. | Same |
| Specification<br>/<br>Property | Predicate Device<br>NuVasive NuvaLine<br>Mobile App (K162647) | Reference Device<br>NucleusHealth Nucleus Image<br>Management System (K171130) | Nemaris Surgimap 2.0<br>(K141669) | Subject Device<br>NuVasive NuvaLine | Discussion |
| | | Medicine (NM), Positron Emission<br>Tomography (PT), and X-Ray Angiography<br>(XA). When appropriate, the Nucleus IMS<br>provides and installs software and, optionally,<br>server hardware at client facilities to facilitate<br>secure, web-based connections for image<br>transmission to and from hospital central<br>servers via the Internet. Additionally, industry<br>standard HTTPS, VPNs, and other encryption<br>methodologies are utilized to allow for<br>optimal, secure, rapid streaming of images.<br>Lossless image compression and encryption<br>adhere to standard industry protocols. The<br>Nucleus IMS can be used as a full featured<br>PACS or as an independent viewer in clinical<br>settings.<br><br>Nucleus Image Management System is not<br>intended for display of mammography imaging<br>for diagnosis. | | | |
| Device Class | II | II | II | II | Same |
| Product Code | LLZ | LLZ | LLZ | LLZ | Same |
| Regulation<br>Number<br>(21CFR) | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Device<br>Classification<br>Name | Picture archiving and<br>communications system | Picture archiving and communications<br>system | Picture archiving and<br>communications system | Picture archiving and<br>communications system | Same |
| Software<br>Functionaliti<br>es/<br>Modalities | Spinal alignment<br>assessments of images | PACS image transfer, sharing, storage,<br>management | Spinal alignment assessments of<br>images | Spinal alignment assessments<br>of images | Same |
| Specification<br>/<br>Property | Predicate Device<br>NuVasive NuvaLine<br>Mobile App (K162647) | Reference Device<br>NucleusHealth Nucleus Image<br>Management System (K171130) | Nemaris Surgimap 2.0<br>(K141669) | Subject Device<br>NuVasive NuvaLine | Discussion |
| Algorithms | Various spinal<br>assessment algorithms | N/A | Various spinal assessment<br>algorithms | Various spinal assessment<br>algorithms | Same |
| User<br>Interface | Mobile device | PC or mobile device or web interface | PC or mobile device | PC or mobile device or web<br>interface | Same |
| Obtaining an<br>image | Mobile Device Camera | N/A | Transferred from other devices | Transferred from PACS | Same |
| Online<br>synchronizati<br>on of<br>database | N/A | N/A | Yes | Yes | Same |
| PACS<br>connectivity | N/A | Yes | Yes | Yes | Same |
| DICOM | N/A | Yes | Yes | Yes (DICOM images from<br>PACS converted to jpeg for use<br>in NuvaLine) | Same |
| Supported<br>Platforms | Mobile application<br>supported on devices<br>running iOS version<br>10.0 or later. | N/A | N/A | Mobile application supported<br>on devices running iOS version<br>10.0 or later.<br><br>Web client is supported for the<br>following minimum system<br>specifications:<br>• Windows 10<br>• 3GHz processor<br>• 18GB RAM<br>• Modern browser<br>supporting HTML5.2 and<br>JavaScript ES7 or better.<br>• 1920x1200 display<br>resolution | Same |
| Specification<br>/<br>Property | Predicate Device | Reference Device | | Subject Device | Discussion |
| | NuVasive NuvaLine<br>Mobile App (K162647) | NucleusHealth Nucleus Image<br>Management System (K171130)…
