(21 days)
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.
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.
The provided text does not contain explicit acceptance criteria and corresponding performance data in a dedicated table format. However, it does mention performance characteristics in the comparison table and describes the testing performed. I will extract the relevant information and present it in the requested format, inferring acceptance criteria where it implies a match to the predicate device's performance.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance (NuVaLine® NuvaLine®) |
|---|---|
| Spinal alignment assessments of images (Matching predicate functionality) | Spinal alignment assessments of images |
| Various spinal assessment algorithms (Matching predicate functionality) | Various spinal assessment algorithms |
| User Interface: PC or mobile device or web interface (Matching reference devices) | PC or mobile device or web interface |
| Obtaining an image: Transferred from PACS (Matching reference device functionality) | Transferred from PACS (DICOM images from PACS converted to jpeg for use in NuvaLine) |
| Online synchronization of database (Matching reference device functionality) | Yes |
| PACS connectivity (Matching reference device functionality) | Yes |
| DICOM compatibility (Matching reference device functionality) | Yes (DICOM images from PACS converted to jpeg for use in NuvaLine) |
| Supported Platforms: Mobile application on iOS 10.0+; Web client on Windows 10, 3GHz processor, 18GB RAM, modern browser, 1920x1200 display resolution (Matching predicate/reference devices and added web client support) | Mobile application supported on devices running iOS version 10.0 or later.Web client is supported for the following minimum system specifications: Windows 10, 3GHz processor, 18GB RAM, Modern browser supporting HTML5.2 and JavaScript ES7 or better, 1920x1200 display resolution |
| Measurement accuracy: Angles within ± 3°, offsets within ± 1 cm (Improved from predicate's ± 2 cm) | NuvaLine measures angles within ± 3° and offsets within ± 1 cm accuracy. |
| Cloud Connectivity Validation | NuvaLine Cloud Connectivity Validation performed and met |
| Web Client Cloud Connectivity Validation | NuvaLine Web Client Cloud Connectivity Validation performed and met |
| Cloud Connectivity Measurement Library Verification | NuvaLine Cloud Connectivity Measurement Library Verification performed and met |
2. Sample size used for the test set and the data provenance
The document mentions "Nonclinical testing was performed..." and lists types of validation tests. However, it does not specify the sample size for the test set used in these validations (e.g., number of images, number of measurements). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for any test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method for a test set.
5. 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 mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on the device's standalone performance and its equivalence to predicate devices, not on human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the document implies that a standalone performance evaluation was conducted. The "Measurement accuracy" specification confirms the device's ability to measure angles and offsets with specific accuracy limits (angles within ± 3° and offsets within ± 1 cm). This indicates an evaluation of the algorithm's performance independent of human-in-the-loop assistance for measurement, as it's a characteristic directly attributed to NuvaLine.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used for the measurement accuracy evaluation or other validation tests. Given the nature of a "Picture archiving and communications system" and "spinal alignment assessments," it is highly probable that the ground truth for measurement accuracy would have been established through highly precise manual measurements by qualified experts on a reference standard or through established anatomical landmarks on images, but this is not explicitly stated.
8. The sample size for the training set
The document does not provide information regarding the sample size of a training set. This is consistent with the subject device being described as a "medical device software application" that provides measurement tools, rather than a machine learning or AI algorithm that requires a distinct training phase.
9. How the ground truth for the training set was established
Since no training set is mentioned or implied for a machine learning or AI component, the document does not provide information on how ground truth for a training set was established.
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September 26, 2019
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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)
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):
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| 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.
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: | NuVasive ® NuvaLine ® |
|---|---|
| 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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| Table 1 – Comparison of Technical Characteristics | |||||
|---|---|---|---|---|---|
| Specification/Property | Predicate DeviceNuVasive NuvaLineMobile App (K162647) | Reference DeviceNucleusHealth Nucleus ImageManagement System (K171130) | Nemaris Surgimap 2.0(K141669) | Subject DeviceNuVasive NuvaLine | Discussion |
| Intended Use/ Indicationsfor Use | The NuVasive NuvaLineMobile App is a medicaldevice software mobileapplication intended toassist healthcareprofessionals incapturing, measuring,and storing spinalalignment assessmentimages at various timepoints in patient care.The device allows thehealthcare professionalto conveniently performand review spinalalignment assessmentsof images by featuringmeasurement tools ontheir mobile device. | The Nucleus Image Management System(Nucleus IMS) is a software based PACS, tobe used by radiologists and other medicalpersonnel. The Nucleus IMS is comprised ofsoftware modules that provide image receipt,diagnostic viewing, storage, distribution,enhancement, sharing, manipulation, andnetworking of medical 2D/3D images atdistributed locations. All modules of theNucleus IMS are web-based and can operateon off-the-shelf hardware, as needed. TheNucleus IMS consists of the followingprimary components: Nucleus Viewer withimage streaming technology for use bymedical professionals for diagnostic andclinical image review—Nucleus ImageExchange (iX) for image acceptance, transfer,and sharing with hospitals/clinics as well asbetween facilities—and Nucleus Image Storefor secure cloud based image storage andmanagement through HIPAA compliantencryption. Nucleus iX integrates with theNucleus Viewer and Nucleus Image Store.Nucleus.io, a web based class I PaaS device,provides the basis for the system and forvendor neutral applications.The Nucleus IMS interfaces with healthinformation systems (HIS) using industry-standard image transfer and data exchangeprotocols—such as DICOM, HL7, andHTML—through web-based networkedgateways and local and wide area networks.The Nucleus IMS is compatible withmodalities including: Computed Tomography(CT), Magnetic Resonance Imaging (MR),Ultrasound (US), Computed Radiography(CR), Digital Radiography (DX), Nuclear | The Surgimap software assistshealthcare professionals inviewing, storing, and measuringimages as well as planningorthopedic surgeries. The deviceallows service providers toperform generic as well asspecialty measurements of theimages, and to plan surgicalprocedures. The device alsoincludes tools for measuringanatomical components forplacement of surgical implants,and offer online synchronization ofthe database with the possibility toshare data among Surgimap users.Clinical judgment and experienceare required to properly use thesoftware. | NuVasive NuvaLine is amedical device softwareapplication intended to assisthealthcare professionals incapturing, viewing, measuring,and storage and distribution ofspinal alignment assessmentimages at various time points inpatient care. Onlinesynchronization of the databaseallows healthcare professionalsand service providers toconveniently perform andreview spinal alignmentassessments of images byfeaturing measurement tools onvarious platforms. Clinicaljudgment and experience arerequired to properly use thesoftware. | Same |
| Specification/Property | Predicate DeviceNuVasive NuvaLineMobile App (K162647) | Reference DeviceNucleusHealth Nucleus ImageManagement System (K171130) | Nemaris Surgimap 2.0(K141669) | Subject DeviceNuVasive NuvaLine | Discussion |
| Medicine (NM), Positron EmissionTomography (PT), and X-Ray Angiography(XA). When appropriate, the Nucleus IMSprovides and installs software and, optionally,server hardware at client facilities to facilitatesecure, web-based connections for imagetransmission to and from hospital centralservers via the Internet. Additionally, industrystandard HTTPS, VPNs, and other encryptionmethodologies are utilized to allow foroptimal, secure, rapid streaming of images.Lossless image compression and encryptionadhere to standard industry protocols. TheNucleus IMS can be used as a full featuredPACS or as an independent viewer in clinicalsettings.Nucleus Image Management System is notintended for display of mammography imagingfor diagnosis. | |||||
| Device Class | II | II | II | II | Same |
| Product Code | LLZ | LLZ | LLZ | LLZ | Same |
| RegulationNumber(21CFR) | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| DeviceClassificationName | Picture archiving andcommunications system | Picture archiving and communicationssystem | Picture archiving andcommunications system | Picture archiving andcommunications system | Same |
| SoftwareFunctionalities/Modalities | Spinal alignmentassessments of images | PACS image transfer, sharing, storage,management | Spinal alignment assessments ofimages | Spinal alignment assessmentsof images | Same |
| Specification/Property | Predicate DeviceNuVasive NuvaLineMobile App (K162647) | Reference DeviceNucleusHealth Nucleus ImageManagement System (K171130) | Nemaris Surgimap 2.0(K141669) | Subject DeviceNuVasive NuvaLine | Discussion |
| Algorithms | Various spinalassessment algorithms | N/A | Various spinal assessmentalgorithms | Various spinal assessmentalgorithms | Same |
| UserInterface | Mobile device | PC or mobile device or web interface | PC or mobile device | PC or mobile device or webinterface | Same |
| Obtaining animage | Mobile Device Camera | N/A | Transferred from other devices | Transferred from PACS | Same |
| Onlinesynchronization ofdatabase | N/A | N/A | Yes | Yes | Same |
| PACSconnectivity | N/A | Yes | Yes | Yes | Same |
| DICOM | N/A | Yes | Yes | Yes (DICOM images fromPACS converted to jpeg for usein NuvaLine) | Same |
| SupportedPlatforms | Mobile applicationsupported on devicesrunning iOS version10.0 or later. | N/A | N/A | Mobile application supportedon devices running iOS version10.0 or later.Web client is supported for thefollowing minimum systemspecifications:• Windows 10• 3GHz processor• 18GB RAM• Modern browsersupporting HTML5.2 andJavaScript ES7 or better.• 1920x1200 displayresolution | Same |
| Specification/Property | Predicate Device | Reference Device | Subject Device | Discussion | |
| NuVasive NuvaLineMobile App (K162647) | NucleusHealth Nucleus ImageManagement System (K171130) | Nemaris Surgimap 2.0(K141669) | NuVasive NuvaLine | ||
| Measurementaccuracy | NuvaLine measuresangles within $\pm$ 3° andoffsets within $\pm$ 2 cmaccuracy. | N/A | N/A | NuvaLine measures angleswithin $\pm$ 3° and offsets within$\pm$ 1 cm accuracy. | Same |
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Image /page/6/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape in purple and gray on the left, followed by the word "NUVASIVE" in gray. The leaf shape is partially purple and partially gray, with the purple portion on the top and the gray portion on the bottom. The word "NUVASIVE" is in a sans-serif font.
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Image /page/7/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized purple and gray leaf-like shape on the left, followed by the word "NUVASIVE" in gray, sans-serif font. The logo is simple and modern.
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Image /page/8/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf-like shape in purple and gray, followed by the word "NUVASIVE" in gray sans-serif font. The logo is simple and modern, with a clean design.
- An additional reference device, NuVasive NVM5 System (K152942) is being introduce SVA and TPA measurements to the subject device.
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G. Performance Data
Nonclinical testing was performed to demonstrate that the subject NuVasive is substantially equivalent to other predicate devices and to verify that NuVasive NuvaLine meets design specifications and performance characteristics, based upon the intended use.
NuVasive NuvaLine was subjected to Verification and Validation Testing according to the Software Requirements Specifications defined for the system. The following testing was performed:
- NuvaLine Cloud Connectivity Validation ●
- NuvaLine Web Client Cloud Connectivity Validation
- NuvaLine Cloud Connectivity Measurement Library Verification
H. Conclusions
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject NuVasive NuvaLine has been shown to be substantially equivalent to legally marketed predicate device.
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).