Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes software for measuring spinal parameters and cloud synchronization, with no mention of AI or ML terms or capabilities.

Therapeutic

No
The device is a software application for capturing, viewing, measuring, storing, and distributing spinal alignment assessment images. It does not directly treat or prevent a disease or condition, which is the definition of a therapeutic device. It serves as a tool for assessment and measurement, aiding in diagnosis and treatment planning rather than providing therapy itself.

Diagnostic

Yes

The device is intended to assist healthcare professionals in capturing, viewing, measuring, and storing spinal alignment assessment images, and specifically calculates spinal parameters for pre-operative and post-operative assessment of spinal x-ray images to assess a patient's spinal deformity and correction. These actions are steps in the diagnostic process.

SaMD (Software as a Medical Device)

Yes

The device is described as a "medical device software application" and the submission focuses on software updates for cloud connectivity and multi-platform access. There is no mention of associated hardware being part of the device itself, only the software's function in processing existing image data.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
This device operates on medical images (spinal x-ray images) and assists healthcare professionals in assessing spinal alignment. It does not analyze biological specimens.

The device is a medical device software application used for image analysis and measurement, which falls under a different regulatory category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

LLZ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

spinal x-ray images

Anatomical Site

spinal pelvic, lumbar, thoracic, and cervical

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare professionals and service providers

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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

Key Metrics

NuvaLine measures angles within ± 3° and offsets within ± 1 cm accuracy.

Predicate Device(s)

NuVasive NuvaLine Mobile App (K162647)

Reference Device(s)

NuVasive NVM5 System (K152942), Nemaris Surgimap 2.0 (K141669), and NucleusHealth Nucleus Image Mangement System (K171130)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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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

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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):

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.

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:	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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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
/
Property	Predicate Device
NuVasive NuvaLine
Mobile App (K162647)	Reference Device
NucleusHealth Nucleus Image
Management System (K171130)	Nemaris Surgimap 2.0
(K141669)	Subject Device
NuVasive NuvaLine	Discussion
Intended Use
/ Indications
for Use	The NuVasive NuvaLine
Mobile App is a medical
device software mobile
application intended to
assist healthcare
professionals in
capturing, measuring,
and storing spinal
alignment assessment
images at various time
points in patient care.
The device allows the
healthcare professional
to conveniently perform
and review spinal
alignment assessments
of images by featuring
measurement tools on
their mobile device.	The Nucleus Image Management System
(Nucleus IMS) is a software based PACS, to
be used by radiologists and other medical
personnel. The Nucleus IMS is comprised of
software modules that provide image receipt,
diagnostic viewing, storage, distribution,
enhancement, sharing, manipulation, and
networking of medical 2D/3D images at
distributed locations. All modules of the
Nucleus IMS are web-based and can operate
on off-the-shelf hardware, as needed. The
Nucleus IMS consists of the following
primary components: Nucleus Viewer with
image streaming technology for use by
medical professionals for diagnostic and
clinical image review—Nucleus Image
Exchange (iX) for image acceptance, transfer,
and sharing with hospitals/clinics as well as
between facilities—and Nucleus Image Store
for secure cloud based image storage and
management through HIPAA compliant
encryption. Nucleus iX integrates with the
Nucleus Viewer and Nucleus Image Store.
Nucleus.io, a web based class I PaaS device,
provides the basis for the system and for
vendor neutral applications.
The Nucleus IMS interfaces with health
information systems (HIS) using industry-
standard image transfer and data exchange
protocols—such as DICOM, HL7, and
HTML—through web-based networked
gateways and local and wide area networks.
The Nucleus IMS is compatible with
modalities including: Computed Tomography
(CT), Magnetic Resonance Imaging (MR),
Ultrasound (US), Computed Radiography
(CR), Digital Radiography (DX), Nuclear	The Surgimap software assists
healthcare professionals in
viewing, storing, and measuring
images as well as planning
orthopedic surgeries. The device
allows service providers to
perform generic as well as
specialty measurements of the
images, and to plan surgical
procedures. The device also
includes tools for measuring
anatomical components for
placement of surgical implants,
and offer online synchronization of
the database with the possibility to
share data among Surgimap users.
Clinical judgment and experience
are required to properly use the
software.	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.	Same
Specification
/
Property	Predicate Device
NuVasive NuvaLine
Mobile App (K162647)	Reference Device
NucleusHealth Nucleus Image
Management System (K171130)	Nemaris Surgimap 2.0
(K141669)	Subject Device
NuVasive NuvaLine	Discussion
		Medicine (NM), Positron Emission
Tomography (PT), and X-Ray Angiography
(XA). When appropriate, the Nucleus IMS
provides and installs software and, optionally,
server hardware at client facilities to facilitate
secure, web-based connections for image
transmission to and from hospital central
servers via the Internet. Additionally, industry
standard HTTPS, VPNs, and other encryption
methodologies are utilized to allow for
optimal, secure, rapid streaming of images.
Lossless image compression and encryption
adhere to standard industry protocols. The
Nucleus IMS can be used as a full featured
PACS or as an independent viewer in clinical
settings.

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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.