K Number
K162647
Device Name
NuVasive NuvaLine Mobile App
Date Cleared
2017-05-01

(221 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
The NuVasive NuvaLine Mobile App is a medical device software used to measure spinal pelvic and cervical parameters from an image of patient's x-rays taken with the device's camera. 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.
More Information

No
The summary describes standard image measurement tools and verification testing focused on accuracy and functionality, with no mention of AI/ML terms or training/test data sets.

No
The device is described as a measurement tool for spinal parameters from X-ray images, used to assess deformity and correction. It does not state that it directly treats or cures any condition.

Yes
The device is described as a medical device software that measures spinal parameters from X-ray images, providing a quantifiable way to assess spinal deformity and correction. This assessment is a diagnostic function.

Yes

The device is described as a "medical device software mobile application" and "medical device software" throughout the summary. While it uses images taken with the device's camera, the core functionality and regulatory focus appear to be on the software's ability to measure and store spinal alignment parameters from these images. The performance studies focus on software verification and validation, not hardware performance.

Based on the provided information, the NuVasive® NuvaLine™ Mobile App is not an In Vitro Diagnostic (IVD).

Here's why:

  • IVDs analyze samples taken from the human body. The NuvaLine Mobile App analyzes images of the human body (x-rays), not biological samples like blood, urine, or tissue.
  • The intended use is for image analysis and measurement. The app assists healthcare professionals in capturing, measuring, and storing spinal alignment assessment images. This is a function related to medical imaging and analysis, not laboratory testing of biological samples.
  • The device description focuses on image measurement. It describes measuring spinal pelvic and cervical parameters from x-ray images.
  • There is no mention of analyzing biological samples or performing laboratory tests.

Therefore, the NuVaLine Mobile App falls under the category of a medical device software used for image analysis and measurement, not an In Vitro Diagnostic device.

N/A

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.

Product codes

LLZ

Device Description

The NuVasive NuvaLine Mobile App is a medical device software used to measure spinal pelvic and cervical parameters from an image of patient's x-rays taken with the device's camera. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

x-rays

Anatomical Site

spinal, spinal pelvic, cervical

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare professionals

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical testing was performed to demonstrate that the subject NuvaLine Mobile App is substantially equivalent to other predicate devices and to verify that the NuvaLine Mobile App meets design specifications and performance characteristics, based upon the intended use.

The NuvaLine Mobile App was subjected to Verification and Validation Testing according to the Software Requirements Specifications defined for the system. Verification testing was performed to confirm that NuvaLine accurately measures and offsets based off of x-ray images, and that these values are displayed properly with correct color-coded alert indications. Angle measurements were verified within ± 3° while offset measurement were verified within ± 2 cm accuracy. Verification activities also included testing specific to positioning of the camera and reproducibility.

Validation testing was performed to confirm that the graphical user interface (GUI) and device components function as intended.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Angle measurements were verified within ± 3° while offset measurement were verified within ± 2 cm accuracy.

Predicate Device(s)

K141669

Reference Device(s)

K152942

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 1, 2017

NuVasive, Incorporated % Ms. Olga Lewis Senior Manager, Regulatory Affairs 7475 Lusk Blvd. SAN DIEGO CA 92121

Re: K162647

Trade/Device Name: NuVasive® NuvaLine™ Mobile App Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 7, 2017 Received: April 10, 2017

Dear Ms. Lewis:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael O'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K162647

Device Name NuVasive® NuvaLine™ Mobile App

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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:

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Image /page/3/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font, with the word "Speed" in gray and the rest of the phrase in purple.

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:

A. Submitted by:

Olga Lewis Senior Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800 Date Prepared: April 7, 2017

B. Device Name

Trade or Proprietary Name:NuVasive® NuvaLine™ Mobile App
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 Mobile App is substantially equivalent to the primary predicate Nemaris Surgimap 2.0 K141669 and the reference predicate NuVasive NVM5 System K152942.

D. Device Description

The NuVasive NuvaLine Mobile App is a medical device software used to measure spinal pelvic and cervical parameters from an image of patient's x-rays taken with the device's camera. 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.

E. Indications for Use

The NuVasive NuvaLine Mobile App is a medical device software mobile application intended to assist healthcare professionals in capturing, 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.

F. Technological Characteristics

As was established in this submission, the subject NuvaLine Mobile App 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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510(k) Premarket Notification NuVasive® NuvaLine™ Mobile App System

Image /page/4/Picture/1 description: The image shows the Nuvasive logo. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray, and the words "Speed of Innovation" in a smaller font below. The logo is clean and modern, and the colors are eye-catching.

Table 1 – Comparison of Technical Characteristics
Specification/
PropertyPredicate DeviceSubject Device
NuVasive NuvaLine
Mobile AppDiscussion
NuVasive NVM5 System (K152942)Nemaris Surgimap 2.0
(K141669)
Intended
Use /
Indications
for UseThe NVM5® System is a medical
device that is intended for
intraoperative neurophysiologic
monitoring during spinal surgery. The
device provides information directly to
the surgeon, to help assess a patient's
neurophysiologic status. NVM5
provides this information by
electrically stimulating nerves via
electrodes located on surgical
accessories and monitoring
electromyography (EMG), transcranial
or lumbar motor evoked potential
(MEP) or somatosensory evoked
potential (SSEP) responses of nerves.
The System also integrates Bendini™
software used to locate spinal implant
instrumentation for the placement of
spinal rods.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.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.Same
Device
Classificatio
n NameSurgical nerve stimulatory/locator;
Evoked response electrical stimulator;
Neurological stereotaxic instrument;
Electromyography (EMG)
monitor/stimulatorPicture archiving and
communications systemPicture archiving and
communications systemSame
Software
Functionalit
ies/
ModalitiesFor NuvaLine - spinal alignment
assessments of imagesSpinal alignment assessments of
imagesSpinal alignment
assessments of imagesSame
Specification/
PropertyPredicate DeviceSubject Device
NuVasive NVM5 System (K152942)Nemaris Surgimap 2.0
(K141669)NuVasive NuvaLine
Mobile AppDiscussion
AlgorithmsLumbar Algorithm (PT, PI-LL, SVA)
Cervical Algorithm (TPA, TS-CL,
CSVA)VariousLumbar Algorithm (PT, PI-LL, SVA)
Cervical Algorithm (TPA,
TS-CL, CSVA)Same
User
InterfaceNuVasive-supplied computer with
optional touch screen and/or
keyboard/mouse
Mobile device (for NuvaLine only)PC or mobile deviceMobile deviceSame
Obtaining
an imageMobile Device CameraTransferred from other devicesMobile Device CameraSame
DICOMN/AYesN/ASame

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Image /page/5/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font, with the word "Speed" in purple and the rest of the phrase in gray.

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G. Performance Data

Nonclinical testing was performed to demonstrate that the subject NuvaLine Mobile App is substantially equivalent to other predicate devices and to verify that the NuvaLine Mobile App meets design specifications and performance characteristics, based upon the intended use.

The NuvaLine Mobile App was subjected to Verification and Validation Testing according to the Software Requirements Specifications defined for the system. Verification testing was performed to confirm that NuvaLine accurately measures and offsets based off of x-ray images, and that these values are displayed properly with correct color-coded alert indications. Angle measurements were verified within ± 3° while offset measurement were verified within ± 2 cm accuracy. Verification activities also included testing specific to positioning of the camera and reproducibility.

Validation testing was performed to confirm that the graphical user interface (GUI) and device components function as intended.

H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject NuvaLine App has been shown to be substantially equivalent to legally marketed predicate device.