(221 days)
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)
Reference Device(s)
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)
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)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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/ | ||||
Property | Predicate Device | Subject Device | ||
NuVasive NuvaLine | ||||
Mobile App | Discussion | |||
NuVasive NVM5 System (K152942) | Nemaris Surgimap 2.0 | |||
(K141669) | ||||
Intended | ||||
Use / | ||||
Indications | ||||
for Use | The 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 Name | Surgical nerve stimulatory/locator; | |||
Evoked response electrical stimulator; | ||||
Neurological stereotaxic instrument; | ||||
Electromyography (EMG) | ||||
monitor/stimulator | Picture archiving and | |||
communications system | Picture archiving and | |||
communications system | Same | |||
Software | ||||
Functionalit | ||||
ies/ | ||||
Modalities | For NuvaLine - spinal alignment | |||
assessments of images | Spinal alignment assessments of | |||
images | Spinal alignment | |||
assessments of images | Same | |||
Specification/ | ||||
Property | Predicate Device | Subject Device | ||
NuVasive NVM5 System (K152942) | Nemaris Surgimap 2.0 | |||
(K141669) | NuVasive NuvaLine | |||
Mobile App | Discussion | |||
Algorithms | Lumbar Algorithm (PT, PI-LL, SVA) | |||
Cervical Algorithm (TPA, TS-CL, | ||||
CSVA) | Various | Lumbar Algorithm (PT, PI-LL, SVA) | ||
Cervical Algorithm (TPA, | ||||
TS-CL, CSVA) | Same | |||
User | ||||
Interface | NuVasive-supplied computer with | |||
optional touch screen and/or | ||||
keyboard/mouse | ||||
Mobile device (for NuvaLine only) | PC or mobile device | Mobile device | Same | |
Obtaining | ||||
an image | Mobile Device Camera | Transferred from other devices | Mobile Device Camera | Same |
DICOM | N/A | Yes | N/A | Same |
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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.