NuVasive NuvaLine Mobile App

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines connecting them. 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. {1}------------------------------------------------ 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). 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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 {2}------------------------------------------------ # 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. 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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. {4}------------------------------------------------ 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/<br>Property | Predicate Device | | Subject Device<br>NuVasive NuvaLine<br>Mobile App | Discussion | | | NuVasive NVM5 System (K152942) | Nemaris Surgimap 2.0<br>(K141669) | | | | Intended<br>Use /<br>Indications<br>for Use | The NVM5® System is a medical<br>device that is intended for<br>intraoperative neurophysiologic<br>monitoring during spinal surgery. The<br>device provides information directly to<br>the surgeon, to help assess a patient's<br>neurophysiologic status. NVM5<br>provides this information by<br>electrically stimulating nerves via<br>electrodes located on surgical<br>accessories and monitoring<br>electromyography (EMG), transcranial<br>or lumbar motor evoked potential<br>(MEP) or somatosensory evoked<br>potential (SSEP) responses of nerves.<br>The System also integrates Bendini™<br>software used to locate spinal implant<br>instrumentation for the placement of<br>spinal rods. | The Surgimap software assists<br>healthcare professionals in<br>viewing, storing, and measuring<br>images as well as planning<br>orthopedic surgeries. The<br>device allows service providers<br>to 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<br>synchronization of the database<br>with the possibility to share data<br>among Surgimap users. Clinical<br>judgment and experience are<br>required to properly use the<br>software. | The NuVasive NuvaLine<br>Mobile App is a medical<br>device software mobile<br>application intended to<br>assist healthcare<br>professionals in capturing,<br>measuring, and storing<br>spinal alignment<br>assessment images at<br>various time points in<br>patient care. The device<br>allows the healthcare<br>professional to<br>conveniently perform and<br>review spinal alignment<br>assessments of images by<br>featuring measurement<br>tools on their mobile<br>device. | Same | | Device<br>Classificatio<br>n Name | Surgical nerve stimulatory/locator;<br>Evoked response electrical stimulator;<br>Neurological stereotaxic instrument;<br>Electromyography (EMG)<br>monitor/stimulator | Picture archiving and<br>communications system | Picture archiving and<br>communications system | Same | | Software<br>Functionalit<br>ies/<br>Modalities | For NuvaLine - spinal alignment<br>assessments of images | Spinal alignment assessments of<br>images | Spinal alignment<br>assessments of images | Same | | Specification/<br>Property | Predicate Device | | Subject Device | | | | NuVasive NVM5 System (K152942) | Nemaris Surgimap 2.0<br>(K141669) | NuVasive NuvaLine<br>Mobile App | Discussion | | Algorithms | Lumbar Algorithm (PT, PI-LL, SVA)<br>Cervical Algorithm (TPA, TS-CL,<br>CSVA) | Various | Lumbar Algorithm (PT, PI-LL, SVA)<br>Cervical Algorithm (TPA,<br>TS-CL, CSVA) | Same | | User<br>Interface | NuVasive-supplied computer with<br>optional touch screen and/or<br>keyboard/mouse<br>Mobile device (for NuvaLine only) | PC or mobile device | Mobile device | Same | | Obtaining<br>an image | Mobile Device Camera | Transferred from other devices | Mobile Device Camera | Same | | DICOM | N/A | Yes | N/A | Same | {5}------------------------------------------------ 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. {6}------------------------------------------------ #### 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.