ATEC Alignment App

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. October 29, 2021 Alphatec Spine, Inc. David Gramse Sr. Director, Regulatory Affairs 1950 Camino Vida Roble CARLSBAD CA 92008 Re: K211987 Trade/Device Name: ATEC Alignment App Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: LLZ Dated: September 30, 2021 Received: October 1, 2021 Dear David Gramse: 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 (OS) 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 mediation-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, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211987 Device Name ATEC Alignment App ### Indications for Use (Describe) The ATEC Alignment App assists healthcare professionals in viewing, and storing images as well as planning orthopedic surgeries. The app allows the healthcare professional to perform generic and specialty measurements of the images, and to plan surgical procedures. The app includes tools for measuring anatomical components for implant selection, and offers the possibility to share data among ATEC Alignment App users. The app is for planning use only and is not intended for primary diagnostic use. Type of Use (Select one or both, as applicable): | <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |----------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary of Safety and Effectiveness (21 CFR 807.92) | I. | SUBMITTER: | Alphatec Spine, Inc.<br>1950 Camino Vida Roble<br>Carlsbad, CA 92008<br>Phone: (760) 431-9286<br>Fax: (760) 431-0289 | |----|-----------------|----------------------------------------------------------------------------------------------------------------------| | | Contact Person: | David Gramse<br>Sr. Director, Regulatory Affairs<br>Contact Phone: (760) 494-6711 | Date Summary Prepared: June 25, 2021 #### II. DEVICE | Name of Device: | ATEC Alignment App | |-----------------------|---------------------------------------------------------------------| | 510(k) Number: | K211987 | | Common or Usual Name: | Medical Image Management and Processing System | | Classification Name: | Medical Image Management and Processing System<br>(21 CFR 892.2050) | | Regulatory Class: | Class II | | Product Code: | LLZ | #### LEGALLY MARKETED PREDICATE DEVICES III. | 510(k) | Product Code | Trade Name | Manufacturer | |-----------------------------|--------------|------------------------------|----------------| | Primary Predicate Device | | | | | K141669 | LLZ | Surgimap 2.0 | Nemaris, Inc. | | Additional Predicate Device | | | | | K162647 | LLZ | NuVasive NuvaLine Mobile App | NuVasive, Inc. | #### IV. DEVICE DESCRIPTION The ATEC Alignment App is intended for use by trained healthcare professionals as a standalone software for viewing, measuring, and storing of x-ray images. The app is a medical device software used to measure spinopelvic parameters from patient x-rays images 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 based on published literature. Clinical judgment and experience are required to properly use the software. {4}------------------------------------------------ #### V. INDICATIONS FOR USE The ATEC Alignment App assists healthcare professionals in viewing, measuring, and storing images as well as planning orthopedic surgeries. The app allows the healthcare professional to perform generic and specialty measurements of the images, and to plan surgical procedures. The app includes tools for measuring anatomical components for implant selection, and offers the possibility to share data among ATEC Alignment App users. The app is for planning use only and is not intended for primary diagnostic use. #### VI. TECHNOLOGICAL COMPARISON TO PREDICATES The technological design features of the subject ATEC Alignment App were compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent. | | Predicate Devices | | Subject Device | | |----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | Nemaris Surgimap | NuVasive NuvaLine | ATEC | | | | 2.0 (K141669) | Mobile App<br>(K162647) | Alignment<br>App (K211987) | Discussion | | Indications for<br>Use | The Surgimap software<br>assists healthcare<br>professionals in<br>viewing, storing, and<br>measuring images as<br>well as planning<br>orthopedic surgeries.<br>The device allows<br>service providers to<br>perform generic as well<br>as specialty<br>measurements of the<br>images, and to plan<br>surgical procedures.<br>The device also<br>includes tools for<br>measuring anatomical<br>components for<br>placement of surgical<br>implants, and offer<br>online synchronization<br>of the database with the<br>possibility to share data<br>among Surgimap users.<br>Clinical judgment and<br>experience are required<br>to properly use the<br>software. | The NuVasive<br>NuvaLine Mobile App<br>is a medical device<br>software mobile<br>application intended to<br>assist healthcare<br>professionals in<br>capturing, measuring,<br>and storing spinal<br>alignment assessment<br>images at various time<br>points in patient care.<br>The device allows the<br>healthcare professional<br>to conveniently perform<br>and review spinal<br>alignment assessments<br>of images by featuring<br>measurement tools on<br>their mobile device. | The ATEC<br>Alignment App<br>assists healthcare<br>professionals in<br>viewing,<br>measuring, and<br>storing images as<br>well as planning<br>orthopedic<br>surgeries. The<br>device allows the<br>healthcare<br>professional to<br>perform generic<br>and specialty<br>measurements of<br>the images, and<br>to plan surgical<br>procedures. The<br>device offers the<br>possibility to<br>share data<br>among ATEC<br>Alignment App<br>users. | Similar to Surgimap<br>— the only difference<br>is that the subject<br>device does not<br>include tools for<br>measuring<br>anatomical<br>components for<br>implant selection.<br>This difference does<br>not affect substantial<br>equivalence to the<br>predicate.<br>Same as NuvaLine | | Regulatory<br>Class/Code | Class II<br>LLZ<br>(21 CFR 892.2050) | Class II<br>LLZ<br>(21 CFR 892.2050) | Class II<br>LLZ<br>(21 CFR<br>892.2050) | Same | | Device<br>Classification<br>Name | Medical Image<br>Management and<br>Processing System | Medical Image<br>Management and<br>Processing System | Medical Image<br>Management and<br>Processing<br>System | Same | | Operating<br>System | PC: Windows + MAC<br>Mobile: Android + iOS | Mobile: Android + iOS | Mobile: Android<br>+ iOS | Similar to Surgimap<br>— the subject device<br>is limited to use on<br>mobile phones (iOS<br>and Android). This<br>difference does not<br>affect substantial<br>equivalence to the<br>predicate. | | Software<br>Functionalities /<br>Modalities | Spinal alignment<br>assessments of images | Spinal alignment<br>assessments of images | Spinal alignment<br>assessments of<br>images | Same as NuvaLine<br>Similar | | Provides<br>Normative Values<br>for Measurement<br>Comparison | Yes | Yes | Yes | Same | | Includes user-<br>defined circles for<br>anatomical<br>location of<br>femoral head for<br>sagittal<br>measurements | Yes | Yes | Yes | Same | | Includes user-<br>defined lines for<br>identification of<br>endplates for<br>sagittal and<br>coronal<br>measurements | Yes | Yes | Yes | Same | | Provides color-<br>coded<br>measurement<br>results to display<br>variance from the<br>defined norm | Yes | Yes | Yes | Same | | Algorithms | Patient parameters and<br>calculations based on<br>published literature | Lumbar Algorithm (PT,<br>PI-LL, SVA)<br>Cervical Algorithm<br>(TPA,<br>TS-CL, CSVA) | Patient<br>parameters and<br>calculations<br>based on<br>published<br>literature | Same | | User Interface | PC or mobile device | Mobile device | Mobile device | Similar to Surgimap<br>- the subject device<br>is limited to use on | | | | | | mobile phones (iOS<br>and Android). This<br>difference does not<br>affect substantial<br>equivalence to the<br>predicate. | | | | | | Same as NuvaLine | | Obtaining an<br>image | Transferred from other<br>devices, or mobile<br>device camera | Mobile Device Camera | Transferred from<br>other devices, or<br>mobile device<br>camera | Same | | Sharing an<br>image | Email | None | Email/QR Code | Same | | Human<br>Intervention for<br>interpretation<br>and<br>manipulation of<br>images | Required | Required | Required | Same | | Control of life-<br>saving devices | None | None | None | Same | {5}------------------------------------------------ {6}------------------------------------------------ #### VII. PERFORMANCE DATA The ATEC Alignment App was subjected to verification and validation testing in accordance with the functional requirements. Performance testing confirmed that the app accurately measures angles from x-ray images, and that resultant values are displayed properly with correct color-coded range. Angle measurements were verified within ± 2° accuracy. Validation testing was performed to confirm that the graphical user interface (GUI) and that data system features function as intended. A direct comparison test between the ATEC Alignment App and the Surgimap device using the same clinically representative images was conducted which concluded that the performance between the two devices was similar. The results demonstrate that the subject ATEC Alignment App is substantially equivalent to Surgimap 2.0 (K141669) and the NuvaLine Mobile App (K162647) and verifies that the subject device meets design specifications and performance characteristics based upon its intended use. ## Clinical Information Not applicable: determination of substantial equivalence is not based on an assessment of clinical performance data. #### VIII. CONCLUSION Based upon the information provided in this 510(k) submission. it has been determined that the subject device is substantially equivalent to the legally marketed primary predicate {7}------------------------------------------------ device (Surgimap 2.0, K141669) based on intended use, design, functionality, performance testing and other key technological characteristics.