← Product Code [LLZ](/productcode/LLZ) · K230252 # OFIX MIS App (K230252) _Orthofix US, LLC · LLZ · Sep 26, 2023 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K230252 ## Device Facts - **Applicant:** Orthofix US, LLC - **Product Code:** [LLZ](/productcode/LLZ.md) - **Decision Date:** Sep 26, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** AI/ML, Software as a Medical Device ## Indications for Use The OFIX MIS App software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The app allows service providers to plan surgical procedures by making measurements for the placement of surgical implants. Clinical judgement and experience are required to properly use the software. ## Device Story OFIX MIS App is a mobile application for orthopedic surgical planning; specifically, selecting rod lengths for pedicle screw spinal systems. The device captures 2D images of fluoroscopy monitors via a mobile phone camera. The app processes these images to measure distances between placed pedicle screws; it then compares these measurements against known Orthofix pedicle screw diameters to recommend an appropriate rod length and corresponding product number. Used by surgeons in the intraoperative environment; the app serves as a supplement to traditional calipers. The surgeon retains clinical control and may use manual measurements as a safeguard to confirm the app's output. The device streamlines the selection process for spinal implants. ## Clinical Evidence No clinical data. Substantial equivalence supported by bench testing, software verification and validation, and usability testing. Testing demonstrated that the app meets specifications and provides accurate measurements for implant selection in simulated use conditions. ## Technological Characteristics Mobile application software; operates on mobile device touch screen. Inputs: 2D images via mobile camera. Outputs: implant rod length recommendations. Connectivity: standalone mobile app. Software algorithm: non-machine learning, rule-based module using Orthofix-specific implant data. Sterilization: N/A (used outside sterile field). ## Regulatory 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. ## Special Controls *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). ## Predicate Devices - Nemaris Surgimap 2.0 ([K141669](/device/K141669.md)) ## Reference Devices - Nuvaline ([K162647](/device/K162647.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration". Orthofix US LLC % Shant Aghyarian Regulatory Affairs Program Manager 3451 Plano Parkway LEWISVILLE TX 75056 September 26, 2023 Re: K230252 Trade/Device Name: OFIX MIS App Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: January 31, 2023 Received: August 30, 2023 Dear Shant Aghyarian: 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ 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 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. Jessica Lamb Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. Submission Number (if known) K230252 Device Name OFIX MIS App Indications for Use (Describe) The OFIX MIS App software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The app allows service providers to plan surgical procedures by making measurements for the placement of surgical implants. Clinical judgement 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) ### 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}------------------------------------------------ Image /page/3/Picture/0 description: The image features the logos of two companies, Orthofix and SeaSpine, side by side. The Orthofix logo is in blue and black, with a stylized blue symbol to the left of the company name. The SeaSpine logo is in orange and blue, with a stylized blue symbol to the left of the company name. # 510(k) SUMMARY K230252 OFIX MIS App | 510(k) Owner Information
Name:
Address: | Orthofix US LLC
3451 Plano Parkway
Lewisville, TX, USA | |-----------------------------------------------------|--------------------------------------------------------------| | Telephone Number:
Fax Number:
Email: | 214-937-2176
214-937-3322
shantaghyarian@orthofix.com | | Registration Number: | 2183449 | | Contact Person: | Shant Aghyarian | | Date Prepared: | September 21, 2023 | | Name of Device
Trade Name / Proprietary
Name: | OFIX MIS App | | Common Name: | OFIX MIS App | | Product Code(s): | LLZ | | Classification Name: | System, Image Processing, Radiological | | Regulatory Class: | Class II per 21 CFR 892.2050 | | Predicate Devices: | Nemaris Surgimap 2.0, K141669 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logos of two companies, Orthofix and SeaSpine. The Orthofix logo is on the left and consists of a blue abstract shape followed by the word "ORTHOFIX" in bold, black letters. To the right of the Orthofix logo is the SeaSpine logo, which features a stylized wave design in blue and gray, followed by the word "SeaSpine" in orange. Device Description OFIX MIS App > The OFIX MIS App will provide a novel mobile phone solution to supplement the use of calipers when selecting rods used in immobilization of pedicle screw type spinal systems. The App will rely on capturing 2D images used in spinal implant procedures through use of mobile phone camera. The App measures the difference between known Orthofix pedicle screw diameters and provides feedback useful in determining appropriate rod length with corresponding Orthofix product number. ### Indications for Use The OFIX MIS App software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The App allows service providers to plan surgical procedures by including tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software. ### Technological Comparison The technological comparison is provided as the Substantial Equivalence table below. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logos of two companies, Orthofix and SeaSpine, side by side. The Orthofix logo is on the left and consists of a blue abstract shape followed by the company name in black, bold letters. A vertical line separates the two logos, and the SeaSpine logo is on the right, featuring a stylized wave design in gray and the company name in orange. ## Substantial Equivalence Table | Specification/Property | Predicate Device
Nemaris Surgimap 2.0 (K141669) | Subject Device
OFIX MIS App | Discussion | | | | | |-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use / Indications for
Use | 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 OFIX MIS App software assists
healthcare professionals in viewing,
storing, and measuring images as well
as planning orthopedic surgeries. The
app allows service providers to plan
surgical procedures by making
measurements for the placement of
surgical implants. Clinical judgement
and experience are required to
properly use the software. | The OFIX App doesn't measure anatomical
components but helps measure distances on
anatomical components between placed marker
(pedicle screws).

The predicate is more involved in overall pre-
operative planning. This could be determinant of
the surgical procedure or approach taken by the
surgeon. The OFIX MIS App, is a lower risk tool
used to streamline the process of measuring and
choosing the correct rod to be used in the surgical
procedure. The surgical procedure and approach
would already be decided at this point. As a
safeguard, the surgeon has access to traditional
means of measurement such as calipers. This is a
check in case the surgeon wants to confirm the
OFIX MIS App's measurement. | | | | | | Device Classification Name | Medical image management and processing system | Medical image management and
processing system | Same | | | | | | Software Functionalities/
Modalities | Generic, Spine, and Lower Limbs Measurements, Pre-op
Planning, Templating (vendor specific implants and
custom implants), Database, Case Sharing | Templating (vendor specific
implants), Database | The OFIX MIS App is a simplified software that
for templating Orthofix specific implants. It is
comparable to the predicate in that manner without
the additional functionalities that the predicate
offers. The predicate has previously been used by
medical professionals to template Orthofix
implants. After measuring, the OFIX MIS App
recommends a rod length pulled from its database
This doesn't not affect the safety and effectiveness
of the device and the OFIX MIS App is of lower
risk than the predicate. | | | | | | Algorithms | Osteotomy Module | Orthofix Implants Module (Not
machine-learning based) | The OFIX MIS App is a simplified software that
is for templating Orthofix specific implants. The
algorithm used is not machine learning based and
uses information specific to Orthofix implant
systems to analyze the captured image (input) and
recommend the correct implant (output). | | | | | | User Interface | PC | Mobile Device | This difference is expanded on more in the 510(k)
Summary in which the OFIX MIS App is
compared with the Surgimap 2.0 predicate and the
Nuvaline reference devices. All the devices are
used outside the sterile field and are accessible
without impedance (no gloves). Compared the PC
interface of Monitor/Keyboard/Mouse, The
Mobile Device touch screen provides the same
sufficient image handling (moving/zooming in)
needed to perform the steps to measure and
template the implant
Compared to the predicate, as discussed above,
the overall risk is lower for the OFIX MIS App
compared to the predicate in terms of its single
functionality. The mobile interface makes it more
accessible in the intraoperative environment. The
safety and effectiveness of the App is
demonstrated through user validation and testing,
and this difference does not render the OFIX MIS
App not substantially equivalent. | | | | | | Obtaining an image | DICOM | Transferred from other devices | Yes | Mobile Device Camera | N/A | This difference is expanded on more in the 510(k)
Summary in which the OFIX MIS App is
compared with the Surgimap 2.0 predicate and the
Nuvaline reference devices. The Nuvaline
(K162647) uses a Mobile Device Camera to
obtain the image and predicated against the
Surgimap 2.0. The use of a Mobile Device
Camera to obtain the image has been validated to
demonstrate sufficient input to the OFIX MIS
App to measure and output an accurate implant
length. User validation was performed to ensure
safety and effectiveness. This difference does not
render the App not substantially equivalent. | The OFIX MIS App, is a lower risk tool used to streamline the process of choosing the correct rod to be used in the surgical procedure. It processes pictures of a fluoroscopy monitor acquired by a cell phone camera. | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logos of two companies, Orthofix and SeaSpine. The Orthofix logo is on the left and consists of a blue abstract shape followed by the company name in black, sans-serif font. The SeaSpine logo is on the right and features a stylized wave graphic in blue and gray, followed by the company name in orange, sans-serif font. ### Non-Clinical Test Conducted for Determination of Substantial Equivalence ### Software Verification and Validation Testing Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The testing demonstrated that the App meets the required specifications. ### Usability Testing The OFIX MIS App demonstrated accuracy and usability with bench top and simulated use testing. ### Conclusion The OFIX MIS App is substantially equivalent to the predicate despite the minor technological differences described. The testing data support the safety and effectiveness of the OFIX MIS App and demonstrate performance as intended in the specified use conditions. This performance is comparable to the predicate's respective software functionality. --- **Source:** [https://fda-staging.innolitics.com/device/K230252](https://fda-staging.innolitics.com/device/K230252) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com