OrthoNext Platform System

K202519 · Orthofix Srl · LLZ · Oct 27, 2020 · Radiology

Device Facts

• Record ID: K202519
• Device Name: OrthoNext Platform System
• Applicant: Orthofix Srl
• Product Code: LLZ · Radiology
• Decision Date: Oct 27, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The OrthoNext ™ Platform system is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of Orthofix Product templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgments and experience are required to properly use the software. The OrthoNext ™ Platform system is not to be used for mammography.

Device Story

Web-based software platform for orthopedic surgeons; used for preoperative and postoperative treatment planning. Inputs: digital radiological images (X-rays). Operation: surgeon imports images, overlays Orthofix device templates, performs measurements, and simulates treatment options. Output: visual surgical plan with measurements and template positioning. Used in hospital environments; operated by surgeons/healthcare professionals. Benefits: digital planning, case documentation, and access to a library of tools compared to traditional acetate overlays. Clinical decision-making remains with the surgeon, who verifies and adjusts all parameters based on clinical judgment.

Clinical Evidence

Bench testing only. No clinical data. Performance was validated through non-clinical software testing (unit, system, integration, acceptance, security, stress, and regression testing) and usability testing simulating a clinical environment. Clinical literature on similar devices was reviewed to support performance.

Technological Characteristics

Web-based software application; runs on common web browsers (Chrome, Internet Explorer, Safari) on PC/MAC. Features include image importation, measurement/parameter analysis tools, and surgical planning modules for template overlay. Secure access via license activation code and password. No patient contact. No life-saving device control.

Indications for Use

Indicated for healthcare professionals performing preoperative planning for orthopedic surgery, specifically for skeletal appendicular trauma and deformity analysis. Not for use in mammography.

Regulatory Classification

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

• TraumaCad Mobile 1.0 (K142923)
• TraumaCAD Version 2.0 (K073714)

Submission Summary (Full Text)

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October 27, 2020

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Orthofix Srl % Ms. Cheryl Wagoner Consultant Wagoner Consulting LLC P O Box 15729 WILMINGTON NC 28408

Re: K202519

Trade/Device Name: OrthoNext™ Platform System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: August 25, 2020 Received: September 1, 2020

Dear Ms. Wagoner:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For

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

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# Indications for Use

510(k) Number (if known) K202519

Device Name OrthoNext TM Platform system

### Indications for Use (Describe)

The OrthoNext ™ Platform system is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of Orthofix Product templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgments and experience are required to properly use the software.

The OrthoNext ™ Platform system is not to be used for mammography.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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Image /page/3/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape above the word "ORTHOFIX" in black, with a registered trademark symbol next to it. The abstract shape is a curved, geometric design.

#### 510(k) Summary (21 CFR 807.92) K202519 Submitter information Submitter Name Orthofix Srl Via delle Nazioni, 9 | 37012 Bussolengo (VR) - Italy Address Telephone + 39 045 6719.000 Fax + 39 045 6719.380

| Contact Person | Gianluca Ricadona<br>Sr. Quality & Regulatory Affairs Manager |
|--------------------|---------------------------------------------------------------|
| Address | Via delle Nazioni, 9<br>37012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719 000 |
| Fax | + 39 045 6719 380 |
| Email address | [e-mail] |
| Date of submission | October 22, 2020 |

### Trade Name, Common Name, Classification

| Trade Name | OrthoNext ™ Platform system |
|----------------------------------|--------------------------------------|
| Device Classification name | Image Processing System Radiological |
| Product code | LLZ |
| Panel Code | Radiology |
| Class | Class II |
| Classification Regulation Number | 21 CFR § 892.2050 |

### Predicate devices

| Primary Predicate Device | 510(k) Number | Manufacturer |
|-----------------------------|---------------|------------------------------------------------------------|
| TraumaCad Mobile 1.0 | K142923 | ORTHOCRAT,LTD.<br>291Hillside Avenue<br>Somerset, MA 02726 |
| Additional Predicate Device | | |
| TraumaCAD Version 2.0 | K073714 | ORTHOCRAT,LTD.<br>291Hillside Avenue<br>Somerset, MA 02726 |

| Device description | The OrthoNextTM Platform is a web-based platform module system, to<br>allow surgeons to evaluate digital images while performing various pre-<br>operative treatment planning, evaluation of images and post-operative<br>treatment planning.<br>This software application enables surgeons to import radiological<br>images, display various 2D views of the images, overlays the<br>positioning of the Orthofix devices template and simulate the treatment<br>options, generate parameters and/or measurements to be verified or<br>adjusted by the surgeons based on their clinical judgment. |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The OrthoNextTM Platform system is indicated for assisting healthcare<br>professionals in preoperative planning of orthopedic surgery. The<br>device allows for overlaying of Orthofix Product templates on<br>radiological images, and includes tools for performing measurements<br>on the image and for positioning the template. Clinical judgments and<br>experience are required to properly use the software.<br>The OrthoNextTM Platform system is not to be used for mammography. |

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| Technological<br>Characteristics and<br>Intended Use | | The OrthoNext™ Platform operating principles and technological characteristic, including the intended use and users are the same as, or similar to, the chosen predicate devices.<br>Summary of the equivalence in technological characteristics and Intended Use:<br>✓ Intended use: identical.<br>✓ Operating principles, technological characteristics and conditions of use are substantially equivalent to predicates:<br>the OrthoNext ™ Platform system is a web-based software executed on a common web browser (Chrome, Internet Explorer, Safari), intended to run on a PC, MAC by Windows and Mac OS package , accessible in a secure environment by a license activation code and password provided by the manufacturer.<br>Principle of operation includes:<br>• Importation medical images format (x-ray images)<br>• Processing tools<br>• Measurements and parameters analysis tools<br>• Surgical planning tools<br>• Enable SW Modules (operative treatment planning) for overlaying template for simulation. |
|------------------------------------------------------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Analysis | | Subject device has similar configuration, and operating principle as the predicate device. Non-clinical software testing on operative treatment planning of orthopedic surgery using OrthoNext ™ Platform system produces results comparable to planning using acetate overlays but with the additional advantages of digital planning and simulations including ease of use, library, case documentation, access to a wider arrange of tools, and secure accessibility. Any potential hazards have been evaluated and controlled through Risk Management activities.<br>The review of clinical literatures on similar devices support the clinical performance of the Subject device with no additional clinical data. Usability testing have been performed by simulating a clinical environment requiring the test participants to perform treatment |

## Basis for Substantial Equivalence

| | SUBJECT DEVICE | PRIMARY<br>PREDICATE DEVICE |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| System<br>Features | OrthoNext ™ Platform | TraumaCad Mobile 1.0 |
| Product Code | LLZ | Identical |
| Indications for Use | The OrthoNext ™ Platform system is<br>indicated for assisting healthcare<br>professionals in preoperative planning of<br>orthopedic surgery. The device allows for<br>overlaying of Orthofix Product templates<br>on radiological images, and includes tools<br>for performing measurements on the<br>image and for positioning the template.<br>Clinical judgments and experience are<br>required to properly use the software. The<br>OrthoNext ™ Platform system is not to be<br>used for mammography | Identical |
| Intended Enviroment | Hospital | Identical |

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| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------|
| Specialties Sites | Easy-to-use solutions for various orthopedic subspecialties for skeletal appendicular trauma and deformity analysis | Identical |
| Configuration | Web- based | Identical |
| Image Input | Can receive digital images | Identical |
| Run on server | YES | Identical |
| Digital Device Template | YES | Identical |
| Interactive Template positioning | YES | Identical |
| Automatic scaling | YES | Identical |
| Template support from the manufacturer | YES | Identical |
| Permits template rotation | YES | Identical |
| Treatment operative planning | YES | Identical |
| Patient contacting | NO | Identical |
| Control of Life-Saving Devices | NO | Identical |
| HCP intervention for interpretation and manipulation of images | YES | Identical |

| Conclusion | The successful non-clinical testing demonstrates the safety and effectiveness of the OrthoNext ™ Platform system when used for the defined indications for use and demonstrates that the subject device, for which this Traditional 510(k) is submitted, performs as well as or better than the legally marketed predicate devices. OrthoNext ™ Platform contains a subset of the same features and algorithms as those that are in the predicate devices. The testing for each release consisted of Unit, System/Integration and Acceptance test levels. Testing included also security, negative testing, error message handling, stress testing, platform testing, workflow testing, functional testing, multi-user/external access testing, data integrity testing, compatibility testing, load testing, regression testing, and hazard mitigation testing. In case a test was failed any necessary corrections were made, the relevant test was executed and repeated again until all passed. |
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