Intellijoint VIEW

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". Intellijoint Surgical Inc. % Katarina Jugovic Regulatory Affairs Associate 809 Wellington Street North, Unit 2 Kitchener. Ontario N2H 5L6 CANADA November 12, 2021 # Re: K211876 Trade/Device Name: Intellijoint VIEW Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: October 14, 2021 Received: October 15, 2021 Dear Katarina Jugovic: 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR {1}------------------------------------------------ 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 (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 medical devices and radiation-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, 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 {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K211876 Device Name Intellijoint VIEW #### Indications for Use (Describe) Intellijoint VIEW is indicated to assist qualified healthcare professionals in preoperative planning and postoperative review of orthopedic surgery. The device allows for orthopedic implant to be overlaid on medical images for the purpose of selecting and positioning implants. The device includes tools for performing measurements and evaluating surgical treatment options. 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/2 description: The image contains the logo for "Intellijoint Surgical". The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is made up of three triangles, one blue, one light blue, and one gray. The company name is written in a sans-serif font, with the word "Intellijoint" in a larger font size than the word "Surgical". # 510(k) Summary # 1. Submitter Information | Submitter: | Intellijoint Surgical Inc. | |----------------|------------------------------------------------------------------| | Address: | 809 Wellington St. N., Unit 2<br>Kitchener, ON<br>Canada N2H 5L6 | | Telephone: | (519) 342-3178 | | Fax: | (226) 317-0471 | | Contact: | Andrew Graham | | Date Prepared: | 7 Oct 2021 | ## 2. Device Information | Trade Name: | Intellijoint® VIEW | |-----------------|------------------------------------------------| | Common Name: | Medical Image Management and Processing System | | Classification: | Class II per 21 CFR 892.2050 | | Product Code: | LLZ | ## 3. Purpose of Submission The purpose of this submission is to gain clearance for a new software as a medical device, Intellijoint® VIEW. ## 4. Predicate Device Information The Intellijoint® VIEW product described in this substantially equivalent to the following predicates: | Predicate Device | Manufacturer | 510(k) No. | |---------------------|-----------------|------------| | TraumaCAD (primary) | OrthoCrat Ltd | K042816 | | Cuptimize | Cuptimize, Inc. | K203651 | ## 5. Device Description Intellijoint® VIEW is a web-based software as a medical device (SaMD) product that assists health care professionals complete preoperative planning and postoperative review for orthopedic surgery. Preoperative planning on Intellijoint® VIEW involves the user completing measurements on medical images to inform the selection and intraoperative positioning of orthopedic implant system components. Intellijoint® VIEW also allows for postoperative image review and measurement. {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the logo for "Intellijoint Surgical". The logo consists of a blue triangle on the left, with a smaller gray triangle below it. To the right of the triangles is the word "intellijoint" in gray, with the word "surgical" in a smaller font below it. Intellijoint® VIEW Templating tool allows the user to perform distance and angular measurements on scaled medical images, to inform selection of acetabular and femoral implant components. Intellijoint® VIEW Hip-Spine Assessment allows the user to assess a patient's spinopelvic relationship for preoperative functional acetabular cup position planning. The Application overlays acetabular measurement tools on standing and sitting lateral functional patient images to inform an appropriate implant position based on the functional relationship between the hips and spine. # 6. Indications for Use Intellijoint VIEW is software indicated to assist qualified healthcare professionals in preoperative planning and postoperative review of orthopedic surgery. The device allows for orthopedic implant templates to be overlaid on medical images for the purpose of selecting and positioning implants. The device includes tools for performing measurements and evaluating surgical treatment options. Clinical judgement and experience are required to properly use the software. # 7. Comparison of Technological Characteristics The substantial equivalence of Intellijoint® VIEW to the predicates is shown by similarities in intended use, indications for use, and performance. | Property | Intellijoint® VIEW | Primary Predicate<br>TraumaCAD<br>(K042816) | Predicate 2<br>Cuptimize<br>(K203651) | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) No. | K211876 | K042816 | K203651 | | Classification | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | | Product Code | LLZ | LLZ | LLZ; HAW | | | | Primary Predicate | Predicate 2 | | Property | Intellijoint® VIEW | TraumaCAD<br>(K042816) | Cuptimize<br>(K203651) | | Indications for Use | Intellijoint VIEW is<br>indicated to assist qualified<br>healthcare professionals in<br>preoperative planning and<br>postoperative review of<br>orthopedic surgery.<br>The device allows for<br> | The TraumaCAD program<br>is indicated for assisting<br>healthcare professionals in<br>preoperative planning or<br>orthopedic surgery. The<br>device allows for<br>overlaying of prosthesis<br>templates on radiological<br>images and includes tools<br>for performing<br>measurements on the<br>image and for positioning<br>the template. Clinical<br>judgements and experience<br>are required to properly<br>use the software. | Cuptimize is an image-<br>processing software<br>indicated to assist in the<br>positioning of total hip<br>replacement components,<br>with a specific focus on<br>the acetabular component.<br>It is intended to assist in<br>the precise positioning of<br>the acetabular<br>component intra-<br>operatively by measuring<br>its position relative to the<br>bone structures of interest<br>provided that the points of<br>interest can be identified<br>from radiology images.<br>The device allows for<br>overlaying of digital<br>annotations on radiological<br>images and includes tools<br>for performing<br>measurements using the<br>images and digital<br>annotations. Clinical<br>judgment and experience<br>are required to properly<br>use the<br>software. The software is<br>not for primary image<br>interpretation. The<br>software is not for use on<br>mobile phones. | | Versions | Web version | Client/server version<br>Standalone version<br>Web version | Web version | | | PC and MAC Compatible | PC and MAC Compatible | PC and MAC Compatible | | Computer | Not for use on mobile<br>phones | Not for use on mobile<br>phones | Not for use on mobile<br>phones | | | Not tablet compatible | iPad compatible | | | Operating Systems | MacOS<br>Windows | MacOS<br>Windows | MacOS<br>Windows | | Anatomical Locations | Hip | Hip, Knee, Upper Limb,<br>Foot and Ankle, Trauma,<br>Spine, Pediatric,<br>Deformity, 3D Suite | Hip | | Image Input | 2D radiographs | 2D radiographs | 2D radiographs | | | Templating | | | | Image Measurements | Leg Length Discrepancy | Leg Length Discrepancy | N/A | | Property | Intellijoint® VIEW | Primary Predicate<br>TraumaCAD<br>(K042816) | Predicate 2<br>Cuptimize<br>(K203651) | | | Hip-Spine Assessment<br>Angular measurements<br>(Inclination Reference,<br>Pelvic Tilt, Sacral Slope,<br>Pelvic Incidence, Lumbar<br>Lordosis, Pelvic<br>Incidence-Lumbar<br>Lordosis mismatch) | Angular measurements | Angular measurements<br>(Inclination Reference,<br>Pelvic Tilt, Sacral Slope,<br>Pelvic Incidence,<br>Spinopelvic Tilt Angle) | | Output Data | Templating<br>Selected Implants<br>Anticipated anatomical<br>changes (Leg Length,<br>Offset, Femoral Stem<br>Positioning, Acetabular<br>Cup Position) | Selected Implants<br>Anticipated anatomical<br>changes (Leg Length,<br>Offset, Femoral Stem<br>Positioning, Acetabular<br>Cup Position) | N/A | | | Hip-Spine Assessment<br>Anatomical measurements<br>(Pelvic Tilt, Sacral Slope,<br>Pelvic Incidence, Lumbar<br>Lordosis, Pelvic<br>Incidence-Lumbar<br>Lordosis mismatch)<br>Target Cup Position<br>(Inclination and<br>Anteversion) | N/A | Anatomical measurements<br>Target Cup Position<br>(Inclination and<br>Anteversion) | | Software Features | Templating<br>Template overlay<br>capability, Interactive<br>template positioning,<br>Image Scaling, Template<br>support from<br>manufacturers, Permits<br>template rotation | Template overlay<br>capability, Interactive<br>template positioning,<br>Image Scaling, Template<br>support from<br>manufacturers, Permits<br>template rotation | N/A | | | Hip-Spine Assessment<br>Preoperative cup position<br>analysis. | N/A | Preoperative and<br>intraoperative cup position<br>analysis. | {5}------------------------------------------------ Image /page/5/Picture/2 description: The image shows the logo for "Intellijoint Surgical". The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is made up of three triangles, one dark blue, one light blue, and one gray. The company name is written in gray, with the word "surgical" in a smaller font size below "intellijoint". {6}------------------------------------------------ Image /page/6/Picture/2 description: The image shows the logo for "IntelliJoint Surgical". The logo consists of a blue triangle shape on the left, with the text "IntelliJoint" in a sans-serif font to the right of the triangle. Below "IntelliJoint" is the word "surgical" in a smaller font size. {7}------------------------------------------------ Image /page/7/Picture/2 description: The image shows the logo for "Intellijoint Surgical". The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is made up of three triangles, one dark blue, one light blue, and one gray. The company name is written in a sans-serif font, with the word "Intellijoint" in a larger font size than the word "Surgical". # 8. Performance Data The following tests were performed to demonstrate the substantial equivalence of Intellijoint® VIEW to its predicate devices: | Test | Summary | Result | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------| | Verification | | | | Software Functional<br>and Unit Tests | Verified that Intellijoint® VIEW satisfies functional requirements and performs as intended.<br>Algorithms and measurement calculations were verified in these tests. | Software satisfied all requirements and specifications. | | Accuracy Test | Provides confirmation that distance and angular measurements satisfy requirements for accuracy.<br>Provides confirmation that implant templates are displayed correctly and accurately. | Software satisfied all accuracy requirements. | | Validation | | | | Simulated Use and<br>Usability Validation | Simulated use testing was performed by qualified orthopedic surgeons on radiographic images following a typical workflow.<br>This test validated that Intellijoint® VIEW satisfies user needs and intended use. | All user needs were met. | The testing demonstrated that the Intellijoint® VIEW is substantially equivalent to the legally marketed predicate devices for its intended use. ## Non-Clinical Testing Non-clinical testing was performed to assess the safety and effectiveness of the device, to demonstratethat themeasurement tools produced accurate, repeatable, and reproducible implant selection, sizing, and placement of components. Testing verified that the software application is operating according to specified design requirements. Intellijoint VIEW displays angular measurements to within ± 0.8°and distance measurements to within ± 0.3 mm of their true value. Distance measurements of resultant position changes due to implant placement, are displayed to within ± 1 mm of their true value. Supporting documentation is included in this 510(k) Premarket Notification and supports the claims of substantial equivalence to the predicate devices. Software testing was 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 as a Medical Device". The software application was of "moderate" level of concern because a failure or latent flaw in the software could indirectly result in minor injury to the patient through incorrect or delayed information. ## Clinical Testing Clinical testing was not necessary for this Traditional 510(k). {8}------------------------------------------------ Image /page/8/Picture/2 description: The image shows the logo for "Intellijoint Surgical". The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is made up of three triangles, stacked on top of each other, in different shades of blue and gray. The company name is written in a sans-serif font, with the word "Intellijoint" in a larger font size than the word "Surgical". # 9. Conclusion Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate devices, Intellijoint® VIEW has been shown to be substantially equivalent to the legally marketed predicate devices identified in this submission and does not present any increased risk to safety or effectiveness. Based on the information supplied in this 510(k), it is our conclusion that our device is safe, effective, and substantially equivalent to the primary predicate device.