(148 days)
Not Found
No
The summary describes standard image measurement and templating tools, and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
Explanation: The device is a software tool for preoperative planning and postoperative review, assisting healthcare professionals in selecting and positioning implants. It provides measurements and helps evaluate treatment options, but it does not directly treat or diagnose a disease or condition. It is a tool for information and planning, not a therapeutic intervention itself.
No
The device is described as assisting healthcare professionals in preoperative planning and postoperative review, and for selecting and positioning implants. It provides tools for measurements and evaluating treatment options but does not make a diagnosis itself.
Yes
The device description explicitly states it is a "web-based software as a medical device (SaMD) product" and the performance studies focus solely on software functionality, accuracy, and usability, with no mention of hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Intended Use: The intended use of Intellijoint VIEW is to assist healthcare professionals in preoperative planning and postoperative review of orthopedic surgery by overlaying implants on medical images and performing measurements. This is a planning and review tool based on medical images, not a device that analyzes biological specimens.
- Device Description: The description reinforces that it's a web-based software that assists with planning and review using medical images.
- Input: The input is 2D radiographs (medical images), not biological specimens.
The device falls under the category of medical imaging software used for planning and analysis, which is distinct from In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
LLZ
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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D radiographs
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following tests were performed to demonstrate the substantial equivalence of Intellijoint® VIEW to its predicate devices:
| Test | Summary | Result |
|---|---|---|
| Verification | ||
| Software Functional | ||
| and Unit Tests | Verified that Intellijoint® VIEW satisfies functional requirements and performs as intended. | |
| 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. | |
| Provides confirmation that implant templates are displayed correctly and accurately. | Software satisfied all accuracy requirements. | |
| Validation | ||
| Simulated Use and | ||
| Usability Validation | Simulated use testing was performed by qualified orthopedic surgeons on radiographic images following a typical workflow. | |
| This test validated that Intellijoint® VIEW satisfies user needs and intended use. | All user needs were met. |
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).
Key Metrics
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.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
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
- 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)
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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 |
| Kitchener, ON | |
| 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
TraumaCAD
(K042816) | Predicate 2
Cuptimize
(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
(K042816) | Cuptimize
(K203651) |
| Indications for Use | Intellijoint VIEW is
indicated to assist qualified
healthcare professionals in
preoperative planning and
postoperative review of
orthopedic surgery.
The device allows for
| The TraumaCAD program
is indicated for assisting
healthcare professionals in
preoperative planning or
orthopedic surgery. The
device allows for
overlaying of prosthesis
templates on radiological
images and includes tools
for performing
measurements on the
image and for positioning
the template. Clinical
judgements and experience
are required to properly
use the software. | Cuptimize is an image-
processing software
indicated to assist in the
positioning of total hip
replacement components,
with a specific focus on
the acetabular component.
It is intended to assist in
the precise positioning of
the acetabular
component intra-
operatively by measuring
its position relative to the
bone structures of interest
provided that the points of
interest can be identified
from radiology images.
The device allows for
overlaying of digital
annotations on radiological
images and includes tools
for performing
measurements using the
images and digital
annotations. Clinical
judgment and experience
are required to properly
use the
software. The software is
not for primary image
interpretation. The
software is not for use on
mobile phones. |
| Versions | Web version | Client/server version
Standalone version
Web version | Web version |
| | PC and MAC Compatible | PC and MAC Compatible | PC and MAC Compatible |
| Computer | Not for use on mobile
phones | Not for use on mobile
phones | Not for use on mobile
phones |
| | Not tablet compatible | iPad compatible | |
| Operating Systems | MacOS
Windows | MacOS
Windows | MacOS
Windows |
| Anatomical Locations | Hip | Hip, Knee, Upper Limb,
Foot and Ankle, Trauma,
Spine, Pediatric,
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
TraumaCAD
(K042816) | Predicate 2
Cuptimize
(K203651) |
| | Hip-Spine Assessment
Angular measurements
(Inclination Reference,
Pelvic Tilt, Sacral Slope,
Pelvic Incidence, Lumbar
Lordosis, Pelvic
Incidence-Lumbar
Lordosis mismatch) | Angular measurements | Angular measurements
(Inclination Reference,
Pelvic Tilt, Sacral Slope,
Pelvic Incidence,
Spinopelvic Tilt Angle) |
| Output Data | Templating
Selected Implants
Anticipated anatomical
changes (Leg Length,
Offset, Femoral Stem
Positioning, Acetabular
Cup Position) | Selected Implants
Anticipated anatomical
changes (Leg Length,
Offset, Femoral Stem
Positioning, Acetabular
Cup Position) | N/A |
| | Hip-Spine Assessment
Anatomical measurements
(Pelvic Tilt, Sacral Slope,
Pelvic Incidence, Lumbar
Lordosis, Pelvic
Incidence-Lumbar
Lordosis mismatch)
Target Cup Position
(Inclination and
Anteversion) | N/A | Anatomical measurements
Target Cup Position
(Inclination and
Anteversion) |
| Software Features | Templating
Template overlay
capability, Interactive
template positioning,
Image Scaling, Template
support from
manufacturers, Permits
template rotation | Template overlay
capability, Interactive
template positioning,
Image Scaling, Template
support from
manufacturers, Permits
template rotation | N/A |
| | Hip-Spine Assessment
Preoperative cup position
analysis. | N/A | Preoperative and
intraoperative cup position
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".
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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 | ||
| and Unit Tests | Verified that Intellijoint® VIEW satisfies functional requirements and performs as intended. | |
| 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. | |
| Provides confirmation that implant templates are displayed correctly and accurately. | Software satisfied all accuracy requirements. | |
| Validation | ||
| Simulated Use and | ||
| Usability Validation | Simulated use testing was performed by qualified orthopedic surgeons on radiographic images following a typical workflow. | |
| 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.