(28 days)
No
The summary does not mention AI, ML, or deep learning, and the description of the software's function (providing a recommended cup target based on spinopelvic mobility) does not inherently require AI/ML. The performance studies focus on measurement accuracy and usability, not AI/ML model performance.
No.
The device is a planning software used for pre-operative planning, not for active treatment or diagnosis.
No
The device is a pre-operative planning software used to assist surgeons in component selection and positioning. It does not diagnose a disease or condition; it aids in the planning of a surgical procedure.
Yes
The device description explicitly states it is "software as a medical device (SaMD)" and describes its function as a "non-invasive total hip arthroplasty planning software." While it uses external X-ray images as input, the device itself is solely the software for planning.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Navbit Rapid Surgical Plan is a software tool used for pre-operative planning for total hip arthroplasty. It analyzes medical images (X-rays) and provides recommendations for component placement.
- No Biological Samples: The device does not involve the analysis of any biological samples from the patient. Its input is medical imaging data.
- Purpose: Its purpose is to assist the surgeon in surgical planning, not to diagnose a disease or condition based on biological markers.
Therefore, the Navbit Rapid Surgical Plan falls under the category of a medical device, specifically Software as a Medical Device (SaMD), but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Navbit Rapid Surgical Plan is intended for pre-operative planning for primary total hip arthroplasty. Rapid Surgical Plan is intended to be used as a tool to assist the surgeon in the selection and positioning of components in primary total hip arthroplasty.
Rapid Surgical Plan is indicated for individuals undergoing primary hip surgery.
Product codes
LLZ
Device Description
The Navbit Rapid Surgical Plan is a non-invasive total hip arthroplasty planning software. It is software as a medical device (SaMD) which provides pre-operative planning for acetabular component orientation for orthopaedic surgeons. The software provides a recommended cup target intended to reduce impingement based on each patient's spinopelvic mobility. The ultimate decision to use the cup target recommended by Navbit is the surgeon's based on their clinical judgement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray images are acquired externally to the system by healthcare professionals following an imaging protocol to produce DICOM files. The DICOM files are uploaded directly to the RSP and displayed in PNG format for planning and visualization purposes. The RSP itself does not acquire images directly.
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Navbit RSP report is intended to be used by in a clinical setting by a qualified surgeon.
The RSP pre-operative planning process is conducted by trained planning technicians whereas RI.HIP Modeler analysis is conducted by surgeons.
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
Clinical Measurement Accuracy Evaluation: Used representative patient images to compare RSP outputs against a ground truth data set established by surgeons.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing, which included clinical measurement accuracy testing, sufficiently demonstrated substantial equivalence in safety and effectiveness. No clinical testing required.
The Rapid Surgical Plan (RSP) underwent extensive design verification and validation to confirm that it meets all design requirements and is as safe and effective as the predicate device. Comprehensive performance testing validated that the device fulfills the necessary design inputs. The performance data included:
- Software Verification Testing: Conducted software integration and workflow assessments in compliance with IEC 62304: Medical Device Software—Software Life Cycle Processes. Documentation aligns with the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- Clinical Measurement Accuracy Evaluation: Used representative patient images to compare RSP outputs against a ground truth data set established by surgeons. Testing confirmed that the device achieves the required accuracy in clinical measurements.
- Device Measurement Accuracy Evaluation: Used test patterns to assess the nonclinical measurement accuracy of the RSP. Testing confirmed that the device achieves the required non-clinical measurement accuracy, with limits defined as follows:
- Linear measurements: ±0.1 mm with at least 95% confidence
- Angular measurements: ±0.3° with at least 95% confidence
- Ratio measurements: ±0.1 with at least 95% confidence
- Usability Engineering Validation: Demonstrated that representative users can safely and effectively operate the RSP in a simulated clinical environment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Linear measurements: ±0.1mm with at least 95% confidence
Angular measurements: ±0.3° with at least 95% confidence
Ratio measurements: ±0.1 with at least 95% confidence
Predicate Device(s)
RI.HIP MODELER (K212040)
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).
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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.
Navbit Pty Ltd % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
December 5, 0224
Re: K243447
Trade/Device Name: Rapid Surgical Plan (RSP-SW-001) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: November 6, 2024 Received: November 7, 2024
Dear Dave Yungvirt:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
(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-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 Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of 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) K243447
Device Name Navbit Rapid Surgical Plan
Indications for Use (Describe)
Navbit Rapid Surgical Plan is intended for pre-operative planning for primary total hip arthroplasty. Rapid Surgical Plan is intended to be used as a tool to assist the surgeon in the selection and positioning of components in primary total hip arthroplasty.
Rapid Surgical Plan is indicated for individuals undergoing primary hip surgery.
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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510(k) Summary K243447
| 510(k) Owner | Navbit Pty Ltd
Suite 201, National Innovation Centre, 4 Cornwallis Street
South Eveleigh 2015, Eveleigh, NSW, Australia
Phone: +612 9209 4130 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | David Thomson
Chief Regulatory Affairs and Commercial Risk Officer
Email: dave.thomson@navbit.com
Phone: +61(0)433482325 |
| Date of Submission | 5 Dec, 2024 |
| Classification Reference | 21 CFR 892.2050 |
| Product Code | LLZ |
| Common/Usual name | Medical Image Management And Processing System |
| Trade/Proprietary Name | Navbit Rapid Surgical Plan® |
| Predicate Device(s) | RI.HIP MODELER (K212040) |
| Reason for Submission | New Device |
Indications for Use
Navbit Rapid Surgical Plan is intended for pre-operative planning for primary total hip arthroplasty. Rapid Surgical Plan is intended to be used as a tool to assist the surgeon in the selection and positioning of components in primary total hip arthroplasty.
Rapid Surgical Plan is indicated for individuals undergoing primary hip surgery.
Device Description
The Navbit Rapid Surgical Plan is a non-invasive total hip arthroplasty planning software. It is software as a medical device (SaMD) which provides pre-operative planning for acetabular component orientation for orthopaedic surgeons. The software provides a recommended cup target intended to reduce impingement based on each patient's spinopelvic mobility. The ultimate decision to use the cup target recommended by Navbit is the surgeon's based on their clinical judgement.
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Discussion of Similarities and Differences
Navbit RSP is substantially equivalent to its predicate device. The table below compares Navbit RSP to the selected predicate device, RI.HIP MODELER. The predicate device information has been sourced from the 510k premarket notification (K212040). An assessment of the substantially equivalent differences is included after the table.
| Characteristic | Subject Device
Navbit RSP | Predicate Device
RI.HIP Modeler (K212040) |
|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications
for Use | Navbit Rapid Surgical Plan is
intended for pre-operative planning
for primary total hip arthroplasty.
Rapid Surgical Plan is intended to be
used as a tool to assist the surgeon in
the selection and positioning of
components in primary total hip
arthroplasty. | RI.HIP MODELER is intended for pre-
operative planning for primary total
hip arthroplasty. RI.HIP MODELER is
intended to be used as a tool to assist
the surgeon in the selection and
positioning of components in primary
total hip arthroplasty. |
| (same) | Rapid Surgical Plan is indicated for
individuals undergoing primary hip
surgery | RI.HIP MODELER is indicated for
individuals undergoing primary hip
surgery. |
| Classification
and regulation | LLZ
892.2050 | LLZ
892.2050 |
| (same) | | |
| Main system
components | Standalone software | Standalone software |
| (same) | | |
| Operational
environment | Navbit RSP report is intended to be
used by in a clinical setting by a
qualified surgeon. | RI.HIP MODELER is intended to be
used in a clinical setting by a qualified
surgeon. |
| (same) | | |
| Imaging
requirements | Weightbearing AP, lateral standing,
lateral relaxed seated and lateral
flexed seated | Weightbearing lateral standing and
lateral relaxed seated |
| (substantially
equivalent)1 | | |
| Image
acquisition,
source and
modalities
features
(substantially
equivalent)2 | X-ray images are acquired externally
to the system by healthcare
professionals following an imaging
protocol to produce DICOM files. The
DICOM files are uploaded directly to
the RSP and displayed in PNG format
for planning and visualization
purposes. The RSP itself does not
acquire images directly. | X-ray images are acquired externally
to the system by healthcare
professionals following an imaging
protocol to produce DICOM files.
These images are made available in
RI.HIP MODELLER by downloading
from Brainlab Quentry, or via an iPad
camera roll, or iPad camera and are
displayed in PNG format for planning
and visualization purposes. The RI.HIP
MODELLER itself does not acquire
images directly. |
| Image Types
Used
(same) | PNG Images | PNG Images |
| Measurements
and tools
(substantially
equivalent)3 | Navbit RSP uses qualified surgical
planning engineers to perform
clinically relevant anatomical
measurements that are based on
supporting literature. Measurements
are achieved using annotation tools
that facilitate point placement,
including lines and circles. The
measurements include angles and
linear measurements. | RI.HIP MODELER allows the surgeon
to perform clinically relevant
anatomical measurements that are
based on supporting literature.
Measurements are achieved using
annotation tools that facilitate point
placement, including lines. The
measurements include angles. |
| Primary device
function
(substantially
equivalent)4 | Navbit RSP uses stand-alone
software for computer assisted
surgical planning.
The primary function of the software
is to provide a baseline cup
orientation recommendation
intended to reduce incidences of
implant impingement based on
inclination/anteversion and
spinopelvic mobility. | RI.HIP MODELER uses stand-alone
software for computer assisted
surgical planning.
The primary function of the software is
to provide a baseline cup orientation
recommendation intended to reduce
incidences of implant impingement
based on inclination/anteversion and
implant specifications, and stem
anteversion. |
| Clinical testing
(same) | Non-clinical testing, which included
clinical measurement accuracy
testing, sufficiently demonstrated
substantial equivalence in safety and
effectiveness. No clinical testing
required. | Non-clinical testing sufficiently
demonstrated substantial
equivalence in safety and
effectiveness. No clinical testing
required. |
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1 Imaging Requirements
Navbit RSP requires 2 additional x-rays: weightbearing AP and flexed-seated. Weightbearing AP x-rays are standard practice in THA. The flexed-seated x-ray has been included based on the results of the literature review which identify its importance and use in identifying patients at risk of post-operative complications. The risks associated with radiation exposure from additional x-rays have been assessed in risk management activities. There are no new questions of safety or effectiveness due to the difference in imaging requirements. The imaging requirements are substantially equivalent to the requirements for the predicate device.
2 Image acquisition, source and modalities features
Both the predicate device and the RSP utilise PNG images for landmarking in surgical planning. The RSP accepts PNG images that are uploaded via a DICOM modality, while the predicate device can receive PNG images through a broader range of methods, including the iPad Camera Roll, iPad Camera, and Brainlab Quentry, the latter being a DICOM modality.
Although the predicate device relies on Brainlab Quentry as an intermediate system to receive DICOM files, the RSP achieves the same functionality by allowing DICOM files to be downloaded from any third-party system and then uploaded into the RSP. Since DICOM is a standardised format, and both methods involve extracting a DICOM file from one system and uploading it into another, these approaches are considered substantially equivalent.
The RSP does not include iPad Camera Roll and iPad Camera as input methods, as no clinical need for these was identified. The iPad Camera Roll and Camera are used to capture images of a source image displayed on a screen, which would result in image quality that is equal to or lower than the original DICOM image. Therefore, the absence of a camera-based input does not introduce any new concerns regarding the safety and effectiveness of the RSP.
³Measurements and Tools
Both systems utilise annotation tools that allow users to place points, which define basic geometries such as lines and circles. These geometries are then used to perform simple measurements like angles. Unlike the predicate, the RSP additionally uses these geometries to perform length measurements, however this is also a simple measurement. The predicate does not use circle annotation tools. However, this functionality is equivalent in both systems as the circle annotation tool is a means of performing point placement.
Additionally, both systems use this user-driven annotation capability to landmark clinically relevant features on radiographs for the purpose of obtaining measurements. The annotated clinical features are based on established clinical definitions from the literature, which is equivalent across both systems.
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The primary difference lies in the user performing the annotations: the predicate device is operated by surgeons, while the RSP is used by qualified planning technicians. To ensure equivalence, the planning technicians undergo performance testing against a reference dataset that has been landmarked by surgeons. This testing demonstrates that the performance of the planning technicians is equivalent to that of the surgeons for the scope of the landmarking tasks involved. Given that the performance of both groups is validated to be equivalent, this difference in user type does not introduce any new concerns regarding the safety or effectiveness of the RSP.
4Primary Device Function
The primary device function is substantially equivalent between the subject device and the predicate device. Both devices provide a recommended inclination/anteversion cup targets based on spinopelvic mobility. Navbit RSP provides additional spinopelvic analysis from the inclusion of the flexed-seated x-ray, however this does not contribute to the cup target recommendation and does not raise new questions of safety or effectiveness.
Principles of Operation
Navbit RSP is substantially equivalent to RI.HIP Modeler in principles of operations. Spinopelvic mobility of THA patients is assessed from standing and sitting x-rays. Navbit RSP uses an algorithm based on clinical recommendations for spinopelvic mobility to provide cup target recommendations. Similarly, RI.HIP Modeler uses an algorithm based on spinopelvic mobility classifications and hip kinematics in literature to recommend cup targets.
The RSP pre-operative planning process is conducted by trained planning technicians whereas RI.HIP Modeler analysis is conducted by surgeons. User validation showed that RSP planning technicians can conduct analyses that are as accurate as surgeon analyses. There are no new questions of safety or effectiveness due to the difference in pre-operative planning users as the processes involved in operation have been verified and validated for accuracy. Orthopaedic surgeons are the end users for both devices.
Technological Characteristics
- . The subject and predicate device both recommend acetabular cup placement based on spinopelvic mobility classification.
- . Both devices use functional lateral 2D x-rays to assess Spinopelvic mobility. Navbit RSP uses one extra x-ray (lateral flexed-seated x-ray).
- . Rapid Surgical Plan analysis is performed by trained planning technicians. RI.HIP Modeler analysis is performed by surgeons.
- Rapid Surgical Plan is a web application and RI.HIP Modeler is an iPad application. Both devices are stand-alone software.
There are no new concerns for safety or effectiveness due to the difference in technological characteristics because Rapid Surgical Plan was designed to meet its intended use with the technological characteristics within the web-based software. Verification and Validation from Testing confirms that the Rapid Surgical Plan is safe and effective and meets its intended use. Validation Testing confirms that users of the Rapid Surgical Plan software were able to successfully and accurately perform analysis in a safe and effective way in the intended use environment.
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User Interface
Navbit RSP is a standalone software that is intended to be installed on any computer. The predicate device is standalone software that can be installed on an iPad. The subject device software was verified and validated to ensure specifications were met. User validation showed that users can use the RSP safely and effectively on a computer to plan for total hip arthroplasty procedures. There are no new questions of safety or effectiveness due to the different interface as the design of Navbit RSP was specific to the intended interface and allows the device to perform its intended use.
Non-Clinical Testing (Bench)
The Rapid Surgical Plan (RSP) underwent extensive design verification and validation to confirm that it meets all design requirements and is as safe and effective as the predicate device. Comprehensive performance testing validated that the device fulfills the necessary design inputs. The performance data included:
- . Software Verification Testing: Conducted software integration and workflow assessments in compliance with IEC 62304: Medical Device Software—Software Life Cycle Processes. Documentation aligns with the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- . Clinical Measurement Accuracy Evaluation: Used representative patient images to compare RSP outputs against a ground truth data set established by surgeons. Testing confirmed that the device achieves the required accuracy in clinical measurements.
- . Device Measurement Accuracy Evaluation: Used test patterns to assess the nonclinical measurement accuracy of the RSP. Testing confirmed that the device achieves the required non-clinical measurement accuracy, with limits defined as follows:
- . Linear measurements: ±0.1mm with at least 95% confidence
- . Angular measurements: ±0.3° with at least 95% confidence
- . Ratio measurements: ±0.1 with at least 95% confidence
- . Usability Engineering Validation: Demonstrated that representative users can safely and effectively operate the RSP in a simulated clinical environment.
No human clinical testing was necessary to establish the safety and effectiveness of the Rapid Surgical Plan.
Conclusion
Navbit RSP has a similar intended use, technological characteristics, principles of operations and primary device function as its predicate, RI.HIP MODELER (K212040). The primary difference between the devices is that Navbit RSP measurements are performed by trained planning technicians while RI.HIP MODELER measurements are performed by surgeons. User validation showed that RSP planning technicians can conduct analyses that are as accurate as
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surgeon analyses. Navbit RSP report is intended to be used by in a clinical setting by a qualified surgeon. The differences do not raise any new questions of safety or effectiveness.
The results of verification and validation activities demonstrate that there are no issues of safety and performance and that the Navbit RSP satisfies its intended use. The information presented in this 510(k) premarket notification demonstrate that Navbit RSP is as safe and effective as the predicate device RI.HIP MODELER (K212040). Navbit RSP is substantially equivalent to the predicate device.