(199 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on 3D visualization and manual implant positioning based on reliable landmarks, not automated analysis or prediction.
No.
The device is described as a web-based surgical planning software application intended to assist in preoperative surgical planning and visualization. It provides information to surgeons to help prepare an intraoperative plan and does not directly treat or diagnose a disease or condition.
No
Explanation: The device is described as an "information tool" and a "pre-surgical planning tool" to assist in "preoperative surgical planning and visualization." It helps surgeons understand patient anatomy and prepare an intraoperative plan, but it does not diagnose a condition or disease.
Yes
The device is described as a "web-based surgical planning software application" and the description focuses solely on its software functionalities for 3D visualization and planning. There is no mention of any accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an "information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement." This is a surgical planning tool, not a diagnostic test performed on biological samples.
- Device Description: The description reinforces that it's a "web-based surgical planning software application" that helps surgeons "understand their patient's anatomy prior to surgery" and "prepare an intraoperative plan." It focuses on visualization and planning based on imaging data.
- Lack of Biological Sample Analysis: IVD devices are designed to perform tests on biological samples (blood, urine, tissue, etc.) to diagnose diseases or conditions. This device uses CT scans, which are imaging data, not biological samples.
Therefore, the function and intended use of this device align with surgical planning software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
E-Ortho shoulder is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.
Product codes
LLZ
Device Description
e-Ortho Shoulder software is a web-based surgical planning software application. e-Ortho Shoulder provides a pre-surgical planning tool for surgeons that helps them understand their patient's anatomy prior to surgery. Compared to using two-dimensional (2D) images to plan a shoulder arthroplasty (current method used by FH-Orthopedic surgeons), e-Ortho supplies information to surgeons to help prepare an intraoperative plan. E-Ortho allows surgeons to work in three-dimensional (3D) visualization, implant visualization and positioning within the specific patient's bone model (scapula and humerus), using reliable landmarks. This allows surgeons to preoperatively select the needed implant and determine its desired position.
The subject submission seeks to add humeral planning capabilities to the previously cleared FH E-Ortho Shoulder Software. Additional changes to the software have been made to improve functionality within the previously cleared intended use.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT Scan per protocol
Anatomical Site
Shoulder (scapula and humerus)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthopedic Surgeon
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
The validation process was implemented through a usability test campaign, with critical features requiring validation by five surgeons. The result of the validation tests coincides with the expected results for each test case and no test failed. Similar to the predicate device, additional accuracy testing was carried out to guarantee the performance of e-Ortho as follows: the sequence of events which could lead to dangerous situations and potential harms were identified then simulated in different virtual cases including right and left sided scenarios in head-first supine positioning of patient as well as feet-first supine patient positioning, varying reaming depths, and implant visualization from varying angles. These simulations were carried out using the subject device, compared to the "gold standard" Materialise innovation Suite (Mimics V 22 and 3matic V 14) and SolidWork 2016 for implant values (version and inclination).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing: In order to ensure the performance of the e-Ortho throughout the project's development, a verification and validation process has been established and conducted per IEC 62304. The verification process was implemented through five test campaigns and was carried out by five different evaluators in two different environments to verify the functional components of the subject device. Three bugs were identified as remaining problems after the debugging campaign; however, all are minor and not expected to impact the planning itself.. The validation process was implemented through a usability test campaign, with critical features requiring validation by five surgeons. The result of the validation tests coincides with the expected results for each test case and no test failed. Similar to the predicate device, additional accuracy testing was carried out to guarantee the performance of e-Ortho as follows: the sequence of events which could lead to dangerous situations and potential harms were identified then simulated in different virtual cases including right and left sided scenarios in head-first supine positioning of patient as well as feet-first supine patient positioning, varying reaming depths, and implant visualization from varying angles. These simulations were carried out using the subject device, compared to the "gold standard" Materialise innovation Suite (Mimics V 22 and 3matic V 14) and SolidWork 2016 for implant values (version and inclination). All tests passed. Thus, the accuracy of e-Ortho is adequate to provide safe use of the product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
FH Industrie – e-Ortho Shoulder – K201928
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 contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
FH Industrie % Dawn Norman Partner MRC Global, LLC 9085 E. Mineral Circle, Suite 110 CENTENNIAL CO 80112
Re: K220758
September 30, 2022
Trade/Device Name: e-Ortho Shoulder Software v1.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: July 29, 2022 Received: August 1, 2022
Dear Dawn Norman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
Jessica Lamb, Ph.D.
Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220758
Device Name e-Ortho Shoulder Software v1.1
Indications for Use (Describe)
E-Ortho shoulder is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ For-Hire Operation with OTP, WIA Authority, or Broker Authority | ☐ Own-Use Operation with OTP, WIA Authority, or Broker Authority |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary FH Industrie e-Ortho Shoulder Software v1.1 September 30, 2022
| Company: | FH INDUSTRIE
ZI DE KERNEVEZ-6 RUE NOBEL
QUIMPER Finistere, FRANCE 29000 |
|-------------------------|-------------------------------------------------------------------------------|
| Company Contact: | Oscar Ramirez -- FH Industrie |
| Official Correspondent: | Dawn Norman – MRC Global, LLC |
| Trade Name: | e-Ortho Shoulder Software v1.1 |
| Common Name: | System, Image Processing, Radiological |
| Classification: | Class II |
| Regulation Number: | 21 CFR 892.2050 (Picture archiving and communications system) |
| Panel: | Radiology |
| Product Code: | LLZ |
| Predicate Device: | FH Industrie – e-Ortho Shoulder – K201928 |
Device Description:
e-Ortho Shoulder software is a web-based surgical planning software application. e-Ortho Shoulder provides a pre-surgical planning tool for surgeons that helps them understand their patient's anatomy prior to surgery. Compared to using two-dimensional (2D) images to plan a shoulder arthroplasty (current method used by FH-Orthopedic surgeons), e-Ortho supplies information to surgeons to help prepare an intraoperative plan. E-Ortho allows surgeons to work in three-dimensional (3D) visualization, implant visualization and positioning within the specific patient's bone model (scapula and humerus), using reliable landmarks. This allows surgeons to preoperatively select the needed implant and determine its desired position.
The subject submission seeks to add humeral planning capabilities to the previously cleared FH E-Ortho Shoulder Software. Additional changes to the software have been made to improve functionality within the previously cleared intended use.
Indications for Use:
E-Ortho shoulder is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.
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Substantial Equivalence:
The subject e-Ortho shoulder software is substantially equivalent to the following predicate: FH Industrie – e-Ortho Shoulder – K201928
The subject e-Ortho Shoulder software is similar to the predicate with respect to intended use, indications for use, technological characteristics, and principles of operation. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.
| Device | SUBJECT DEVICE | PREDICATE DEVICE | |
|---|---|---|---|
| Name | e-Ortho Shoulder Software (V1.1) | e-Ortho Shoulder Software (V1.0) | |
| Company | FH Industrie | FH Industrie | |
| 510k Clearance | K201928 | ||
| Product Code | LLZ | LLZ | |
| Indications for Use | Identical. | ||
| E-Ortho shoulder is intended to be used as an | |||
| information tool to assist in the preoperative | |||
| surgical planning and visualization of a primary | |||
| total shoulder replacement. | E-Ortho shoulder is intended to be used as an | ||
| information tool to assist in the preoperative surgical | |||
| planning and visualization of a primary total shoulder | |||
| replacement. | |||
| User Poplulation | Identical. | ||
| Orthopedic Surgeon | Orthopedic Surgeon | ||
| Principles of Operation | Identical. | ||
| Software system with a user interface that | |||
| provides surgeons with analysis tools to input, | |||
| review, and assess fluoroscopic images to assist in | |||
| implant selection and placement during total | |||
| shoulder replacement procedures. | Software system with a user interface that provides | ||
| surgeons with analysis tools to input, review, and | |||
| assess fluoroscopic images to assist in implant | |||
| selection and placement during total shoulder | |||
| replacement procedures. | |||
| Operating System | Identical. | ||
| Mac OS 10.13 or higher and Windows 8 or higher | Mac OS 10.13 or higher and Windows 8 or higher | ||
| Image Data | Identical. | ||
| CT Scan per protocol | CT Scan per protocol | ||
| Features | Identical with the following additions: | ||
| • added metrics (Elbow version angle (if | |||
| landmarks contain an elbow axis), Native roll, | |||
| Angle of glenoid version and inclination for native | Pre-operatively: • Helps a surgeon better | ||
| understand patient-specific anatomy prior to surgery | |||
| • Provides surgeon three-dimensional (3D) | |||
| visualization in of implant placement prior | |||
| to surgery, allowing for the following: | |||
| Device | SUBJECT DEVICE | PREDICATE DEVICE | K220758 |
| glenoid displayed on 2D views, and Optional extra axis version & inclination) inclusion of more information to be provided about the surgeon and the patient new rendering mode displays, new optional model visualization minor display improvements Expanded correction range to support an extra surgical technique planning (double reaming) if required inclusion of a free planning mode where user can select any value of glenoid correction, in a predefined range Improved keel perforation detection and its visualization Improved prosthesis translation by sliding and rolling the implant into the selected glenoid sphere surface Ability to compute, display, and adjust glenoid graft (3D rendering Width, Height, Thickness max). Adapt planning reference surface to support an extra category of glenoid deformities (bi-concavity) deformity. Added ability to activate and select sphere surface reference in case of bi-concavity (Paleo-glen or Neo-glen). "Relative" angles and reference sphere surface for translating the glenoid implant are based on the selected sphere. Ability to visualize shoulder offset distances (lateralization...) if reduced joint page has been visited. Improved screw perforation detection by adding more perforation landmarks Improved GUI texts. Improve Warnings texts | more appropriate implant selection and sizing. Possible prevention of unintended perforations and complications due to selection of the incorrect implant or screw sizes Better prediction of the optimal option for implant positioning and screw placement Pre-operative, three-dimensional visualization provides landmarks to the surgeon for better pre-surgical preparation and planning Separate screens for each phase of planning: review of patient anatomy, glenoid placement planning, and screw placement planning. Subluxation visualization in 2D and 3D |
Table 1: Comparison of Subject and Predicate Devices
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Performance Testing:
In order to ensure the performance of the e-Ortho throughout the project's development, a verification and validation process has been established and conducted per IEC 62304. The verification process was implemented through five test campaigns and was carried out by five different evaluators in two different environments to verify the functional components of the subject device. Three bugs were identified as remaining problems after the debugging campaign; however, all are minor and not expected to impact the planning itself.. The validation process was implemented through a usability test campaign, with critical features requiring validation by five surgeons. The result of the validation tests coincides with the expected results for each test case and no test failed. Similar to the predicate device, additional accuracy testing was carried out to guarantee the performance of e-Ortho as follows: the
6
sequence of events which could lead to dangerous situations and potential harms were identified then simulated in different virtual cases including right and left sided scenarios in head-first supine positioning of patient as well as feet-first supine patient positioning, varying reaming depths, and implant visualization from varying angles. These simulations were carried out using the subject device, compared to the "gold standard" Materialise innovation Suite (Mimics V 22 and 3matic V 14) and SolidWork 2016 for implant values (version and inclination). All tests passed. Thus, the accuracy of e-Ortho is adequate to provide safe use of the product.
*Note: e-Ortho shoulder is intended to be used only with the following previously cleared FH Orthopedic implants: Arrow Anatomical shoulder prostheses (K093599, K162068), Arrow Reverse shoulder prostheses (K112193, K142778, K171789).
Conclusion
The e-Ortho Shoulder software v1.1 is shown to be substantially equivalent to its previously cleared version, e-Ortho Shoulder Software (K201928). The subject software has similar intended uses, indications, technological characteristics, and principles of operation as its predicate device. The minor differences do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. In addition, performance data demonstrate that e-Ortho raises no new questions of safety or effectiveness. Thus, the updated e-Ortho Shoulder software is substantially equivalent to the previously cleared version.