(82 days)
Not Found
No
The summary describes a 3D visualization and planning tool based on CT scans and reliable landmarks, without mentioning any AI/ML algorithms for analysis or decision support.
No.
The device is described as an "information tool to assist in the preoperative surgical planning and visualization," which makes it a planning/informational tool rather than a device that directly treats or prevents a condition.
No
The device is described as an "information tool" for "preoperative surgical planning and visualization." It helps surgeons understand anatomy and plan procedures in 3D, but it does not diagnose medical conditions.
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 is for "preoperative surgical planning and visualization of a primary total shoulder replacement." This is a planning tool for a surgical procedure, not a diagnostic test performed on biological samples.
- Device Description: The description clearly states it's "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 visualizing anatomy and planning implant placement.
- Input: The input is "CT Scans," which are medical images, not biological samples like blood, urine, or tissue.
- Function: The software provides "three-dimensional (3D) visualization, implant visualization and positioning within the specific patient's bone model." This is a visualization and planning function, not a diagnostic test that detects or measures substances in a biological sample.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform such functions.
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 (comma separated list FDA assigned to the subject device)
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic imaging, CT Scans
Anatomical Site
Shoulder, scapula, humerus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons, e-Ortho engineer; preoperative
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation process established and conducted per IEC 62304. Verification through multiple test campaigns by various evaluators and environments to verify functional components. Validation through a usability test campaign with critical features validated by multiple surgeons. Result of validation tests coincided with expected results, no test failed. Additional accuracy testing carried out.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
JointPoint, Inc. JointPoint - K160284
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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September 30, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo 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.
FH Industrie % Ms. Dawn Norman Exec VP MRC Global, LLC 9085 East Mineral Circle, Suite 110 CENTENNIAL CO 80112
Re: K201928
Trade/Device Name: e-Ortho Shoulder Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: July 9, 2020 Received: July 14, 2020
Dear Ms. 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (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
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Indications for Use
510(k) Number (if known) K201928
Device Name e-Ortho Shoulder Software
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K201928 510(k) Summary FH Industrie e-Ortho Shoulder Software September 9, 2020
| 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 |
| 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 |
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.
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.
Substantial Equivalence:
The subject e-Ortho Shoulder Software is substantially equivalent to the following predicate: JointPoint, Inc. JointPoint - K160284
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Both the subject and predicate devices are image processing softwares intended to aid in planning and positioning orthopedic components during orthopedic surgical procedures by using radiographic imaging to map anatomic landmarks and dimensions. However, the major differences between the subject and predicate device are that the subject e-Ortho software is only intended to be use before surgery as a preplanning tool, while the predicate JointPoint covers a broader range of the surgical workflow. However, the indications for use for the predicate fully encompass the indications for use of e-Ortho Shoulder software. Therefore, this difference does not alter the intended use or otherwise raise new questions compared to the predicate. Additionally, the subject e-Ortho Shoulder software is specific in its indication for arthroscopic total shoulder replacement procedures, while the predicate device is specific to total hip replacement, total knee replacement, and intertrochanteric fracture reduction procedures . However, this minor difference in anatomical location does not alter the intended use of the device and thus, does not raise new questions of safety or effectiveness.
Both the subject and predicate softwares include software prediction of optimal implant sizing as a preoperative planning tool. While e-Ortho's software will be used to provide implant sizing and selection recommendations to the surgeon, the inputs of these recommendations are not generated by the software like JointPoint. Rather, the analysis of the patient CT Scans are performed by an e-Ortho engineer after CT scans are uploaded by the surgeon is then able to virtually visualize potential placement implants but using landmarks populated into the e-Ortho software by the e-Ortho engineer, enabling the surgeon to choose the optimal implant type, sizing, and position. All implant selection and sizing options are specific to previously cleared FH Orthopedic shoulder implants and sizes from the FH Orthopedic Arrow Anatomic and Arrow Reverse shoulder systems. While an e-Ortho engineer provides inputs via the e-Ortho software, the chosen procedure is the responsibility of the Surgeon. Prior to any shoulder surgery, the surgeon should evaluate and validate the appropriateness of the procedure to the specific patient based on his/her medical training.
As discussed above, 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.
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 multiple test campaigns and was carried out by various evaluators and environments to verify the functional components of the subject device. The validation process was implemented through a usability test campaign, with critical features requiring validation by multiple surgeons. The result of the validation tests coincides with the expected results for each test case and no test failed. Additional accuracy testing was carried out to guarantee the performance of e-Ortho.
Conclusion
The e-Ortho Shoulder software is shown to be substantially equivalent to its predicate, JointPoint. The subject software has similar intended uses, indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications 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 e-Ortho Shoulder software is substantially equivalent.