(220 days)
No
The document describes image processing and planning software, but there is no mention of AI, ML, or related terms, nor is there any description of training or test sets typically associated with such technologies.
No
The device is a software for preoperative planning and does not directly treat or diagnose a disease or condition. It assists in surgical planning for Total Hip Arthroplasty.
No
Justification: The "Intended Use / Indications for Use" section explicitly states that the 3D Printed Patient Specific Bone Models requested through the software are "not intended for diagnostic use." The software itself is for preoperative planning, not for diagnosing a medical condition.
Yes
The device description explicitly states "The MyHip Planner is a software". While it facilitates the request of 3D printed models, these models are described as an "additional visual reference" and are not part of the regulated device itself. The core functionality and intended use are centered around the software for image processing and preoperative planning.
Based on the provided information, the MyHip Planner software is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the software is for "image processing and preoperative planning of acetabular cup and femoral stem positioning for Total Hip Arthroplasty (THA)." It assists the user in making decisions based on biomechanical factors and anatomical representation. This is a planning and visualization tool for a surgical procedure, not a test performed on biological samples to diagnose a disease or condition.
- Device Description: The description reinforces the intended use, highlighting its function in creating a "patient-specific preoperative plan based on CT scans" and evaluating the effects of different implant choices. It focuses on anatomical visualization and biomechanical assessment.
- Lack of Biological Sample Analysis: IVDs are designed to analyze biological samples (like blood, urine, tissue) to provide information about a patient's health status. The MyHip Planner software uses medical images (CT scans, X-rays) as input, not biological samples.
- Purpose of 3D Printed Models: The 3D printed models are explicitly stated as "not intended for diagnostic use, but only intended for a physical representation of the 3D anatomical models visualized in the software." This further confirms the non-diagnostic nature of the overall system.
In summary, the MyHip Planner software is a medical device used for surgical planning and visualization based on medical imaging, not an IVD which analyzes biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The MyHip Planner software is intended for image processing and preoperative planning of acetabular cup and femoral stem positioning for Total Hip Arthroplasty (THA). The user is assisted in producing a preoperative plan, making decisions based on the leg offsets, the patient's potential impingement and, optionally, the spino-pelvic interaction. Through the software, the user can request 3D Printed Patient Specific Bone Models not intended for dragnostic use, but only intended for a physical representation of the 3D anatomical models visualized in the software. The 3D Printed Patient Specific Bone Models are provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The MyHip Planner is a software whose output is a patient-specific preoperative plan based on CT scans and aimed at evaluating the effects of different device choices and positioning options on the patient's hip joint biomechanics in terms of leg length and offset.
It is intended to be used in Primary Hip Arthroplasty and it is compatible with Windows and Mac OS operating system.
The subject Advanced version of the MyHip Planner additionally allows to evaluate patient's spinopelvic deformities and pelvic tilt starting from preoperative X-ray images, to help the surgeon to understand the implications of spinopelvic mobility on THA stability and optimize implant components orientation.
Through the software, the user can request non-sterile 3D Printed Patient Specific Bone Models intended to be used as an additional visual reference of the patients' specific anatomy.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan images, X-rays
Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical Studies:
- Software verification and validation including segmentation validation. No statistical divergence between the algorithm and the manual segmentation has been revealed by an analysis of the automatic segmentation and landmark picking performance on a two-sided students t-distribution.
Clinical Studies:
- No clinical studies were conducted.
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.
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.
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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.
Medacta International S.A. % Chris Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 3973 Delp Street MEMPHIS, TENNESSEE 38118
Re: K221725
Trade/Device Name: Advanced MyHip Planner Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: December 22, 2022 Received: December 23, 2022
January 20, 2023
Dear Chris Lussier:
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
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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 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 (OS) 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,
Jessica Lamb
Jessica Lamb. 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)
Device Name Advanced MyHip Planner
Indications for Use (Describe)
The MyHip Planner software is intended for image processing and preoperative planning of acetabular cup and femoral stem positioning for Total Hip Arthroplasty (THA). The user is assisted in producing a preoperative plan, making decisions based on the leg offsets, the patient's potential impingement and, optionally, the spino-pelvic interaction. Through the software, the user can request 3D Printed Patient Specific Bone Models not intended for dragnostic use, but only intended for a physical representation of the 3D anatomical models visualized in the software. The 3D Printed Patient Specific Bone Models are provided non-sterile.
| 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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K221725 510(k) Summary
I. Submitter
Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Sr. Director of Quality, Regulatory, and Clinical Research, Medacta USA Date Prepared: June 13, 2022 Date Revised: January 19, 2023
II. Device
| Device Proprietary Name: | Advanced MyHip Planner |
|---|---|
| Common or Usual Name: | Advanced MyHip Planner |
| Classification Name: | Medical image management and processing system |
| Primary Product Code: | LLZ |
| Regulation Number: | 21 CFR 892.2050 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following primary predicate device:
-
A MyHip Planner, K200350, Medacta Interational SA
In addition, the following reference device is cited within the submission: -
A My Knee Cutting Blocks, K093806, Medacta International SA
IV. Device Description
The MyHip Planner is a software whose output is a patient-specific preoperative plan based on CT scans and aimed at evaluating the effects of different device choices and positioning options on the patient's hip joint biomechanics in terms of leg length and offset.
It is intended to be used in Primary Hip Arthroplasty and it is compatible with Windows and Mac OS operating system.
The subject Advanced version of the MyHip Planner additionally allows to evaluate patient's spinopelvic deformities and pelvic tilt starting from preoperative X-ray images, to help the surgeon to
4
understand the implications of spinopelvic mobility on THA stability and optimize implant components orientation.
Through the software, the user can request non-sterile 3D Printed Patient Specific Bone Models intended to be used as an additional visual reference of the patients' specific anatomy.
V. Indications for Use
The MyHip Planner software is intended for image processing and preoperative planning of acetabular cup and femoral stem positioning for Total Hip Arthroplasty (THA). The user is assisted in producing a preoperative plan, making decisions based on the leg offsets, the patient's potential impingement and, optionally, the spino-pelvic interaction.
Through the software, the user can request 3D Printed Patient Specific Bone Models not intended for diagnostic use, but only intended for a physical representation of the 3D anatomical models visualized in the software. The 3D Printed Patient Specific Bone Models are provided non-sterile.
| Parameters | Advanced MyHip Planner
(Subject device) | MyHip Planner
(Predicate device K200350) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
use | The MyHip Planner software is
intended for image processing and
preoperative planning of acetabular
cup and femoral stem positioning
for Total Hip Arthroplasty (THA).
The user is assisted in producing a
preoperative plan, making decisions
based on the leg offsets, the
patient's potential impingement
and, optionally, the spino-pelvic
interaction.
Through the software, the user can
request 3D Printed Patient Specific
Bone Models not intended for
diagnostic use, but only intended for
a physical representation of the 3D
anatomical models visualized in the
software. The 3D Printed Patient
Specific Bone Models are provided
non-sterile. | The MyHip Planner software is
intended for image processing and pre-
operative planning of acetabular cup
and femoral stem positioning for Total
Hip Arthroplasty (THA). The device
assists the user in assessing potential
leg length and offset differences as
well as potential range of motion
impingement. |
| Operative
system | Windows or Mac OS | Same |
| Hardware | Laptop and/or PC | Same |
| Input images |
• CT scan images | CT scan images |
VI. Comparison of Technological Characteristics
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| Parameters | Advanced MyHip Planner
(Subject device) | MyHip Planner
(Predicate device K200350) |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Input images
acquisition
method | X-rays Through hard disk (CD/USB) or wireless through MySolution website | Same |
| User interface | GUI | Same |
| Workflow | CT images upload Segmentation Planning including spino-pelvic evaluation Bone models production and shipping (optional) | CT images upload Segmentation Planning |
| Segmentation | Automatic but the user has to check, eventually modify, and confirm it | Same |
| Available
implants | Medacta hip implants cleared to FDA by Medacta | Same |
| Measurements
output | Cup positioning Stem positioning ROM evaluation Spino-pelvic evaluation | Cup positioning Stem positioning ROM evaluation |
The subject Advanced MyHip Planner and the predicate device are substantially equivalent with regards to the following characteristics:
- operative system compatibility;
- design concept/principle of operation;
- . user interface;
- images importation method;
- segmentation and landmark acquisition method; and
- . available implants.
The subject Advanced MyHip Planner differs from the predicate device with respect to:
- input images;
- workflow; and
- measurements output.
Discussion
The slightly different input images and workflow of the subject device with respect to the predicate does not affect the safety and effectiveness of the Advanced MyHip Planner since it is only related to the addition of new input images (x-rays) and workflow steps strictly related to the newly developed feature allowing spino-pelvic evaluation and the manufacturing of bone models, both optional steps. Identically to the bone models included in the reference device clearance (K093806), the subject bone models are manufactured through the software starting from the patient's CT as an additional visual reference of the patients' specific anatomy, thus no new issue of safety and effectiveness arise.
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Also measurements output differences are strictly related to the new spino-pelvic evaluation feature and does not raise any new issue of safety and effectiveness since the other output measurements are identical to the ones of the predicate device (K200350).
The comparison of technological characteristics and validation provided within this submission, supports the substantial equivalence of the subject devices respect to the predicate devices.
VII. Performance Data
Based on the risk analysis, verification activities were conducted to written protocols. The following software verification and validation are provided in support of the substantial equivalence determination:
Non-Clinical Studies
- . Software verification and validation including segmentation validation. No statistical divergence between the algorithm and the manual segmentation has been revealed by an analysis of the automatic segmentation and landmark picking performance on a two-sided students t-distribution.
Clinical Studies:
- No clinical studies were conducted. ●
Conclusion VIII.
The information provided above supports that the Advanced MyHip Planner is substantially equivalent to the predicate devices.