(266 days)
Not Found
No
The summary describes image processing and planning software but does not mention AI, ML, or related terms, nor does it describe characteristics typically associated with AI/ML development like training/test sets or performance metrics like AUC.
No
The described devices (MyHip Planner and MyHip Verifier) are software tools intended for image processing, pre-operative planning, and intra-operative evaluation for hip arthroplasty, assisting in assessing surgical outcomes. They do not directly treat or prevent a disease or condition; rather, they provide information to aid a medical professional in surgical procedures.
No
The device is used for pre-operative planning and intra-operative evaluation of implant positioning, which are supportive functions for a medical procedure rather than diagnosing a disease or condition itself.
Yes
The device description explicitly states that both MyHip Planner and MyHip Verifier are "software". The performance studies focus on software verification and validation, as well as validation through retrospective analysis, in-vitro, and cadaver testing, without mentioning any associated hardware components that are part of the regulated device itself. While they process imaging data from hardware (CT and fluoroscopy), the device being cleared is the software.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Function: The MyHip Planner and MyHip Verifier software are used for image processing and surgical planning/evaluation based on medical imaging (CT scans and fluoroscopy). They do not analyze biological samples taken from the patient.
- Intended Use: The intended use clearly states planning and evaluation of surgical procedures (Total Hip Arthroplasty), not diagnostic testing on biological samples.
Therefore, the function and intended use of this software fall outside the scope of In Vitro Diagnostics. It is a medical device used for surgical planning and intra-operative assistance based on imaging data.
N/A
Intended Use / Indications for Use
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.
The MyHip Verifier software is intended to assist in the intra-operative evaluation of leg length and offset differences as well as acetabular cup positioning for anterior approach Total Hip Arthroplasty when the patient is positioned supine.
Product codes
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 devices and positioning options on the patient's hip joint biomechanics in terms of leg length and offset.
The MyHip Verifier is a software whose output is an intra-surgical numerical evaluation of the implant positioning based on fluoroscopy and aimed at evaluating the effects in terms of leg length and offset of cup and stem positioning.
Both software are intended to be used in Primary Hip Arthroplasty and they are compatible with Windows and Mac OS operating system. MyHip Verifier is also compatible with Ubuntu operating system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans, fluoroscopy
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
Non-Clinical Studies:
- MyHip Planner software verification and validation;
- MyHip Planner validation through retrospective analysis;
- MyHip Verifier software verification and validation;
- MyHip Verifier validation through in-vitro and cadaver testing.
Clinical Studies:
- No clinical studies were conducted.
Key Metrics
Not Found
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).
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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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
November 4, 2020
Medacta International SA % Mr. Christopher Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street MEMPHIS TN 38118
Re: K200350
Trade/Device Name: MyHip Planner & Verifier Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: September 24, 2020 Received: September 25, 2020
Dear Mr. 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 and Part 809); 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,
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)
Device Name MyHip Planner & Verifier
Indications for Use (Describe)
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.
The MyHip Verifier software is intended to assist in the intra-operative evaluation of leg length and offset differences as well as acetabular cup positioning for anterior approach Total Hip Arthroplasty when the patient is positioned supine.
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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1.0 510(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 Affairs Manager, Medacta International SA Applicant Correspondent: Christopher Lussier, Director of Quality and Regulatory, Medacta USA Date Prepared: January 20, 2020 Date Revised: November 2, 2020
II. Device
| Device Proprietary Name: | MyHip Planner & Verifier |
|---|---|
| Common or Usual Name: | Picture archiving and communications system (PACS) |
| Classification Name: | System, Image Processing, Radiological |
| Primary Product Code: | LLZ |
| Regulation Number: | 21 CFR 892.2050 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
Primary predicate device for MyHip Planner:
-
o MediCAD 4.0, K170702, MediCAD Hectec Gmbh
Primary predicate device for MyHip Verifier: -
JointPoint, K160284, JointPoint Inc.
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 devices and positioning options on the patient's hip joint biomechanics in terms of leg length and offset.
The MyHip Verifier is a software whose output is an intra-surgical numerical evaluation of the implant positioning based on fluoroscopy and aimed at evaluating the effects in terms of leg length and offset of cup and stem positioning.
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Both software are intended to be used in Primary Hip Arthroplasty and they are compatible with Windows and Mac OS operating system. MyHip Verifier is also compatible with Ubuntu operating system.
V. Indications for Use
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.
The MyHip Verifier software is intended to assist in the intra-operative evaluation of leg length and offset differences as well as acetabular cup positioning for anterior approach Total Hip Arthroplasty when the patient is positioned supine.
Comparison of Technological Characteristics VI.
● MyHip Planner
The MyHip Planner and the predicate device MediCAD 4.0 (K170702) share the following characteristics:
- design concept/principle of operation;
- user interface; ●
- input images; ●
- workflow;
- segmentation and landmark acquisition method;
- . measurements output
The subject MyHip Planner and the predicate device MediCAD 4.0 (K170702) are technologically different with respect to:
- operative system compatibility; ●
- images importation method;
- available implants
- MyHip Verifier ●
The MyHip Verifier and the predicate device JointPoint (K160284) share the following characteristics:
- design concept/principle of operation;
- user interface;
- input images; ●
- workflow; ●
- landmark acquisition method;
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-
measurements output
The subject MyHip Verifier and the predicate device JointPoint (K160284) are technologically different with respect to: -
operative system compatibility;
-
images importation method; ●
-
available implants
Discussion
The subject and predicate devices are substantially equivalent with reference to the intended use, design concept, user interfaces, input images, workflow and measurements output. The slight differences in operative system compatibility, images importation methods and available implants do not raise new questions of safety or effectiveness as demonstrated by design validation testing. The comparison of technological characteristics and performance data provided within this submission, shows that there are no new risks associated with the subject devices design, and supports the substantial equivalence of the MyHip Planner & Verifier to the identified predicate devices.
VII. Performance Data
Based on the risk analysis, software verification and validation were conducted according to written protocols with defined acceptance criteria. The following tests are being provided in support of a substantial equivalence determination:
Non-Clinical Studies
- MyHip Planner software verification and validation; ●
- MyHip Planner validation through retrospective analysis;
- MyHip Verifier software verification and validation;
- MyHip Verifier validation through in-vitro and cadaver testing.
Clinical Studies
- No clinical studies were conducted.
VIII. Conclusion
The information provided above supports that the MyHip Planner & Verifier is as safe and effective as the identified predicate devices.
Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations provided within this submission.
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Therefore, it is concluded that the MyHip Planner & Verifier can be considered substantially equivalent to the identified predicate devices.