(267 days)
Yes
The device description explicitly states that the software uses machine learning algorithms for automatic segmentation.
No.
The device is a preoperative planning software that assists surgeons in making decisions about implant size and positioning; it does not directly treat or diagnose a disease or condition.
No
The "Intended Use / Indications for Use" section explicitly states, "The MyShoulder Planner software should not be used for diagnostic purposes."
Yes
The device description explicitly states "The MyShoulder Planner is a software designed to create patient-specific preoperative plans based on CT scans." The summary focuses entirely on software functionalities, image processing, and algorithms, with no mention of accompanying hardware components included with the device itself. While it facilitates the request of patient-matched guides, the software itself is the medical device being described.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the software is a "preoperative planning tool" and "should not be used for diagnostic purposes." IVDs are specifically designed for diagnostic purposes, such as detecting diseases or conditions.
- Function: The software processes medical images (CT scans) to assist surgeons in planning a surgical procedure (total shoulder replacement). It helps with visualization, measurement, and decision-making regarding implant size and positioning. This is a surgical planning function, not a diagnostic one.
- Input: While it uses medical images, the output is a surgical plan and potentially patient-specific guides, not a diagnostic result or interpretation of a biological sample. IVDs typically analyze biological samples (blood, urine, tissue, etc.).
In summary, the MyShoulder Planner software is a medical device for surgical planning, not for diagnosing a patient's condition.
No
The provided input explicitly states "Control Plan Authorized (PCCP) and relevant text Not Found". This indicates that the letter does not contain any language confirming that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The MyShoulder Planner software is a medical device intended for use by surgeons as a preoperative planning tool for total shoulder replacement surgery in skeletally mature individuals. The MyShoulder Planner software is specifically designed to support the planning of the humeral and glenoid components in a total shoulder replacement using Medacta Shoulder System prosthesis. The MyShoulder Planner software should not be used for diagnostic purposes. The MyShoulder Planner software processes CT scan images in DICOM format to allow surgeons to visualize, measure, and reconstruct anatomic data. These features enable surgeons to make decisions on implant size and positioning, including the ability to annotate anatomical structures. The MyShoulder Planner software leads to the generation of patient-specific planning reports, which summarize the preliminary decisions regarding implant size and positioning. The MyShoulder Planner software allows the surgeons to request the MyShoulder patient matched guides according to the pre-surgical plan.
Product codes
KWS, QHE, LLZ
Device Description
The MyShoulder Planner is a software designed to create patient-specific preoperative plans based on CT scans. It is used to visualize the effect of different devices and positioning options on the patient's shoulder joint biomechanics. It allows the surgeon to preoperatively plan the humeral and glenoid components in total shoulder replacement after the segmentation of a 3D model of the patient's anatomy that can be performed automatically by the software, which uses machine learning algorithms, or manually by a designated Medacta engineer. After the planning, through the software, the user can request patient-matched guides as well as intraoperative guidance system compatible file.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT scan images in DICOM format
Anatomical Site
Shoulder joint
Indicated Patient Age Range
skeletally mature individuals
Intended User / Care Setting
Surgeons; 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 . Automatic segmentation and landmark acquisition performance was adequately verified in comparison to manual segmentation.
Clinical Studies: No clinical studies were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
January 30, 2025
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medacta International S.A. % Christopher Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 6386 Global Drive. Suite 101 Memphis, Tennessee 38141
Re: K241292
Trade/Device Name: MyShoulder Planner (5.3SSWPL) Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, QHE, LLZ Dated: Mav 8, 2024 Received: December 27, 2024
Dear Christopher 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 (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.
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"
1
(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 (QS) 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 OS 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 (QS) 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 Rue"). 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-devices/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 (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).
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Sincerely,
Farzana Sharmin - C Digitally signed by Farzana Shamin -S
Farzana Sharmin, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
MyShoulder Planner (5.3SSWPL)
Indications for Use (Describe)
The MyShoulder Planner software is a medical device intended for use by surgeons as a preoperative planning tool for total shoulder replacement surgery in skeletally mature individuals. The MyShoulder Planner software is specifically designed to support the planning of the humeral and glenoid components in a total shoulder replacement using Medacta Shoulder System prosthesis. The MyShoulder Planner software should not be used for diagnostic purposes. The MyShoulder Planner software processes CT scan images in DICOM format to allow surgeons to visualize, measure, and reconstruct anatomic data. These features enable surgeons to make decisions on implant size and positioning, including the ability to annotate anatomical structures. The MyShoulder Planner software leads to the generation of patient-specific planning reports, which summarize the preliminary decisions regarding implant size and positioning. The MyShoulder Planner software allows the surgeons to request the MyShoulder patient matched guides according to the pre-surgical plan.
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
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
Primary Contact: Chris Lussier, Senior Director, Quality and Regulatory, Medacta USA Applicant Contact: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Date Prepared: May 08, 2024 Date Revised: January 30, 2025
II. Device
| Device Proprietary Name: | MyShoulder Planner (5.3SSWPL) |
|---|---|
| Common or Usual Name: | Prosthesis, shoulder, semi-constrained, metal/polymer cemented |
| Classification Name: | Shoulder joint metal/polymer semi-constrained cemented prosthesis |
| Primary Product Code: | KWS |
| Secondary Product Code: | LLZ, QHE |
| Regulation Number: | 21 CFR 888.3660 |
| Device Classification: | II |
III. Predicate Device
Substantial equivalence is claimed to the following primary predicate device:
- Blueprint Patient Specific Instrumentation, K203315, Tornier SAS
IV. Reference device
- MyShoulder Placement Guides, K190738, Medacta International ●
V. Device Description
The MyShoulder Planner is a software designed to create patient-specific preoperative plans based on CT scans. It is used to visualize the effect of different devices and positioning options on the patient's shoulder joint biomechanics. It allows the surgeon to preoperatively plan the humeral and glenoid components in total shoulder replacement after the segmentation of a 3D model of the patient's anatomy that can be performed automatically by the software, which uses machine learning algorithms, or manually by a designated Medacta engineer.
5
After the planning, through the software, the user can request patient-matched guides as well as intraoperative guidance system compatible file.
VI. Indications for Use
The MyShoulder Planner software is a medical device intended for use by surgeons as a preoperative planning tool for total shoulder replacement surgery in skeletally mature individuals.
The MyShoulder Planner software is specifically designed to support the planning of the humeral and glenoid components in a total shoulder replacement using Medacta Shoulder System prosthesis. The MyShoulder Planner software should not be used for diagnostic purposes.
The MyShoulder Planner software processes CT scan images in DICOM format to allow surgeons to visualize, measure, and reconstruct anatomic data. These features enable surgeons to make decisions on implant size and positioning, including the ability to annotate anatomical structures.
The MyShoulder Planner software leads to the generation of patient-specific planning reports, which summarize the preliminary decisions regarding implant size and positioning.
The MyShoulder Planner software allows the surgeons to request the MyShoulder patient matched guides according to the pre-surgical plan.
VII. Comparison of Technological Characteristics
The subject MyShoulder Planner and the predicate Blueprint Patient Specific Instrumentation (K203315) are substantially equivalent with respect to the following characteristics:
- design concept/principle of operation/general workflow;
- operative system compatibility;
- input images and related importation method;
- user interface:
- segmentation and landmark acquisition method; and ●
- measurements output.
The subject MyShoulder Planner only differs from the predicate Blueprint Patient Specific Instrumentation (K203315) with respect to the management of the patient-matched guides since the subject device does not allow guide design inside the software, but enables guides to be ordered as designed by Medacta. This difference does not raise any new issue of safety and effectiveness since the patient-matched guides are designed and managed as per K190738.
Additional minor differences are related to the compatibility of each device with the related companies' systems and implants, but they have no effect on safety and effectiveness as demonstrated by verification and validation activities.
Discussion
The comparison of technological characteristics and performance data provided within the submission supports the substantial equivalence of the subject device respect to the predicate device.
VIII. Performance Data
6
Based on the risk analysis, verification and validation activities were conducted to written protocols. The following software verification and validations are provided in support of the substantial equivalence determination:
Non-Clinical Studies
-
Software verification and validation including segmentation validation . Automatic segmentation and landmark acquisition performance was adequately verified in comparison to manual segmentation.
Clinical Studies: -
No clinical studies were conducted. ●
IX. Conclusion
The information provided above supports that the subject device is substantially equivalent to the predicate device.