(90 days)
Not Found
No
The summary describes image processing and measurement tools, but there is no mention of AI, ML, or related concepts like training or test sets for such algorithms.
No.
The CUPTIMIZE™ Advanced device is image-processing software intended to assist in the positioning of total hip replacement components. It does not directly treat or cure a disease or condition, which is the primary function of a therapeutic device. Its role is assistive in a surgical context, providing guidance based on measurements and annotations.
No
The software provides tools for measurement and overlaying annotations to assist in positioning and planning but does not diagnose a disease or condition. It aids in surgical planning and execution related to total hip replacement components.
Yes
The device is explicitly described as "software as a medical device (SaMD) system" and its function is based on processing digital images and providing data and annotations. There is no mention of accompanying hardware components that are part of the regulated device.
Based on the provided information, CUPTIMIZE™ Advanced is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- CUPTIMIZE™ Advanced's Function: CUPTIMIZE™ Advanced is an image-processing software that assists in the positioning of surgical components during total hip replacement surgery. It works with radiological images of the patient's bone structures, not with biological specimens.
- Intended Use: The intended use clearly states it's to "assist in the positioning of total hip replacement components" and "assist in the precise positioning of the acetabular component intra-operatively." This is a surgical planning and guidance tool, not a diagnostic tool based on analyzing biological samples.
Therefore, CUPTIMIZE™ Advanced falls under the category of a surgical planning and guidance software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CUPTIMIZE™ Advanced is an image-processing software indicated to assist in the positioning of total hip replacement components, with a specific focus on the acetabular component.
It is intended to assist in the precise positioning of the acetabular component intra-operatively by measuring its position relative to the bone structures of interest provided that the points of interest can be identified from radiology images.
The device allows for overlaving of digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.
Product codes
LLZ
Device Description
CUPTIMIZE™ Advanced is a software as a medical device (SaMD) system that provides acetabular component orientation data for hip replacement surgery. The software guides the user through a workflow that involves positioning digital annotations on preoperative patient radiographic images. CUPTIMIZE™ Advanced utilizes digital annotations to describe the range of motion of the pelvis and provides an orientation of the acetabular component which reduces risk of edge loading and implant impingement. The system also provides warnings for patients with high or low pelvic mobility and high or low pelvic incidence.
CUPTIMIZE™ Advanced will include a pre-operative module that determines spinopelvic tilt relationships and data to provide an implant orientation plan, as well as an intra-operative verification capability that will allow the current implant orientation to be assessed against the plan.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiology images
Anatomical Site
Hip, pelvis
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
The following tests were performed to demonstrate substantial equivalence of safety and efficacy with the predicate device:
- Model verification tests
- System verification tests
- System validation tests
- Usability evaluation
Clinical testing was not required to demonstrate substantial equivalence.
The subject device, Cuptimize Advanced is substantially equivalent to the predicate device.
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
DePuy Orthopaedics, Inc. % Sierra Robinson Regulatory Affairs Specialist II Depuy Ireland UC Loughbeg, Ringaskiddy, Co. Cork IRELAND
August 22, 2023
Re: K231503
Trade/Device Name: CUPTIMIZE™ Advanced Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: July 25, 2023 Received: July 27, 2023
Dear Sierra Robinson:
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
1
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 (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
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
CUPTIMIZE™ Advanced
Indications for Use (Describe)
CUPTIMIZE™ Advanced is an image-processing software indicated to assist in the positioning of total hip replacement components, with a specific focus on the acetabular component.
It is intended to assist in the precise positioning of the acetabular component intra-operatively by measuring its position relative to the bone structures of interest provided that the points of interest can be identified from radiology images.
The device allows for overlaving of digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours be response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| K231503 | 510(k) Summary | Prepared on: 2023-05-24 | |
|---|---|---|---|
| --------- | -- | ---------------- | ------------------------- |
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| Applicant Name | DePuy Orthopaedics, Inc |
| Applicant Address | 700 Orthopaedic Dr Warsaw IN 46582 United States |
| Applicant Contact Telephone | 8502519921 |
| Applicant Contact | Sierra Robinson |
| Applicant Contact Email | srobin24@its.jnj.com |
| Correspondent Name | Depuy Ireland UC |
| Correspondent Address | Loughbeg, Ringaskiddy Co. Cork Ireland |
| Correspondent Contact Telephone | 8502519921 |
| Correspondent Contact | Sierra Robinson |
| Correspondent Contact Email | srobin24@its.jnj.com |
| Device Name | 21 CFR 807.92(a)(2) |
|---|---|
| Device Trade Name | CUPTIMIZE™ Advanced ( ) |
| Common Name | Medical image management and processing system |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 892.2050 |
| Product Code | LLZ |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
|---|---|
| ------------------------------------ | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K203651 | Cuptimize | LLZ |
| Device Description Summary | 21 CFR 807.92(a)(4) |
|---|---|
| ---------------------------- | --------------------- |
CUPTIMIZE™ Advanced is a software as a medical device (SaMD) system that provides acetabular component orientation data for hip replacement surgery., The software guides the user through a workflow that involves positioning digital annotations on preoperativereplacement surgery, The software guides the user through a workflow that involves positioning digital annotations on preoperative patient radiographic images.CUPTIMIZE™ Advanced utilizes digital annotations to describe the range of motion of the pelvis and provides an orientation of the acetabular component which reduces risk of edge loading and implant impingement. The system also provides warnings for patients with high or low pelvic mobility and high or low pelvic incidence.
CUPTIMIZE™ Advanced will include a pre-operative module that determines spinopelvic tilt relationships and data to provide an implant orientation plan, as well as an intra-operative verification capability that will allow the current implant orientation to be assessed against the plan.
Intended Use/Indications for Use
4
CUPTIMIZE™ Advanced is an image-processing software in the positioning of total hip replacement components, with a specific focus on the acetabular component.
It is intended to assist in the precise positionial of the acetabular component intra-operatively by measuring its position relative to the bone structures of interest provided that the points of interest can be identified from radiology images.
The device allows for overlaying of digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. Clinical judgment and experience are required to properly use the software is not for primary image interpretation. The software is not for use on mobile phones.
Indications for Use Comparison
The indications for use are the same as the predicate device, Cuptimize (K203651).
Technological Comparison
The subject CUPTIMIZE Advanced is the predicate CUPTIMIZE in intended use, classification, and principles of operation.
The subject CUPTIMIZE Advanced and the predicate CUPTIMIZE both provide guidance on acetabular cup orientation based on a patient's pelvic mobility. The subject device provides a component orientation which avoids edge loading and implant-implantimpingement.
The subject CUPTIMIZE Advanced and the predicate CUPTIMIZE both have an interoperative workflow that allows the intraoperative implant orientation to be assessed against the preoperative plan.
The subject CUPTIMIZE Advanced and the predicate CUPTIMIZE both are intended to be integrated as a module within VELYS Hip Navigation.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following tests were performed to demonstrate substantial equivalence of safety and efficacy with the predicate device:
-
Model verification tests
-
System verification tests
-
System validation tests
-
Usability evaluation
Clinical testing was not required to demonstrate substantial equivalence.
The subject device, Cuptimize Advanced is substantially equivalent to the predicate device.