(74 days)
Not Found
No
The summary describes image processing and measurement tools that require user input and clinical judgment, without mentioning AI, ML, or related concepts like training/test sets for model development.
No
The device is an image-processing software intended to assist in the precise positioning of surgical components, not to directly treat a disease or condition.
No
The device is image-processing software intended to assist in the precise positioning of acetabular components during total hip replacement surgery by providing measurements and digital annotations, rather than diagnosing a disease or condition. Its purpose is to assist in surgical procedures, not to identify or determine the nature of a patient's medical condition.
Yes
The device is explicitly described as "software as a medical device (SaMD) system" and its function is based on image processing and digital annotations on radiographic images. There is no mention of accompanying hardware components that are part of the regulated device.
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 examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Cuptimize's Function: Cuptimize is an image-processing software that analyzes radiology images of the hip. It assists in the positioning of surgical components during a procedure. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for assisting in the positioning of total hip replacement components intra-operatively by measuring their position relative to bone structures from radiology images. This is a surgical planning and guidance tool, not a diagnostic test performed on a biological sample.
Therefore, Cuptimize falls under the category of a surgical planning or guidance software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Cuptimize 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 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. The software is not for primary image interpretation. The software is not for use on mobile phones.
Product codes (comma separated list FDA assigned to the subject device)
LLZ; HAW
Device Description
Cuptimize is a software as a medical device (SaMD) system that provides acetabular component position data for hip replacement surgery. The software guides the user through a workflow that olves positioning a series of digital annotations on preoperative and intraoperative radiographic images. This enables the system to calculate inclination and anteversion data that describes the acetabular component position.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiology images (radiographic images)
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical judgment and experience are required to properly use the software.
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 activities included system and unit testing via automated regression testing and manual test procedure analyses. Validation testing was performed to analyze acetabular component position on a cadaver by comparing output data from the Cuptimize system to the output of a predicate device, JointPoint.
Performance testing of the Cuptimize system included reproducible verification and validation scripts using known measurements to establish data against a measured control. Additionally, anteversion and inclination data was compared against analysis from the JointPoint predicate device (510k clearance "K160284"). Finally, a cadaveric laboratory was performed to gather data to validate the system's intended use and to perform sensitivity testing.
Cadaver Data - Cup Check: Inclination and Anteversion substantially equivalent to JointPoint
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.
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).
0
February 26, 2021
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is a circular emblem with a stylized human figure. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.
Cuptimize, Inc. % Ms. Michelle McDonough Senior Director, Regulatory and Clinical Affairs MCRA, LLC 1050 K Street NW, Suite 1000 WASHINGTON DC 20001
Re: K203651
Trade/Device Name: Cuptimize Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: December 23, 2020 Received: December 23, 2020
Dear Ms. McDonough:
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) K203651
Device Name Cuptimize
Indications for Use (Describe)
Cuptimize 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 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. The software is not for primary image interpretation. The software is not for use on mobile phones.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Manufacturer: | Cuptimize, Inc.
2840 West Bay Drive, Unit #163
Belleair Bluffs, FL 33770 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Michelle McDonough, MS
MCRA, LLC
1050 K Street NW, Suite 1000
Washington, DC 20001
202.552.5800 (phone)
202.552.5798 (fax) |
| Date Prepared: | February 18, 2021 |
| Device Trade Name: | Cuptimize |
| Common Name: | Picture archiving and communications system (PACS) |
| Classification: | 21 CFR 892.2050 |
| Class: | II |
| Product Code: | LLZ; HAW |
Indications for Use:
Cuptimize 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 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.
Device Description:
Cuptimize is a software as a medical device (SaMD) system that provides acetabular component position data for hip replacement surgery. The software guides the user through a workflow that olves positioning a series of digital annotations on preoperative and intraoperative radiographic
K203651
4
images. This enables the system to calculate inclination and anteversion data that describes the acetabular component position.
Predicate Devices:
Cuptimize is substantially equivalent to JointPoint (K160284).
Verification and Validation Testing Summary:
Verification activities included system and unit testing via automated regression testing and manual test procedure analyses. Validation testing was performed to analyze acetabular component position on a cadaver by comparing output data from the Cuptimize system to the output of a predicate device, JointPoint.
Substantial Equivalence:
Cuptimize and JointPoint are both image-processing software indicated to assist in the positioning of total hip replacement components. The Cuptimize software is focused on a sub-set of the capabilities of the JointPoint system, specifically the acetabular component. Both devices assist in positioning of the acetabular component by measuring the position relative to the bone structures of interest provided that the points of interest can be identified from radiology images.
Testing performed on this device demonstrates that Cuptimize is substantially equivalent to the predicate device. Performance testing of the Cuptimize system included reproducible verification and validation scripts using known measurements to establish data against a measured control. Additionally, anteversion and inclination data was compared against analysis from the JointPoint predicate device (510k clearance "K160284"). Finally, a cadaveric laboratory was performed to gather data to validate the system's intended use and to perform sensitivity testing.
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | Cuptimize | JointPoint |
| Company | Cuptimize, Inc. | JointPoint, Inc. |
| K Number | Subject Device | K160284 |
| Classification | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Product Code | LLZ; HAW | LLZ; HAW |
| Indications for | ||
| Use Statement | Cuptimize 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 overlaying of digital | ||
| annotations on radiological images and | JointPoint is an image-processing software | |
| indicated to assist in the positioning of total | ||
| hip replacement components. It is intended | ||
| to assist in precisely positioning total hip | ||
| replacement components intra-operatively | ||
| by measuring their positions relative to the | ||
| bone structures of interest provided that the | ||
| points of interest can be identified from | ||
| radiology images. | ||
| JointPoint is also indicated for assisting | ||
| healthcare professionals in preoperative | ||
| planning and postoperative analysis of |
Predicate Comparison Table
5
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | Cuptimize | |
| 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. | JointPoint | |
| orthopedic surgery in Total Hip | ||
| Replacement, Total Knee Replacement, and | ||
| Intertrochanteric Fracture Reduction. The | ||
| device allows for overlaying of prosthesis | ||
| templates on radiological images, and | ||
| includes tools for performing measurements | ||
| on the image and for positioning the | ||
| template. 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. | ||
| Components | Identical | Identical |
| Computer | Identical | Identical |
| Operating | ||
| Systems | Identical | Identical |
| Anatomical | ||
| Locations | Hip | Hip; Knee |
| Input Data | Identical | Identical |
| Output Data | Measurements and calculations for cup | |
| position analysis. | Measurements and calculations for cup | |
| position analysis, leg length and offset | ||
| analysis, contralateral leg length analysis and | ||
| intertrochanteric fracture reduction analysis. | ||
| Software Features | Preoperative and intraoperative cup position | |
| analysis. | Preoperative leg length and offset analysis, | |
| interoperative cup position analysis, leg | ||
| length and offset analysis, contralateral leg | ||
| length analysis and intertrochanteric fracture | ||
| reduction analysis. | ||
| V&V Testing | All Unit and System Tests Passed | All Unit and System Tests Passed |
| Cadaver Data - | ||
| Cup Check | Inclination and Anteversion substantially equivalent to JointPoint |
Conclusion:
Cuptimize is shown to be substantially equivalent to previously cleared devices with respect to its intended use, indications for use, technological characteristics, and performance characteristics.