(58 days)
Not Found
No
The summary describes standard preoperative planning software functionalities based on anatomical models, landmarks, and calculations, without mentioning AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is described as preoperative surgical planning software and aids in component selection, sizing, and placement, but it does not directly treat or prevent a disease or condition.
No
This device is described as "preoperative surgical planning software" that "aids orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty." It performs measurements and analysis based on patient data and templated implants, which is a planning function, not a diagnostic one.
Yes
The device description explicitly states that OPSInsight™ is "interactive software" and a "closed platform." It processes patient-specific radiographic data and implant data from a database to perform planning and analysis. There is no mention of any accompanying hardware component that is part of the device itself. The performance studies focus on software verification and validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty." This is a surgical planning tool, not a diagnostic test performed on biological samples.
- Device Description: The description focuses on software for analyzing radiographic images, calculating biomechanical measurements, and performing functional analysis based on anatomical models. It does not mention analyzing blood, urine, tissue, or any other biological specimen.
- Input: The input is "2D and 3D patient-specific radiographic data," which are medical images, not biological samples.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device operates on medical images to assist in surgical planning.
N/A
Intended Use / Indications for Use
OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.
Product codes
LLZ
Device Description
OPSInsight™ is an interactive software for preoperative planning of Total Hip Arthroplasty. It enables 3D sizing and placement of implants in the patient's anatomy, calculates biomechanical measurements and performs functional analysis based on landmarks and anatomical models derived from patientspecific radiographic imaging and the templated implants. The biomechanical measurements include measurements relating to leg length, offset and femoral version, and the functional analysis includes determination of pelvic parameters, cup orientation calculation during flexion and extension, and impingement detection.
The software uses 2D and 3D patient-specific radiographic data. The implant data required by the software is contained within a controlled database. OPSInsight™ is a closed platform. Please refer to the Instructions for Use for compatible implant systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D and 3D patient-specific radiographic data
Anatomical Site
Hip (for Total Hip Arthroplasty)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopaedic 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 testing was performed, assessing the usability and performance testing that was conducted on the predicate device. In addition to this, nonclinical testing was performed to assess the performance of the bony impingement feature in OPSInsight to demonstrate that the feature functions as intended. Software verification and validation testing was conducted according to IEC 62304 and documentation provided as recommended by FDA's Guidance for the Industry: 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.' Clinical testing was not necessary for this Traditional 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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November 20, 2020
Image /page/0/Picture/1 description: The image contains 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 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.
Corin USA % Crissy Tomarelli Regulatory and Quality Director Corin (Australia) 17 Bridge Street Sydney, New South Wales 2073 AUSTRALIA
Re: K202805
Trade/Device Name: Optimized Positioning System (OPS) Insight™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: September 22, 2020 Received: September 23, 2020
Dear Crissy Tomarelli:
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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or post marketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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,
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) K202805
Device Name
Optimized Positioning System (OPS) Insight™
Indications for Use (Describe)
OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(K) SUMMARY
| 1. Applicant/Sponsor: | Corin USA Limited |
|---|---|
| Distributor | 12750 Citrus Park Lane |
| Suite 120 | |
| Tampa, Florida 33625 | |
| Establishment Registration No.: 1056629 | |
| 2. Manufacturer: | Optimized Ortho Pty Ltd |
| 17 Bridge Street | |
| Pymble NSW | |
| 2073 Australia | |
| Establishment Registration No: 3012916784 | |
| 3. Contact Person: | Crissy Tomarelli |
| Regulatory and Quality Director | |
| Corin Australia | |
| +61 (0)2 94977400 | |
| Crissy.Tomarelli@coringroup.com | |
| Jack Liang | |
| Senior Regulatory Affairs Specialist | |
| Corin Australia | |
| +61 (04) 21135848 | |
| Jack.Liang@coringroup.com | |
| 4. Date: | 22nd September 2020 |
| 5. Trade Name: | Optimized Positioning System (OPS) Insight™ |
| 6. Common Name: | OPSInsight™ or OPSInsight |
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8. Classification Name:
- 21 CFR 892.2050 Picture archiving and communications .
9. Substantially Equivalent (predicate) device(s):
- Optimized Positioning System (OPS™) Insight (K192656) .
10. Device Description:
OPSInsight™ is an interactive software for preoperative planning of Total Hip Arthroplasty. It enables 3D sizing and placement of implants in the patient's anatomy, calculates biomechanical measurements and performs functional analysis based on landmarks and anatomical models derived from patientspecific radiographic imaging and the templated implants. The biomechanical measurements include measurements relating to leg length, offset and femoral version, and the functional analysis includes determination of pelvic parameters, cup orientation calculation during flexion and extension, and impingement detection.
The software uses 2D and 3D patient-specific radiographic data. The implant data required by the software is contained within a controlled database. OPSInsight™ is a closed platform. Please refer to the Instructions for Use for compatible implant systems.
11. Indications for Use / Intended Purpose:
OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.
12. Summary of Technologies/Substantial Equivalence:
The subject device and predicate device have the same indications for use, technological characteristics and principles of operation, both utilizing the same imaging protocol to generate an interactive preoperative plan. The predicate outputs the same biomechanical measurements (including those relating to leg length, offset and femoral version, cup orientation), performs
5
the same functional analysis of spinopelvic parameters and functional cup orientation calculations, and performs the same prosthetic impingement detection as the subject device. The end user for both the subject and predicate devices are orthopedic surgeons. The subject and predicate devices do not contact the patient.
The subject device differs from the predicate device in that the subject device also includes a bony impingement detection feature.
The differences between the subject device and its predicate device raise no new issues in terms of safety or effectiveness. Therefore, based on these similarities, Corin believes that the OPSInsight is substantially equivalent to the predicate device.
13. Non-Clinical Testing:
Non-clinical testing was performed, assessing the usability and performance testing that was conducted on the predicate device. In addition to this, nonclinical testing was performed to assess the performance of the bony impingement feature in OPSInsight to demonstrate that the feature functions as intended. Software verification and validation testing was conducted according to IEC 62304 and documentation provided as recommended by FDA's Guidance for the Industry: 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'
14. Clinical Testing:
Clinical testing was not necessary for this Traditional 510(k).
15. Conclusion:
The subject device has similar intended uses, technological characteristics, and principles of operation as its predicate devices. The differences between the subject device and its predicates raise no new issues in terms of safety or effectiveness.