(288 days)
No
The description explicitly states that image processing is completed by an "OPS™ Simulation Engineer," indicating human involvement rather than automated AI/ML processing. There is no mention of AI, ML, or related terms in the document.
No
The device is a pre-operative planning tool used to assist surgeons in selecting, sizing, and positioning components for total hip arthroplasty; it does not directly treat or diagnose a disease.
No
The device is described as a "pre-operative planning tool" and "pre-operative templating tool" for selecting, sizing, and positioning components during total hip arthroplasty. It assists surgeons in planning procedures, rather than diagnosing a disease or condition. While it processes medical images, its purpose is surgical planning, not diagnosis.
Yes
The device description explicitly states it is a "pre-operative templating tool" that processes imaging data to generate a report. It does not mention any hardware components being part of the device itself, and the process described is entirely software-based, involving data transfer, image processing, and report generation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Corin OPS™ Plan is a pre-operative planning tool that uses medical imaging (CT and X-ray) of the patient's anatomy (femur and pelvis) to assist a surgeon in planning a surgical procedure (total hip arthroplasty). It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use is explicitly stated as "pre-operative planning for primary total hip arthroplasty" and "to assist the Surgeon in the selection, sizing and positioning of components." This is a surgical planning function, not a diagnostic function based on in vitro analysis.
- Device Description: The description reinforces that it's a "pre-operative templating tool" that uses imaging and anatomical landmarks.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, diagnostic markers, or providing information for diagnosis or disease prevention based on laboratory tests.
Therefore, the Corin OPS™ Plan falls under the category of a medical device used for surgical planning, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Corin Optimized Positioning System Plan (OPS™ Plan) is indicated for pre-operative planning for primary total hip arthroplasty. OPS™ Plan is intended to be used as a pre-operative tool to assist the Surgeon in the selection (for example, lateralised or standard stem), sizing and positioning of components of primary total hip arthroplasty.
The Corin OPS™ Plan is intended to be used with the Corin TriFit TS (K121563, K153772), MetaFix (K082525, K121439, K131952, K153381), TaperFit (K142761, K153725), MiniHip (K083312, K11046, K131986) Femoral Hip Stems.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, LZO, MEH
Device Description
The Corin Optimized Positioning System™ Plan (OPS™ Plan) is a pre-operative templating tool to assist the Surgeon in the planning of primary total hip arthroplasty using any Corin femoral stem. The Corin OPS™ Plan assists in selection (for example, lateralised or standard stem), sizing and placement of implant components (stem, head, cup) using anatomical landmarks of the femur and pelvis obtained from pre-operative CT scan and AP X-ray. The OPS™ Plan report is a static report which displays the selection (for example, lateralised or standard stem), sizing and placement of implant components.
The Corin OPS™ Plan process begins with booking the OPS case to final release of the OPS Plan Report. OPS™ case booking details and required CT and X-ray imaging in DICOM format are electronically transferred to the manufacturer via the online end-user interface, the OPS™ Portal. Image processing is completed by an OPS™ Simulation Engineer with results of the OPS™ analysis provided in the OPS™ Plan Report. The Surgeon does not actively interact with the image processing, implant positioning and/or report generation. Final acceptance of the OPS™ Plan by the Surgeon is confirmed following any modifications or clarifications of the reported results.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan, AP X-ray
Anatomical Site
Femur and pelvis for total hip arthroplasty
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon / Pre-operative planning
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 to assess the safety and effectiveness of the device, to demonstrate the processing of patient imaging to produce accurate, repeatable and reproducible implant selection, sizing and placement of components, and the usability of the OPS™ Plan that is provided to the Surgeon. Testing verified that the accuracy and performance of the system is adequate to perform as intended.
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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April 5, 2018
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 Limited % Ms. Martina Cecconi Regulatory and Clinical Affairs Team Leader 12750 Citrus Park Lane, Suite 120 TAMPA FL 33625
Re: K171847
Trade/Device Name: Corin Optimized Positioning System (OPSTM) Plan Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, LZO, MEH Dated: March 20, 2018 Received: March 22, 2018
Dear Ms. Cecconi:
We have reviewed vour 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171847
Device Name Corin Optimized Positioning System (OPS™) Plan
Indications for Use (Describe)
The Corin Optimized Positioning System Plan (OPS™ Plan) is indicated for pre-operative planning for primary total hip arthroplasty. OPS™ Plan is intended to be used as a pre-operative tool to assist the Surgeon in the selection (for example, lateralised or standard stem), sizing and positioning of components of primary total hip arthroplasty.
The Corin OPS™ Plan is intended to be used with the Corin TriFit TS (K121563, K153772), MetaFix (K082525, K121439, K131952, K153381), TaperFit (K142761, K153725), MiniHip (K083312, K11046, K131986) Femoral Hip Stems.
| 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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3.2 510(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: | Martina Cecconi |
| Regulatory and Clinical Affairs Team Leader | |
| Corin Australia | |
| 011 61 2 94977400 | |
| Martina.Cecconi@coringroup.com | |
| Lucinda Gerber | |
| Global Regulatory Affairs Manager | |
| Corin USA Limited | |
| 1 (772) 321-2478 | |
| Lucinda.Gerber@coringroup.com | |
| 4. Date: | March 20, 2018 |
| 5. Trade Name: | Corin Optimized Positioning System (OPSTM) Plan |
| 6. Common Name: | Image Processing Software |
| 7. Classification Product Code(s): | LLZ |
Additional Product Code(s): LZO, MEH
-
- Classification Name: 21 CFR 892.2050 Picture archiving and communications
4
Additional Classification Names:
21 CFR 888.3353 – Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis .
21 CFR 888.3353 – Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis .
9. Substantially Equivalent (predicate) device(s):
- . ZedView (K133022)
10. Device Description:
The Corin Optimized Positioning System™ Plan (OPS™ Plan) is a pre-operative templating tool to assist the Surgeon in the planning of primary total hip arthroplasty using any Corin femoral stem. The Corin OPS™ Plan assists in selection (for example, lateralised or standard stem), sizing and placement of implant components (stem, head, cup) using anatomical landmarks of the femur and pelvis obtained from pre-operative CT scan and AP X-ray. The OPS™ Plan report is a static report which displays the selection (for example, lateralised or standard stem), sizing and placement of implant components.
The Corin OPS™ Plan process begins with booking the OPS case to final release of the OPS Plan Report. OPS™ case booking details and required CT and X-ray imaging in DICOM format are electronically transferred to the manufacturer via the online end-user interface, the OPS™ Portal. Image processing is completed by an OPS™ Simulation Engineer with results of the OPS™ analysis provided in the OPS™ Plan Report. The Surgeon does not actively interact with the image processing, implant positioning and/or report generation. Final acceptance of the OPS™ Plan by the Surgeon is confirmed following any modifications or clarifications of the reported results.
11. Indications for Use / Intended Purpose:
The Corin Optimized Positioning System Plan (OPS™ Plan) is indicated for preoperative planning for primary total hip arthroplasty. OPS™ Plan is intended to be used as a pre-operative tool to assist the Surgeon in the selection (for example, lateralised or standard stem), sizing and positioning of components of primary total hip arthroplasty.
The Corin OPS™ Plan is intended to be used with the Corin TriFit TS (K121563, K153772), MetaFix (K082525, K121439, K131952, K153381), TaperFit (K142761, K153725), MiniHip (K083312, K11046, K131986) Femoral Hip Stems.
5
Summary of Technologies/Substantial Equivalence: 12.
The device comparison showed that the subject device is substantially equivalent to the predicate in that both have similar indications for use as a pre-operative surgical planning tool for total hip replacement. The subject device and predicate device have similar technological characteristics and principles of operation with both utilizing CT scans to generate 3D patient specific bone models which enables 3D implant templating for surgical planning and X-ray imaging to identify boney landmarks. The subject device differs from the predicate in that the Surgeon cannot actively generate, alter or change the surgical pre-plan and must communicate any desired changes to the manufacturer so that the OPS™ Simulation Engineer and make the requested changes to the pre-operative plan. The final end user in both the subject and predicate devices is the Surgeon. The subject device is used for total hip replacement while the predicate can be used for pre-operative planning for both total hip and total knee replacement.
13. Non-Clinical Testing:
Non-clinical testing was performed to assess the safety and effectiveness of the device, to demonstrate the processing of patient imaging to produce accurate, repeatable and reproducible implant selection, sizing and placement of components, and the usability of the OPS™ Plan that is provided to the Surgeon. Testing verified that the accuracy and performance of the system is adequate to perform as intended.
14. Clinical Testing:
Clinical testing was not necessary for this Traditional 510(k).
15. Conclusion:
The subject device has similar intended uses and indications, and technological characteristics, and principles of operation as its predicate device. The differences between the device and its predicate device raise no new issues in terms of safety or effectiveness.