(25 days)
No
The description explicitly states that image processing and analysis are completed by a "Corin Simulation Engineer," not an automated system or algorithm. There is no mention of AI, ML, or any related technologies.
No
The device is a pre-operative planning tool used by surgeons to assist in the selection, sizing, and positioning of components for total hip arthroplasty; it does not directly treat or diagnose a disease or condition.
No
This device is described as a "pre-operative templating tool" and "pre-operative planning" tool that assists surgeons in selecting, sizing, and positioning components for total hip arthroplasty, not for diagnosing a medical condition.
Yes
The device description explicitly states that the OPS™ Plan is a "pre-operative templating tool" and describes a process that involves electronic transfer of imaging data, image processing, analysis, and generation of a report. There is no mention of any hardware component being part of the device itself, only the software-based planning process and the resulting report. While it uses input from imaging hardware (CT and X-ray) and is intended for use with physical implants, the device being cleared is the software planning tool.
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, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Corin Optimized Positioning System Plan (OPS™ Plan) is a pre-operative planning tool that uses medical imaging (CT scans and X-rays) of the patient's anatomy to assist in surgical planning for hip replacement. It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use is for pre-operative planning for primary total hip arthroplasty, which is a surgical procedure, not a diagnostic test performed on a specimen.
The device is a medical device used in the planning phase of a surgical procedure, not an in vitro diagnostic test.
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) and TriFit CF (K173880) Femoral Hip Stems.
Product codes
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 consists of the OPS™ Plan Report and the OPS™ Plan Appendix. The OPS™ Plan report is a static report which displays the selection (for example, lateralised or standard stem), sizing and placement of implant components. OPS™ Plan Appendix presents the steps taken by the Engineer on behalf of the Surgeon during the preoperative planning process, which include the identification of anatomical landmarks as well as sizing and positioning of the implants.
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 Corin 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.
The OPS™ Plan was originally cleared in K171847. The purpose of this submission is to include TriFit CF (K173880) to the Femoral Hip systems intended to be used with the OPS™ Plan.
The design and all the other compatible components for use with the OPS™ Plan subject of this submission are identical to that of the predicate device K171847.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan and AP X-ray
Anatomical Site
Femur and pelvis, specifically 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)
K121563, K153772, K082525, K121439, K131952, K153381, K142761, K153725, K083312, K11046, K131986, K173880
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 contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in blue, followed by the words "U.S. Food & Drug Administration" in blue.
November 26, 2018
Corin USA Martina Cecconi Regulatory and Clinical Affairs Team Leader Corin (Australia) 17 Bridge Street PYMBLE, NEW SOUTH WALES 2073 AUSTRALIA
Re: K183038
Trade/Device Name: Corin Optimized Positioning System (OPS) Plan Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, LZO, MEH Dated: October 30, 2018 Received: November 1, 2018
Dear Martina Cecconi:
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 mav, 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 avare 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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
Robert A. 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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2. INDICATION FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
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) and TriFit CF (K173880) 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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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| 1. | Applicant/Sponsor
Distributor: | 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) Pty Limited
Martina.Cecconi@coringroup.com
Lucinda Gerber
Global Regulatory Affairs Manager
Corin USA Limited
1 (772) 321-2478
Lucinda.Gerber@coringroup.com |
-
- Date: Tuesday, 30 October 2018
-
- Trade Name: Corin Optimized Positioning System (OPS™) Plan
-
- Common Name: Image Processing Software
7. Classification Product Code(s): LLZ
Additional Product Code(s): LZO, MEH
8. Classification Name:
21 CFR 892.2050 – Picture archiving and communications system
Additional Classification Names:
21 CFR 888.3353 – Hip joint metal/ceramic/polymer semi-constrained cemented or
4
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):
- . Corin Optimized Positioning System (OPS™) Plan (K171847)
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 consists of the OPS™ Plan Report and the OPS™ Plan Appendix. The OPS™ Plan report is a static report which displays the selection (for example, lateralised or standard stem), sizing and placement of implant components. OPS™ Plan Appendix presents the steps taken by the Engineer on behalf of the Surgeon during the preoperative planning process, which include the identification of anatomical landmarks as well as sizing and positioning of the implants.
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 Corin 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.
The OPS™ Plan was originally cleared in K171847. The purpose of this submission is to include TriFit CF (K173880) to the Femoral Hip systems intended to be used with the OPS™ Plan.
The design and all the other compatible components for use with the OPS™ Plan subject of this submission are identical to that of the predicate device K171847.
5
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) and TriFit CF (K173880) Femoral Hip Stems.
12. Summary of Technologies/Substantial Equivalence:
The Corin OPS™ Plan subject of this submission is identical to the predicate Corin OPS™ Plan (K171847) in design, technological characteristics, principles of operation and indication of use, with both the subject device and predicate device utilizing CT scans to generate 2D patient specific bone models and X-Ray imaging to identify bony landmarks. The end user and site of operation (hip) is identical for both the subject device and predicate device. Based on these similarities, Corin believes that the Corin OPS™ Plan is substantially equivalent to the predicate device.
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, technological characteristics, and principles of operation as its predicate device. The differences between the device and its predicate devices raise no new issues in terms of safety or effectiveness.