(112 days)
No
The summary describes a pre-operative analysis tool based on anatomical landmarks and functional pelvic kinematic analysis, without mentioning AI or ML.
No.
The device is described as a pre-operative analysis tool that assists surgeons in determining patient-specific target orientations for acetabular cups. It provides information and visualization but does not directly treat or prevent a disease or condition.
No
The device is described as a "pre-operative tool" that provides "functional acetabular cup orientations" and "visualisation of the patient's hemipelvis" to assist surgeons in determining a "patient specific target orientation" for a surgical implant. It is not used to diagnose a disease or condition.
Yes
The device description explicitly states it "consists of a pre-operative patient specific analysis and two patient specific reports," and that it "assists the surgeon in determining a patient specific target orientation... using anatomical landmarks... obtained from pre-operative CT scan and X-ray data." This indicates the device is a software tool that processes existing imaging data to generate reports and visualizations, without mentioning any associated hardware components that are part of the device itself.
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 intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The Corin OPS™ FHA is a pre-operative planning tool that uses imaging data (CT and X-ray) to analyze pelvic kinematics and provide recommendations for acetabular cup orientation during total hip arthroplasty. It does not involve the examination of biological specimens.
- Intended Use: The intended use is for pre-operative analysis and planning for a surgical procedure, not for diagnosing a disease or condition based on biological samples.
The device is a medical device used for surgical planning and visualization, but it falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA) is indicated for preoperative analysis of primary total hip arthroplasty. Corin OPS™ FHA is intended to be used as a pre-operative tool which provides the Surgeon with functional acetabular cup orientations based on the patient pelvic kinematics and presents a visualisation of the patient's hemipelvis.
The Corin OPS™ FHA is intended for use with the Corin Trinity Acetabular System (K093472, K11481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
LZO, MEH, LWJ, PLW
Device Description
The Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA) consists of a pre-operative patient specific analysis and two patient specific reports: Functional Hip Analysis (FHA) report and Patient Specific Visualisation (PSV) report.
The Corin OPS™ FHA assists the surgeon in determining a patient specific target orientation for the acetabular cup using anatomical landmarks of the pelvis obtained from pre-operative CT scan and X-ray data and a subsequent functional pelvic kinematic analysis (FHA report), and visualisation of the patient's 3-dimensional anatomy (PSV report).
Corin Optimized Positioning System (OPS™) K152893 consists of FHA and PSV reports provided preoperatively and Patient Specific Instruments and Reusable instrumentation components for intraoperative use to assist the surgeon in the alignment of prosthetic components during total hip arthroplasty.
The purpose of this submission is to separate and create a new submission for the components, FHA and PSV reports. The FHA and PSV reports are the same components, part of the Corin Optimized Positioning System (OPS™) which was a previously cleared in K152893.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan and X-ray data.
Anatomical Site
Pelvis, Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, pre-operative tool
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, Reproducibility and Repeatability study was performed to demonstrate that the process used to generate FHA report is reliable and repeatable.
Clinical testing was not necessary for this Traditional 510(k).
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.
K093472, K110087, K111481, K122305, K123705, K130128, K130343, K131647
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
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
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Corin USA % Martina Cecconi Regulatory and Clinical Affairs Team Leader Corin (Australia) 17 Bridge Street Pymble NSW 2073 Australia
Re: K190834
Trade/Device Name: Corin Optimized Position System Functional Hip Analysis (OPS FHA) Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, PLW, MEH, LWJ Dated: June 19, 2019 Received: June 20, 2019
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 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.
July 22, 2019
1
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 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 (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 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 Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190834
Device Name
Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA)
Indications for Use (Describe)
The Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA) is indicated for preoperative analysis of primary total hip arthroplasty. Corin OPS™ FHA is intended to be used as a pre-operative tool which provides the Surgeon with functional acetabular cup orientations based on the patient pelvic kinematics and presents a visualisation of the patient's hemipelvis.
The Corin OPS™ FHA is intended for use with the Corin Trinity Acetabular System (K093472, K11481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty.
| 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
510 (K) SUMMARY
| Applicant/Sponsor
Distributor: | Corin USA Limited
Distributor
12750 Citrus Park Lane
Suit 120
Tampa, Florida 33625
Establishment Registration No: 1056629 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Optimized Ortho Pty Ltd
17 Bridge Street
Pymble NSW
2073 Australia
Establishment Registration No: 3012916784 |
| Contact Person | Martina Cecconi
Regulatory and Clinical Affairs Team Leader
Corin (Australia Pty Limited
Martina.Cecconi@coringroup.com
Lucina Gerber
Global Regulatory Affairs Manager
Corin USA Limited
1 (772) 321-2478 |
Date: 29 March 2019
Trade name: Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA)
Common name: Hip Prosthesis
Classification product code(s): LZO
Additional Product Code(s): MEH, LWJ, PLW
Classification name:
21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
4
Additional Classification Names:
21 CFR 888.3350 - Hip joint metal/polymer semi-constrained cemented prosthesis
Substantially Equivalent (predicate) device(s):
- . Corin Optimized Positioning System (OPSTM) (K152893)
Device description
The Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA) consists of a pre-operative patient specific analysis and two patient specific reports: Functional Hip Analysis (FHA) report and Patient Specific Visualisation (PSV) report.
The Corin OPS™ FHA assists the surgeon in determining a patient specific target orientation for the acetabular cup using anatomical landmarks of the pelvis obtained from pre-operative CT scan and X-ray data and a subsequent functional pelvic kinematic analysis (FHA report), and visualisation of the patient's 3-dimensional anatomy (PSV report).
Corin Optimized Positioning System (OPS™) K152893 consists of FHA and PSV reports provided preoperatively and Patient Specific Instruments and Reusable instrumentation components for intraoperative use to assist the surgeon in the alignment of prosthetic components during total hip arthroplasty.
The purpose of this submission is to separate and create a new submission for the components, FHA and PSV reports. The FHA and PSV reports are the same components, part of the Corin Optimized Positioning System (OPS™) which was a previously cleared in K152893.
Indications for use / intended purpose:
The Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA) is indicated for preoperative analysis of primary total hip arthroplasty. Corin OPS™ FHA is intended to be used as a pre-operative tool which provides the Surgeon with functional acetabular cup orientations based on the patient pelvic kinematics and presents a visualisation of the patient's hemipelvis.
5
The Corin OPS™ FHA is intended for use with the Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty.
Summary of technologies / substantial equivalence:
The Corin OPS™ FHA is identical to the predicate device Corin OPS™ (K152893) with the exception that no hardware components are part of the subject of this submission.
Therefore, the device has similar intended uses and indications, technological characteristics, and principles of operation as its predicate devices. The differences between the device and its predicate device raise no new issues in terms of safety or effectiveness.
Non-clinical testing:
Non-clinical testing was performed to assess the safety and effectiveness of the device, Reproducibility and Repeatability study was performed to demonstrate that the process used to generate FHA report is reliable and repeatable.
Clinical testing:
Clinical testing was not necessary for this Traditional 510(k).
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.