(137 days)
No
The description focuses on patient-specific instruments based on a pre-operative plan derived from CT and X-ray data, without mentioning AI/ML algorithms for planning or analysis. The planning tool (K171847) is referenced but not described as using AI/ML.
No
The device is described as a patient-specific surgical instrument intended to assist a surgeon in performing a femoral neck osteotomy during total hip arthroplasty by guiding the cut based on a pre-operative plan, rather than treating a disease or condition itself.
No
The device, Corin OPS™ Femoral, is described as a patient-specific surgical instrument designed to assist surgeons in delivering a target femoral neck osteotomy based on a pre-operative plan. It is a guide for surgical procedures, not a tool for diagnosing medical conditions or diseases.
No
The device description explicitly states that the Corin OPS™ Femoral consists of "Femoral Patient Specific Instruments (PSI) and reusable instrumentation," including a "Femoral Guide" and an "optional Trial Femoral Head (Bone Model)." These are physical components, not software.
Based on the provided information, the Corin OPS™ Femoral is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "patient-specific surgical instrument to assist the surgeon in delivering a target femoral neck osteotomy". This describes a surgical tool used during a procedure, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description reinforces that it's a "Femoral Patient Specific Instruments (PSI)" and "reusable instrumentation" used "during total hip arthroplasty". It guides a surgical cut.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, measure a substance in a biological sample, or provide information about a patient's health status based on in vitro analysis.
- Input Imaging Modality: While it uses imaging (CT and X-ray) for pre-operative planning, this is for creating the patient-specific guide for surgery, not for in vitro diagnostic purposes.
- Predicate Devices: The predicate devices listed (K152893 and K141056) are also surgical systems, not IVDs.
In summary, the Corin OPS™ Femoral is a surgical instrument designed to aid in a specific surgical procedure based on pre-operative planning, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Corin OPS™ Femoral is intended to be used as a patient-specific surgical instrument to assist the surgeon in delivering a target femoral neck osteotomy, based on a pre-operative plan with implant sizing, type and placement.
The Corin OPS™ Femoral is intended to be used with the Corin OPS™ Plan (K171847) and the compatible components. The dislocating Femoral Guide is intended for use with the posterolateral surgical approach and the in-situ Femoral Guide is intended for use with the direct anterior surgical approach.
The Corin OPS™ Femoral PSI is intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
LZO, LWJ, MEH, PBF
Device Description
The Corin Optimized Positioning System (OPS™) Femoral consists of Femoral Patient Specific Instruments (PSI) and reusable instrumentation. The Femoral Patient Specific Instruments include a Femoral Guide and an optional Trial Femoral Head (Bone Model).
The Femoral Guide is shape-matched to the patient's femoral anatomy and provides a guide for the femoral neck osteotomy during total hip arthroplasty. The planned femoral resection, or target osteotomy, is defined by the previously cleared OPS™ Plan (K171847). The OPS™ Plan is a pre-operative tool used by the Surgeon for the selection, sizing and placement of implant components using anatomical landmarks of the femur and pelvis identified from pre-operative CT scan and AP X-ray. The OPS™ Plan was previously cleared under K171847 and is not submitted for review in this 510k submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
pre-operative CT scan and AP X-ray
Anatomical Site
femoral neck, femur and pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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.
Testing included quantitative assessments of clinical accuracy, biocompatibility and dimensional stability. Packaging, distribution, cleaning and sterilization validation of the OPS™ Femoral PSI was completed.
Testing verified that the accuracy and performance of the device 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): 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.
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
September 7, 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Corin USA % Crissy Tomarelli Clinical, Regulatory and Quality Affairs Manager Corin (Australia) 17 Bridge Street Sydney, 2073 Australia
Re: K181061
Trade/Device Name: Corin Optimized Positioning System (OPS) Femoral 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, LWJ, MEH, PBF Dated: August 6, 2018 Received: August 8, 2018
Dear Ms. 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
1
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181061
Device Name
Corin Optimized Positioning System (OPSTM) Femoral
Indications for Use (Describe)
The Corin OPS™ Femoral is intended to be used as a patient-specific surgical instrument to assist the surgeon in delivering a target femoral neck osteotomy, based on a pre-operative plan with implant sizing, type and placement.
The Corin OPS™ Femoral is intended to be used with the Corin OPS™ Plan (K171847) and the compatible components. The dislocating Femoral Guide is intended for use with the posterolateral surgical approach and the in-situ Femoral Guide is intended for use with the direct anterior surgical approach.
The Corin OPSTM Femoral PSI is intended for single use only.
| 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
| 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: | Crissy Tomarelli
Clinical, Regulatory and Quality Affairs
Manager
Corin (Australia) Pty Limited
Crissy.Tomarelli@coringroup.com
Lucinda Gerber
Global Regulatory Affairs Manager
Corin USA Limited
1 (772) 321-2478
Lucinda.Gerber@coringroup.com | |
-
- Date: April 20, 2018
-
- Trade Name: Corin Optimized Positioning System (OPS™) Femoral
-
- Common Name: OPS™ Femoral
-
- Classification Product Code(s): LZO, LWJ, MEH
4
8. Classification Name:
21 CFR 888.3353 – Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
21 CFR 888.3030 - Orthopaedic Surgical Planning And Instrument Guides.
9. Substantially Equivalent (predicate) device(s):
10. Device Description:
The Corin Optimized Positioning System (OPS™) Femoral consists of Femoral Patient Specific Instruments (PSI) and reusable instrumentation. The Femoral Patient Specific Instruments include a Femoral Guide and an optional Trial Femoral Head (Bone Model).
The Femoral Guide is shape-matched to the patient's femoral anatomy and provides a guide for the femoral neck osteotomy during total hip arthroplasty. The planned femoral resection, or target osteotomy, is defined by the previously cleared OPS™ Plan (K171847). The OPS™ Plan is a pre-operative tool used by the Surgeon for the selection, sizing and placement of implant components using anatomical landmarks of the femur and pelvis identified from pre-operative CT scan and AP X-ray. The OPS™ Plan was previously cleared under K171847 and is not submitted for review in this 510k submission.
11. Indications for Use / Intended Purpose:
The Corin OPS™ Femoral is intended to be used as a patient-specific surgical instrument to assist the surgeon in delivering a target femoral neck osteotomy, based on a pre-operative plan with implant sizing, type and placement.
The Corin OPS™ Femoral is intended to be used with the Corin OPS™ Plan (K171847) and the compatible components. The dislocating Femoral Guide is intended for use with the posterolateral surgical approach and the in-situ Femoral Guide is intended for use with the direct anterior surgical approach.
5
The Corin OPS™ Femoral PSI is intended for single use only.
12. Summary of Technologies/Substantial Equivalence:
Device comparison showed that the proposed device is substantially equivalent in intended use, technology, material and performance characteristics to the predicate devices.
13. Non-Clinical Testing:
Non-clinical testing was performed to assess the safety and effectiveness of the device.
Testing included quantitative assessments of clinical accuracy, biocompatibility and dimensional stability. Packaging, distribution, cleaning and sterilization validation of the OPS™ Femoral PSI was completed.
Testing verified that the accuracy and performance of the device 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 material as its predicate devices. The differences between the device and its predicate devices raise no new issues in terms of safety or effectiveness.