(228 days)
No
The summary describes patient-specific surgical instruments and pre-operative planning tools that use anatomical landmarks from CT and X-ray images. There is no mention of AI or ML being used in the planning or instrument design process. The focus is on shape-matching and guiding based on a pre-defined plan.
No
The device is a patient-specific surgical instrument designed to assist surgeons in performing femoral neck osteotomies during total hip arthroplasty, not to treat a condition itself.
No
The device, Corin OPS™ Femoral, is described as a patient-specific surgical instrument ("surgical instrument to assist the surgeon") and a guide for an osteotomy. It aids in delivering a pre-operative plan. While it uses pre-operative imaging and planning tools (OPS™ Plan and OPS™ Insight) which might involve diagnostic steps, the device itself is an instrument used during surgery to implement a plan, not to diagnose a condition or provide diagnostic information.
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. While the device relies on pre-operative software plans (OPS™ Plan and OPS™ Insight), the device itself includes hardware.
Based on the provided text, the Corin OPS™ Femoral is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Corin OPS™ Femoral's Function: The Corin OPS™ Femoral is described as a "patient-specific surgical instrument" and a "Femoral Patient Specific Instrument (PSI)". Its purpose is to assist the surgeon during total hip arthroplasty by providing a guide for the femoral neck osteotomy based on pre-operative imaging.
- No Specimen Analysis: The device does not analyze any biological specimens from the patient. It is a physical tool used during surgery.
- Input is Imaging: The input for the device's design is pre-operative imaging (CT scan and AP X-ray), not biological samples.
Therefore, the Corin OPS™ Femoral falls under the category of a surgical instrument or guide, not an in vitro diagnostic device.
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 OPS™ Insight, Corin OPS™ Plan and 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 a preoperative plan (either OPS™ Plan (K171847, K183038) or OPS™ Insight (K192656)). OPS™ Plan and OPS™ Insight are pre-operative tools 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.
Corin OPS™ Femoral was originally cleared under K181061. The purpose of this submission is to include OPS™ Insight (K192656) to the Indications for Use as an alternative compatible component. The design and manufacturing process of the device subject of this submission is identical to that of the predicate device K181061.
OPS™ Plan was previously cleared under K171847 and K183038; OPS™ Insight (K192656) is currently under review with FDA. OPS™ Plan (K171847, K183038) and OPS™ Insight (K192656) are not submitted for review in this 510k submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan and AP X-ray
Anatomical Site
Femur, 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.
Corin Optimized Positioning System (OPS™) Femoral (K181061), OPS™ Plan (K171847, K183038), OPS™ Insight (K192656)
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue and white.
August 4, 2020
Corin USA % Martina Cecconi Regulatory and Clinical Affairs Team Leader Corin (Australia) 17 Bridge Street Sydney, 2073 Australia
Re: K193545
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: May 14, 2020 Received: May 15, 2020
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.
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
1
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 (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,
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
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) K193545
Device Name
Corin Optimized Positioning System Femoral (Corin 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 dalgoement.
The Corin OPS™ Femoral is intended to be used with OPS™ Plan and compatible components. The dislocating Femoral Guide is intended for use with the posterolateral surgical approach and the in-site Ferrorel. 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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FORM FDA 3881 (7/17)
3
1. 510(K) SUMMARY
| 1. Applicant/Sponsor | Corin USA Limited | ||
|---|---|---|---|
| Distributor: | 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 - Australia | |||
| Corin Australia | |||
| 0011 61 2 94977400 | |||
| crissy.tomarelli@coringroup.com | |||
| Lucinda Gerber | |||
| Global Regulatory Affairs Manager | |||
| Corin USA Limited | |||
| 1 (772) 321-2478 | |||
| Lucinda.Gerber@coringroup.com |
-
- Date: July 14, 2020
-
- Trade Name: Corin Optimized Positioning System (OPS™) Femoral
-
- Common Name: OPS™ Femoral
-
- Classification Product Code(s): LZO, LWJ, MEH, PBF
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):
Primary predicate:
-
Corin Optimized Positioning System (OPS™) Femoral (K181061) .
Other predicates: -
. OPS™ Insight (K192656)
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 a preoperative plan (either OPS™ Plan (K171847, K183038) or OPS™ Insight (K192656)). OPS™ Plan and OPS™ Insight are pre-operative tools 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.
Corin OPS™ Femoral was originally cleared under K181061. The purpose of this submission is to include OPS™ Insight (K192656) to the Indications for Use as an alternative compatible component. The design and
5
manufacturing process of the device subject of this submission is identical to that of the predicate device K181061.
OPS™ Plan was previously cleared under K171847 and K183038; OPS™ Insight (K192656) is currently under review with FDA. OPS™ Plan (K171847, K183038) and OPS™ Insight (K192656) are 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 OPS™ Insight, Corin OPS™ Plan and 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.
12. Summary of Technologies/Substantial Equivalence:
The Corin OPS™ Femoral is identical to the primary predicate device Corin OPS™ Femoral (K181061).
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 device raise no new issues in terms of safety or effectiveness.
Device comparison showed that the proposed device is substantially equivalent in intended use, technology, material and performance characteristics to the predicate devices.
The subject device works with predicate preoperative plans, OPS™ Plan (K171847, K183038) and OPS™ Insight (K192656)
6
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 device. The differences between the device and its predicate device raise no new issues in terms of safety or effectiveness.