(62 days)
No
The document describes software used by personnel for pre-operative planning and modeling, with no mention of AI or ML terms or concepts.
No.
This device is a pre-operative planning and modeling service for surgical procedures, which assists in planning rather than directly treating a condition.
No
Explanation: The device is described as a pre-operative planning and modeling service for surgical procedures, specifically knee replacements. It uses patient imaging to generate bone models and patient-specific pre-operative plans that may be used with a surgical system. Its function is to aid in planning surgery, not to diagnose a medical condition.
Yes
The device description explicitly states that the subject of the submission is the "CORIOGRAPH Knee Pre-Op Plan Software System V1.0" and that the plans are generated by personnel using this software. While the output is used with a hardware system (CORI Surgical System), the device being cleared is the software itself which generates the plans and models.
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 CORIOGRAPH Pre-Op Planning and Modeling Service is used for pre-operative planning for surgical procedures based on patient imaging. It generates bone models and patient-specific pre-operative plans.
- Input: The input is patient imaging scans (MRI), not biological specimens.
- Output: The output is a pre-operative plan and bone models, not diagnostic information derived from analyzing biological samples.
- Intended Use: The intended use is for surgical planning, not for diagnosing or monitoring a disease through the analysis of in vitro samples.
The device is a surgical planning tool that utilizes medical imaging, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Intended Use
CORIOGRAPH Pre-Op Planning and Modeling Service is intended to provide pre-operative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
Indications for Use
The CORIOGRAPH Pre-op Planning and Modeling Service is indicated for use for the following procedures:
- unicondylar knee replacement (UKR)
- total knee arthroplasty (TKA)
Product codes (comma separated list FDA assigned to the subject device)
PBF
Device Description
The subject CORIOGRAPH Knee Pre-Op Plan is a medical function module within the CORIOGRAPH Pre-Op Planning and Modeling Service. This service is an additional offering being introduced by Smith & Nephew to allow for preoperative planning for surgical procedures based on patient imaging for total knee arthroplasty (TKA) and unicondylar knee replacement (UKR). The CORIOGRAPH Knee Pre-Op Plans will be generated for specific patients and anatomy by Smith and Nephew personnel using the CORIOGRAPH Knee Pre-Op Plan Software System V1.0, which is the subject of this submission. The CORIOGRAPH Knee Pre-Op Plans will output bone models of the patient anatomy and will generate patient-specific pre-operative plans which may be used on the REAL INTELLIGENCE CORI Surgical System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient imaging scans, MRI
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional healthcare facility
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)
Verification and validation testing demonstrated the safety and effectiveness of the software applications used in the CORIOGRAPH Knee Pre-Op Plan and demonstrated the safety and effectiveness of the generated CORIOGRAPH Knee Pre-Op Plan when used as an input to the CORI Surgical System. Summative usability testing demonstrated that participating surgeons were able use the subject device safely and effectively in a simulated use environment. Smith and Nephew, Inc. has concluded that all design inputs have been met and that the verification and validation testing performed did not raise any new questions of safety or effectiveness.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
March 18, 2024
Image /page/0/Picture/1 description: The image shows 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 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.
Smith & Nephew, Inc Wilcox Miriam Sr. Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116
Re: K240113
Trade/Device Name: CORIOGRAPH Knee Pre-Op Plan Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 16, 2024 Received: January 16, 2024
Dear Wilcox Miriam:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Shumaya Ali-S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
CORIOGRAPH Knee Pre-Op Plan
Indications for Use (Describe)
Intended Use
CORIOGRAPH Pre-Op Planning and Modeling Service is intended to provide pre-operative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
Indications for Use
The CORIOGRAPH Pre-op Planning and Modeling Service is indicated for use for the following procedures:
- · unicondylar knee replacement (UKR)
- · total knee arthroplasty (TKA)
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
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3
Smith & Nephew, Inc.
1450 Brooks Road Memphis, TN 38116 USA
T: + 1-901-396-2121 T: + 1-800-821-5700 (USA toll free) www.smith-nephew.com
Smith Nephew
510(k) Summary
| 510(k) Owner | Smith & Nephew, Inc.
1450 Brooks Road
Memphis, Tennessee 38116 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Miriam Wilcox
Senior Regulatory Affairs Specialist
Email: miriam.wilcox@smith-nephew.com |
| Date Prepared | 18-March-2023 |
| Classification Reference | 21 CFR 888.3030 |
| Product Code | PBF |
| Supported Codes | JWH, MBH, OOG, HSX |
| Common/Usual Name | Orthopaedic Surgical Planning and Instrument Guides |
| Trade/Proprietary Name | CORIOGRAPH Knee Pre-Op Plan |
| Predicate Device(s) | VISIONAIRE UK Patient Matched Cutting Guides (K211512) |
| Reason for Submission | This Traditional 510(k) submission is seeking clearance for a new
offering, CORIOGRAPH Knee Pre-Op Plan V1.0, a module of the
CORIOGRAPH Pre-Op Planning and Modeling Service |
4
Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 USA
-821-5700 (USA toll free) -nephew.com
Intended Use
CORIOGRAPH Pre-Op Planning and Modeling Service is intended to provide pre-operative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
Indications for Use
The CORIOGRAPH Pre-op Planning and Modeling Service is indicated for use for the following procedures:
- unicondylar knee replacement (UKR)
- . total knee arthroplasty (TKA)
Device Description
The subject CORIOGRAPH Knee Pre-Op Plan is a medical function module within the CORIOGRAPH Pre-Op Planning and Modeling Service. This service is an additional offering being introduced by Smith & Nephew to allow for preoperative planning for surgical procedures based on patient imaging for total knee arthroplasty (TKA) and unicondylar knee replacement (UKR). The CORIOGRAPH Knee Pre-Op Plans will be generated for specific patients and anatomy by Smith and Nephew personnel using the CORIOGRAPH Knee Pre-Op Plan Software System V1.0, which is the subject of this submission. The CORIOGRAPH Knee Pre-Op Plans will output bone models of the patient anatomy and will generate patient-specific pre-operative plans which may be used on the REAL INTELLIGENCE CORI Surgical System.
5
Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 USA
: + 1-901-396-2121 T: + 1-800-821-5700 (USA toll free) www.smith-nephew.com
Currently Supported Knee Implants
The CORIOGRAPH Knee Pre-Op Plan is compatible with implant systems aligned to those supported with the REAL INTELLIGENCE CORI Surgical System. Compatible implant systems and clearance numbers are provided in Table 1.
TABLE 1. CURRENTLY SUPPORTED SMITH+ NEPHEW KNEE IMPLANTS FOR THE CORIOGRAPH KNEE PRE-OP PLAN V1.0
| Implant Model Name | 510(k) Number | Classification
Product Code |
|--------------------------------------------|---------------------------|--------------------------------|
| JOURNEY II Unicompartmental Knee System | K191211 | HSX |
| JOURNEY UNI | K102069 | HSX |
| JOURNEY II CR | K121443 | JWH |
| JOURNEY II BCS | K111711 | JWH |
| JOURNEY II XR | K141471, K152726 | JWH |
| LEGION CR/PS | K951987, K962557, K093746 | JWH |
| LEGION Porous CR Femoral Components | K073325, K091543 | MBH |
| LEGION Porous CR Narrow Femoral Components | K210566 | MBH |
| LEGION Porous Tibia | K100897 | MBH |
| Porous Tibia Baseplate | K211221 | MBH |
| GENESIS II CR/PS | K951987, K962557 | JWH |
| ANTHEM | K142807 | JWH |
| LEGION Knee System | K180334 | JWH, MBH |
REAL INTELLIGENCE CORI Surgical System Compatibility
The CORIOGRAPH Knee Pre-Op Plan is compatible with the following versions of the REAL INTELLIGENCE CORI surgical system.
TABLE 2. CURRENTLY SUPPORTED SYSTEM COMPATIBILITY FOR THE CORIOGRAPH KNEE PRE-OP PLAN V1.0
| Device Name | Version | 510(k) Number | Classification
Product Code |
|------------------------|---------|---------------|--------------------------------|
| REAL INTELLIGENCE CORI | 3.0 | K240139 | HSX |
Discussion of Similarities and Differences
The purpose of this Traditional 510(k) submission is to seek clearance for the CORIOGRAPH Knee Pre-Op Plan V1.0, which is a medical function module of the CORIOGRAPH Pre-Op Planning and Modeling Service. This Software as a Medical Device (SaMD) is based on the VISIONAIRE Patient-Matched Technology Software Process also used to generate preoperative plans and physical instruments by the predicate device VISIONAIRE Patient-Matched Cutting Guides (K211512).
The modifications made to the VISIONAIRE Patient-Matched Technology Software Process include an update to a software application to allow for:
- A new pre-operative planning workflow within the software application. This workflow will use the same implant database used on the CORI Surgical System.
- Added ability to detect if the case is intended for Visionaire Patient Matched Cutting Guide or for CORIOGRAPH Pre-operative planning from the surgeon inputs.
6
1-800-821-5700 (USA toll free) www.smith-nephew.com
- . Added ability to create a .json file and pre-operative plan images as outputs for pre-operative planning workflow.
- Implementation of minor bug fixes.
The software planning tools and processes used for the CORIOGRAPH Knee Pre-Op Plan have similar intended use, indications for use and technological characteristics as the software planning tools used for the preoperative plans generated for surgeon concurrence in the predicate VISIONAIRE UK Patient Matched Cutting Guides (K211512).
Smith & Nephew believes that CORIOGRAPH Knee Pre-Op Plan V1.0 is subject to premarket notification requirements under Section 510(k) of the Federal Food, Drug and Cosmetic Act ("FFDCA" or "the Act") and is substantially equivalent to the previously cleared REAL INTELLIGENCE CORI (K221224).
TABLE 3. PREDICATE DEVICE
| Manufacturer | Description | Submission Number | Clearance Date |
|---|---|---|---|
| Smith & Nephew, Inc | VISIONAIRE UK Patient | ||
| Matched Cutting Guides | K211512 | 09/16/2021 |
Substantial equivalence analysis for the CORIOGRAPH Knee Pre-Op Plan is provided in Table 4.
TABLE 4. SUBSTANTIAL EQUIVALENCE TABLE
| Design Aspect
Reviewed | CORIOGRAPH Knee Pre-Op
Plan
(Subject Device) | VISIONAIRE UK Patient
Matched Cutting Guides
(Predicate Device) | Comparison |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K240113 | K211512
S.E. 09/16/2021 | N/A |
| Manufacturer | Smith & Nephew, Inc. | Smith & Nephew, Inc. | Same as predicate |
| Design Aspect
Reviewed | CORIOGRAPH Knee Pre-Op
Plan
(Subject Device) | VISIONAIRE UK Patient
Matched Cutting Guides
(Predicate Device) | Comparison |
| Indications for
Use | Intended Use
CORIOGRAPH Pre-operative
Planning Service is intended
to provide pre-operative
planning for surgical
procedures based on patient
imaging, provided that
anatomic landmarks
necessary for alignment and
positioning of the implant
are identifiable on patient
imaging scans.
Indications for Use
The CORIOGRAPH Pre-
operative Planning Service is
indicated for use for the
following procedures:
unicondylar knee
replacement (UKR)total knee arthroplasty
(TKA) | Smith & Nephew's
VISIONAIRE UK Patient
Matched Cutting Guides are
intended to be used as
patient-specific surgical
instrumentation to assist in
the positioning of knee
replacement components
intra-operatively and in
guiding the marking of bone
before cutting provided that
anatomic landmarks
necessary for alignment and
positioning of the implant
are identifiable on patient
imaging scans.
The Smith & Nephew
VISIONAIRE UK Patient
Matched Cutting Guides are
intended for use with the
following existing Smith &
Nephew, Inc. Knee Systems
and their cleared indications
for use:
Genesis II Knee SystemLegion Knee SystemJourney BCS Knee
SystemJourney II Knee SystemJOURNEY II
Unicompartmental Knee
(JOURNEY II UK) System
(K190085)
The Smith & Nephew
VISIONAIRE UK Patient
Matched Cutting Guides are
intended for single use only. | Substantially equivalent -
Intended use is modified to
reflect that the output is a
software file instead of a
physical patient-matched
part. The indications for use
are updated to reflect the
surgical procedures instead
of the specific implant
systems. As the software
output is used within the
CORI surgical system, the
device is not limited by
manufacture of physical
parts. Compatible Implant
Systems will be disclosed in
the case management portal |
| Target
Population | Patients who are able to
undergo an MRI safely, fit
the indications, and do not
present any
contraindications for the
existing knee implant system
to which it is designed. | Patients who are able to
undergo an MRI safely, fit
the indications, and do not
present any
contraindications for the
existing knee implant system
to which it is designed. | Same as predicate |
| Target
Anatomy | Knee | Knee | Same as predicate |
| | CORIOGRAPH Knee Pre-Op
Plan
(Subject Device) | VISIONAIRE UK Patient
Matched Cutting Guides
(Predicate Device) | Comparison |
| Design Aspect
Reviewed | | | |
| Where used | Professional healthcare facility | Professional healthcare facility | Same as predicate |
| Compatible
Total Knee
Systems | Genesis II CR
Genesis II PS
LEGION CR
LEGION CR Porous
LEGION CR Narrow Porous
LEGION PS
Journey II BCS
Journey II CR
Journey II XR
Journey II BCS ROX
Journey II CR ROX
Journey II UK
Journey Uni | Genesis II CR
Genesis II PS
LEGION CR
LEGION PS
Journey II BCS
Journey II CR
Journey II XR
JOURNEY II
Unicompartmental Knee
(JOURNEY II UK) | Substantially equivalent - As
a software device,
compatible implant systems
for the subject device are
aligned with implants cleared
for use with the CORI
Surgical System, while
compatible implants for the
predicate device were
defined by cleared product
offerings for physical patient
matched guides. |
| Design Type
Output | Patient Matched
Preoperative surgical plan
provided in PDF for surgeon
review. After surgeon
acceptance of the plan
parameters, PDF and/or
software file is provided to
be used as an input to
robotic surgical system. | Patient Matched
Preoperative surgical plan
provided in PDF for surgeon
review. After surgeon
acceptance of the plan
parameters, Physical Patient
Matched Cutting Block is
provided. | Same as predicate
Substantially equivalent -
Final output is a software file
instead of a physical patient-
matched cutting guide |
| Common Name | Orthopaedic Surgical
Planning and Instrument
Guides | Knee Prosthesis | Substantially Equivalent -
Output of Pre-Operative plan
is SaMD instead of a physical
guide, therefore product
code is updated to reflect
output. |
| Device Class | Class II | Class II | Same as predicate |
| Device
Classification
Name and
Reference | 21 CFR 888.3030 -
Single/multiple component
metallic bone fixation
appliances and accessories. | 21 CFR 888.3520- Knee Joint
Femorotibial metal/polymer
nonconstrained cemented
prosthesis
21 CFR 888.3560- Knee Joint
Patellofemorotibial
polymer/metal/polymer
semi-constrained cemented
prosthesis | Substantially Equivalent -
Output of Pre-Operative plan
is SaMD instead of a physical
guide, therefore product
code is updated to reflect
output. |
| Panel Code | Orthopaedics/87 | Orthopaedics/87 | Same as predicate |
| Product Code | PBF | HSX
OOG | Substantially Equivalent -
Output of Pre-Operative plan
is SaMD instead of a physical
guide, therefore product
code is updated to reflect
output. |
| Design Aspect
Reviewed | CORIOGRAPH Knee Pre-Op
Plan
(Subject Device) | VISIONAIRE UK Patient
Matched Cutting Guides
(Predicate Device) | Comparison |
| Supported
Product Code | JWH
MBH
OOG
HSX | JWH
MBH
OOG
HSX | Same as predicate |
7
Smith Nephew
Smith & Nephew, Inc.
1450 Brooks Road Memphis, TN 38116
USA T: + 1-901-396-2121 T: + 1-800-821-5700 (USA toll free) www.smith-nephew.com
8
Smith Nephew
Smith & Nephew, Inc.
1450 Brooks Road Memphis, TN 38116
USA T: + 1-901-396-2121 T: + 1-800-821-5700 (USA toll free) www.smith-nephew.com
9
Smith & Nephew, Inc. 1450 Brooks Road Memnhis TN 38116
USA
5700 (USA toll free) ephew.com
Non-Clinical Testing (Bench)
Verification and validation testing demonstrated the safety and effectiveness of the software applications used in the CORIOGRAPH Knee Pre-Op Plan and demonstrated the safety and effectiveness of the generated CORIOGRAPH Knee Pre-Op Plan when used as an input to the CORI Surgical System. Summative usability testing demonstrated that participating surgeons were able use the subject device safely and effectively in a simulated use environment. Smith and Nephew, Inc. has concluded that all design inputs have been met and that the verification and validation testing performed did not raise any new questions of safety or effectiveness.
Conclusion
The software tools and process used for CORIOGRAPH Knee Pre-Op Plan have similar intended use and indications for use and the same technological characteristics used in the software planning tools and processes used for the preoperative plans generated for the predicate VISIONAIRE UK Patient Matched Cutting Guides (K211512). The differences between the two systems include an update to support the implant database used by the CORI Surgical System as well as a modification of the output to include a JSON file and preoperative plan images for use on the CORI Surgical System.
Verification testing demonstrated that the system meets required design inputs. Summative usability testing results demonstrate that representative users can use the safely and effectively in a simulated use environment. The information presented in this 510(k) premarket notification demonstrates that the CORIOGRAPH Knee Pre-Op Plan System may be used to generative plans for surgical procedures based on patient imaging. This information also demonstrates that the CORIOGRAPH Knee Pre-Op Plan system is as safe and effective as the software and planning process used in the predicate VISIONAIRE UK Patient Matched Cutting Guides (K211512). Smith and Nephew, Inc. believes that FDA can find CORIOGRAPH Knee Pre-Op Plan V1.0 to be substantially equivalent to the predicate device.