(106 days)
Intended Use
CORIOGRAPH Pre-Op Planning and Modeling Services are intended to provide preoperative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for generating the plan are identifiable on patient imaging scans.
Indications for Use
The CORIOGRAPH Pre-op Planning and Modeling Services are indicated for use for the following procedures:
- · Unicondylar Knee Replacement (UKR)
- · Total Knee Arthroplasty (TKA)
- · Primary Total Hip Arthroplasty (THA)
The subject CORIOGRAPH Hip Pre-Op Plan and CORIOGRAPH Modeler are medical function modules within the CORIOGRAPH Pre-Op Planning and Modeling Services are additional offerings being introduced by Blue Belt Technologies, Inc. to allow for pre-operative planning for surgical procedures based on patient imaging for primary total hip arthroplasty (THA). The CORIOGRAPH Hip Pre-Op Plan system will utilize Smith and Nephew personnel to generate patient specific bone models and preoperative plans for primary THA which will be viewable and editable on CORIOGRAPH Modeler 1.0. Together, CORIOGRAPH Hip Pre-Op Plan and CORIOGRAPH Modeler are the subject of this submission.
The acceptance criteria for the CORIOGRAPH Pre-Op Planning and Modeling Services V2.0 were demonstrated through verification and validation testing, and summative usability testing. The provided document does not explicitly list numerical acceptance criteria values for metrics like accuracy, sensitivity, or specificity. Instead, it broadly states that testing demonstrated the safety and effectiveness of the software applications and that all design inputs were met.
Acceptance Criteria and Reported Device Performance
Note: The document does not provide specific quantitative acceptance criteria or detailed performance metrics. It indicates that the device met its design inputs and was found to be safe and effective.
| Acceptance Criteria Category | Reported Device Performance (as stated in document) |
|---|---|
| Verification and Validation Testing | Demonstrated the safety and effectiveness of the software applications used in CORIOGRAPH Pre-Op Planning & Modeling Services V2.0. All design inputs were met. |
| Summative Usability Testing | Demonstrated that participating surgeons were able to use the subject device safely and effectively in a simulated use environment. |
| Credibility Evaluation | Demonstrated that the kinematic models and Activities of Daily Living (ADLs) utilized in the subject device are clinically relevant. |
Study Details:
-
Sample size used for the test set and the data provenance:
- The document mentions "sumative usability testing" was performed, indicating a test set was used, but does not specify the sample size for the test set.
- The document does not specify the data provenance (e.g., country of origin, retrospective or prospective) for the data used in testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies that "participating surgeons" were involved in the summative usability testing, but does not state the number of experts used to establish ground truth or their specific qualifications (e.g., years of experience, subspecialty).
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe any specific adjudication method used for the test set.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or report any effect size for human reader improvement with AI assistance. The study focuses on the device's ability to generate pre-operative plans and its usability.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document states that the software applications underwent "verification and validation testing," implying a standalone component to ensure functional correctness. However, it also highlights "summative usability testing" with "participating surgeons," which indicates human-in-the-loop performance was also evaluated, particularly for the overall service. It is not explicitly stated whether fully standalone performance was evaluated as a separate metric without any human involvement.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "credibility evaluation," the document states it "demonstrated that the kinematic models and Activities of Daily Living (ADLs) utilized in the subject device are clinically relevant." This suggests clinical relevance or expert opinion/consensus as a form of ground truth for these aspects. For the outputs of the pre-operative planning, the implied ground truth is agreement with surgical principles and objectives, likely assessed by participating surgeons during usability testing.
-
The sample size for the training set:
- The document does not specify the sample size for the training set. It describes the device as providing "Pre-Op Planning and Modeling Services" based on patient imaging and does not detail a machine learning model's training process or associated dataset sizes.
-
How the ground truth for the training set was established:
- Since the document does not explicitly mention a training set or machine learning components in terms of specific algorithms that require labeled training data (beyond general software development and functionality), it does not describe how ground truth for a training set was established. The "services" aspect implies that the system is used by human personnel (Smith and Nephew personnel, as stated in device description) to generate plans, meaning the "training" might refer to the development and refinement of these human-led processes and software functionalities under established surgical guidelines.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
November 15, 2024
Blue Belt Technologies, Inc. Chandler Caufield Senior Regulatory Affairs Specialist 2875 Railroad Street Pittsburgh, Pennsylvania 15222
Re: K242272
Trade/Device Name: CORIOGRAPH Pre-Op Planning and Modeling Services Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: PBF Dated: July 31, 2024 Received: August 1, 2024
Dear Chandler Caufield:
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).
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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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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).
{2}------------------------------------------------
Sincerely,
Tejen D. Soni -S
For
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
Enclosure
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Indications for Use
510(k) Number (if known) K242272
Device Name
CORIOGRAPH Pre-Op Planning and Modeling Services
Indications for Use (Describe) Intended Use
CORIOGRAPH Pre-Op Planning and Modeling Services are intended to provide preoperative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for generating the plan are identifiable on patient imaging scans.
Indications for Use
The CORIOGRAPH Pre-op Planning and Modeling Services are indicated for use for the following procedures:
- · Unicondylar Knee Replacement (UKR)
- · Total Knee Arthroplasty (TKA)
- · Primary Total Hip Arthroplasty (THA)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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2875 Railroad Street Pittsburgh, Pennsylvania 15222 USA
Image /page/4/Picture/3 description: The image shows the logo for Smith+Nephew. The logo is in a bright orange color. The words "Smith" and "Nephew" are connected by a plus sign.
Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc.
510(k) Summary
| 510(k) Owner | Blue Belt Technologies, Inc.2875 Railroad StreetPittsburgh, Pennsylvania 15222 |
|---|---|
| Contact Person | Chandler CaufieldSenior Regulatory Affairs SpecialistEmail: chandler.caufield@smith-nephew.com |
| Date Prepared | 31-July-2024 |
| Classification Reference | 21 CFR 888.3030 |
| Product Code | PBF |
| Supported Codes | JDI, KWZ, LPH, LWJ, LZO, MBL, MEH |
| Common/Usual Name | Orthopaedic Surgical Planning and Instrument Guides |
| Trade/Proprietary Name | CORIOGRAPH Pre-Op Planning and Modeling Services |
| Primary Predicate Device | CORIOGRAPH Knee Pre-Op Plan (K240113) |
| Secondary PredicateDevice | RI.HIP Modeler (K212040) |
| Reason for Submission | This Traditional 510(k) submission is seeking clearance for a newoffering CORIOGRAPH Hip Pre-Op Plan V1.0 and CORIOGRAPH ModelerV1.0, modules of the CORIOGRAPH Pre-Op Planning and ModelingServices V2.0. |
{5}------------------------------------------------
2875 Railroad Street Pittsburgh, Pennsylvania 15222 USA
T: 412-683-3844
Smith+Nephew
Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc.
Intended Use
CORIOGRAPH Pre-Op Planning and Modeling Services are intended to provide pre-operative planning for surgical procedures based on patient imaging, provided that anatomic landmarks generating the plan 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)
- . primary total hip arthroplasty (THA)
Device Description
The subject CORIOGRAPH Hip Pre-Op Plan and CORIOGRAPH Modeler are medical function modules within the CORIOGRAPH Pre-Op Planning and Modeling Services are additional offerings being introduced by Blue Belt Technologies, Inc. to allow for pre-operative planning for surgical procedures based on patient imaging for primary total hip arthroplasty (THA). The CORIOGRAPH Hip Pre-Op Plan system will utilize Smith and Nephew personnel to generate patient specific bone models and preoperative plans for primary THA which will be viewable and editable on CORIOGRAPH Modeler 1.0. Together, CORIOGRAPH Hip Pre-Op Plan and CORIOGRAPH Modeler are the subject of this submission.
{6}------------------------------------------------
T: 412-683-3844 www.smith-nephew.com
Image /page/6/Picture/2 description: The image shows the logo for Smith+Nephew. The logo is in orange and features the company name in a sans-serif font. The plus sign is slightly larger than the other characters and is positioned between "Smith" and "Nephew."
2875 Railroad Street Pittsburgh, Pennsylvania 15222 USA
Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc.
Currently Supported Hip Implants
The CORIOGRAPH Hip Pre-Op Plan is compatible with implant systems provided in Table 1.
TABLE 1. CURRENTLY SUPPORTED SMITH+ NEPHEW HIP IMPLANTS FOR THE CORIOGRAPH HIP PRE-OP PLAN V1.0
| Implant System Name | 510(k) |
|---|---|
| ANTHOLOGY HIP SYSTEM | K211176 |
| CATALYSTEM | K240381 |
| CPCS CEMENTED HIP SYSTEM | K970351 |
| K211176 | |
| POLARSTEM | K203175 |
| K211176 | |
| REDAPT MONOBLOCK REVISION FEMORAL SYSTEM | K211176 |
| SL-PLUS AND SLR-PLUS CEMENTLESS FEMORAL HIP SYSTEM | K211176 |
| SYNERGY HIP SYSTEM | K963509 |
| K211176 | |
| FEMORAL HEADS | K021673 |
| K211176 | |
| OR30 HIP SYSTEM | K220959 |
| K232667 | |
| R3 ACETABULAR SYSTEM - STIKTITE SHELLS | K070756 |
| R3 ACETABULAR SYSTEM | K211176 |
| REDAPT ACETABULAR SYSTEM | K211176 |
Discussion of Similarities and Differences
The purpose of this Traditional 510(k) submission is to seek clearance for the CORIOGRAPH Hip Pre-Op Plan V1.0 and CORIOGRAPH Modeler V1.0, which are medical function modules of the CORIOGRAPH Pre-Op Planning and Modeling Services V2.0. This Software as a Medical Device (SaMD) is based on CORIOGRAPH Knee Pre-Op Plan V1.0 also used to generate preoperative plans (K240113) as well as the secondary predicate RI.HIP Modeler (K212040).
The software planning tools and processes used for the CORIOGRAPH Hip 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 CORIOGRAPH Knee Pre-Op Plan V1.0 (K240113) as well as in the secondary predicate RI.HIP Modeler (K212040).
Smith & Nephew believes that CORIOGRAPH Hip 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 primary predicate CORIOGRAPH Knee Pre-Op Plan V1.0 (K240113) and secondary predicate RI.HIP Modeler (K212040).
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T: 412-683-3844
Image /page/7/Picture/2 description: The image shows the logo for Smith+Nephew. The logo is in orange color. The words "Smith" and "Nephew" are connected by a plus sign.
2875 Railroad Street Pittsburgh, Pennsylvania 15222 USA
Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc.
Table 2. Primary Predicate Device
| Manufacturer | Description | Submission Number | Clearance Date |
|---|---|---|---|
| Smith & Nephew, Inc. | CORIOGRAPH Knee Pre-Op Plan V1.0 | K240113 | 03/18/2024 |
Table 3. Secondary Predicate Device
| Manufacturer | Description | Submission Number | Clearance Date |
|---|---|---|---|
| Blue Belt Technologies Inc. | RI.HIP MODELER | K212040 | 03/11/2022 |
Substantial equivalence analysis for the CORIOGRAPH Knee Pre-Op Plan is provided in Table 4.
{8}------------------------------------------------
2875 Railroad Street Pittsburgh, Pennsylvania 15222 USA
T: 412-683-3844
Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc.
Table 4. Substantial Equivalence Table
| Design AspectReviewed | CORIOGRAPH Hip Pre-Op Plan(Subject Device) | CORIOGRAPH Knee Pre-Op Plan(Primary Predicate Device) | RI.HIP Modeler(Secondary Predicate Device) | Comparison |
|---|---|---|---|---|
| 510(k) Number | K242272 | K240113 | K212040 | N/A |
| Indications forUse | Intended UseCORIOGRAPH Pre-operative PlanningService is intended toprovide pre-operativeplanning for surgicalprocedures based onpatient imaging,provided that anatomiclandmarks necessarygenerating the plan areidentifiable on patientimaging scans.Indications for UseThe CORIOGRAPH Pre-operative PlanningService is indicated foruse for the followingprocedures:unicondylar kneereplacement (UKR) total kneearthroplasty (TKA) primary total hiparthroplasty (THA) | Intended UseCORIOGRAPH Pre-operative PlanningService is intended toprovide pre-operativeplanning for surgicalprocedures based onpatient imaging,provided thatanatomic landmarksnecessary foralignment andpositioning of theimplant areidentifiable on patientimaging scans.Indications for UseThe CORIOGRAPH Pre-operative PlanningService is indicated foruse for the followingprocedures:unicondylar kneereplacement(UKR) total kneearthroplasty (TKA) | Intended UseThe RI.HIP MODELER isintended forpreoperative planningfor primary total hiparthroplasty. RI.HIPMODELER is intendedto be used as a tool toassist the surgeon inthe selection andpositioning ofcomponents in primarytotal hip arthroplasty.Indications for UseRI.HIP MODELER isindicated forindividuals undergoingprimary hip surgery. | Substantiallyequivalent -New indicationadded for Total HipArthroplasty Introduction of HipModules has madethe services offeredplural. Anatomiclandmarksnecessarystatement haschanged from"alignment andpositioning ofimplant" to"generating theplan". |
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2875 Railroad Street Pittsburgh, Pennsylvania 15222 USA
Smith ew
| Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc. | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| -- | -- | ---------------------------------------------------------------------- | -- | -- | -- | -- | -- | -- | -- |
| Design AspectReviewed | CORIOGRAPH Hip Pre-Op Plan(Subject Device) | CORIOGRAPH KneePre-Op Plan(Primary PredicateDevice) | RI.HIP Modeler(Secondary PredicateDevice) | Comparison |
|---|---|---|---|---|
| TargetPopulation | Patients who are ableto undergo an CTsafely, fit theindications, and do notpresent anycontraindications forthe existing hip implantsystem to which it isdesigned. | Patients who are ableto undergo an MRIsafely, fit theindications, and donot present anycontraindications forthe existing kneeimplant system towhich it is designed. | The patient populationis adults only. | Substantiallyequivalent -CORIOGRAPH Pre-OpPlanning and ModelingServices isincorporating newmodules that use analternative imagingmodality with potentialpatient restrictions.Therefore, the TargetPopulation statement isbeing updated toreflect the broaderapplications. |
| TargetAnatomy | KneeHip | Knee | Hip | Substantiallyequivalent -CORIOGRAPH Pre-OpPlanning and ModelingServices are expandingthe offering to planningfor Hip implants.Compatible implantsfor both primarypredicate device andsecondary predicatedevice are implantsmanufactured by BlueBelt Technologies,Inc.'s parent companySmith+Nephew. |
| Where used | Professional healthcarefacility | Professionalhealthcare facility | Clinical Setting | Same as primarypredicate |
| CompatibleTotal KneeSystems | Smith and Nephew Inc.Implants:Genesis II CRGenesis II PSLEGION CRLEGION PSJourney II BCSJourney II CRJourney II XRJOURNEY IIUnicompartmental Knee | Smith and Nephew Inc.Implants:Genesis II CRGenesis II PSLEGION CRLEGION PSJourney II BCSJourney II CRJourney II XRJOURNEY IIUnicompartmental Knee | N/A | Same as primarypredicate |
| Design AspectReviewed | CORIOGRAPH Hip Pre-Op Plan(Subject Device) | CORIOGRAPH KneePre-Op Plan(Primary PredicateDevice) | RI.HIP Modeler(Secondary PredicateDevice) | Comparison |
| CompatibleTotal HipSystems | Smith and Nephew Inc.Implants:ANTHOLOGY HIP SystemCATALYSTEMCPCS Cemented HipSystemPOLARSTEM StandardOffset StemPOLARSTEM Lateral OffsetStemPOLARSTEM Valgus OffsetStem REDAPT MonoblockRevision Femoral SystemSL-PLUS AND SLR-PLUSCementless Femoral HipSystemFemoral HeadsOR30 Hip SystemR3 Acetabular SystemR3 Acetabular SystemAnteverted LinerR3 Constrained LinerSYNERGY Hip System | N/A | Smith and Nephew Inc.Implants:ANTHOLOGY StemPOLARSTEM StandardOffset StemPOLARSTEM Lateral OffsetStemPOLARSTEM Valgus OffsetStemFemoral HeadsR3 Acetabular SystemR3 Acetabular SystemAnteverted LinerR3 Constrained LinerOR30 LinerSYNERGY Hip system | Substantiallyequivalent tosecondary predicate.CORIOGRAPH Pre-OpPlanning and ModelingServices are expandingthe CORIOGRAPHoffering to planning forprimary Total HipArthroplasty Hipimplants. Compatibleimplants for bothprimary predicatedevice and secondarypredicate device areimplants manufacturedby Blue BeltTechnologies, Inc.'sparent companySmith+Nephew. |
| Design Type | Patient Matched | Patient Matched | Patient Matched | Same as predicatedevices. |
| Input | Surgeon PreferencesX-RayMRICT Scan | Surgeon PreferencesX-RayMRI | Surgeon PreferencesX-Ray | SubstantiallyEquivalent |
| Output | Preoperative surgicalplanSimulation of implantposition | Preoperative surgicalplan | Simulation of implantposition | SubstantiallyEquivalent - Hipmodules are generatinga preoperative planthat the surgeon mayuse to drive clinicaldecisions which issimilar to the Kneemodule.Computationalmodeling simulation isequivalent toSecondary PredicateDevice RI.HIPMODELER. |
| Design AspectReviewed | CORIOGRAPH Hip Pre-Op Plan(Subject Device) | CORIOGRAPH KneePre-Op Plan(Primary PredicateDevice) | RI.HIP Modeler(Secondary PredicateDevice) | Comparison |
| Common Name | Orthopaedic SurgicalPlanning andInstrument Guides | Orthopaedic SurgicalPlanning andInstrument Guides | System, ImageProcessing, Radiological | Same as primarypredicate |
| Device Class | Class II | Class II | Class II | Same as primarypredicate andsecondary predicate |
| DeviceClassificationName andReference | 21 CFR 888.3030 -Single/multiplecomponent metallicbone fixationappliances andaccessories. | 21 CFR 888.3030 -Single/multiplecomponent metallicbone fixationappliances andaccessories. | 21 CFR 892.2050 -Medical imagemanagement andprocessing system. | Same as primarypredicate |
| Panel Code | Orthopaedics/87 | Orthopaedics/87 | Radiology/90 | Same as primarypredicate |
| Product Code | PBF | PBF | LLZ | Same as primarypredicate |
| SupportedProduct Code(Knee) | HSX | HSX | N/A | Same as primarypredicate |
| JWH | JWH | N/A | ||
| MBH | MBH | N/A | ||
| OOG | OOG | N/A | ||
| SupportedProduct Code(Hip) | JDI | N/A | JDI | Same as secondarypredicate |
| KWZ | N/A | KWZ | ||
| LPH | N/A | LPH | ||
| LWJ | N/A | LWJ | ||
| LZO | N/A | LZO | ||
| MBL | N/A | MBL | ||
| MEH | N/A | MEH |
{10}------------------------------------------------
2875 Railroad Street Pittsburgh, Pennsylvania 15222 USA
T: 412-683-3844
Sn W
Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc.
{11}------------------------------------------------
T: 412-683-3844
2875 Railroad Street Pittsburgh, Pennsylvania 15222 USA
Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc.
Non-Clinical Testing (Bench)
Verification and validation testing demonstrated the safety and effectiveness of the software applications used in the CORIOGRAPH Pre-Op Planning & Modeling Services V2.0. Summative usability testing demonstrated that participating surgeons were able use the subject device safely and effectively in a simulated use environment. In addition, the credibility evaluation demonstrated that the kinematic models and Activities of Daily Living (ADLS) utilized in the subject device are clinically relevant. Blue Belt Technologies, 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.
{12}------------------------------------------------
2875 Railroad Street Pittsburgh, Pennsylvania 15222 USA
Blue Belt Technologies, Inc. is a subsidiary of Smith & Nephew, Inc.
Conclusion
The software tools and process used for CORIOGRAPH Pre-Op Planning & Modeling Services V2.0 have similar intended use, indications for use and technological characteristics used in the software planning tools and processes used for the preoperative plans generated for the primary predicate CORIOGRAPH Knee Pre-Op Plan (K240113) and the secondary predicate RI.HIP Modeler (K212040).
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 Pre-Op Planning & Modeling Services V2.0, specifically the CORIOGRAPH Hip Pre-Op Plan System V1.0 and the CORIOGRAPH Modeler V1.0 may be used to generative plans for surgical procedures based on patient imaging. This information also demonstrates that the CORIOGRAPH Pre-Op Planning & Modeling Services V2.0 are as safe and effective as the software and planning process used in the primary predicate CORIOGRAPH Knee Pre-Op Plan (K240113) and secondary predicate RI.HIP Modeler (K212040). Blue Belt Technologies, Inc. believes that FDA can find CORIOGRAPH Pre-Op Planning & Modeling Services V2.0 to be substantially equivalent to the primary and secondary predicate devices.
N/A