(28 days)
Smith & Nephew's VISIONAIRE Patient Matched Cutting Blocks are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total 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 Patient Matched Cutting Blocks are intended for use with the following existing Smith & Nephew, Inc. Knee Systems and their cleared indications for use:
- Genesis II Knee System
- Legion Knee System
- Journey BCS Knee System
- Journey II Knee System
The Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks are intended for single use only.
The subject of this premarket notification is to seek FDA clearance of software components to be used in the design and manufacture of the VISIONAIRE Patient Matched Cutting Blocks. Patient Matched Cutting Blocks were previously cleared for market via premarket notifications- K172336. The blocks are designed utilizing the VISIONAIRE Patient Matched Technology software components and patient imaging data (MRI, X-Ray). The blocks are intended to be used as patient-specific surgical instrument to assist in the positioning of total knee replacement implant components intra-operatively and in guiding the marking of bone before cutting.
This document is a 510(k) premarket notification decision letter from the FDA regarding the Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks. It is a notification for a software component update, not for a new device requiring extensive clinical trials. Therefore, the information typically requested about acceptance criteria and study data for a new device's performance is largely not applicable or not detailed in this type of submission.
The document explicitly states:
- "No new mechanical testing was performed."
- "No implants or new blocks are being introduced in this premarket notification."
- "There are no changes to the block design, packaging, material composition or manufacturing of Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks as a result of these changes described in the premarket notification."
- "Clinical data was not needed to support the safety and effectiveness of the subject device(s)."
The submission focuses on technological differences related to internal software components:
- "The use of a different X-ray measurement tool."
- "The upgrade of an alignment tool."
Software verification and validation testing was completed, which is the primary evidence for this submission.
Therefore, I cannot populate the table and answer the study-specific questions as they would apply to a clinical performance study of a new medical device. The document states that the device is "substantially equivalent" to a predicate device (K172336), and the current submission is for software updates to an already cleared device.
However, I can extract the relevant information about the software validation:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from FDA Guidance for Software Validation) | Reported Device Performance |
|---|---|
| Software validation demonstrating performance as intended | Software verification and validation testing was completed in line with FDA's guidance document "General Principles of Software Validation; Final Guidance for Industry and FDA Staff," dated January 11, 2002. This testing "demonstrated that there are no new issues related to the safety and effectiveness of the subject device and the software will perform as intended." |
2. Sample size used for the test set and the data provenance: Not applicable. This was a software validation, not a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was a software validation.
4. Adjudication method for the test set: Not applicable. This was a software validation.
5. 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: Not applicable. This device is not an AI for human reader assistance; it's patient-matched surgical instrumentation software.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The software components were validated to perform as intended in the design and manufacture of the cutting blocks. This is a standalone software validation, not a clinical performance study.
7. The type of ground truth used: For software validation, the "ground truth" would be the specified functional requirements and design specifications of the software, verified through testing against those predefined requirements.
8. The sample size for the training set: Not applicable. This was a software validation for existing components, not a deep learning model requiring a training set in the typical sense.
9. How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) pertains to software updates for an already cleared device, and thus, the primary evidence presented is software validation and a claim of substantial equivalence, rather than a new clinical performance study with patient data.
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November 28, 2018
Smith & Nephew, Inc. Brad Sheals Regulatory Affairs Manager 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K183010
Trade/Device Name: Smith & Nephew Patient Matched Cutting Blocks Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH. MBH. OOG Dated: October 30, 2018 Received: October 31, 2018
Dear Brad Sheals:
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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,
Image /page/1/Figure/5 description: The image shows a digital signature. The signature is for Peter G. Allen -S. The date of the signature is 2018.11.28, and the time is 11:43:36 -05'00'.
FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K183010
Device Name Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks
Indications for Use (Describe)
Smith & Nephew's VISIONAIRE Patient Matched Cutting Blocks are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total 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 Patient Matched Cutting Blocks are intended for use with the following existing Smith & Nephew, Inc. Knee Systems and their cleared indications for use:
-
Genesis II Knee System
-
Legion Knee System
-
Journey BCS Knee System
-
Journey II Knee System
The Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks are 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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| Submitted by: | Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116 |
|---|---|
| Date of Summary: | 11/27/2018 |
| Contact Person and Address: | Brad ShealsRequlatory Affairs ManagerT 901-399-6897F 901-566-7911 |
| Name of Device: | Smith & Nephew VISIONAIRE Patient Matched CuttingBlocks |
| Common Name: | Knee Prosthesis |
| Device Classification Name andReference: | 21 CFR 888.3560- Knee joint patellofemorotibialpolymer/metal/polymer non-constrained cementedprosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | JWH, MBH, OOG |
Device Description
The subject of this premarket notification is to seek FDA clearance of software components to be used in the design and manufacture of the VISIONAIRE Patient Matched Cutting Blocks. Patient Matched Cutting Blocks were previously cleared for market via premarket notifications- K172336. The blocks are designed utilizing the VISIONAIRE Patient Matched Technology software components and patient imaging data (MRI, X-Ray). The blocks are intended to be used as patient-specific surgical instrument to assist in the positioning of total knee replacement implant components intra-operatively and in guiding the marking of bone before cutting.
Intended Use
Smith & Nephew's VISIONAIRE Patient Matched Cutting Blocks are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total 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 Patient Matched Cutting Blocks are intended for use with the following existing Smith & Nephew, Inc. Knee Systems and their cleared indications for use:
- Genesis II Knee System
- Legion Knee System
- Journey BCS Knee System
- Journey II Knee System
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The Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks are intended for single use only.
Technological Characteristics
No new mechanical testing was performed. No implants or new blocks are being introduced in this premarket notification. There are no changes to the block design, packaging, material composition or manufacturing of Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks as a result of these changes described in the premarket notification. Clinical data was not needed to support the safety and effectiveness of the subject device(s). The following technological differences exist between the subject device and predicate device, which are related to the manufacturing and design process:
-The use of a different X-ray measurement tool.
-The upgrade of an alignment tool.
Software verification and validation testing was completed in line with FDA's guidance document entitled, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff," dated January 11, 2002. A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject device and the software will perform as intended. Based on FDA's recommendations, the VISIONAIRE Patient Matched Technology software components for this device were considered as a "major" level of concern, since a failure in the software could directly result in serious injury or death to the patient or operator.
Based on the documentation within this premarket notification, there are no new issues related to the safety and effectiveness of the subject device. Clinical data was not needed to support the safety and effectiveness of the subject device.
Substantial Equivalence Information
The Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks are identical in function, equivalent design features, intended use, indications for use, operational principles, manufacturing processes, and materials as the predicate device- Patient Matched Cutting Blocks (K172336, S.E. 01/10/2018).
Conclusion
This premarket notification is being submitted to request clearance of the subject Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks. Based on the similarities to the predicate cutting blocks and a review of the testing performed, the subject device is substantially equivalent to the predicate device- Patient Matched Cutting Blocks (K172336, S.E. 01/10/2018).
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.