(112 days)
Not Found
No
The summary describes patient-specific surgical guides designed and manufactured from patient imaging data using software, but there is no mention of AI or ML being used in the design or manufacturing process. The focus is on patient-matched cutting blocks and software modifications for their design.
No
The device is described as surgical instrumentation used to assist in the positioning of knee replacement components and guiding bone marking, rather than directly treating or diagnosing a condition. It is a tool for a surgeon, not a therapeutic device.
No
Explanation: The device is described 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." It uses imaging data to create guides for surgery, but does not provide a diagnosis or interpretation of a medical condition.
No
The device description explicitly states that the subject of the notification is the "Smith & Nephew VISIONAIRE Adaptive Guides" and "surgical alignment instruments," which are physical, manufactured components. While software is used in the design and manufacturing process, the cleared device itself includes hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "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." This describes a surgical tool used directly on the patient during a procedure.
- Device Description: The description reinforces this by stating the guides are "designed, manufactured from patient imaging data... and offered in various femur/tibia options and features requested by the surgeon." This is about creating a physical guide for surgery.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not involve testing biological samples.
The device is a surgical planning and guidance tool, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
Smith & Nephew's VISIONAIRE Adaptive Guides 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 Adaptive Guides 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 Adaptive Guides are intended for single use only.
Product codes
JWH, MBH, OOG
Device Description
The subject of this premarket notification is to seek FDA clearance of the Smith & Nephew VISIONAIRE Adaptive Guides and the modifications to the software components used to design and manufacture the VISIONAIRE Patient Matched Cutting Blocks. The subject guides are designed, manufactured from patient imaging data (i.e. MRI, X-Ray) and offered in various femur/tibia options and features requested by the surgeon: a tibia-cut-first guide and options for removable tabs. Also within this notification are surgical alignment instruments to evaluate guide position. Patient Matched Cutting Blocks were previously cleared for market via premarket notification K130708.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI, X-Ray
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon / intra-operatively
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)
Smith & Nephew conducted cadaveric testing of the subject device. The results of this testing demonstrated that the patient matched cutting blocks/guides designed using the case processing applications perform equivalent to the predicate cutting blocks.
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 the testing 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2017
Smith & Nephew, Inc Brad Sheals Principal Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K170282
Trade/Device Name: Smith & Nephew VISIONAIRE Adaptive Guides Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH, OOG Dated: January 27, 2017 Received: January 30, 2017
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Form Approved: OMB No. 0910-0120 | |
|---|---|
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K170282 |
|---|---|
| Device Name | Smith & Nephew VISIONAIRE Adaptive Guides |
| Indications for Use (Describe) | Smith & Nephew's VISIONAIRE Adaptive Guides 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 Adaptive Guides 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 Adaptive Guides 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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| FORM FDA 3881 (8/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | EF |
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Image /page/3/Picture/1 description: The image shows the Smith & Nephew logo. The words "We are" are in gray, while "smith&nephew" is in orange. To the left of the text is an orange star-like symbol.
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Date of Summary: | May 18, 2017 |
| Contact Person and Address: | Brad Sheals
Principal Regulatory Affairs Specialist
T 901-399-6897
F 901-566-7911 |
| Name of Device: | Smith & Nephew VISIONAIRE Adaptive Guides |
| Common Name: | Knee Prosthesis |
| Device Classification Name and
Reference: | 21 CFR 888.3560- Knee joint patellofemorotibial
polymer/metal/polymer non-constrained cemented
prosthesis |
| 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 the Smith & Nephew VISIONAIRE Adaptive Guides and the modifications to the software components used to design and manufacture the VISIONAIRE Patient Matched Cutting Blocks. The subject guides are designed, manufactured from patient imaging data (i.e. MRI, X-Ray) and offered in various femur/tibia options and features requested by the surgeon: a tibia-cut-first guide and options for removable tabs. Also within this notification are surgical alignment instruments to evaluate guide position. Patient Matched Cutting Blocks were previously cleared for market via premarket notification K130708.
Intended Use
Smith & Nephew's VISIONAIRE Adaptive Guides 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 Adaptive Guides 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 Adaptive Guides are intended for single use only.
Page 1 of 2.
4
Technological Characteristics
Smith & Nephew conducted cadaveric testing of the subject device. The results of this testing demonstrated that the patient matched cutting blocks/guides designed using the case processing applications perform equivalent to the predicate cutting blocks.
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 the testing 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 Adaptive Guides 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 (K130708, S.E. 02/28/2014).
Conclusion
This premarket notification is being submitted to request clearance for the Smith & Nephew VISIONAIRE Adaptive Guides. Based on the similarities to the predicate cutting blocks, cadaveric testing, and a review of the software validation testing performed, the subject device is substantially equivalent to the predicate device- Patient Matched Cutting Blocks (K130708, S.E. 02/28/2014).