(24 days)
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No
The document describes mechanical surgical instruments and does not mention any AI or ML capabilities.
No
The device, Smith & Nephew Journey II XR Instruments, is an accessory device used to assist in the implantation of a knee system, and it is not directly involved in treating or mitigating a disease or condition. The therapeutic effect comes from the implanted knee system, not the instruments themselves.
No
The device is described as "accessory devices intended to be used to assist in the implantation" of a knee system, and its description focuses on instruments used during surgical procedures, not for diagnosing conditions.
No
The device description explicitly states "modified Journey II XR Instruments" and describes testing related to "tibial impactor design" and "keel prep instruments," which are physical surgical instruments, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the instruments are "accessory devices intended to be used to assist in the implantation of Smith & Nephew Journey II XR Knee System". This describes a surgical tool used during a procedure, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description reinforces that these are "modified Journey II XR Instruments," which are tools for surgical implantation.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on laboratory testing
The device is a surgical instrument used in the operating room to facilitate the implantation of a knee replacement system.
N/A
Intended Use / Indications for Use
Smith & Nephew Journey II XR Instruments are accessory devices intended to be used to assist in the implantation of Smith & Nephew Journey II XR Knee System and their cleared Indications for Use.
Total knee components are indicated for rheumatoid arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.
The Journey II XR Knee system components are indicated for use only with cement and are single use devices.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
Subject of this Special Premarket Notification are modified Journey II XR Instruments. The subject devices are modifications of existing instrumentation cleared for use with the Journey II XR Knee system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Knee
Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility assessments for the instruments were conducted per the recommendations of ISO 10993-1 and the FDA guidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical device – Part 1: Evaluation and testing within a risk management process, " issued June 16, 2016. A review of the results indicates that the modified knee instruments are equivalent to existing, legally marketed predicate instrumentation with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
The following testing was conducted to evaluate substantial equivalence:
- Biocompatibility risk assessment on the materials was performed in accordance with FDA . guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical device - Part 1: Evaluation and testing within a risk management process," issued June 16, 2016
- Testing was performed to evaluate impact resistance of the proposed tibial impactor design to ● the previously tested current design
- . Testing was performed to evaluate the performance of the modified keel prep instruments as compared to the predicate keel prep instruments
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.
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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
§ 888.3560 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which 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.
November 16, 2017
Smith & Nephew, Inc. Shereen Bienz Senior Regulatory Affairs Specialist 1450 E. Brooks Road Memphis, Tennessee 38116
Re: K173331
Trade/Device Name: JOURNEY II XR Knee Instruments Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: October 20, 2017 Received: October 23, 2017
Dear Shereen Bienz:
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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173331
Device Name Journey II XR Knee Instruments
Indications for Use (Describe)
Smith & Nephew Journey II XR Instruments are accessory devices intended to be used to assist in the implantation of Smith & Nephew Journey II XR Knee System and their cleared Indications for Use.
Total knee components are indicated for rheumatoid arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.
The Journey II XR Knee system components are indicated for use only with cement and are single use devices.
| 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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| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Date of Summary: | November 13, 2017 |
| Contact Person and Address: | Shereen Bienz
Senior Regulatory Affairs Specialist
T (901) 800-3161
F (901) |
| Name of Device: | Smith & Nephew, Inc. Journey II XR Knee System Instruments |
| Common Name: | Knee Prosthesis |
| Device Classification Name and
Reference: | 21 CFR 888.3560 Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented
prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | JWH |
Device Description
Subject of this Special Premarket Notification are modified Journey II XR Instruments. The subject devices are modifications of existing instrumentation cleared for use with the Journey II XR Knee system.
Technological Characteristics
Biocompatibility assessments for the instruments were conducted per the recommendations of ISO 10993-1 and the FDA guidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical device – Part 1: Evaluation and testing within a risk management process, " issued June 16, 2016. A review of the results indicates that the modified knee instruments are equivalent to existing, legally marketed predicate instrumentation with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
Intended Use
Journey II XR Instruments are accessory devices and intended to assist in the implantation of Smith & Nephew Journey II XR Knee systems. Table 1 includes the Smith & Nephew Total Knee systems to be used in conjunction with the subject devices.
| Manufacturer | Description | Submission
Number | Clearance Date |
|----------------------|---------------------------------------------------|----------------------|----------------|
| Smith & Nephew, Inc. | Smith & Nephew, Inc. Journey II
XR Knee system | K141471 | 11/14/2014 |
| Smith & Nephew, Inc. | Smith & Nephew, Inc. Journey II
XR Knee system | K152726 | 10/21/2015 |
| Table 2: Smith & Nephew Inc. Compatible Total Knee Systems |
|---|
| ------------------------------------------------------------ |
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Indications for Use
Smith & Nephew Journey II XR Instruments are accessory devices intended to be used to assist in the implantation of Smith & Nephew Journey II XR Knee System and their cleared Indications for Use.
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.
The Journey II XR Knee system components are indicated for use only with cement and are single use devices.
Substantial Equivalence Information
The substantial equivalence of the Journey II XR Instruments is based on its similarities in indications for use, design features, and operational principles to the predicate systems listed in the following table.
Table 1: Predicate Devices
| Manufacturer | Description | Submission
Number | Clearance Date |
|----------------------|---------------------------------------------------|----------------------|----------------|
| Smith & Nephew, Inc. | Smith & Nephew, Inc. Journey II
XR Knee system | K141471 | 11/14/2014 |
| Smith & Nephew, Inc. | Total Knee Instruments | K121393 | 08/08/2012 |
Performance and Biocompatibility Testing
The following testing was conducted to evaluate substantial equivalence:
- Biocompatibility risk assessment on the materials was performed in accordance with FDA . guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical device - Part 1: Evaluation and testing within a risk management process," issued June 16, 2016
- Testing was performed to evaluate impact resistance of the proposed tibial impactor design to ● the previously tested current design
- . Testing was performed to evaluate the performance of the modified keel prep instruments as compared to the predicate keel prep instruments
Conclusion
As previously noted, this Special 510|k) Premarket Notification is being submitted to request clearance for modified Journey II XR Instruments. Based on the similarities to the predicate components and a review of the testing performed, the device is substantially equivalent to above predicate systems.