(80 days)
Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:
- · Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
- · Correction of functional deformity.
- · Revision of previous arthroplasty procedures.
- · Treatment of fractures that are unmanageable using other techniques.
Unicompartmental knee implants are single use only and are intended for implantation only with bone cement
The subject of this traditional 510(k) is to add the MR safety information to the Journey II Unicompartmental Knee System (Journey II UK) labeling. The Journey II UK was cleared under K190085.
Journey II UK system consist of a femoral implant, tibia baseplate, modular articular insert, and requisite US Class II surgical instruments.
The package insert and label of Journey II UK is being updated to add MR conditional information.
The indication for use of Journey II UK system was updated to clarify the definition of the revision cases. This change does not change the indication for use.
The provided text describes a 510(k) premarket notification for the Smith & Nephew JOURNEY II Unicompartmental Knee System. This submission is primarily to add MR safety information to the labeling and clarify the definition of revision cases for an already cleared device (K190085).
Therefore, the "device" in question for this specific submission is essentially the MR safety information for the JOURNEY II Unicompartmental Knee System, not a new or modified implant design. The performance data presented pertains to the MR compatibility of the existing implant.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative format for the MR safety tests. Instead, it states that testing was conducted "as per the FDA's guidance 'Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment', December 11, 2014 and the standards listed below." The implicit acceptance criterion is that the device demonstrates MR compatibility according to these standards, allowing it to be labeled as MR Conditional.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Conformance to ASTM F2052 for magnetically induced displacement force | Testing was conducted as per ASTM F2052. (The specific results or "passing" thresholds are not detailed, but the conclusion is that the labeling can be updated with MR conditional information, implying successful conformance.) |
| Conformance to ASTM F2213 for magnetically induced torque | Testing was conducted as per ASTM F2213. (The specific results or "passing" thresholds are not detailed, but the conclusion is that the labeling can be updated with MR conditional information, implying successful conformance.) |
| Conformance to ASTM F2182 for radiofrequency (RF) induced heating | Testing was conducted as per ASTM F2182. (The specific results or "passing" thresholds are not detailed, but the conclusion is that the labeling can be updated with MR conditional information, implying successful conformance.) |
| Conformance to ASTM F2119 for MR image artifact | Testing was conducted as per ASTM F2119. (The specific results or "passing" thresholds are not detailed, but the conclusion is that the labeling can be updated with MR conditional information, implying successful conformance.) |
| The device design, materials, and indications for use are substantially equivalent to the predicate (K190085 and K160738) | "The device design, material, and indications for use of the subject device are same as the predicate JOURNEY II UK system cleared under K190085." and "In summary, the Smith & Nephew's JOURNEY II Unicompartmental Knee System is identical in function, design features, intended use, indications for use, materials, sterilization, manufacturing methods, and operational principles as the predicate device JOURNEY II Unicompartmental Knee System cleared under K190085." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document relates to testing of the implant's physical properties for MR compatibility, not a clinical study on patients. Therefore, the "sample size for the test set" would refer to the number of implant components tested. This information is not provided in the document. The data provenance would be laboratory testing, not patient data, and thus country of origin or retrospective/prospective does not apply in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable. The "ground truth" for MR compatibility testing is established by adherence to recognized ASTM standards and FDA guidance, performed by engineers or technicians experienced in medical device testing. It does not involve expert clinical assessment or interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is laboratory testing against standards, not a clinical assessment requiring adjudication of diagnostic findings.
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 document does not describe a comparative effectiveness study, MRMC study, or AI-assisted diagnostic device. It pertains to the MR compatibility of a knee implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance data (MR compatibility) is defined by the ASTM test standards (ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119) and FDA guidance ("Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment"). These standards provide the methodology and criteria for evaluating the physical interactions of an implant with an MR environment.
8. The sample size for the training set
Not applicable. This is not a study involving a training set for an AI/machine learning model.
9. How the ground truth for the training set was established
Not applicable.
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July 25, 2019
Smith & Nephew, Inc. Meenakshi Gupta Senior Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K191211
Trade/Device Name: JOURNEY II Unicompartmental Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX, KRR, NPJ Dated: May 3, 2019 Received: May 6, 2019
Dear Meenakshi Gupta:
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 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
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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/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 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 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).
Sincerely,
FOR Vesa Vuniqi, MS Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality 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)
K191211
Device Name
JOURNEY II Unicompartmental Knee System
Indications for Use (Describe)
Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:
- · Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
- · Correction of functional deformity.
- · Revision of previous arthroplasty procedures.
- · Treatment of fractures that are unmanageable using other techniques.
Unicompartmental knee implants are single use only and are intended for implantation only with bone cement
| 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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510(K) SUMMARY
| Submitted by: | Smith & Nephew, Inc.Advanced Surgical Devices Division7135 Goodlett Farms ParkwayCordova, Tennessee 38016 |
|---|---|
| Date of Submission: | May 3, 2019 |
| Contact Person: | Meenakshi Gupta, Sr. Regulatory Affairs SpecialistT (901) 399-6139F (901) 721-2748 |
| Name of Device: | Smith & Nephew, Inc. JOURNEY II® UnicompartmentalKnee System (Journey II UK) |
| Common Name: | Knee Prosthesis |
| Device ClassificationName and Reference: | 21 CFR 888.3520 Knee Joint FemorotibialMetal/Polymer Non-Constrained Cemented Prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | HSX, KRR, NPJ |
| Predicate Device: | Primary Predicate: JOURNEY II® UnicompartmentalKnee System (Journey II UK)–K190085Secondary Predicate: Zimmer Unicompartmental KneeSystem–K160738The predicate devices have not been subject to adesign related recall. |
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Device Description:
The subject of this traditional 510(k) is to add the MR safety information to the Journey II Unicompartmental Knee System (Journey II UK) labeling. The Journey II UK was cleared under K190085.
Journey II UK system consist of a femoral implant, tibia baseplate, modular articular insert, and requisite US Class II surgical instruments.
The package insert and label of Journey II UK is being updated to add MR conditional information.
The indication for use of Journey II UK system was updated to clarify the definition of the revision cases. This change does not change the indication for use.
Indications for Use
Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:
- . Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
- . Correction of functional deformity.
- . Revision of previous arthroplasty procedures.
- . Treatment of fractures that are unmanaqeable using other techniques.
Unicompartmental knee implants are single use only and are intended for implantation only with bone cement.
Technological Characteristics
The device design, material, and indications for use of the subject device are same as the predicate JOURNEY II UK system cleared under K190085.
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Performance Data
Below listed Magnetic resonance imaging (MRI) compatibility testing were conducted as per the FDA's guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", December 11, 2014 and the standards listed below:
-
- Magnetically induced displacement force (ASTM F2052)
-
- Magnetically induced torque (ASTM F2213)
-
- Radiofrequency (RF) induced heating (ASTM F2182)
-
- MR image artifact (ASTM F2119)
Substantial Equivalence Information
The device design, materials, and indications for use for the Journey II UK are substantially equivalent to the commercially available predicate devices identified in table below:
Table 6.1: Predicates to the Journey II UK
| Manufacturer | Description | SubmissionNumber | ClearanceDate |
|---|---|---|---|
| Smith & Nephew, Inc. | Journey II UnicompartmentalKnee System | K190085 | 02/11/2019 |
| Smith & Nephew, Inc. | Zimmer UnicompartmentalKnee System (ZUK) | K160738 | 06/15/2016 |
Conclusion
In summary, the Smith & Nephew's JOURNEY II Unicompartmental Knee System is identical in function, design features, intended use, indications for use, materials, sterilization, manufacturing methods, and operational principles as the predicate device JOURNEY II Unicompartmental Knee System cleared under K190085
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.