(28 days)
Total knee components are indicated for:
- Rheumatoid arthritis
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
- The posterior-stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The Journey BCS STD Inserts are indicated for use without bone cement, and are single use devices.
Subject of this premarket notification is a review of changes to the High Performance Knee (previously cleared for market via premarket notification K042515) to result in the Revision Journey BCS STD Inserts. The subject devices are articular inserts manufactured from UHMWPE material. The devices will be available in left and right configurations in sizes 1-2, 3-4, 5-6, and 7-8 and thicknesses from 9-18mm.
When compared to the predicate High Performance Knee, the Revisoin Journey BCS STD Inserts have been modified as follows:
- Utilization of a modified articular insert-tibial baseplate locking mechanism
- Post Height Changes
- Increase in the blend radius at the bottom of the post
This document is a 510(k) premarket notification for a medical device called "Revision Journey BCS STD Inserts," which are components of a total knee prosthesis. It's a submission for changes to an already cleared device, the "High Performance Knee." The primary purpose of this type of submission is to demonstrate that the modified device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, there are no specific quantitative acceptance criteria or reported device performance metrics in the sense of accuracy, sensitivity, specificity, or similar statistical outputs found for AI/software devices. This document deals with mechanical changes to a physical implant.
Instead, the "acceptance criteria" are implied by the regulatory framework for medical devices, particularly regarding substantial equivalence (SE). The criteria revolve around demonstrating that the modified device's safety and effectiveness are not adversely affected by the changes, and that it performs comparably to its predicate.
The reported device performance is described as:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No new issues related to safety or effectiveness due to modifications. | "Design verification testing has been performed based on requirements outlined in FDA's Draft Guidance For the Preparation of Premarket Notifications (510(k)s) For Cemented, Semi-Constrained total Knee Prostheses dated April 1993. A review of the testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices." |
| Substantially equivalent to predicate devices considering modifications. | "Based on the similarities to the predicate device and a review of the testing, the devices are substantially equivalent to knee components currently marketed under K042515." |
| Overall design philosophy, intended use, and material choices remain unchanged. | "Giving consideration to the device modifications described in the Device Description section, no changes have been made to the overall design philosophy, intended use, and material choices when compared to the predicate knee system." |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a submission for a physical medical device (knee implant components), not a software or AI device. Therefore, the concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) as they apply to AI/software performance studies do not apply here.
The "testing" mentioned refers to design verification testing on the physical components, likely involving mechanical tests, fatigue tests, wear tests, etc., in a lab setting rather than clinical trials with human subjects. The details of these specific tests (e.g., number of cycles, number of samples per test) are not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable for this type of device and submission. "Ground truth" established by experts is a concept primarily used in evaluating diagnostic accuracy for AI/software, where human expert interpretation is the gold standard. For physical device modifications, the "truth" is established through engineering and biomechanical testing standards.
4. Adjudication Method for the Test Set
This is not applicable for this type of device validation. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations in diagnostic studies, which is not relevant here.
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
This is not applicable. An MRMC study is relevant for evaluating the impact of AI on human readers' diagnostic performance. This submission is for a physical orthopedic implant component, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This question pertains to AI algorithm performance in isolation. This document is about a physical implant.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For this physical device, the "ground truth" (or demonstration of safety and effectiveness) is established through:
- Compliance with recognized engineering and biomechanical test standards: The document explicitly mentions "requirements outlined in FDA's Draft Guidance For the Preparation of Premarket Notifications (510(k)s) For Cemented, Semi-Constrained total Knee Prostheses dated April 1993." This guidance would specify the types of mechanical, material, and performance tests required.
- Comparison to a legally marketed predicate device: The core of a 510(k) is demonstrating "substantial equivalence," meaning that the new device performs similarly and is as safe and effective as a device already on the market. The predicate device (K042515 - High Performance Knee) serves as the benchmark.
8. The Sample Size for the Training Set
This is not applicable as this describes a physical medical device, not an AI/software device that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
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Summary of Safety and Effectiveness Revision Journey BCS STD Inserts Smith & Nephew, Inc.
Date of Summary: March 23, 2011
Contact Person and Address Megan Bevill Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116 T (901) 399-5340
APR 2 2 2011
Name of Device: Revision Journey BCS STD Inserts
Common Name: Total 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 JWH
Device Description
Subject of this premarket notification is a review of changes to the High Performance Knee (previously cleared for market via premarket notification K042515) to result in the Revision Journey BCS STD Inserts. The subject devices are articular inserts manufactured from UHMWPE material. The devices will be available in left and right configurations in sizes 1-2, 3-4, 5-6, and 7-8 and thicknesses from 9-18mm.
When compared to the predicate High Performance Knee, the Revisoin Journey BCS STD Inserts have been modified as follows: -
- I Utilization of a modified articular insert-tibial baseplate locking mechanism
- Post Height Changes I
- Increase in the blend radius at the bottom of the post
Intended Use
Total knee components are indicated for:
-
- Rheumatoid arthritis
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
- Failed osteotomies, unicompartmental replacement, or total knee replacement. 3.
-
- The posterior-stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The Revision Journey BCS STD Inserts are indicated for use with bone cement, and are single use devices.
Performance Data
Design verification testing has been performed based on requirements outlined in FDA's Droft Guidance For the Preparation of Premarket Notifications (510(k)s) For Cemented, Semi-Constrained total Knee Prostheses dated April 1993. A review of the testing has demonstrated that there are no new issues related to the J safety or effectiveness of the subject devices.
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Clinical data was not needed to support the safety and effectiveness of the subject device.
Substantial Equivalence Information
The Revision Journey BCS STD Inserts are substantially equivalent to previously cleared device listed below . Giving consideration to the device modifications described in the Device Description section, no changes have been made to the overall design philosophy, intended use, and material choices when compared to the predicate knee system.
Table 1: Predicate knee systems
| STATION CALL-1 6 81Call Concession Comparent Carder Comparent of Children· Geenntion | -------------------------------------.C | . 16. READ BYSal man an and |
|---|---|---|
| 1 1499 99 11 | 10000000 | 3/14/05 |
Conclusion
As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for the Revision Journey BCS STD Inserts. Based on the similarities to the predicate device and a review of the testing, the devices are substantially equivalent to knee components currently marketed under K042515.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002
Smith & Nephew. Inc. % Ms. Megan Bevill Regulatory Affairs Specialist 1450 Brooks Road Memphis. Tennessee 38116
APR 2 2 2011
Re: K110837
Trade/Device Name: Revision Journey BCS STD Inserts Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: March 23, 2011 Received: March 25, 2011
Dear Ms. Bevill:
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 (reporting of medical
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device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
AS. 15. R h
for
Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _ K \ \ 0837
Device Name: Revision Journey BCS STD Inserts
Total knee components are indicated for:
- Rheumatoid arthritis 1.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
- కి. Failed osteotomies, unicompartmental replacement, or total knee replacement.
- এ. The posterior-stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The Journey BCS STD Inserts are indicated for use without bone cement, and are single use devices.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K. B. R. ha for Nixon
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110837
§ 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.