(48 days)
The Arthrex iBalance® TKA System is indicated for use in individuals undergoing surgery for:
- Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis;
- Post-traumatic loss of knee joint configuration and function;
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;
- Revisions of previous unsuccessful knee replacement or other procedure.
Additional indications for posteriorly stabilization components:
- Ligamentous instability requiring implant bearing surfaces with increased constraint;
- Absent or non-functioning posterior cruciate ligament.
These devices are single use only and are intended for implantation with bone cement.
The Arthrex iBalance® TKA System consists of femoral components, tibial tray. tibial bearing components and patellar components. All components are available in a range of sizes to fit varying anatomical requirements. Femoral components and tibial bearing components are available in both posteriorly stabilized (PS) and cruciate (CR) configurations. Femoral components are available in left and right versions and are designed to work with the Arthrex dome patella components. Femoral and tibial tray components are manufactured from Cobalt-Chromium Alloy conforming to ASTM F-75. Tibial bearing and patellar components are manufactured from UHMWPE conforming to ASTM F-648.
The provided text describes a 510(k) premarket notification for the Arthrex iBalance® TKA System, specifically addressing a change in the sterilization method for the UHMWPE tibial bearing components from EtO to Gamma Irradiation. The submission focuses on demonstrating substantial equivalence to a predicate device (K081127: Accin™ Total Knee System) despite this change.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material properties of Gamma-sterilized UHMWPE (adherence to ASTM F648 for Type 2 PE) | "Material properties of the gamma UHMWPE components have been fully characterized per ASTM F2565. Gamma sterilization had minimal effects on the mechanical properties of the PE, and the properties meet those listed in ASTM standard F648 for Type 2 PE." |
| Mechanical strength of Gamma-sterilized UHMWPE (comparison to EtO sterilized) | "The mechanical testing data submitted demonstrates that there is no significant difference in mechanical strength between EtO and Gamma specimens." |
| Substantial equivalence to predicate device (K081127) | "The Arthrex iBalance® TKA System is substantially equivalent to the predicate devices, in which the basic design features and intended uses are the same. Any differences between the Arthrex iBalance® TKA System and the predicates are considered minor and do not raise questions concerning safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the mechanical testing of the UHMWPE components. It generally refers to "mechanical testing data submitted."
The data provenance is not explicitly stated. However, given that it's a 510(k) submission to the FDA, the testing would typically be conducted according to recognized ASTM standards, implying a controlled laboratory setting. It is a retrospective analysis comparing the properties of gamma-sterilized and EtO-sterilized UHMWPE.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study described is a laboratory-based mechanical testing study, not one requiring expert human interpretation of medical images or clinical outcomes for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable to the type of study described (mechanical testing). Adjudication methods are typically used in studies involving human interpretation or clinical outcomes.
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?
No, an MRMC comparative effectiveness study was not done. This submission is for a knee prosthesis and focuses on material properties after a sterilization change, not on AI assistance for human readers or interpretation of data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This submission is about the physical properties of a medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for this study is based on established material science standards and physical measurements. Specifically, the "ground truth" for the material properties of UHMWPE is defined by ASTM standard F648 for Type 2 PE, and the characterization of material properties after gamma sterilization was conducted per ASTM F2565. The comparison of mechanical strength between EtO and Gamma specimens relies on direct physical measurement of these properties.
8. The Sample Size for the Training Set
This information is not applicable as there is no "training set" in the context of this mechanical testing study. The device is a physical implant, not an AI system that requires training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set."
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K133342 Page 1 of 3
DEC 1 7 2013
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2.6 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared | December 13, 2013 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Mariela CabarcasRegulatory Affairs Project ManagerArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553. ext. 71246Fax: 239/598.5508Email: mcabarcas@arthrex.com |
| Trade Name | Arthrex iBulance® TKA System |
| Common Name | Knee Prosthesis |
| Product Code -ClassificationNameCFR | JWH888.3560: Prosthesis. Knee, Patellofemorotibial, Semi-Constrained. Cemented. Polymer/Metal/Polymer |
| Predicate Device | K081127: Accin™ Total Knee System |
| Purpose of Submission | special 510(k) premarket notificationThisisintended to address the use of Gamma Irradiationsterilization method on the UHMWPE tibial bearingcomponents of the Arthrex iBalance® TKA System. |
| Device Description | The Arthrex iBalance® TKA System consists offemoral components, tibial tray. tibial bearing componentsand patellar components. All components are available ina range of sizes to fit varying anatomical requirements.Femoral components and tibial bearing components areavailable in both posteriorly stabilized (PS) and cruciate(CR) configurations. Femoral components are availablein left and right versions and are designed to work withthe Arthrex dome patella components. Femoral and tibialtray components are manufactured from Cobalt-Chromium Alloy conforming to ASTM F-75. Tibialbearing and patellar components are manufactured fromUHMWPE conforming to ASTM F-648. |
| Intended Use | The Arthrex iBalance® TKA System is indicated foruse in individuals undergoing surgery for: |
| Painful, disabling joint disease of the knee resultingfrom degenerative arthritis, rheumatoid arthritis orpost-traumatic arthritis; Post-traumatic loss of knee joint configuration andfunction Moderate varus, valgus, or flexion deformity in whichthe ligamentous structures can be returned to adequatefunction and stability; Revisions of previous unsuccessful knee replacementor other procedure. | |
| Additional indications for posteriorly stabilizedcomponents: | |
| Ligamentous instability requiring implant bearingsurfaces with increased constraint; Absent or non-functioning posterior cruciate ligament | |
| These devices are single use only and are intended forimplantation with bone cement. | |
| Substantial EquivalenceSummary | The Arthrex iBalance® TKA System is substantiallyequivalent to the predicate devices, in which the basicdesign features and intended uses are the same. Anydifferences between the Arthrex iBalance® TKA Systemand the predicates are considered minor and do not raisequestions concerning safety and effectiveness. |
| In the predicates, Gamma Irradiation sterilization is usedfor the Chromium Alloy components, and EtOsterilization is used for the UHMWPE components. In theproposed Arthrex iBalance® TKA System, the UHMWPEcomponents will also undergo Gamma Irradiationsterilization. | |
| Material properties of the gamma UHMWPE componentshave been fully characterized per ASTM F2565. Gammasterilization had minimal effects on the mechanicalproperties of the PE, and the properties meet those listedin ASTM standard F648 for Type 2 PE. The mechanicaltesting data submitted demonstrates that there is nosignificant difference in mechanical strength betweenEtO and Gamma specimens. | |
| Based on the indication for use, technologicalcharacteristics, and the summary of data submitted.Arthrex, Inc. has determined that the Arthrex iBalance® |
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| TKA System is substantially equivalent to currently marketed predicate devices. |
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and the comments of the comments of
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle.
Food and Drug Administration 10903 New Hampshire Avenue -Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2013
Arthrex, Incorporated Ms. Mariela Cabarcas Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108
Re: K133342
Trade/Device Name: Arthrex iBalance® TKA System 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 Dated: October 30, 2013 Received: November 4, 2013
Dear Ms. Cabarcas:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Mariela Cabarcas
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/default.htm for the CDRH3s 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.
Ronald#19ean -S for
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): K133342
INDICATIONS FOR USE
Device Name: Arthrex iBalance® TKA System
Indications For Use:
The Arthrex iBalance® TKA System is indicated for use in individuals undergoing surgery for:
- Painful, disabling joint disease of the knee resulting from degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis;
- Post-traumatic loss of knee joint configuration and function; ●
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures . can be returned to adequate function and stability;
- Revisions of previous unsuccessful knee replacement or other procedure. .
Additional indications for posteriorly stabilization components:
- Ligamentous instability requiring implant bearing surfaces with increased ● constraint;
- Absent or non-functioning posterior cruciate ligament. .
These devices are single use only and are intended for implantation with bone cement.
Prescription Use _ AND/OR Over-The-Counter Use (Per 21 CER 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE I of I
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
§ 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.