(20 days)
The Vanguard® Asymmetrical Patella is intended for replacement of part of the knee joint in conjunction with a femoral and tibial component.
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis traumatic arthritis where one or more compartments are involved;
- Correction of varus, valgus, or posttraumatic deformity;
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total joint replacement procedure.
Femoral components and tibial tray components with porous coatings are indicated for cemented and un-cemented biological fixation application. Non-coated (Interlok) devices and all polyethylene patellar components are indicated for cemented application only.
The Vanguard® Patellar Component is machined of polyethylene (UHMWPE) conforming to ASTM F-648.
This is a 510(k) premarket notification for a medical device (Knee Prosthesis), and as such, the "study" described is a demonstration of substantial equivalence to predicate devices, primarily through non-clinical testing and engineering rationale, rather than a clinical trial with acceptance criteria for device performance in patients. Therefore, many of the requested fields related to clinical studies, expert-established ground truth, and AI-specific metrics will not be applicable.
Here's the breakdown of the provided information within the context of a 510(k) submission:
Acceptance Criteria and Device Performance for Biomet Manufacturing Corp.'s Vanguard® Asymmetrical Patellar Component (K110362)
(Note: This submission focuses on demonstrating substantial equivalence through non-clinical performance and engineering rationale, not a clinical study with traditional performance endpoints. Therefore, terms like "acceptance criteria," "reported device performance," and "ground truth" are interpreted within the context of mechanical testing and comparative analysis to predicate devices.)
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Requirement) | Reported Device Performance (New Device) | Predicate Device Comparison |
|---|---|---|---|
| Patellofemoral Stability | Meet or exceed parameters (of predicate) | Meet | K921182 |
| Contact Area Analysis | Meet or exceed parameters (of predicate) | Meet | K921182 |
| Peg Shear Area Analysis | Meet or exceed parameters (of predicate) | Meet | K040770 |
Interpretation of "Acceptance Criteria" in this context: The acceptance criteria are "Meet or exceed parameters" of the identified predicate devices for the respective tests. This implies that the new device's performance in these mechanical tests must be at least as good as, or better than, the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes (N numbers) for the mechanical tests. However, implicitly, a sufficient number of samples would have been tested to demonstrate consistency and compliance with the specified parameters.
Data Provenance: The data is from non-clinical laboratory testing conducted by the manufacturer, Biomet Manufacturing Corp. (Warsaw, IN, USA). It is retrospective in the sense that it's performed on manufactured devices for regulatory submission, rather than a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. For non-clinical mechanical testing of a knee implant component, "ground truth" is established by adherence to recognized engineering standards, test methods, and quantitative measurements. It does not involve expert medical review of images or clinical outcomes. The "experts" involved would be the engineers and technicians conducting the tests and analyzing the data, ensuring the tests are performed according to established protocols.
4. Adjudication Method for the Test Set
Not Applicable. As this involves mechanical testing rather than interpretation of clinical data or images, there is no "adjudication method" in the sense of multiple medical experts resolving discrepancies. The results are quantitative and objective measurements from the tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a 510(k) submission for a medical device focusing on mechanical equivalency, not a comparative effectiveness study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is a physical knee implant component, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on objective, quantitative mechanical test results and engineering rationale demonstrating that the new device's physical and mechanical properties meet or exceed those of the predicate devices. This includes measurements of patellofemoral stability, contact area, and peg shear area.
8. The Sample Size for the Training Set
Not Applicable. There is no "training set" as this is not an AI or algorithm-based device. Mechanical tests are performed on manufactured components.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set.
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FEB 2 8 2011
Image /page/0/Picture/2 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in a stylized, blocky font with a small trademark symbol in the upper right corner. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font.
21 CFR 807.92
| Submitter Information | |
|---|---|
| Name | Biomet Manufacturing Corp. |
| Address | 56 East Bell DriveWarsaw, IN 46581-0857 |
| Phone number | (574) 267-6639 |
| Fax number | (574) 371-1027 |
| EstablishmentRegistration Number | 1825034 |
| Name of contactperson | Tamara West |
| Date prepared | February 4, 2011 |
| Name of device | |
| Trade or proprietaryname | Vanguard® Asymmetrical Patellar Component |
| Common or usualname | Knee Prosthesis |
| Classification name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (21CFR §888.3560) |
| Classification panel | Orthopedic |
| Regulation | 21CFR §888.3560 |
| Product Code(s) | JWH |
| Legally marketeddevice(s) to whichequivalence is claimed | K040770 Vanguard Patellar ComponentsK051977 Scorpio X3 UHMWPE Patellar Components |
| Reason for 510(k)submission | Addition of asymmetrical designed patella to the Vanguard® product line |
| Device description | The Vanguard® Patellar Component is machined of polyethylene (UHMWPE) conforming to ASTM F-648. |
| Intended use of thedevice | The Vanguard® Asymmetrical Patellar is intended for replacement of part of the knee joint in conjunction with a femoral and tibial component. |
| Indications for use | 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis traumatic arthritis where one or more compartments are involved. |
- Box 56
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KII0362
BIOMET®
MANUFACTURING CORP.
- Correction of varus, valqus, or posttraumatic deformity: 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total joint replacement procedure.
Femoral components and tibial tray components with porous coatings are indicated for cemented and un-cemented biological fixation application. Non-coated (Interlok(8) devices and all polyethylene patellar components are indicated for cemented application only.
Summary of the technological characteristics of the device compared to the predicate
| Characteristic | New Device | Predicate |
|---|---|---|
| Design | Asymmetrical or medializeddome | K051977 & K040770 |
| Material | UHMWPE | K040770 |
| Principal of operation | Primary replacement of atotal knee joint | K040770 |
| Dimensions | 25, 28 & 31 x 8 mm34 x 8.5 mm37 & 40 x 10 mm | K040770 |
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Performance Test Summary-New Device
The Vanguard® Asymmetrical Patellar component has the same technological characteristics as the predicate devices except for a slight modification to the general design as described in this 510(k) notification. A risk analysis was conducted along with an engineering rationale to demonstrate equivalence of the subject products to the predicate devices.
Comparative Performance Information Summary
| Characteristic | Requirement | New Device | Predicate Device |
|---|---|---|---|
| PatellofemoralStability | Meet or exceed parameters | Meet | K921182 |
| Contact AreaAnalysis | Meet or exceed parameters | Meet | K921182 |
| Peg Shear AreaAnalysis | Meet or exceed parameters | Meet | K040770 |
PO Box 587
Warsaw. IN 46081-0557
Toll Free: 800.348.9500
Oficer 574 257,683
Main F74.2878137
wwww.bmet.an
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SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Clinical Performance Data/Information: N/A
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
No clinical testing was necessary for a determination of substantial equivalence.
The results of mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.
PO Box 587
Warsaw, IN 46081-000?
Toll Free: 800 348.9000
Offor: 574 257.6833
Main Fax: 574.287.8137
www.comet.axn
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomet Inc. % Ms. Tamara West Senior Regulatory Affairs Specialist 56 East Bell Drive, POB 587 Warsaw, Indiana 46581-0587
FEB 2 8 201
Re: K110362
Trade/Device Name: Vanguard® Asymmetrical Patellar components 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: February 04, 2011
Received: February 08, 2011
Dear Ms. West:
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
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Page 2 - Ms. Tamara West
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 forth in the quality systems (OS) 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/CDRH0ffices/ycm115809.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,
yours,
Mark N. Melkerson 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):_ k1/0362
Device Name: Vanguard® Asymmetrical Patella
Indications For Use:
The Vanguard® Asymmetrical Patella is intended for replacement of part of the knee joint in conjunction with a femoral and tibial component.
-
Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis traumatic arthritis where one or more compartments are involved;
-
Correction of varus, valgus, or posttraumatic deformity;
-
Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total joint replacement procedure.
Femoral components and tibial tray components with porous coatings are indicated for cemented and un-cemented biological fixation application. Non-coated (interlok) devices and all polyethylene patellar components are indicated for cemented application only.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use no (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. Melker
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K110362
§ 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.