(29 days)
Indications for use of the proposed devices will not change from the indications for use as described in their respective predicate device 510(k)s; only a change in packaging is being proposed.
All standard UHMWPE components of the following legacy Centerpulse trade names: Apollo® Knee System, APR® Hip System, Bipolar Prosthesis, Epsilon™ Acetabular System, MOST® System, Natural-Knee® System, Natural-Knee® II System. The packaging for the legacy Centerpulse standard UHMWPE devices will be changed from the current packaging to the packaging used for legacy Zimmer, Inc. UHMWPE device in order to standardize packaging within Zimmer, Inc.
This document describes an "Oxygenless Packaging Conversion of Legacy Centerpulse Standard Polyethylene Devices" for various joint replacement systems. The study focuses on comparing a new packaging configuration to existing ones rather than the performance of the medical device itself. As such, many of the typical acceptance criteria and study data points for a traditional medical device (e.g., accuracy, sensitivity, specificity, clinical outcomes, multi-reader studies) are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Packaging) | Reported Device Performance (for Packaging) |
|---|---|
| Residual Oxygen Levels: The new package configuration should maintain acceptable levels of residual oxygen. | The legacy Zimmer Inc. nitrogen-flushed package (the new proposed packaging for legacy Centerpulse devices) outperformed the legacy Centerpulse package containing an oxygen absorber in terms of residual oxygen. |
| Surface Oxidation Index: The new package configuration should prevent or minimize surface oxidation on the polyethylene components. | Surface oxidation was not detected on any of the samples, regardless of the package configuration (both legacy Zimmer and legacy Centerpulse packages). |
| Sufficiency for Legacy Centerpulse Polyethylene Inserts: The new package must be deemed sufficient for the legacy Centerpulse standard polyethylene inserts. | The legacy Zimmer Inc. nitrogen-flushed package for standard polyethylene devices is sufficient for use for packaging of legacy Centerpulse standard polyethylene inserts. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size. It refers to "samples" being tested.
- Data Provenance: The study was non-clinical performance testing. The origin of the data (country) is not specified, but the submitter is Zimmer, Inc., P.O. Box 708, Warsaw, IN 46581-0708, USA, implying the testing likely occurred within the USA or was overseen by a US-based entity. The study is retrospective in the sense that it compares existing packaging configurations (legacy Zimmer and legacy Centerpulse) and their performance after "long-term shelf-life aging."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The study is a non-clinical performance test of packaging, not a clinical study requiring expert interpretation of medical data or ground truth establishment in a clinical context. The "ground truth" here is the objective measurement of residual oxygen and surface oxidation.
4. Adjudication Method for the Test Set
This information is not applicable. There was no need for adjudication as the study involved objective measurements of chemical properties (residual oxygen, surface oxidation) rather than subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance in interpreting medical images or data. This submission focuses on the performance of device packaging, not AI.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This information is not applicable. This is not an AI or algorithm-based device. The study evaluates the performance of physical packaging.
7. Type of Ground Truth Used
The "ground truth" for this non-clinical study was based on objective measurements of:
- Residual oxygen levels within the package.
- Surface oxidation index on the Ultra High Molecular Weight Polyethylene (UHMWPE) components after long-term shelf-life aging.
8. Sample Size for the Training Set
This information is not applicable. This is a non-clinical performance study of packaging, not a machine learning or AI-based device that would require training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of non-clinical packaging study.
{0}------------------------------------------------
Kou1882 (pg 1 of 3)
AUG 0 1 2005
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Mason W. RobbinsRegulatory Affairs SpecialistTelephone: (574) 371-8065Fax: (574) 372-4605 |
| Date: | June 30, 2006 |
| Trade Names: | Apollo® Knee SystemAPR® Hip SystemBipolar ProsthesisEpsilon™ Acetabular SystemMOST® SystemNatural-Knee® SystemNatural-Knee® II System |
| Common Names: | Total Knee Prosthesis, Articulating SurfaceUnicondylar Knee Prosthesis, Articulating SurfaceTotal Hip Prosthesis, Bipolar ProsthesisTotal Hip Prosthesis, Acetabular ArticulatingSurface |
| Classification Namesand References: | Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis, 21 CFR 888.3560Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis, 21CFR 888.3353Hip joint femoral (hemi-hip) metal/polymercemented or uncemented prosthesis, 21 CFR888.3390Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis, 21 CFR888.3358Hip joint metal/polymer semi-constrained cementedprosthesis, 21 CFR 888.3350 |
| Knee joint femorotibial metal/polymer constrainedcemented prosthesis, 21 CFR 888.3510Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis, 21 CFR 888.3530Knee joint femorotibial (uni-compartmental)metal/polymer porous-coated uncementedprosthesis, 21 CFR 888.3535 | |
| Predicate Devices: | All standard ultra high molecular weightpolyethylene (UHMWPE) components of thefollowing legacy Centerpulse trade names:Apollo® Knee SystemAPR® Hip SystemBipolar ProsthesisEpsilon™ Acetabular SystemMOST® SystemNatural-Knee® SystemNatural-Knee® II System |
| Device Descriptions: | All standard UHMWPE components of thefollowing legacy Centerpulse trade names:Apollo® Knee SystemAPR® Hip SystemBipolar ProsthesisEpsilon™ Acetabular SystemMOST® SystemNatural-Knee® SystemNatural-Knee® II System |
| Intended Uses: | Indications for use of the proposed devices will notchange from the indications for use as described intheir respective predicate device 510(k)submissions. |
| Comparison to Predicate Devices: | The proposed devices are identical to the predicatedevices. The packaging for the legacy Centerpulsestandard UHMWPE devices will be changed fromthe current packaging to the packaging used forlegacy Zimmer, Inc. UHMWPE device in order tostandardize packaging within Zimmer, Inc. |
| Performance Data (Non-clinicaland/or Clinical): | Non-clinical Performance and Conclusions:Package configurations for legacy Zimmer Inc. andlegacy Centerpulse were compared for levels of |
{1}------------------------------------------------
K Q6142 (pg 2 of 3)
{2}------------------------------------------------
Koblitz (pg. 53)
residual oxygen and surface oxidation index in standard polyethylene devices after long-term shelflife aging. The legacy Zimmer Inc. nitrogenflushed package outperformed the legacy Centerpulse package containing an oxygen absorber. Surface oxidation was not detected on any of the samples, regardless of package configuration. The legacy Zimmer Inc. nitrogenflushed package for standard polyethylene devices is sufficient for use for packaging of legacy Centerpulse standard polyethylene inserts.
Zimmer Inc. does not believe clinical data are needed in support of this submission.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The bird is positioned within a circular border. The text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 1 2006
Zimmer, Inc % Mason W. Robbins, MS, RPCV, CCRP Regulatory Affairs Specialist P.O. Box 708 Warsaw, Indiana 46581
Re: K061882 Trade/Device Name: Oxygenless Packaging Conversion of Legacy Centerpulse Standard Polyethylene Devices Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MEH, LPH, JDI, KWY, KRO, HRY, NJD, LZO Dated: June 30, 2006 Received: July 3, 2006
Dear Mr. Robbins:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality
{4}------------------------------------------------
Page 2 - Mason W. Robbins. MS. RPCV. CCRP
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.
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrt/industry/support/index.html.
Sincerely yours,
Hubert Lemercier
$\int$
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name:
Oxygenless Packaging Conversion of Legacy Centerpulse Standard Polyethylene Devices
Apollo® Knee System Trade Names: APR& Anatomical Hip System Bipolar Prosthesis Epsilon™ Acetabular System MOST® System Natural-Knee® System Natural-Knee® II System
Indications for Use:
Indications for use of the proposed devices will not change from the indications for use as described in their respective predicate device 510(k)s; only a change in packaging is being proposed.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of D uation (ODE)
(Division Division of General, Restorative, and Neurological Devices
510(k) Number K061882
§ 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.