(88 days)
The Search Evolution Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, posttraumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.
For Posterior Stabilized (PS) Components:
Absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.
The Search Evolution Knee is designed for use with bone cement.
The cemented Search Evolution Knee System is available with two femoral designs, the Posterior Stabilizing (PC) and the Ligament, Cruciate (LC) which retains the ligament (PCL) during implantation. Both designs of the femoral components, and interchangeable tibial plateaus (trays) are manufactured from CoCrMo. The tibial "gliding surfaces" (inserts) and patellas are manufactured from UHMWPE.
The provided text describes the "Search Evolution Total Knee System" (K021313). However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.
The document is a 510(k) Pre-market Notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing performance data against predefined acceptance criteria for a novel device.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Missing. The document states: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-constrained Total Knee Prostheses' were completed. Biomechanical testing results demonstrate the Search Evolution Knee System is substantially equivalent to other knee systems currently on the market."
This indicates that specific biomechanical tests were performed according to a guidance document, and the results were deemed equivalent to other marketed devices. However, the document does not list the specific acceptance criteria from that guidance (e.g., maximum deflection under load, wear rates, fatigue life) nor does it report the actual numerical performance results of the Search Evolution Total Knee System against these criteria. It only states that the results "demonstrate substantial equivalence."
2. Sample Size Used for the Test Set and Data Provenance
Missing. No information on the sample size for individual tests (e.g., number of knee implants tested for fatigue or wear) or the provenance of any data (e.g., country of origin, retrospective/prospective clinical data) is provided. The document primarily refers to biomechanical testing, which typically involves in-vitro lab tests rather than human subject data for 510(k) clearance of this type of device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable/Missing. This information is relevant for studies involving expert review (e.g., image analysis, clinical judgment). For a knee implant demonstrating substantial equivalence through biomechanical testing, "ground truth" as typically understood in AI/imaging studies (e.g., expert consensus on a diagnosis) is not applicable. The "ground truth" would be the performance standards set by the guidance document for mechanical properties.
4. Adjudication Method
Not applicable/Missing. See point 3. This is relevant for expert-based assessments, not for demonstrating mechanical properties against a standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention any MRMC study. This type of study is relevant for diagnostic devices that involve human interpretation of outputs (e.g., AI for medical imaging). The Search Evolution Total Knee System is a physical implant.
6. Standalone (Algorithm Only) Performance
Not applicable. The device is a physical knee implant, not an algorithm.
7. Type of Ground Truth Used
For a device like the Search Evolution Total Knee System, the "ground truth" effectively refers to established mechanical and material performance standards and specifications detailed in the "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-constrained Total Knee Prostheses." The device's performance is compared against these industry-accepted benchmarks and those of legally marketed predicate devices.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI/ML model that requires a training set. The term "training set" is typically used in the context of machine learning model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
Summary of available information regarding the "study" for K021313:
The "study" or testing conducted for the Search Evolution Total Knee System involved biomechanical testing as required by the "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-constrained Total Knee Prostheses." The purpose of these tests was to demonstrate substantial equivalence to several predicate devices, including the Scorpio and Gem Knee Systems. The document explicitly states that the "biomechanical testing results demonstrate the Search Evolution Knee System is substantially equivalent to other knee systems currently on the market." This suggests that the performance metrics measured during these biomechanical tests met or were comparable to the performance of the predicate devices and the standards outlined in the guidance document. However, numerical results or specific acceptance criteria are not provided in this summary document.
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K021313
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS In Accordance with SMDA of 1990
Search Evolution Total Knee System
April 1, 2001
| COMPANY: | Aesculap ®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034 |
|---|---|
| CONTACT: | Joyce Kilroy800-258-1946 (phone)610-791-6882 (fax)joyce.kilroy@aesculap.com (email) |
| TRADE NAME: | Search Evolution |
| COMMON NAME: | Search Evolution Total Knee System |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | 87 JWH |
| CLASSIFICATION: | 888.3560 - Prosthesis, Knee, Patellofemortibial Semi-constrainedCemented, polymer/metal/polymer |
| REVIEW PANEL: | Orthopedics |
INDICATIONS FOR USE
The Search Evolution Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, posttraumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.
For Posterior Stabilized (PS) Components:
Absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.
The Search Evolution Knee is designed for use with bone cement.
DEVICE DESCRIPTION
The cemented Search Evolution Knee System is available with two femoral designs, the Posterior Stabilizing (PC) and the Ligament, Cruciate (LC) which retains the ligament (PCL) during implantation. Both designs of the femoral components, and interchangeable tibial plateaus (trays) are manufactured from CoCrMo. The tibial "gliding surfaces" (inserts) and patellas are manufactured from UHMWPE.
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510(K) Premarket Notification
Search Evolution Total Knee System
KO21313
PAGE Z OF Z
PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-constrained Total Knee Prostheses" were completed. Biomechanical testing results demonstrate the Search Evolution Knee System is substantially equivalent to other knee systems currently on the market.
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Search Evolution Total Knee System is substantially equivalent to:
- . Scorpio Posteriorly Stabilized Knee System (K962152)
- Scorpio Total Stabilizer Total Knee System (K994128) .
- . Scorpio Posterior Cruciate Retaining Knee System (K974556)
- Gem Knee System (K994214) .
- Gem Posterior Stabilized Total Knee System (K010101) .
Attachme]
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, with wavy lines extending from the bottom of the profiles.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 2 2002
Ms. Joyce Kilroy Director, Regulatory Affairs and Quality Assurance Aesculap®, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K021313
Trade/Device Name: Search Evolution Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: April 23, 2002 Received: April 25, 2002
Dear Ms. Kilroy:
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 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.
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Page 2 - Ms. Joyce Kilroy
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark A Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT B.
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Search Evolution Total Knee System Device Name:
Indication for Use:
The Search Evolution Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.
For Posterior Stabilized (PS) components:
Absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.
The Search Evolution Knee is designed to for use with bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OD Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number K021313
| Prescription Use | ______________________________________________________________________________________________________________________________________________________________________________ | or Over-the-Counter Use | ______________________________________________________________________________________________________________________________________________________________________________ |
|---|---|---|---|
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(per 21 CFR 801.109)
§ 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.