(137 days)
No
The summary describes a mechanical knee replacement system and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "Total Knee System intended to replace a knee joint in order to relieve pain and restore knee function," which directly addresses a medical condition (pain) and restores function, classifying it as therapeutic.
No
The device is a knee replacement system intended to relieve pain and restore knee function, not to diagnose a condition.
No
The device description clearly states it is a "Total Knee System" with femoral components manufactured from CoCrMo and titanium plasma spray coated, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to replace a knee joint to relieve pain and restore function. This is a surgical implant, not a test performed on a sample from the body to diagnose a condition.
- Device Description: The device is a total knee system, consisting of femoral components made of CoCrMo with a titanium plasma spray coating. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a therapeutic device used to physically replace a damaged joint.
N/A
Intended Use / Indications for Use
The Search Evolution (LC) Total Knee System is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as, osteoarthritis, inflammatory arthritis, traumatic arthritis, varus, valgus or flexion deformities and revision surgery.
The Search Evolution non-porous titanium plasma spray coated femoral components are designed for use with bone cement.
Product codes
JWH
Device Description
The Search Evolution (LC) Total Knee System is available with two femoral designs. Each retains the PCL, ligament cruciate (LC) during implantation and both fernoral components are manufactured from CoCrMo. The titanium plasma spray coated femoral components are intended to be used with bone cement (previously cleared in K021313). It conforms to ISO 5832 and is applied using the plasma spray technique.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Ellements" were done where applicable. In addition, testing per the;
- "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces . Apposing Bone or Bone Cement",
- "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on . Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements".
The Aesculap titanium plasma spray coated femoral components are considered substantially equivalent to other legally marketed systems with a titanium plasma spray coating. Testing done on the plasma spray coating found it to be similar in performance to previously cleared devices with the same type of coating.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K032108, K040191, K042344, K021313
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Spacial 510(k)
Search Evolution Knee System Ti, Plasma Spray Femoral Component
K070981
Page 1 of 1
B. 510(K) SUMMARY (as required by 21 CFR 807.92)
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM August 20, 2007
- Aesculap® Implant Systems, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034
Lisa M. Boyle CONTACT: 800-258-1946 (phone) 610-791-6882 (fax)
| TRADE NAME: | Search Evolution (LC) Total Knee System (Plasmapore®) |
|---|---|
| COMMON NAME: | Titanium (Ti.) Plasma Spray Coated Femoral Component |
| DEVICE CLASS: | CLASS II |
| PRODUCT CODE: | JWH |
| CLASSIFICATION: | 888.3560 |
| REVIEW PANEL: | Orthopedics |
SUBSTANTIAL EQUIVALENCE
Aesculap believes that the titanium plasma spray coated femoral component of the Search Evolution Total Knee System is substantially equivalent in design fundamental technology, and coating when compared to:
- Aesculap Search Evolution Porous Coated Femoral Component (K032108) .
- Aesculap Bicontact Hip System (K040191) .
- Aesculap Excia Total Hip System (K042344) .
- Aesculap Search Evolution Total Knee System (K021313) .
DEVICE DESCRIPTION
The Search Evolution (LC) Total Knee System is available with two femoral designs. Each retains the PCL, ligament cruciate (LC) during implantation and both fernoral components are manufactured from CoCrMo. The titanium plasma spray coated femoral components are intended to be used with bone cement (previously cleared in K021313). It conforms to ISO 5832 and is applied using the plasma spray technique.
INTENDED USE
The Search Evolution (LC) Total Knee System is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as, osteoarthritis, inflammatory arthritis, traumatic arthritis, varus, valgus or flexion deformities and revision surgery.
The Search Evolution non-porous titanium plasma spray coated femoral components are designed for use with bone cement.
1
PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Ellements" were done where applicable. In addition, testing per the;
- "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces . Apposing Bone or Bone Cement",
- "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on . Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements".
TECHNOLOGICAL CHARACTERISTICS (compared to Predicate (s)}
The Aesculap titanium plasma spray coated femoral components are considered substantially equivalent to other legally marketed systems with a titanium plasma spray coating. Testing done on the plasma spray coating found it to be similar in performance to previously cleared devices with the same type of coating.
2
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 stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2007
Aesculap Implant Systems, Inc. % Ms. Lisa M. Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
K070981 Trade/Device Name: Search Evolution (LC) Total Knee system (Plasmapore®) Regulation Number: 21 CFR 888.3560 Regulation Name: Knec joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: July 19, 2007 Received: July 23, 2007
Dear Ms. Boyle:
Re:
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. Iisting 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.
3
Page 2 – Ms. Lisa M. Boyle
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. 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Sincerely yours,
Barbarg Bneem
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
INDICATIONS FOR USE STATEMENT A.
510(k) Number (if known):
Device Name: Search Evolution (LC) Total Knee System
Indication for Use:
The Search Evolution (LC) Total Knee System is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as, osteoarthritis, inflammatory arthritis, traumatic arthritis, varus, valgus or flexion deformities and revision surgery.
The Search Evolution non-porous titanium plasma spray coated femoral components are designed for use with bone cement.
| Prescription Use | X |
|---|---|
| or Over-the-Counter Use |
(per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Oubare buelll for rxM
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510(k) Number K070981