(35 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical plating system for fracture fixation and does not mention any software, image processing, or AI/ML capabilities. The performance studies are mechanical testing.
Yes
The device is indicated for the fixation of fractures and osteotomies, which directly treats a medical condition (fractures/non-unions/malunions) and aims to restore normal function to the affected bone, aligning with the definition of a therapeutic device.
No
The device is described as a plating system intended for fixation of fractures and osteotomies, which is a treatment rather than a diagnostic function.
No
The device description and performance studies clearly indicate this is a hardware-based plating system for fracture fixation, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "fixation of fractures and osteotomies involving the femur or tibia." This describes a surgical implant used to stabilize bones, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: While the description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
- Other Sections: The absence of information about image processing, AI/ML, input imaging modality, training/test sets, performance studies focused on diagnostic metrics (like sensitivity, specificity, AUC), and key metrics further supports that this is not an IVD. IVDs typically involve analyzing biological samples and would have performance data related to the accuracy of those analyses.
This device is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The EBI® OptiLock® Periarticular Plating System (The System) is indicated for fixation of fractures and osteotomies involving the femur or tibia.
The System is intended for buttressing multifragment distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures in normal or osteopenic bone and non-unions and malunions.
The System is intended for the treatment of non-unions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial vecomes of bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures.
The System is intended to buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibial shaft.
The System is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.
Product codes
HRS, HWC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, tibia, ankle
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)
Mechanical testing of the Modified System was conducted which demonstrates that the Modified System conforms to its design specifications. Additionally, Engineering Rationales were written to demonstrate why further testing on the additional sizes of the Modified System components was not required to establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
EBI® Pertiarticular Plating System
Reference Device(s):
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Kolo1098
510(k) SUMMARY
MAY 2 4 2006
EBI, L.P.'s
EBI® OptiLock® Periarticular Plating System
| SUBMITTER: | EBI, L.P. |
|---|---|
| ADDRESS: | 100 Interpace Parkway |
| Parsippany, NJ 07054 | |
| PHONE: | (973) 299-9300 |
| FAX: | (973) 257-0232 |
| CONTACT PERSON: | Jennifer P. Harakal |
| DATE PREPARED: | April 18, 2006 |
| TRADE NAME: | EBI® OptiLock® Periarticular Plating System |
| COMMON NAME: | Internal Fixation Device |
| CLASSIFICATION NAME: | Single/Multiple Component Metallic Bone Fixation |
| Appliances and Accessories, Smooth or threaded metallic | |
| bone fixation fastener, 21 CFR 888.3030, 21 CFR 888.3040 | |
| CLASSIFICATION #: | Class II |
| PREDICATE DEVICES: | EBI® Pertiarticular Plating System |
INTENDED/INDICATIONS FOR USE:
The EBI® OptiLock® Periarticular Plating System (The System) is indicated for fixation of fractures and osteotomies involving the femur or tibia.
The System is intended for buttressing multifragment distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures in normal or osteopenic bone and non-unions and malunions.
The System is intended for the treatment of non-unions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial vecomes of bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures.
The System is intended to buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau. Also, for use in the fixation
1
of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibial shaft.
The System is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.
TECHNOLOGICAL CHARACTERISTICS:
Performance Data
Mechanical testing of the Modified System was conducted which demonstrates that the Modified System conforms to its design specifications. Additionally, Engineering Rationales were written to demonstrate why further testing on the additional sizes of the Modified System components was not required to establish substantial equivalence.
Substantial Equivalence
The Modified System is as safe and effective as its predicate devices with respect to intended use, indications for use, technological characteristics and principles of operation. The technological differences between the Modified System and its predicate devices do not raise any new issues of safety or effectiveness. Performance data and Engineering Analyses demonstrate that the Modified System is as safe and effective as its predicate devices. As such, the Modified System is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a stylized eagle with three legs and the text "DEPARTMENT OF HEALTH AND" arranged in a semi-circle above the eagle. The text is in all caps and is black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2006
EBI, L.P. % Ms. Jennifer P. Harakal 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K061098
Trade/Device Name: EBI® OptiLock® Periarticular Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: April 18, 2006 Received: April 19, 2006
Dear Ms. Harakal:
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
3
Page 2 - Ms. Jennifer P. Harakal
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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Herbert Lomarino
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K001098
Device Name: EBI® OptiLock® Periarticular Plating System
Indications for Use:
The EBI® OptiLock® Periarticular Plating System (The System) is indicated for the fixation of fractures and osteotomies involving the femur or tibia.
The System is intended for buttressing multifragment distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures in normal or osteopenic bone, and nonunions and malunions.
The System is intended for the treatment of nonunions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures.
The System is intended to buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibial shaft.
The System is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.
Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off Division of General. Restorative. and Neurological Devices
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510(k) Number
115