(14 days)
Not Found
Not Found
No
The summary describes a system of plates and screws for bone fixation, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes.
The device is intended for fixation of fractures, osteotomies, and nonunions, which are therapeutic interventions.
No
Explanation: The device description states its intended use is for fixation of fractures, osteotomies, and nonunions, which is a therapeutic function, not a diagnostic one. There is no mention of it being used to diagnose conditions.
No
The device description explicitly states it consists of plates and screws, which are hardware components.
No, 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, osteotomies and nonunions of the olecranon, humerus, radius, ulna." This describes a surgical implant used to stabilize bones within the body.
- Device Description: The device description details plates and screws made of specific materials (ASTM F138, F139, F2229) and their design features (precontoured, compression slots, locking screw holes). This is consistent with orthopedic implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a physical implant used for structural support.
N/A
Intended Use / Indications for Use
The EVOLVE® EPS ORTHOLOC™ System is intended for fixation of fractures, osteotomies and nonunions of the olecranon, humerus, radius, ulna.
Product codes
HRS
Device Description
The EVOLVE® EPS ORTHOLOC™ System consists of plates manufactured per ASTM F138 or F139 and screws manufactured per ASTM F138 or F2229. The plates are precontoured with compression slots and locking screw holes. The screws will be available in both locking and non-locking designs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
olecranon, humerus, radius, ulna
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K100146 (1/1)
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
FEB - 2 2010
ﺮﻳﺐ ﻓﻲ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the EVOLVE® EPS ORTHOLOCTM System.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | January 11, 2010 |
| Contact Person: | Kelsey Lee |
| Regulatory Affairs Specialist | |
| Proprietary Name: | EVOLVE® EPS ORTHOLOC TM |
| Common Name: | Bone Plate System |
| Classification Name and Reference: | 21 CFR 888.3030 - Plate, Fixation, Bone- Class II |
| Device Product Code and Panel Code: | Orthopedics/87/HRS |
DEVICE INFORMATION
A. INTENDED USE
The EVOLVE® EPS ORTHOLOC™ System is intended for fixation of fractures, osteotomies and nonunions of the olecranon, humerus, radius, ulna.
B. DEVICE DESCRIPTION
The EVOLVE® EPS ORTHOLOC™ System consists of plates manufactured per ASTM F138 or F139 and screws manufactured per ASTM F138 or F2229. The plates are precontoured with compression slots and locking screw holes. The screws will be available in both locking and non-locking designs.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The design features of the EVOLVE® EPS ORTHOLOC™ System are substantially equivalent to the design features of the predicates identified in this 510(k) submission. The safety and effectiveness of the EVOLVE® EPS ORTHOLOC™ System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this 510(k).
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Public Health Service
Food and Druq Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 · Silver Spring, MD 20993-0002
Wright Medical Technology, Inc. % Ms. Kelsey Lee Regulatory Affairs Specialist · 5677 Airline Road Arlington, Tennessee 38002
FEB - 2 2010
Re: K100146
Trade/Device Name: Evolve® EPS ORTHOLOC™ 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: January 11, 2010 Received: January 19, 2010
Dear Ms. Lee:
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 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.
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Page 2 - Ms. Kelsey Lee
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/CDRH/CDRHOffices/ucm115809.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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Barbara Muchmo
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K100|46
Device Name: EVOLVE® EPS ORTHOLOC™ System
Indications For Use:
The EVOLVE® EPS ORTHOLOC™ System is intended for fixation of fractures, osteotomies and nonunions of the olecranon, humerus, radius, ulna.
Prescription Use XXX (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 Device Evaluation (ODE)
1 of 1
Sonita for mxn
(Patient Signat
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100146