(59 days)
No
The summary describes a mechanical external fixation system and does not mention any software, algorithms, or AI/ML terms.
Yes
The device is an external fixation system used for medical procedures like arthrodesis and trauma repair, which are therapeutic interventions.
No
The device is an external fixation system used for surgical procedures such as arthrodesis and trauma reconstruction, which are treatments rather than diagnostic processes.
No
The device description explicitly states it uses "a series of pins and wires" and a "boot," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a system for external fixation of the foot and tibia for various surgical procedures. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details a system of pins, wires, and a boot used for mechanical support and manipulation of bones. This is a physical device used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on biological samples to provide diagnostic information. This device is a surgical tool used for external fixation.
N/A
Intended Use / Indications for Use
Wright's SIDEKICK® EZ FRAME™ External Fixation System is intended for:
- · Triple Arthrodesis
- · Isolated Rearfoot Arthrodesis
- · Midfoot Arthrodesis
- Comminuted Trauma
- · Diabetic Charcot Reconstruction
- · Most foot pathology not requiring fixation above the ankle
Product codes
KTT
Device Description
The SIDEKICK® EZ FRAME™ External Fixation System uses a series of pins and wires for compression or distraction in the foot and uses a boot to secure the tibia. The system is adjustable to accommodate variations in patient anatomy. The SIDEKICK® EZ FRAMETM External Fixation System is compatible with the SIDEKICK® FREEDOM External Fixation System (K043289) components, and these components provide additional fixation options in the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot, 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)
Substantial Equivalence - Non-Clinical Evidence: Through technological comparison, the subject system does not represent a new worst-case.
Substantial Equivalence Clinical Evidence: N/A
Substantial Equivalence - Conclusions: The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K130044: SIDEKICK® EZ FRAME™ External Fixation System
Reference Device(s)
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 8, 2015
Wright Medical Technology, Incorporated Ms. Leslie Fitch Senior Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K143220
Trade/Device Name: SIDEKICK® EZ FRAME™ External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: November 6, 2014 Received: November 10, 2014
Dear Ms. Fitch:
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
1
Page 2 - Ms. Leslie Fitch
(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education 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,
Lori A. Wiggins -S
for Mark N. Melkerson Director. Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
SIDEKICK® EZ FRAME™ External Fixation System
Indications for Use (Describe) Wright's SIDEKICK® EZ FRAME™ External Fixation System is intended for:
- · Triple Arthrodesis
- · Isolated Rearfoot Arthrodesis
- · Midfoot Arthrodesis
- Comminuted Trauma
- · Diabetic Charcot Reconstruction
- · Most foot pathology not requiring fixation above the ankle
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Headquarters Wright Medical Technology, Inc.
1023 Cherry Road Memphis, TN 38117
01 867 9971 mt.com
510(K) SUMMARY
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 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the SIDEKICK® EZ FRAME™ External Fixation System.
| (a)(1). Submitted By: | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
|---|---|
| Date: | November 6, 2014 |
| Contact Person: | Leslie Fitch, PhD Senior Regulatory Affairs Specialist Office: (901) 867-4120 Fax: (901) 867-4190 |
| (a)(2). Proprietary Name: | SIDEKICK® EZ FRAME™ External Fixation System |
| Common Name: | External Fixation System |
| Classification Name and Reference: | 21 CFR 888.3030 – Class II |
| Device Product Code, Device Panel: | KTT, Orthopedic |
| (a)(3). Predicate Devices: | K130044: SIDEKICK® EZ FRAME™ External Fixation System |
(a)(4). Device Description
The SIDEKICK® EZ FRAME™ External Fixation System uses a series of pins and wires for compression or distraction in the foot and uses a boot to secure the tibia. The system is adjustable to accommodate variations in patient anatomy. The SIDEKICK® EZ FRAMETM External Fixation System is compatible with the SIDEKICK® FREEDOM External Fixation System (K043289) components, and these components provide additional fixation options in the system.
4
(a)(5). Intended Use
- · Triple arthrodesis
- Isolated rearfoot arthrodesis
- Midfoot arthrodesis
- · Comminuted trauma
- Diabetic Charcot reconstruction
- · Most foot pathology not requiring fixation above the ankle
(a)(6). Technological Characteristics Comparison
The SIDEKICK® EZ FRAMETM External Fixation System is technologically substantially equivalent to predicate devices in material and design,
(b)(1). Substantial Equivalence - Non-Clinical Evidence
Through technological comparison, the subject system does not represent a new worst-case.
- (b)(2). Substantial Equivalence Clinical Evidence N/A
(b)(3). Substantial Equivalence - Conclusions
The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.