(246 days)
Not Found
No
The summary describes a mechanical external fixator and does not mention any software, image processing, AI, or ML capabilities.
Yes.
The device is used for external fixation of fractures, mal-union, and non-union of bones in the hand to promote healing. This directly addresses medical conditions and aims to restore normal physiological function, which aligns with the definition of a therapeutic device.
No
Explanation: The device, NBX® Non-Bridging External Fixator – Hand, is used for the "fixation of open or closed fractures, mal-union, and non-union of the metacarpals and phalanges of the hand" until healing. This indicates a therapeutic or treatment function, not a diagnostic one.
No
The device description explicitly states it consists of a "body with its proprietary locking mechanism and a multiple of pins," indicating it is a physical hardware 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 it's for "definitive external fixation" of fractures and related conditions in the hand. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description mentions a "fixator" with a "body," "locking mechanism," and "pins." These are components of a mechanical device used to stabilize bone, not to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to physically stabilize bone.
N/A
Intended Use / Indications for Use
The NBX® Non-Bridging External Fixator - HAND, is used for definitive external fixation, until healing. This device is used for the fixation of open or closed fractures, mal-union, and nonunions of the metacarpals and phalanges of the hand.
Product codes (comma separated list FDA assigned to the subject device)
KTT, JEC
Device Description
The NBX® Non-Bridging Fixator - Hand is provided sterile. The fixator consists of the body with its proprietary locking mechanism and a multiple of pins.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metacarpals and phalanges of the hand
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)
Non-Clinical Performance Data of use is covered in other sections of the application and based on nonclinical data. The performance data as defined in the study titled, Comparative Testing of External Fixation Devices in the following pages includes, Pin to Frame Coupling Pin Slip Tests, Pin to Frame Coupling Bend Test, Frame - Bone Axial Load Test, Construct Cantilever Bend Test
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.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
510(k) Summary Date Prepared: 5-14-13
MAY 1 5 2013
Name of Sponsor:
NUTEK Orthopaedics, Inc. 641 SW 3rd Ave Ft. Lauderdale, FL 33315
510(k) Contact:
Peter Mincieli Chief Operating Officer Phone: (954) 818-9204 Fax: (954) 779-1900
Class II per 21 CFR 888.3030;
Appliances and accessories
NBX® Non-Bridging External Fixator - Hand
Multiple component metallic bone fixation
External Fixation Devices - Bone Fixation Fasteners
Trade Name:
Common Name:
Classification:
Device Product Code:
KTT - JEC
Substantially Equivalent Devices: K051605 Small Bone Innovations K033476 Howmedica Osteonics Equivalence to accepted methods of treatment for the products indications Non-Clinical Performance Data of use is covered in other sections of the application and based on nonclinical data. The performance data as defined in the study titled, Comparative Testing of External Fixation Devices in the following pages includes, Pin to Frame Coupling Pin Slip Tests, Pin to Frame Coupling Bend Test, Frame - Bone Axial Load Test, Construct Cantilever Bend Test The NBX® Non-Bridging Fixator - Hand is provided sterile. The fixator consists of the Device Description body with its proprietary locking mechanism and a multiple of pins. The NBX® Non-Bridging External Fixator - HAND, is used for definitive external fixation, until Indications for Use: healing. This device is used for the fixation of open or closed fractures, mal-union, and nonunions of the metacarpals and phalanges of the hand.
316 Stainless Steel, ULTEM 1000 (Polyether Imide) Material
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: May 15, 2013
NUTEK Orthopedics, Incorporated % Mr. Peter Mincieli Chief Operating Officer 301 Southwest 7th Street Ft. Lauderdale, Florida 33315
Re: K122777
Trade/Device Name: NBX® - Non-Bridging External Fixator - Hand Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, JEC Dated: April 17, 2013 Received: April 18, 2013
Dear Mr. Mincieli:
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
2
Page 2 - Mr. Peter Mincieli
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark NMelkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K122777
Device Name: NBX® Non-Bridging External Fixator - Hand
Indications for Use:
The NBX® Non-Bridging External Fixator – Hand, is used for definitive external fixation, until healing. This device is used for the fixation of open or closed fractures, mal-union, and non-union of the metacarpals and phalanges of the hand.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey Lanley Phy D. Division of Orthopedic Devices