(250 days)
Not Found
No
The summary describes a mechanical external fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for fracture fixation, limb lengthening, and correction of deformities, which are all therapeutic interventions aimed at treating a medical condition or injury.
No
The device is described as an external fixator system used for fracture fixation, limb lengthening, and correction of deformities, which are therapeutic interventions, not diagnostic ones.
No
The device description clearly outlines physical components like bone anchorage elements, bridge elements, connection elements, an Angular Correction Clamp, and Struts, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of the D.N.E. Ring Fixator clearly indicate it is a surgical device used for the mechanical fixation and manipulation of bones. It is applied externally to the body and does not involve testing samples taken from the body.
The device is an external fixation system used in orthopedic surgery.
N/A
Intended Use / Indications for Use
The D.N.E. Ring Fixator and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonumions of long bones, limb lengthening by epiphyseal or metaphyseal distraction or bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The D.N.E. Ring Fixator is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
The D.N.E. External Fixation System assembly consists of three basic types of elements: 1) bone anchorage elements, 2) bridge elements, and 3) connection elements. The design allows freedom of pin placement, ease of assembly and stable fixation of bone fragments with the possibility of axial loading of the extremity and immediate range of motion of all adjacent joints.
An Angular Correction Clamp and associated Struts have been added to the system in order to facilitate a surgeons ability to step down in ring sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
all long bones including: tibia, fibula, femur, humerus, radius and 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)
Static and Dynamic Axial Compression testing was performed per ASTM F1541 and showed the subject device to be substantially equivalent to the predicate device.
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.
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Image /page/0/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 three human profiles facing right, stacked on top of each other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 16, 2016
DNE, LLC % Christine Scifert Official Correspondent Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, Tennessee 38133
Re: K151580
Trade/Device Name: D.N.E. 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: January 20, 2016 Received: January 21, 2016
Dear Ms. Scifert:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 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. 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,
Mark N. Melkerson -S
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
D.N.E. External Fixation System
Indications for Use (Describe)
The D.N.E. Ring Fixator and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonumions of long bones, limb lengthening by epiphyseal or metaphyseal distraction or bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The D.N.E. Ring Fixator is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Special 510(k) Summary
D.N.E. External Fixation System February 3, 2016
- D.N.E., LLC Company: 2225 Park Place Drive Slatington, Pa. 18080 Christine Scifert Primary Contact: 3416 Roxee Run Cove Bartlett, TN 38133 scifert@memphisregulatory.com Trade Name: D.N.E. External Fixation System Common Name: External Fixation Frame Classification: Class II Regulation Number: 21 CFR 888.3030 Panel: Orthopedic Product Code: KTT Primary Predicate: K113106 - D.N.E. External Fixation System
Device Description:
The D.N.E. External Fixation System assembly consists of three basic types of elements: 1) bone anchorage elements, 2) bridge elements, and 3) connection elements. The design allows freedom of pin placement, ease of assembly and stable fixation of bone fragments with the possibility of axial loading of the extremity and immediate range of motion of all adjacent joints.
An Angular Correction Clamp and associated Struts have been added to the system in order to facilitate a surgeons ability to step down in ring sizes.
Indications for Use:
The D.N.E. External Fixation System and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or
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metaphyseal distraction, correction or bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The D.N.E. External Fixation System is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.
Substantial Equivalence:
The D.N.E. External Fixation Angular Correction Clamp and associated Struts are substantially equivalent to the predicate plates, nuts, washers and rods previously cleared in K113106 in terms of intended use, mechanical safety and performances. The clamp and thicker struts add stability and strength to the system when compared with the existing components. Static and Dynamic Axial Compression testing was performed per ASTM F1541 and showed the subject device to be substantially equivalent to the predicate device.