(76 days)
The DNE External Fixation System and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal distraction, correction of bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The DNE External Fixation System is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.
The DNE 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. Bone anchorage elements include pins and wires. Bridge elements include rings or arches and extensions. Connection elements include struts, nuts and bolts, wire fixation bolts and pin clamps.
The DNE External Fixation System is a medical device, and the provided text is a 510(k) summary for its clearance. It is crucial to understand that 510(k) clearance is not an approval based on meeting specific performance acceptance criteria from a study demonstrating efficacy. Instead, a 510(k) demonstrates substantial equivalence to a legally marketed predicate device. This means the new device is as safe and effective as a device already on the market, not that it independently proves performance against predefined benchmarks through clinical studies.
Therefore, many of the questions regarding acceptance criteria and performance data for this device, in the typical sense of a clinical study proving efficacy, are not applicable based on the provided document.
Here's a breakdown of the information as it relates to the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: No specific numerical acceptance criteria (e.g., a certain percentage of efficacy or a specific mechanical strength threshold) are provided in the 510(k) summary for the DNE External Fixation System. The "acceptance criteria" for a 510(k) submission are generally that the device demonstrates substantial equivalence to a predicate device.
- Reported Device Performance: The document states that "No testing was performed." and "No clinical studies were performed." The "performance" claimed is therefore based on its similarity to the predicate device, the R&R External Fixator System (K052005). The conclusion is that "The DNE External Fixation System is substantially equivalent to the predicate device in terms of indications for use, design, material, performance and function."
| Acceptance Criteria (from a traditional study) | Reported Device Performance (from a traditional study) |
|---|---|
| Not applicable; no specific criteria defined for this 510(k) submission. | No performance data from studies were reported. |
| Substantial equivalence to predicate device. | Claimed to be substantially equivalent to the R&R External Fixator System. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. No test set was used as no testing was performed.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. No ground truth was established for a test set as no testing was performed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication was performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an external fixation system, not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an external fixation system, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth was established as no testing was performed.
8. The sample size for the training set
- Not applicable. This device is an external fixation system; it does not involve machine learning or a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this type of device.
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510(k) Summary for the DNE External Fixation System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is subm the DNE External Fixation System
1. GENERAL INFORMATION
Date Prepared: October 7, 2011
Trade Name: DNE External Fixation System
Common Name: External fixation frame
Classification Name: Single/multiple component metallic bone fixation appliances and accessories.
Class: Class II per 21 CFR section 888.3030
Product Code: KTT
CFR section: 21 CFR section 888.
Device panel: Orthopedic
Legally Marketed
Predicate Device: R&R External Fixator System (K052005)
Submitter: DNE, LLC
2225 Park Place Drive Slatington, Pa. 18080 TEL. (610)-442-101
Contact: J.D. Webb
1001 Oakwood Blvd Round Rock, TX 78681 TEL. (512)-388-0199
e-mail: jdwebb@orthomedix.net
2. DEVICE DESCRIPTION
The DNE 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.
Bone anchorage elements include pins and wires. Bridge elements include rings or arches and extensions. Connection elements include struts, nuts and bolts, wire fixation bolts and pin clamps.
Materials:
Aluminum, Ti6Al4V alloy, stainless steel
3. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES
The DNE External Fixation System is substantially equivalent to the predicate device in terms of intended use, design, materials used, mechanical safety and performances.
4. INTENDED USE
The DNE External Fixation System and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal distraction, correction of bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The DNE External Fixation System is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.
ട്. NON-CLINICAL TEST SUMMARY No testing was performed.
No testing was performed.
6. CLINICAL TEST SUMMARY
No clinical studies were performed
7. CONCLUSIONS NONCLINICAL AND CLINICAL
The DNE External Fixation System is substantially equivalent to the predicate device in terms of indications for use, design, material, performance and function.
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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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DNE, LLC % Mr. J.D. Webb 1001 Oakwood Blvd Round Rock. TX 78681
JAN - 4 2012
Re: K113106 Trade/Device Name: DNE External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances & Accessories Regulatory Class: II Product Code: KTT Dated: October 17, 2011 Received: October 20, 2011
Dear Mr. Webb:
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
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Page 2 – Mr. J.D. Webb
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 (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 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/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 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 vours.
Eunel Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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11 11 3106 510(k) Number (if known): _
Device Name: DNE External Fixation System
Indications for Use:
The DNE External Fixation System and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal distraction, correction of bony or soft tissue deformities, and correction of segmental bony or soft tissue defects. The DNE External Fixation System is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
RBB
Bink
for
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number KII
§ 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.