(127 days)
Not Found
No
The document describes a mechanical external fixation device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used for external fixation of fractures and/or reconstruction of small bones, which are therapeutic interventions.
No
The device is described as an external fixation system for fractures and bone reconstruction, not for diagnosis. Its function involves providing stability and allowing for compression/distraction, which are therapeutic actions.
No
The device description clearly describes a physical external fixation system with components like tubes, pin clamps, and a frame, which are hardware.
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 (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Description: The S.E.A.L. Fracture Fusion Tube is a physical device used for external fixation of fractures and reconstruction of small bones. It is applied directly to the body to stabilize and support bone healing.
- Intended Use: The intended use clearly states its purpose is for "external fixation of fractures and/or reconstruction of small bones." This is a mechanical/surgical intervention, not a diagnostic test performed on a sample.
The information provided describes a medical device used for treatment and stabilization, not for diagnosing a condition based on laboratory analysis of biological samples.
N/A
Intended Use / Indications for Use
The S.E.A.L. Fracture Fusion Tube is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
The S.E.A.L. Fracture Fusion Tube provides a solution for fractures and for lengthening of small bones. The system allows controlled compression / distraction and early weight bearing. The articulating pin clamps allow adjustment around three axes and linear translation so that it can be used for comminuted intra-articular fractures or arthrodesis of the fixator design enables pins to be located in multi-planar arrangements, allowing the frame to be built around the fractures in the hand or foot.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones, including metacarpal and metatarsal.
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 Test Summary: Testing was performed following ASTM F1541-02 Annex 7. The results of this analysis indicate that the S.E.A.L. Fracture Fusion Tube is equivalent to predicate devices.
Clinical Test Summary: No clinical studies were performed.
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.
K093550, K052196, K951357/K970290, K052005
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
K140158
510(k) Summary for the S.E.A.L. Fracture Fusion Tube
MAY 2 9 2014
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the S.E.A.L. Fracture Fusion Tube.
1. GENERAL INFORMATION
| Date Prepared: January 15, 2014 | |
|---|---|
| Trade Name: S.E.A.L. Fracture Fusion Tube | |
| Common Name: External Fixation Frame | |
| Classification Name: Single/multiple component metallic bone fixation appliances and accessories. | |
| Class: | II |
| Product Code: | KTT |
| CFR section: 21 CFR section 888.3030 | |
| Device panel: | Orthopedic |
| Legally Marketed | SBi Mini Rail External Fixation System (Small Bone Innovations, Inc., K093550) |
| Predicate Devices: | Vilex Rail Fixation System (Vilex eX-Fix, K052196) |
| DFS ® MiniFixator (EBI (Biomet), K951357/K970290) | |
| Tomahawk Mini Fixator (Wright Medical, K052005) | |
| Submitter: | DNE, LLC |
| 2225 Park Place | |
| Slatington, PA 18080 | |
| (610)-442-1017 | |
| Contact: J.D. Webb | |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| 512-692-3699 Fax | |
| e-mail: idwebb@orthomedix.net |
2. DEVICE DESCRIPTION
The S.E.A.L. Fracture Fusion Tube provides a solution for fractures and for lengthening of small bones. The system allows controlled compression / distraction and early weight bearing. The articulating pin clamps allow adjustment around three axes and linear translation so that it can be used for comminuted intra-articular fractures or arthrodesis of the fixator design enables pins to be located in multi-planar arrangements, allowing the frame to be built around the fractures in the hand or foot.
Materials:
6061-T6 Aluminum 316L Stainless steel PTFE PEEK
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K140158
Function:
The S.E.A.L. Fracture Fusion Tube is indicated for stabilizing various fractures including open and/or comminuted fractures, fractures with length discrepancies, fusions and corrective osteotomies of the metacarpal and metatarsal bones
3. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES
The S.E.A.L. Fracture Fusion Tube is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.
4. INTENDED USE
The S.E.A.L. Fracture Fusion Tube is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.
5. NON-CLINICAL TEST SUMMARY
Testing was performed following ASTM F1541-02 Annex 7.
The results of this analysis indicate that the S.E.A.L. Fracture Fusion Tube is equivalent to predicate devices.
6. CLINICAL TEST SUMMARY
No clinical studies were performed
7. CONCLUSIONS NONCLINICAL AND CLINICAL
D.N.E considers the S.E.A.L. Fracture Fusion Tube to be equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.
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Image /page/2/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. In the center of the circle is a stylized image of an eagle. The eagle is facing to the right and has its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
May 29, 2014
DNE. LLC % J.D. Webb The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock. Texas 78681
Re: K140158
Trade/Device Name: S.E.A.L. Fracture Fusion Tube 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: April 17, 2014 Received: April 21, 2014
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 10 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. Iabeling, 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 complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I ederal 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
3
Page 2 - Mr. J.D. Webb
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
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
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
Device Name
S.E.A.L. Fracture Fusion Tube
Indications for Use (Describe)
The S.E.A.L. Fracture Fusion Tube is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.
Type of Use (Select one or both, as applicable)
.. '
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)
Casey Li Hanley, Ph. D Division of Orthopedic Devices
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