(262 days)
Not Found
No
The summary describes a mechanical external fixation system with no mention of AI or ML components or functionality.
Yes.
The device is used for stabilization of bones and addresses various orthopedic conditions like fractures, non-unions, and deformities, which directly contribute to the treatment and healing of patients.
No
The Austin Miller External Fixation System is a surgical device used for the stabilization of bones, not for diagnosing medical conditions.
No
The device description explicitly states it consists of physical components like stainless steel bone pins, composite bars, and titanium clamps, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Austin Miller External Fixation System is a physical device used to stabilize bones externally. Its intended use is for the treatment of fractures and other orthopedic conditions by physically supporting and aligning bones. It does not involve the analysis of biological specimens.
The description clearly indicates it's a surgical/orthopedic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Austin Miller External Fixation System is intended to be used on adult or pediatic patients for stabilization of the long bones, feet, and pelvis. The most common indication of long bone or pelvic fractures, especially when the fractures are combined with soft tissue trauma. Additional indications include non-unions, periarticular fractures, infected fractures or non-unions, joint-bridging immobilization in severe soft-tissue and ligament injuries, arthrodeses, and osteotomies. It can be used in conjunction with internal fixation and can be used intraoperatively as a reduction tool.
Product codes (comma separated list FDA assigned to the subject device)
KTT, JDW
Device Description
The Austin Miller External Fixation System is an external fixation system that consists of various components used in the management of pelvic, feet and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application. All half pins and frame components are single use devices and are provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones, feet, and pelvis
Indicated Patient Age Range
adult or pediatric patients
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)
Testing was conducted following guidelines from ASTM F1541. Pin pullout and strength testing showed substantial equivalence to predicate designs. Grip testing of the clamps showed that the clamp designs have grip strength at least equivalent to the predicate designs. Construct testing to failure showed the frame was able to support the compressive load up to the limit of the test. All structural testing shows a system performance at least equivalent to the predicate devices.
Simulations and testing were conducted to determine the performance of the system in the Magnetic Resonance environment. Force and torque testing showed limited effect of the magnetic field on the device. Image distortion testing identified the size of the image artifact expected due to the device. Radiofrequency induced heating simulation determined the worst case device construct for heating testing. Radiofrequency induced heating testing demonstrated limited levels of heating with the device placed at the edge of the bore of the MR machine. The labeling has been written to inform the user of the proper conditions in which the device can be safely scanned.
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.
K082650, K090658, K113383, K072212
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
February 28, 2019
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Austin Miller Trauma LLC Steve Miller President 3011 Centre Oak Way Suite 102 Germantown, Tennessee 38138
Re: K181528
Trade/Device Name: Austin Miller Large 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, JDW Dated: January 31, 2019 Received: February 1, 2019
Dear Steve Miller:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination. product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Peter G.
Allen -S
Digitally signed by Peter G. Allen -S Date: 2019.02.28 23:40:02 -05'00'
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181528
Device Name Austin Miller External Fixation System
Indications for Use (Describe)
The Austin Miller External Fixation System is intended to be used on adult or pediatic patients for stabilization of the long bones, feet, and pelvis. The most common indication of long bone or pelvic fractures, especially when the fractures are combined with soft tissue trauma. Additional indications include non-unions, periarticular fractures, infected fractures or non-unions, joint-bridging immobilization in severe soft-tissue and ligament injuries, arthrodeses, and osteotomies. It can be used in conjunction with internal fixation and can be used intraoperatively as a reduction tool.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
510(k) Summary
I. SUBMITTER
Austin Miller Trauma LLC 3011 Centre Oak Way, Suite 102 Germantown, TN 38138
Phone: (901) 748-2581 Fax: (901) 748-2583
| Contact Person: | Steve Miller |
|---|---|
| Date Prepared: | January 31, 2019 |
II. DEVICE
| Proprietary Name: | Austin Miller External Fixation System |
|---|---|
| Common Name: | External Fixation System |
| Classification Name: | Single/multiple component metallic bone fixation appliances and |
| accessories (21 CFR 888.3030) and Smooth or threaded metallic | |
| bone fixation fastener (21 CFR 888.3040) | |
| Regulatory Class: | Class II |
| Product Codes: | KTT and JDW/Orthopedic/87 |
III. PREDICATE DEVICES
- . K082650, Synthes Large External Fixation, MR Conditional
- K090658, Synthes Medium External Fixation, MR Conditional ●
- K113383, XtraFix External Fixation System ●
- K072212, Smith & Nephew Jet-X Bar System Clamps, Bars and Posts MR Cond. ●
IV. DEVICE DESCRIPTION
The Austin Miller External Fixation System is an external fixation system that consists of various components used in the management of pelvic, feet and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application. All half pins and frame components are single use devices and are provided non-sterile.
V. INDICATIONS FOR USE
The Austin Miller External Fixation System is intended to be used on adult or pediatric patients for stabilization of the long bones, feet, and pelvis. The most common indication is for stabilization of long bone or pelvic fractures, especially when the fractures are combined with soft tissue trauma. Additional indications include non-unions, periarticular fractures,
4
infected fractures or non-unions, joint-bridging immobilization in severe soft-tissue and ligament injuries, arthrodeses, and osteotomies. It can be used in conjunction with internal fixation and can be used intraoperatively as a reduction tool.
VL COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The principle of operation for the subject and the predicate devices is stabilization of bones through fixation with pins clamped to an external fixation frame built with composite bars. The Austin Miller External Fixation System is similar to legally marketed predicate devices in that they are manufactured from similar materials, are of structurally similar size, strength and stiffness, and incorporate similar methods of assembly and adjustment.
VII. PERFORMANCE DATA
Testing was conducted following guidelines from ASTM F1541. Pin pullout and strength testing showed substantial equivalence to predicate designs. Grip testing of the clamps showed that the clamp designs have grip strength at least equivalent to the predicate designs. Construct testing to failure showed the frame was able to support the compressive load up to the limit of the test. All structural testing shows a system performance at least equivalent to the predicate devices.
Simulations and testing were conducted to determine the performance of the system in the Magnetic Resonance environment. Force and torque testing showed limited effect of the magnetic field on the device. Image distortion testing identified the size of the image artifact expected due to the device. Radiofrequency induced heating simulation determined the worst case device construct for heating testing. Radiofrequency induced heating testing demonstrated limited levels of heating with the device placed at the edge of the bore of the MR machine. The labeling has been written to inform the user of the proper conditions in which the device can be safely scanned.
VIII. CONCLUSIONS
The claim of substantial equivalence of the Austin Miller External Fixation System to the predicate devices is based on the comparison of the intended use, device description, and technological characteristics. Austin Miller Trauma LLC considers the External Fixation System to be as safe and as effective, with substantially equivalent performance to the predicate device.