(214 days)
Not Found
No
The description focuses on mechanical components and their function in stabilizing fractures and correcting deformities, with no mention of AI or ML.
Yes
The device is indicated for stabilizing various fractures, Fusions, and corrective osteotomies, which are therapeutic interventions.
No
The device description indicates that the Arrowhead Mini-Rail Fixator is used for stabilizing fractures, lengthening bones, and correcting deformities through mechanical means (e.g., applying compression or distraction). It does not mention any function related to diagnosing medical conditions or diseases.
No
The device description clearly outlines physical components made of aluminum and stainless steel, including rails, clamps, and screws, which are hardware. The performance studies also focus on the mechanical properties of these physical components.
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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Arrowhead Mini-Rail Fixator is a physical device used to stabilize bones externally. It is applied directly to the patient's body.
- Intended Use: The intended use is to stabilize fractures, lengthen bones, and correct deformities. This is a therapeutic and structural function, not a diagnostic one based on analyzing biological samples.
The device description and intended use clearly indicate that this is a surgical/orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
The Arrowhead Mini-Rail Fixator is indicated for stabilizing various fractures including open and comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metarsal, ulnar, and calcaneal bones.
Product codes (comma separated list FDA assigned to the subject device)
KTT, JDW, HTY
Device Description
The Arrowhead Mini-Rail Fixator is a unilateral fixator that provides a stable solution for fractures, for lengthening of bones and for correcting deformities.
The Fixation Clamps are capable of controlled linear translation along the rail and of applying either compression or distraction forces. Because the Fixation Clamps can move along the rail independently of one another, a distraction force can be applied at one location along the Fixation Rail and distraction forces applied at another location along the same Fixation Rail.
The Fixation Clamps are capable of securing Fixation Screws with a diameter of 1.6mm to 3.0mm. The rail system and clamps are manufactured from aluminum and stainless steel. The fixation screws are stainless steel and available with and without hydroxyapatite coating.
The fixation screws are provided sterile while the non-implantable fixator components are provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metarsal, ulnar, and calcaneal bones (as inferred from the text due to the typo in the last mention of "metarsal", the first mention lists "metacarpal, metatarsal, ulnar, and calcaneal bones.")
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)
The Arrowhead Mini-Rail Fixator was evaluated using Finite Element Analysis (FEA) in accordance with ASTM F1541-02. The FEA testing demonstrated that The Arrowhead Mini-Rail Fixator components met performance requirements and are equivalent in strength and stiffness 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.
0
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 an emblem featuring a stylized human figure with three faces in profile, representing health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2017
Arrowhead DE, LLC Thomas Twardzik VP-Marketing and Operations 328 Poplar View Lane East, Suite 2 Collierville, Tennessee 38017
Re: K162032 Trade/Device Name: Arrowhead Mini-Rail Fixator 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, HTY Dated: January 18, 2017 Received: January 23, 2017
Dear Thomas Twardzik:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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" (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 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,
Vincent J. Devlin -S
for
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) K162032
Device Name Arrowhead Mini-Rail Fixator
Indications for Use (Describe)
The Arrowhead Mini-Rail Fixator is indicated for stabilizing various fractures including open and comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metarsal, ulnar, and calcaneal bones.
| 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)
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3
Section 1: 510(k) Summary
The following information is provided as required by 21 CFR § 807.87 for the Arrowhead Mini-Rail Fixator 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.
| Sponsor: | Arrowhead Medical Device Technologies, LLC
328 Poplar View Lane East, Suite 2
Collierville, TN 38017 | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Thomas J. Twardzik
Vice President, Marketing and Operations
Office: (901) 853-4366
Fax: (206) 222-9173
Email: Tom@ArrowheadDevices.com | |
| Date of
Submission: | July 20, 2016 | |
| Proprietary
Name: | Arrowhead Mini-Rail Fixator | |
| Common Name | External Fixator and fixations screws | |
| Regulatory Class | Class II | |
| Regulation | 21 CFR 888.3030 | Single/multiple component metallic bone fixation appliances and accessories |
| | 21 CFR 888.3040 | Smooth or threaded metallic bone fixation fastener |
| Device Product
Code and Panel | KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component - Single/multiple component metallic bone fixation appliances and accessories. |
| | HTY | Pin, Fixation, Smooth - Smooth or threaded metallic bone fixation fastener. |
| | JDW | Pin, Fixation, Threaded - Smooth or threaded metallic bone fixation fastener. |
| | Orthopedic | |
4
| Predicate
Devices | SIDEKICK Rail Fixator
Apex Kirschner Wires and Steinmann Pins
ST.A.R.90 F4 External Fixation Screws
With Hydroxyapatite | K080071
K121004
K150661 |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Device
Description | The Arrowhead Mini-Rail Fixator is a unilateral fixator that provides a
stable solution for fractures, for lengthening of bones and for correcting
deformities. | |
| | The Fixation Clamps are capable of controlled linear translation along the rail and of applying either compression or distraction forces. Because the Fixation Clamps can move along the rail independently of one another, a distraction force can be applied at one location along the Fixation Rail and distraction forces applied at another location along the same Fixation Rail.
The Fixation Clamps are capable of securing Fixation Screws with a diameter of 1.6mm to 3.0mm. The rail system and clamps are manufactured from aluminum and stainless steel. The fixation screws are stainless steel and available with and without hydroxyapatite coating.
The fixation screws are provided sterile while the non-implantable fixator components are provided non-sterile. | |
| Intended Use | The Arrowhead Mini-Rail Fixator is indicated for stabilizing various
fractures including open and comminuted fractures, infected non-unions,
fractures with length discrepancies, fusions and corrective osteotomies of
the metacarpal, metatarsal, ulnar, and calcaneal bones. | |
| Performance
Data | The Arrowhead Mini-Rail Fixator was evaluated using Finite Element
Analysis (FEA) in accordance with ASTM F1541-02. The FEA testing
demonstrated that The Arrowhead Mini-Rail Fixator components met
performance requirements and are equivalent in strength and stiffness to
the predicate device. | |
| Technological
Characteristics
and Substantial
Equivalence | The Arrowhead Mini-Rail Fixator is technologically substantially
equivalent to predicate devices in terms of intended use, material, design,
mechanical performance and safety. The design characteristics of the
subject system do not raise any new types of questions of safety or
effectiveness. From the evidence submitted in this 510(k), the subject
devices can be expected to perform at least as well as the predicate device. | |