(168 days)
No
The device description and performance studies focus on the material properties and mechanical performance of a physical implant (K-Wire). There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for "fixation of osteotomies and reconstruction of the lesser toes following correction procedure for hammertoe", which is a form of treatment, thus classifying it as therapeutic.
No
Explanation: The device is an implantable K-Wire used for fixation of osteotomies and reconstruction, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is an "implantable Nickel Titanium (Nitinol) K-Wire," which is a physical hardware component. The performance studies also focus on mechanical and biological testing of this physical implant.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of osteotomies and reconstruction of the lesser toes following correction procedure for hammertoe." This is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is described as an "implantable Nickel Titanium (Nitinol) K-Wire." Implants are placed inside the body.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens.
The information provided describes a surgical implant used directly on bone within the body, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Arthrex DynaNite K-Wire is indicated for fixation of osteotomies and reconstruction of the lesser toes following correction procedure for hammertoe.
Product codes
HTY
Device Description
The Arthrex DynaNite K-Wire is a double tipped, unthreaded implantable Nickel Titanium (Nitinol) K-Wire consisting of two regions: a longer, superelastic end and a shorter, malleable end to allow fixation of bone fragments while being able to deform the protruding end. The Arthrex DynaNite K-Wire family ranges from 0.86 mm to 2.5 mm in diameter and is 5.91 inches in length. The Arthrex DynaNite K-Wire is sold sterile and is single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lesser toes
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)
Tensile (ASTM F2516), Reverse Bend (ISO 7801), Cantilever Static and Dynamic Fatigue Bend testing was conducted to demonstrate that the proposed Arthrex DynaNite K-Wire performs statistically equivalent to the predicate device cleared under K052736. Single Bend and Recovery, Transformation Temperature (ASTM F2082), and Cyclic Potentiodynamic Polarization Corrosion (ASTM F2129) testing was also conducted.
MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, ASTM F2182 Standard Test Method for Measurement of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging and ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
Bacterial Endotoxins Test (BET) was performed on the Arthrex DynaNite K-Wire utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14. The testing conducted demonstrates that the Arthrex DynaNite K-Wire meets pyrogen limit Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation and Material Characterization testing was conducted on the Arthrex DynaNite K-Wire in accordance with ISO 10993-1:2018.
Assessment of physical product attributes including product, design, size, and materials as well as the conditions of manufacture and packaging has determined that the Arthrex DynaNite K-Wire does not introduce additional risks or concerns regarding sterilization and shelf-life.
The submitted mechanical testing data demonstrates that the tensile and fatigue strength of the proposed device is substantially equivalent to that of the predicate device for the desired indications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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June 29, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Arthrex Inc. Ms. Rebecca Homan Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K200068
Trade/Device Name: Arthrex DynaNite K-Wire Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: May 22, 2020 Received: May 26, 2020
Dear Ms. Homan:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Colin O'Neill, M.B.E. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200068
Device Name Arthrex DynaNite K-Wire
Indications for Use (Describe)
The Arthrex DynaNite K-Wire is indicated for fixation of osteotomies and reconstruction of the lesser toes following correction procedure for hammertoe.
| 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)
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| Date Prepared | May 22, 2020 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Rebecca R. Homan |
| Regulatory Affairs Specialist | |
| 1-239-643-5553, ext. 73429 | |
| rebecca.homan@arthrex.com | |
| Name of Device | Arthrex DynaNite K-Wire |
| Common Name | Single/multiple component metallic bone fixation appliances and accessories |
| Product Code | HTY |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | II |
| Predicate Device | K132895: WMT Implantable K-Wires |
| Reference Devices | K052736: Arthrex K-Wire |
| K172052: Arthrex DynaNite Nitinol Staple | |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex DynaNite K-Wire. | |
| Device Description | The Arthrex DynaNite K-Wire is a double tipped, unthreaded implantable Nickel |
| Titanium (Nitinol) K-Wire consisting of two regions: a longer, superelastic end | |
| and a shorter, malleable end to allow fixation of bone fragments while being able | |
| to deform the protruding end. The Arthrex DynaNite K-Wire family ranges from | |
| 0.86 mm to 2.5 mm in diameter and is 5.91 inches in length. The Arthrex | |
| DynaNite K-Wire is sold sterile and is single-use. | |
| Indications for Use | The Arthrex DynaNite K-Wire is indicated for fixation of osteotomies and |
| reconstruction of the lesser toes following correction procedure for hammertoe. | |
| Performance Data | Tensile (ASTM F2516), Reverse Bend (ISO 7801), Cantilever Static and Dynamic |
| Fatigue Bend testing was conducted to demonstrate that the proposed Arthrex | |
| DynaNite K-Wire performs statistically equivalent to the predicate device cleared | |
| under K052736. Single Bend and Recovery, Transformation Temperature (ASTM | |
| F2082), and Cyclic Potentiodynamic Polarization Corrosion (ASTM F2129) testing | |
| was also conducted. |
MRI force, torque, and image artifact testing were conducted in accordance with
FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic
Resonance (MR) Environment, ASTM F2052 Standard Test Method for
Measurement of Magnetically Induced Displacement Force on Medical Devices in
the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for
Evaluation of MR Image Artifacts from Passive Implants, ASTM F2182 Standard
Test Method for Measurement of Measurement of Radio Frequency Induced
Heating Near Passive Implants During Magnetic Resonance Imaging and ASTM
F2213 Standard Test Method for Measurement of Magnetically Induced Torque
on Medical Devices in the Magnetic Resonance Environment.
Bacterial Endotoxins Test (BET) was performed on the Arthrex DynaNite K-Wire
utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI
ST72:2011/(R)2016, USP , USP , EP 2.6.14. The testing conducted
demonstrates that the Arthrex DynaNite K-Wire meets pyrogen limit |
| | Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation and Material Characterization testing was conducted on the Arthrex DynaNite K-Wire in accordance with ISO 10993-1:2018. |
| | Assessment of physical product attributes including product, design, size, and materials as well as the conditions of manufacture and packaging has determined that the Arthrex DynaNite K-Wire does not introduce additional risks or concerns regarding sterilization and shelf-life. |
| Conclusion | The Arthrex DynaNite K-Wire is substantially equivalent to the predicate device in which the basic design features and intended uses are the same. Any differences between the proposed device and the predicate device are considered minor and do not raise different questions concerning safety or effectiveness. |
| | The submitted mechanical testing data demonstrates that the tensile and fatigue strength of the proposed device is substantially equivalent to that of the predicate device for the desired indications. |
| | Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex Inc. has determined that the proposed device is substantially equivalent to the currently marketed predicate device. |
510(k) Summary or 510(k) Statement
4