(168 days)
The Arthrex DynaNite K-Wire is indicated for fixation of osteotomies and reconstruction of the lesser toes following correction procedure for hammertoe.
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.
This document, K200068, is a 510(k) premarket notification for the Arthrex DynaNite K-Wire. It's important to understand that a 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than providing the detailed clinical trial data and acceptance criteria typically associated with de novo classifications or PMA applications for novel devices or high-risk devices.
Therefore, the document describes engineering and biocompatibility testing to demonstrate performance and safety, not an AI model that requires a "study that proves the device meets acceptance criteria" in terms of performance metrics like sensitivity, specificity, or human reader improvement.
Based on the provided text, here's what can be extracted and how it differs from a typical AI/software as a medical device (SaMD) study:
1. Table of Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" here are based on meeting performance requirements comparable to the predicate device and established standards for metallic bone fixation fasteners, and ensuring biocompatibility.
| Acceptance Criteria (Type of Test) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance | |
| Tensile (ASTM F2516) | Proposed Arthrex DynaNite K-Wire performs statistically equivalent to the predicate device (K052736). |
| Reverse Bend (ISO 7801) | Proposed Arthrex DynaNite K-Wire performs statistically equivalent to the predicate device (K052736). |
| Cantilever Static Fatigue Bend | Proposed Arthrex DynaNite K-Wire performs statistically equivalent to the predicate device (K052736). |
| Dynamic Fatigue Bend | Proposed Arthrex DynaNite K-Wire performs statistically equivalent to the predicate device (K052736). |
| Single Bend and Recovery | Testing was conducted. (Specific performance not detailed, but implied to be acceptable based on overall conclusion.) |
| Transformation Temperature (ASTM F2082) | Testing was conducted. (Specific performance not detailed, but implied to be acceptable based on overall conclusion.) |
| Biocompatibility | |
| Cyclic Potentiodynamic Polarization Corrosion (ASTM F2129) | Testing was conducted. (Specific performance not detailed, but implied to be acceptable based on overall conclusion.) |
| Bacterial Endotoxins Test (BET) (ANSI/AAMI ST72:2016, USP <161>, USP <85>, EP 2.6.14) | Meets pyrogen limit. |
| Cytotoxicity (ISO 10993-1:2018) | Testing was conducted, and the overall assessment states the device does not introduce additional risks. |
| Sensitization (ISO 10993-1:2018) | Testing was conducted, and the overall assessment states the device does not introduce additional risks. |
| Irritation (ISO 10993-1:2018) | Testing was conducted, and the overall assessment states the device does not introduce additional risks. |
| Genotoxicity (ISO 10993-1:2018) | Testing was conducted, and the overall assessment states the device does not introduce additional risks. |
| Systemic Toxicity (ISO 10993-1:2018) | Testing was conducted, and the overall assessment states the device does not introduce additional risks. |
| Subchronic/Subacute Toxicity (ISO 10993-1:2018) | Testing was conducted, and the overall assessment states the device does not introduce additional risks. |
| Implantation (ISO 10993-1:2018) | Testing was conducted, and the overall assessment states the device does not introduce additional risks. |
| Material Characterization (ISO 10993-1:2018) | Testing was conducted, and the overall assessment states the device does not introduce additional risks. |
| MRI Safety | |
| MRI force (ASTM F2052) | Testing conducted in accordance with FDA guidance. (Implied safe, specific values not given.) |
| MRI torque (ASTM F2213) | Testing conducted in accordance with FDA guidance. (Implied safe, specific values not given.) |
| Image artifact (ASTM F2119) | Testing conducted in accordance with FDA guidance. (Implied acceptable artifact profile, specific values not given.) |
| Radio Frequency Induced Heating (ASTM F2182) | Testing conducted in accordance with FDA guidance. (Implied acceptable heating, specific values not given.) |
2. Sample Size Used for the Test Set and Data Provenance:
- For the mechanical tests related to performance (tensile, bend, fatigue), the sample sizes are not explicitly stated but would be the number of test articles (K-wires) subjected to each specific test. These are in-vitro (lab-based) tests, not human data.
- For biocompatibility tests, sample sizes are implied to be sufficient for the specific biological tests (e.g., cell cultures for cytotoxicity, animal models for implantation/systemic toxicity, or specific chemical analyses). These are also in-vitro or in-vivo (animal model) tests, not human data.
- Data Provenance: The data comes from the manufacturer's internal testing as part of their design verification and validation process, conducted according to recognized ASTM and ISO standards. It is prospective in the sense that the tests were specifically performed for this submission, using newly manufactured devices. It is not patient data from a specific country.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This section is not applicable to this type of device and submission. "Ground truth" in the context of an AI/SaMD diagnostic device typically refers to clinical diagnosis or pathology verified by multiple expert readers. For a medical device like a K-wire, "ground truth" is established by adherence to engineering standards, material science principles, and biocompatibility guidelines. The "experts" are the engineers, material scientists, and toxicologists who conducted and interpreted these tests.
4. Adjudication Method for the Test Set:
This is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical trial data involving image interpretation or clinical outcomes where there might be inter-reader variability. For engineering and biocompatibility testing, success or failure is determined by whether the device meets predefined pass/fail criteria for each test according to the relevant standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This is not applicable. MRMC studies are used to evaluate the impact of an AI algorithm on human reader performance for diagnostic tasks. The Arthrex DynaNite K-Wire is a physical implantable device, not a diagnostic AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
This is not applicable. This concept applies to AI algorithms. The K-wire's "performance" is its physical and biological properties.
7. Type of Ground Truth Used:
As explained above, the "ground truth" is defined by:
- Engineering standards: ASTM and ISO specifications for mechanical properties (e.g., required tensile strength, fatigue life).
- Biocompatibility standards: ISO 10993 series and USP for biological safety (e.g., acceptable cytotoxicity limits, pyrogen limits).
- Predicate device performance: The performance of the predicate device (K132895: WMT Implantable K-Wires) serves as a benchmark for demonstrating substantial equivalence for mechanical properties.
8. Sample Size for the Training Set:
This is not applicable. "Training set" refers to data used to train machine learning models. This device does not involve machine learning.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable.
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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
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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 BoulevardNaples, FL 34108-1945 |
| Contact Person | Rebecca R. HomanRegulatory Affairs Specialist1-239-643-5553, ext. 73429rebecca.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-WireK172052: Arthrex DynaNite Nitinol Staple |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance forthe Arthrex DynaNite K-Wire. |
| Device Description | The Arthrex DynaNite K-Wire is a double tipped, unthreaded implantable NickelTitanium (Nitinol) K-Wire consisting of two regions: a longer, superelastic endand a shorter, malleable end to allow fixation of bone fragments while being ableto deform the protruding end. The Arthrex DynaNite K-Wire family ranges from0.86 mm to 2.5 mm in diameter and is 5.91 inches in length. The ArthrexDynaNite K-Wire is sold sterile and is single-use. |
| Indications for Use | The Arthrex DynaNite K-Wire is indicated for fixation of osteotomies andreconstruction of the lesser toes following correction procedure for hammertoe. |
| Performance Data | Tensile (ASTM F2516), Reverse Bend (ISO 7801), Cantilever Static and DynamicFatigue Bend testing was conducted to demonstrate that the proposed ArthrexDynaNite K-Wire performs statistically equivalent to the predicate device clearedunder K052736. Single Bend and Recovery, Transformation Temperature (ASTMF2082), and Cyclic Potentiodynamic Polarization Corrosion (ASTM F2129) testingwas also conducted.MRI force, torque, and image artifact testing were conducted in accordance withFDA guidance Testing and Labeling Medical Devices for Safety in the MagneticResonance (MR) Environment, ASTM F2052 Standard Test Method forMeasurement of Magnetically Induced Displacement Force on Medical Devices inthe Magnetic Resonance Environment, ASTM F2119 Standard Test Method forEvaluation of MR Image Artifacts from Passive Implants, ASTM F2182 StandardTest Method for Measurement of Measurement of Radio Frequency InducedHeating Near Passive Implants During Magnetic Resonance Imaging and ASTMF2213 Standard Test Method for Measurement of Magnetically Induced Torqueon Medical Devices in the Magnetic Resonance Environment.Bacterial Endotoxins Test (BET) was performed on the Arthrex DynaNite K-Wireutilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMIST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14. The testing conducteddemonstrates 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
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§ 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.