(188 days)
The Arthrex Minimally Invasive Ankle Fusion Plate is intended to be used for fixation of bone fractures and fusions in the foot and ankle. The Arthrex Minimally Invasive Ankle Fusion Plate is to be used with the Arthrex Low Profile Screws.
The Arthrex Minimally Invasive Ankle Fusion Plate is a Titanium bone fixation device intended to be permanently implanted. The implant is contoured with a tapered proximal end and contoured bend on the distal end. The implant has a 3-hole design and is 1.74 inches in length. The implant is single-use and may be available in sterile and non-sterile versions.
The Arthrex Minimally Invasive Ankle Fusion Plate is a bone fixation device intended for permanent implantation to fix bone fractures and fusions in the foot and ankle, to be used with Arthrex Low Profile Screws. The device is made of Titanium, has a 3-hole design, and is 1.74 inches in length.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Study Type) | Standard/Method | Device Performance | Conclusion |
|---|---|---|---|
| Static Bending Strength | ASTM F382-17 | Statistically equivalent to predicate device (K141735) | Met |
| Fatigue Bending Strength | ASTM F382-17 | Statistically equivalent to predicate device (K141735) | Met |
| MRI Safety (Force, Torque, Image Artifact) | FDA Guidance: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment | Testing conducted for force, torque, and image artifact. Specific values not reported in this summary, but the implication is that it meets safety guidelines. | Met |
| Bacterial Endotoxins Test (BET) | ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14 | Meets pyrogen limit specifications | Met |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided document for each specific test. However, the document refers to "testing conducted" generally.
- Data Provenance: Not explicitly stated. The studies are laboratory-based performance tests evaluating the physical and biological properties of the device, rather than clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The studies conducted are mechanical and material property tests against established engineering and biological standards (ASTM F382-17, FDA Guidance for MRI Safety, ANSI/AAMI ST72, etc.), not studies relying on expert interpretation of medical data. Therefore, there is no "ground truth" in the clinical sense established by medical experts for these tests. The "ground truth" is defined by the objective performance criteria outlined in the standards.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, particularly for diagnostic devices where multiple readers might interpret data to establish a consensus ground truth. The studies performed here are objective laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance
No. An MRMC comparative effectiveness study is not discussed. This device is a bone fixation plate, not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This information is not applicable as the device is a physical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests conducted (static bending, fatigue bending, MRI safety, bacterial endotoxins) is based on established engineering and biological standards and specifications. For instance, the mechanical tests are compared against the performance of a predicate device cleared under K141735, implying that the predicate's performance against ASTM F382-17 served as the benchmark ("ground truth") for equivalence. The Bacterial Endotoxins Test has specific pyrogen limit specifications as its "ground truth."
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical implant and does not involve AI or machine learning models that require training sets.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for this device.
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October 16, 2019
Arthrex, Inc. Rebecca R. Homan Senior Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K190953
Trade/Device Name: Arthrex Minimally Invasive Ankle Fusion Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: April 5, 2019 Received: April 11, 2019
Dear Rebecca R. 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
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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 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,
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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) K190953
Device Name
Arthrex Minimally Invasive Ankle Fusion Plate
Indications for Use (Describe)
The Arthrex Minimally Invasive Ankle Fusion Plate is intended to be used for fixation of bone fractures and fusions in the foot and ankle. The Arthrex Minimally Invasive Ankle Fusion Plate is to be used with the Arthrex Low Profile Screws.
| 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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510(k) Summary
| Date Prepared | October 15, 2019 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Caroline BloemkerSenior Regulatory Affairs Associate1-239-643-5553, ext. 71639caroline.bloemker@arthrex.com |
| Name of Device | Arthrex Minimally Invasive Ankle Fusion Plate |
| Common Name | Plate, Fixation, Bone |
| Product Code | HRS, HWC |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation applianceand accessories21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | II |
| Predicate Device | K141735: Arthrex Ankle Fusion Plating SystemK040907: Arthrex Small Fragment Plates and Screws (Reference)K150456: Arthrex Plates, Screws, and Staples (Reference) |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance forthe Arthrex Minimally Invasive Ankle Fusion Plate. |
| Device Description | The Arthrex Minimally Invasive Ankle Fusion Plate is a Titanium bone fixationdevice intended to be permanently implanted. The implant is contoured with atapered proximal end and contoured bend on the distal end. The implant has a 3-hole design and is 1.74 inches in length. The implant is single-use and may beavailable in sterile and non-sterile versions. |
| Indications for Use | The Arthrex Minimally Invasive Ankle Fusion Plate is intended to be used forfixation of bone fractures and fusions in the foot and ankle. The ArthrexMinimally Invasive Ankle Fusion Plate is to be used with the Arthrex Low ProfileScrews. |
| Performance Data | Static and fatigue bending strength testing was conducted in accordance withASTM F382-17 to demonstrate that the Arthrex Minimally Invasive Ankle FusionPlate performed statistically equivalent to the predicate device cleared underK141735 Arthrex Ankle Fusion Plating System on August 15, 2014.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.Bacterial Endotoxins Test (BET) was performed on the Arthrex Minimally InvasiveAnkle Fusion Plate utilizing the Kinetic Chromogenic Method in accordance withANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14. Testing wasperformed in compliance with US FDA good manufacturing practice (GMP)regulations 21 CFR Parts 210, 211 and 820. The testing conducted demonstratesthat the Arthrex Minimally Invasive Ankle Fusion Plate meets pyrogen limitspecifications. |
| Conclusion | The Arthrex Minimally Invasive Ankle Fusion Plate is substantially equivalent tothe predicate device in which the basic design features and intended uses are thesame. Any differences between the proposed device and the predicate deviceare considered minor and do not raise different questions of safety oreffectiveness. |
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K190953
Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex Inc. has determined that the Arthrex Minimally Invasive Ankle Fusion Plate is substantially equivalent to the currently marketed predicate device.
§ 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.