(87 days)
The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.
The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System consists of one 2 Hole Syndesmosis Buttress Plate (titanium alloy), two Knotless TightRopes (titanium alloy buttons and UHMWPE braid suture) and various ancillary instruments to aid in insertion. The proposed Arthrex Buttress Plate is a metal plate is manufactured from either titanium alloy or stainless steel. The implantable devices are packaged with various ancillary instruments to aid in insertion. The implantable devices and various ancillary instruments are provided sterile and are single use.
The provided text describes the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System, a medical device for fracture repair. It is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies typical for AI/software devices.
Therefore, many of the requested details regarding acceptance criteria for AI software, human reader studies, and large-scale ground truth establishment for training and test sets are not applicable to this type of medical device submission.
However, I can extract information related to the acceptance criteria and performance data as presented for this specific orthopedic implant system.
Acceptance Criteria and Reported Device Performance (based on provided text):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Equivalent cyclic fatigue to predicate device. | Cyclic fatigue testing demonstrated that the proposed Arthrex Syndesmosis TightRope XP Buttress Plate Implant System performs statistically equivalent to the predicate device cleared under K043248. |
| Ultimate tensile strength equivalent to predicate device. | The submitted mechanical testing data demonstrates that the ultimate tensile strength of the proposed device is substantially equivalent to that of the predicate device for the desired indications. | |
| MRI Compatibility | Safety in Magnetic Resonance (MR) Environment. | MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance and ASTM standards (F2052, F2119, F2182, F2213). The device has been evaluated for MR Conditional labeling. |
| Biocompatibility | Meets pyrogen limit specifications. | Bacterial Endotoxins Test (BET) utilizing the Kinetic Chromogenic Method (in accordance with ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP<85>, EP 2.6.14) demonstrated that the device meets pyrogen limit specifications. |
| Biocompatibility ISO 10993-1:2018. | Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation and Material Characterization testing was conducted in accordance with ISO 10993-1:2018. (Implies all sections were successfully met). | |
| Substantial Equivalence | Basic design features, intended use, materials, fundamental scientific technology, indications for use, sterility, and shelf-life are identical or minor differences do not raise different questions of safety or effectiveness compared to predicate. | The device is substantially equivalent to the predicate device (K043248) in which basic design features and intended uses are the same. Differences (preloaded inserter, buttress plate, MR conditional labeling) are considered minor and do not raise different questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each mechanical or biocompatibility test. It mentions "Cyclic fatigue testing was conducted" and "MRI force, torque, and image artifact testing were conducted," which typically implies a statistically relevant number of samples for each specific test, but the exact count is not disclosed.
- Data Provenance: The studies were conducted by the manufacturer (Arthrex Inc.) for regulatory submission to the FDA. The data provenance is internal testing performed by the company or by contract labs on their behalf. Specific country of origin for data generation (beyond "Naples, FL 34108" for the submitter) is not detailed. All studies were prospective in the sense that they were designed and executed specifically for this regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This submission is for an orthopedic implant (hardware), not an AI/software device that requires expert human interpretation of medical images. Ground truth for device performance is established through internationally recognized and standardized laboratory testing (e.g., ASTM, ISO standards) conducted by qualified engineers and scientists in a controlled environment, not by clinical expert consensus on patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. As explained above, this is not an AI/software device involving human review and adjudication of medical imaging. Performance is assessed through objective physical and chemical testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This device is an implant, not an AI software. No human reader study was conducted, nor would it be relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical implant, not an algorithm. Its performance is inherent to its physical properties and mechanical behavior, which are tested directly.
7. The type of ground truth used:
- For mechanical performance: The "ground truth" is defined by established engineering and material science principles, measured by standardized test methods (e.g., cyclic loading to failure limits, ultimate tensile strength measurements).
- For MRI compatibility: The "ground truth" is adherence to established safety thresholds for magnetic field interactions (displacement, torque, heating) and acceptable levels of image artifact as defined by reference standards (ASTM, FDA guidance).
- For biocompatibility: The "ground truth" is compliance with international biological evaluation standards (ISO 10993) and pharmacopoeial methods (USP, EP) for pyrogenicity, cytotoxicity, and other biological effects, which rely on defined thresholds and observation of biological responses.
8. The sample size for the training set:
- N/A. This is not an AI/machine learning device; therefore, there is no "training set" in the computational sense. The device design and manufacturing processes are informed by accumulated engineering knowledge and prior predicate device designs, not by a data-driven training process.
9. How the ground truth for the training set was established:
- N/A. No training set as per AI/ML terminology. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science data, and validated manufacturing processes (Quality Systems Regulation 21 CFR Part 820).
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September 3, 2020
Arthrex Inc. Rebecca R. Homan Regulatory Affairs Specialist 1370 Creekside Boulevard Naples. Florida 34108
Re: K201522
Trade/Device Name: Arthrex Syndesmosis TightRope XP Buttress Plate Implant System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HTN Dated: June 4, 2020 Received: June 8, 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
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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,
Laura C. Rose, Ph.D. 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)
Device Name
Arthrex Syndesmosis TightRope XP Buttress Plate Implant System
Indications for Use (Describe)
The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.
| 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 | September 3, 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 Syndesmosis TightRope XP Buttress Plate Implant System |
| Common Name | Button/Suture |
| Product Code | HTN |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances |
| and accessories | |
| Regulatory Class | II |
| Predicate Device | K043248: Arthrex TightRope Syndesmosis Devices |
| Purpose of | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| Submission | the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System. |
| Device Description | The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System consists of |
| one 2 Hole Syndesmosis Buttress Plate (titanium alloy), two Knotless TightRopes | |
| (titanium alloy buttons and UHMWPE braid suture) and various ancillary | |
| instruments to aid in insertion. The proposed Arthrex Buttress Plate is a metal | |
| plate is manufactured from either titanium alloy or stainless steel. The | |
| implantable devices are packaged with various ancillary instruments to aid in | |
| insertion. The implantable devices and various ancillary instruments are provided | |
| sterile and are single use. | |
| Indications for Use | The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is intended |
| as an adjunct in fracture repair involving metaphyseal and periarticular small | |
| bone fragments where screws are not indicated, and as an adjunct in external | |
| and intramedullary fixation systems involving plates and rods, with fracture | |
| braces and casting. | |
| Specifically, the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System | |
| is intended to provide fixation during the healing process following a syndesmotic | |
| trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection | |
| with Weber B and C ankle fractures. | |
| Performance Data | Cyclic fatigue testing was conducted to demonstrate that the proposed Arthrex |
| Syndesmosis TightRope XP Buttress Plate Implant System performs statistically | |
| equivalent to the predicate device cleared under K043248. | |
| 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 SyndesmosisTightRope XP Buttress Plate Implant System utilizing the Kinetic ChromogenicMethod in accordance with ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP<85>, EP 2.6.14. The testing conducted demonstrates that the ArthrexSyndesmosis TightRope XP Buttress Plate Implant System meets pyrogen limitspecifications. | |
| Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity,Subchronic/Subacute Toxicity, Implantation and Material Characterization testingwas conducted on the Arthrex Syndesmosis TightRope XP Buttress Plate ImplantSystem in accordance with ISO 10993-1:2018. | |
| TechnologicalComparison | Assessment of physical product attributes including product, design, size, andmaterials as well as the conditions of manufacture and packaging has determinedthat the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System doesnot introduce additional risks or concerns regarding sterilization and shelf-life.The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System issubstantially equivalent to the predicate devices cleared under K043248 in whichthe basic design features, intended use, materials, fundamental scientifictechnology, indications for use, sterility and shelf-life are identical.The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System contains apreloaded disposable inserter and an Arthrex Buttress Plate. The predicatedevices cleared under K043248 did not contain a preloaded disposable inserter oran Arthrex Buttress Plate.The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System has beenevaluated for MR Conditional labeling; whereas the predicate devices clearedunder K043248 were not evaluated for MR Conditional labeling.The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is a lineextension to the predicate devices, which include minor dimensionalmodifications with no change to intended use or function. Any differencesbetween the Arthrex Syndesmosis TightRope XP Buttress Plate Implant Systemand the predicate devices are considered minor and do not raise differentquestions of safety or effectiveness. |
| Conclusion | The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System issubstantially equivalent to the predicate device in which the basic design featuresand intended uses are the same. Any differences between the proposed deviceand the predicate device are considered minor and do not raise differentquestions concerning safety or effectiveness.The submitted mechanical testing data demonstrates that the ultimate tensilestrength and cyclic fatigue of the proposed device is substantially equivalent tothat of the predicate device for the desired indications.Based on the indications for use, technological characteristics, and the summaryof data submitted, Arthrex Inc. has determined that the proposed device issubstantially equivalent to the currently marketed predicate device. |
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§ 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.