(33 days)
The Arthrex SwiveLock Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
· Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair, Tendon Repair, Bunionectomy
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
- · Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
- · Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondy.itis Repair
· Hip: Capsular Repair, Acetabular labral repair
The Arthrex SwiveLock Anchor is a sterile two-component suture anchor comprised of an eyelet and a hollow anchor body. The Arthrex SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. Arthrex 510(k) cleared suture may also be provided with the device.
This document describes the FDA clearance for the Arthrex SwiveLock Anchor. As such, the information provided focuses on the regulatory review process and the basis for substantial equivalence to predicate devices, rather than a clinical study evaluating the performance of a medical device against specific acceptance criteria.
Therefore, the specific information requested in your prompt regarding acceptance criteria and a study to prove the device meets these criteria (including sample sizes, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance, training sets, etc.) is not present in the provided text.
The document primarily states:
- Performance Data: "Mechanical testing demonstrated that the pull-out (tensile) strength of the proposed Arthrex SwiveLock Anchor met the criteria established by the predicate device and that the anchor was successfully inserted into the bone substitute. Geometric analysis and Load vs Degradation Time comparison was conducted to demonstrate that the expected degradation and pull out strength of the proposed anchor is not a new worst case over the predicate and referenced predicate devices. Bacterial endotoxin per USP <161>, USP <85>, FDA Guidance for Industry Pyrogen & Endotoxin Testing and EP 2.6.14 was conducted to demonstrate that the device meets pyrogen limit specifications."
This indicates that mechanical and biocompatibility tests were performed, and the results were compared against established criteria or predicate device performance. However, it does not provide the quantitative acceptance criteria, the specific methodology of these tests (e.g., number of samples tested, blinding, etc.), or details of a study meeting the criteria you've outlined for clinical performance or an AI/human-in-the-loop system.
In summary, the provided text from the FDA 510(k) clearance letter and summary does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria in the context of an AI-driven or diagnostic device. This document pertains to a mechanical surgical implant, and the assessment for such a device is typically based on mechanical properties, biocompatibility, and substantial equivalence to existing devices, rather than the types of performance metrics and study designs common for AI/human reader studies.
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Arthrex Inc. Ivette Galmez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K192532
Trade/Device Name: Arthrex SwiveLock Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, HWC Dated: September 12, 2019 Received: September 16, 2019
Dear Ms. Galmez:
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,
Laurence D. Coyne, Ph.D. Acting 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 SwiveLock Anchor
Indications for Use (Describe)
The Arthrex SwiveLock Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
· Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair, Tendon Repair, Bunionectomy
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
- · Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
- · Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondy.itis Repair
· Hip: Capsular Repair, Acetabular labral repair
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 1.
| Date Prepared | October 8, 2019 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Ivette GalmezSenior Regulatory Affairs Specialist1-239-643-5553, ext. 71263ivette.galmez@arthrex.com |
| Name of Device | Arthrex SwiveLock Anchor |
| Common Name | Suture Anchor |
| Product Code | MAI, HWC |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances andaccessories21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | Class II |
| Predicate Device | K101823: Arthrex SwiveLock Anchors |
| Reference Device | K173788: Arthrex Corkscrew FTK180594: Knotless SutureTak AnchorsK082810: BioComposite Suture Anchors (Hip)K101679: Arthrex PushLock |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain clearance for the3.9mm BioComposite SwiveLock suture anchor made of the same materials as thepredicate. |
| Device Description | The Arthrex SwiveLock Anchor is a sterile two-component suture anchor comprised ofan eyelet and a hollow anchor body. The Arthrex SwiveLock Anchor is pre-mounted ona driver with the anchor body and eyelet physically separated on the driver shaft.Arthrex 510(k) cleared suture may also be provided with the device. |
| Indications for Use | The Arthrex SwiveLock Anchor is intended for fixation of suture (soft tissue) to bone inthe shoulder, foot/ankle, knee, hand/wrist, elbow, and hip the following procedures:• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift orCapsulolabral Reconstruction• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, HalluxValgus Reconstruction, Mid-foot Reconstruction, Metatarsal LigamentRepair/Tendon Repair, Bunionectomy• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, PatellarTendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial CollateralLigament reconstruction.• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral LigamentReconstruction, Lateral Epicondylitis Repair (Tennis elbow)• Hip: Capsular Repair, Acetabular labral repair |
| Performance Data | Mechanical testing demonstrated that the pull-out (tensile) strength of the proposedArthrex SwiveLock Anchor met the criteria established by the predicate device and thatthe anchor was successfully inserted into the bone substitute. Geometric analysis andLoad vs Degradation Time comparison was conducted to demonstrate that theexpected degradation and pull out strength of the proposed anchor is not a new worstcase over the predicate and referenced predicate devices.Bacterial endotoxin per USP <161>, USP <85>, FDA Guidance for Industry Pyrogen &Endotoxin Testing and EP 2.6.14 was conducted to demonstrate that the device meetspyrogen limit specifications. |
| Conclusion | The Arthrex SwiveLock Anchor is substantially equivalent to the predicate device inwhich the basic design features and intended uses are the same. Any differencesbetween the proposed device and the predicate device is considered minor and do notraise questions concerning safety or effectiveness. |
| Based on the indications for use, technological characteristics, and the summary of datasubmitted, Arthrex Inc. has determined that the proposed device is substantiallyequivalent to the currently marketed predicate devices. |
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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.