(28 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 skeletally mature pediatric and adult patients for the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis Capsulolabral Reconstruction, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulo labral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament/Tendon Repair, and Bunionectomy.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, and MPFL Repair/Reconstruction.
Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction, and Lateral Epicondylitis Repair.
Hip: Capsular Repair, Acetabular labral repair.
The proposed Arthrex 3.9 mm SwiveLock Anchor is a sterile two-component suture anchor comprised of an eyelet and a hollow anchor body. The Arthrex 3.9 mm SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. The Arthrex 3.9 mm SwiveLock Anchor can be used with Arthrex 510(k) cleared suture.
The provided text is a 510(k) summary for a medical device (Arthrex 3.9 mm SwiveLock Anchor). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria for an AI/algorithm-driven device through a clinical study.
Therefore, the information required to answer your specific questions about acceptance criteria, study design, ground truth establishment, expert adjudication, and MRMC studies for an AI device is not present in this document.
The performance data mentioned in the document relates to:
- Packaging validation and 5-year accelerated aging shelf-life testing: This ensures the packaging maintains product integrity and sterility.
- Bacterial Endotoxins Test (BET): This tests for pyrogens to ensure the device is safe for implantation.
These are engineering/manufacturing performance tests, not clinical performance studies typically associated with AI/algorithmic devices.
Here's why your questions cannot be answered from this text:
- AI/Algorithm-driven device: The Arthrex 3.9 mm SwiveLock Anchor is a mechanical bone fixation appliance, not an AI or algorithm-driven medical device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI performance (e.g., sensitivity, specificity, AUC) do not apply to this submission.
- Clinical Study Design: The document describes a "Special 510(k)" submission, which typically focuses on minor modifications to a previously cleared device. It relies heavily on comparisons to predicate devices and engineering bench testing rather than new, large-scale clinical trials with human subjects.
- Ground Truth: The concept of "ground truth" (expert consensus, pathology, outcomes data) is relevant for diagnostic or image-analysis AI. For a mechanical implant, "performance" is assessed through biomechanical testing, material properties, and sterility, not clinical diagnostic accuracy.
In summary, the provided document does not contain the information required to address your specific questions because the medical device it describes is a mechanical implant, not an AI or algorithm-driven device.
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March 17, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Arthrex, Inc. Stacy Valdez, M.S. Sr. Regulatory Affairs Specialist 370 Creekside Boulevard Naples, Florida 34113
Re: K230435
Trade/Device Name: Arthrex 3.9 mm 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: February 14, 2023 Received: February 17, 2023
Dear Ms. Valdez:
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 mediation-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.
Sara S. Thompson -S
For
Laurence D. Coyne. Ph.D. 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
Submission Number (if known)
Device Name
Arthrex 3.9 mm 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 skeletally mature pediatric and adult patients for the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis Capsulolabral Reconstruction, Acromio-Clavicular Separation Repair, Capsular Shift or Capsulo labral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament/Tendon Repair, and Bunionectomy
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, and MPFL Repair Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction, and Lateral Epicondvlitis repair
Hip: Capsular Repair and 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
| Date Prepared | February 14, 2023 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Stacy ValdezSenior Regulatory Affairs Specialist1-239-643-5553, ext. 72010stacy.valdez@arthrex.com |
| Name of Device | Arthrex 3.9 mm SwiveLock Anchor |
| Common Name | Suture Anchor |
| Product Code | MAI, HWC |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixationappliances and accessories (Primary)21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | II |
| Primary Predicate Device | K192532: Arthrex SwiveLock Anchor |
| Additional Predicate Device | K203495: Arthrex SwiveLock Anchor |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtainclearance for the Arthrex 3.9 mm SwiveLock Anchor |
| Device Description | The proposed Arthrex 3.9 mm SwiveLock Anchor is a sterile two-component suture anchor comprised of an eyelet and a hollow anchorbody. The Arthrex 3.9 mm SwiveLock Anchor is pre-mounted on a driverwith the anchor body and eyelet physically separated on the driver shaft.The Arthrex 3.9 mm SwiveLock Anchor can be used with Arthrex 510(k)cleared suture. |
| Indications for Use | The Arthrex SwiveLock Anchor is intended for fixation of suture (softtissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, andhip in skeletally mature pediatric and adult patients for the followingprocedures:Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis Capsulolabral Reconstruction, Acromio-Clavicular SeparationRepair, Deltoid Repair, Capsular Shift or Capsulo labral Reconstruction.Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles TendonRepair, Hallux Valgus Reconstruction, Mid-foot Reconstruction,Metatarsal Ligament/Tendon Repair, and Bunionectomy.Knee: Medial Collateral Ligament Repair, Lateral Collateral LigamentRepair, Patellar Tendon Repair, Posterior Oblique Ligament Repair,Iliotibial Band Tenodesis, and MPFL Repair/Reconstruction.Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/RadialCollateral Ligament Reconstruction.Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral LigamentReconstruction, and Lateral Epicondylitis Repair.Hip: Capsular Repair, Acetabular labral repair. |
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| Performance Data | Packaging validation and 5-year accelerated aging shelf-life testing wasperformed to demonstrate that the packaging configurations are capableof maintaining and protecting the product and sterility of the devicethroughout the shipping and handling environment. The packagingconfiguration met all the packaging testing acceptance criteria inconformance to ISO 11607 and applicable standards.Bacterial Endotoxins Test (BET) was performed on the representativesamples utilizing the Kinetic Chromogenic Method in accordance withANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14 todemonstrate that the proposed device meets pyrogen limit specifications. |
|---|---|
| Technological Comparison | The Arthrex 3.9 mm SwiveLock Anchor is substantially equivalent to thepredicate devices cleared under K192532 and K203495 in which theoverall design, intended use, indications, materials, design, sterility, shelf-life, surgical technique, and MRI safety labeling is identical.The Arthrex 3.9 mm SwiveLock Anchor will be packaged in inner PETGblister tray with Tyvek lid and outer poly/Tyvek pouch. The predicatedevices cleared under K192532 and K203495 are packaged in an innerPETG blister tray with Tyvek lid and outer foil pouch.Any differences between the Arthrex 3.9 mm SwiveLock Anchor and thepredicate devices are considered minor and do not raise differentquestions of safety or effectiveness. |
| Conclusion | The Arthrex 3.9 mm SwiveLock Anchor is substantially equivalent to thepredicate devices in which the basic design features and intended use arethe same. Any differences between the proposed Arthrex 3.9 mmSwiveLock Anchor and the predicate devices are considered minor and donot result in new or different questions of safety or effectiveness. Basedon the indications for use, technological characteristics, and the summaryof data submitted, Arthrex Inc. has determined that the proposed deviceis substantially equivalent to the currently marketed 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.