(56 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, 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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis and MPFL Repair/Reconstruction
- · Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
· Elbow: Biceps Tendon Reattachment, Unar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair (Tennis Elbow)
· 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.
The provided text describes a 510(k) premarket notification for the Arthrex SwiveLock Anchor. It aims to expand the indications for use of the 3.9mm BioComposite SwiveLock suture anchor to include MPFL Repair/Reconstruction. The submission focuses on demonstrating substantial equivalence to a predicate device (K192532).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing: Pull-out (tensile) strength of the proposed Arthrex SwiveLock Anchor for MPFL repair/reconstruction should meet criteria established by published literature. | Met the criteria established by published literature for MPFL repair/reconstruction. |
| Bacterial Endotoxin Testing: Device must meet pyrogen limit specifications as per USP <161>, USP <85>, FDA Guidance for Industry Pyrogen & Endotoxin Testing, and EP 2.6.14. | Met pyrogen limit specifications. |
| Substantial Equivalence: The device should have the same technological characteristics (device design, sterilization, biocompatibility) and substantially equivalent intended uses as the predicate device (K192532). Differences should be minor and not raise questions concerning safety or effectiveness. (This is a regulatory rather than a performance criterion, but it's central to the submission.) | The proposed and predicate devices have the same technological characteristics. Differences are minor and do not raise questions concerning safety or effectiveness. |
No clinical studies involving human readers or AI performance are mentioned in this document. This 510(k) pertains to a physical medical device and its mechanical/biocompatibility performance, not a software device that interprets images or data. Therefore, many of the requested sections below are not applicable.
2. Sample size used for the test set and the data provenance
- Mechanical Testing: The document does not specify the sample size for the mechanical testing (pull-out strength).
- Bacterial Endotoxin Testing: The document does not specify the sample size for the bacterial endotoxin testing.
- Data Provenance: Not applicable as this is laboratory testing of a device, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for mechanical and endotoxin testing is established by standard laboratory methods and specifications, not by expert consensus on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for expert consensus on clinical data, not for laboratory 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
No MRMC comparative effectiveness study was done or is referenced in this document. This filing is for a physical medical device (suture anchor), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Mechanical Testing: Ground truth is defined by established "published literature" regarding the required pull-out strength for MPFL repair/reconstruction.
- Bacterial Endotoxin Testing: Ground truth is defined by established regulatory and quality standards (USP <161>, USP <85>, FDA Guidance, EP 2.6.14) for pyrogen limits.
8. The sample size for the training set
Not applicable. This is a physical device and does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. This is a physical device and does not involve a "training set" or "ground truth" establishment in the context of machine learning.
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August 21, 2020
Arthrex Inc. Jessica Singelais Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108
Re: K201749
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: June 24, 2020 Received: June 26, 2020
Dear Ms. Singelais:
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,
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 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, 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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis and MPFL Repair/Reconstruction
- · Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
· Elbow: Biceps Tendon Reattachment, Unar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair (Tennis Elbow)
· 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 | August 21, 2020 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Jessica SingelaisRegulatory Affairs Specialist1-239-598-4302, ext. 73091Jessica.singelais@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 andaccessories |
| Regulatory Class | Class II |
| Predicate Device | K192532: Arthrex SwiveLock Anchor |
| Reference Device(s) | K191226: Arthrex SwiveLock Suture AnchorK190728: Arthrex SwiveLock Anchors |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to expand indications of the3.9mm BioComposite SwiveLock suture anchor to include MPFL Repair/Reconstruction. |
| 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. |
| Comparison Summary ofTechnologicalCharacteristics andModificationsProposed | The proposed and predicate devices (K192532) have the same technologicalcharacteristics (device design, sterilization and biocompatibility). The proposed devicemodification consists of the addition of the MPFL Repair/Reconstruction indication andan extended shelf life.The Arthrex SwiveLock Suture Anchor is substantially equivalent to the predicate devicein which the design features and intended uses are thesame. Any differences between the proposed device and the predicate device areconsidered minor and do not raise questions concerning safety or effectiveness. |
| 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 andMPFL Repair/Reconstruction• 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 published literature for MPFLrepair/reconstruction. |
| 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.