(56 days)
No
The device description and performance studies focus on the mechanical properties and sterility of a physical suture anchor, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is an anchor intended for fixation of suture to bone in various joints, not for treating a disease or condition in a therapeutic manner.
No
Explanation: The device is described as a two-component suture anchor intended for fixation of suture to bone in various surgical procedures. Its purpose is to repair or reconstruct tissues, not to diagnose a condition.
No
The device description clearly states it is a "sterile two-component suture anchor comprised of an eyelet and a hollow anchor body," indicating it is a physical implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for fixing suture to bone in various anatomical locations. This is a direct surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a sterile, two-component suture anchor used in surgical procedures. This aligns with a surgical implant/device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
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
Product codes
MAI, HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, foot/ankle, knee, hand/wrist, elbow, and hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing demonstrated that the pull-out (tensile) strength of the proposed Arthrex SwiveLock Anchor met the criteria established by published literature for MPFL repair/reconstruction.
Bacterial endotoxin per USP , USP , FDA Guidance for Industry Pyrogen & Endotoxin Testing and EP 2.6.14 was conducted to demonstrate that the device meets pyrogen limit specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary 1.
| Date Prepared | August 21, 2020 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Jessica Singelais |
| Regulatory Affairs Specialist | |
| 1-239-598-4302, ext. 73091 | |
| Jessica.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 and |
| accessories | |
| Regulatory Class | Class II |
| Predicate Device | K192532: Arthrex SwiveLock Anchor |
| Reference Device(s) | K191226: Arthrex SwiveLock Suture Anchor |
| K190728: Arthrex SwiveLock Anchors | |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to expand indications of the |
| 3.9mm BioComposite SwiveLock suture anchor to include MPFL Repair/Reconstruction. | |
| Device Description | 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. | |
| Comparison Summary of | |
| Technological | |
| Characteristics and | |
| Modifications | |
| Proposed | The proposed and predicate devices (K192532) have the same technological |
| characteristics (device design, sterilization and biocompatibility). The proposed device | |
| modification consists of the addition of the MPFL Repair/Reconstruction indication and | |
| an extended shelf life. |
The Arthrex SwiveLock Suture Anchor is substantially equivalent to the predicate device
in which the design features and intended uses are the
same. Any differences between the proposed device and the predicate device are
considered 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 in
the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip the following procedures:
• Shoulder: Rotator Cuff Repairs, 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 and
MPFL Repair/Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral
Ligament reconstruction
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament
Reconstruction, Lateral Epicondylitis Repair (Tennis elbow)
• Hip: Capsular Repair, Acetabular labral repair |
| Performance Data | Mechanical testing demonstrated that the pull-out (tensile) strength of the proposed
Arthrex SwiveLock Anchor met the criteria established by published literature for MPFL
repair/reconstruction. |
| | Bacterial endotoxin per USP , USP , FDA Guidance for Industry Pyrogen &
Endotoxin Testing and EP 2.6.14 was conducted to demonstrate that the device meets
pyrogen limit specifications. |
| Conclusion | The Arthrex SwiveLock Anchor is substantially equivalent to the predicate device in
which the basic design features and intended uses are the same. Any differences
between the proposed device and the predicate device is considered minor and do not
raise questions concerning safety or effectiveness. |
| | Based on the indications for use, technological characteristics, and the summary of data
submitted, Arthrex Inc. has determined that the proposed device is substantially
equivalent to the currently marketed predicate devices. |
4