(28 days)
Not Found
No
The summary describes a mechanical suture anchor and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
This device is intended for fixation of suture to bone in various anatomical locations for the purpose of repairing damaged tissues, which falls under the definition of a therapeutic intervention.
No
The device description and intended use indicate it is an orthopedic implant for fixing soft tissue to bone, not a tool for diagnosing medical conditions.
No
The device description clearly states it is a "sterile two-component suture anchor comprised of an eyelet and a hollow anchor body," which are physical hardware components. The summary also details packaging and sterilization testing, further indicating a physical device.
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 implant for fixing soft tissue to bone in various anatomical locations. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a physical implant (suture anchor) and its components, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on packaging, sterility, and shelf-life, which are relevant to a surgical implant, not an IVD.
IVD devices are used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. 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 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 Epicondylitis repair
Hip: Capsular Repair and Acetabular labral repair
Product codes (comma separated list FDA assigned to the subject device)
MAI, HWC
Device Description
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.
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
Skeletally mature pediatric and adult patients
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)
Packaging validation and 5-year accelerated aging shelf-life testing was performed to demonstrate that the packaging configurations are capable of maintaining and protecting the product and sterility of the device throughout the shipping and handling environment. The packaging configuration met all the packaging testing acceptance criteria in conformance to ISO 11607 and applicable standards.
Bacterial Endotoxins Test (BET) was performed on the representative samples utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14 to demonstrate that the proposed device meets pyrogen limit specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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
2
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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3
510(k) Summary
| Date Prepared | February 14, 2023 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Stacy Valdez |
| Senior Regulatory Affairs Specialist | |
| 1-239-643-5553, ext. 72010 | |
| stacy.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 fixation |
| appliances 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 obtain |
| clearance 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 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. | |
| 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 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. |
4
| Performance Data | Packaging validation and 5-year accelerated aging shelf-life testing was
performed to demonstrate that the packaging configurations are capable
of maintaining and protecting the product and sterility of the device
throughout the shipping and handling environment. The packaging
configuration met all the packaging testing acceptance criteria in
conformance to ISO 11607 and applicable standards.
Bacterial Endotoxins Test (BET) was performed on the representative
samples utilizing the Kinetic Chromogenic Method in accordance with
ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14 to
demonstrate that the proposed device meets pyrogen limit specifications. |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Comparison | The Arthrex 3.9 mm SwiveLock Anchor is substantially equivalent to the
predicate devices cleared under K192532 and K203495 in which the
overall 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 PETG
blister tray with Tyvek lid and outer poly/Tyvek pouch. The predicate
devices cleared under K192532 and K203495 are packaged in an inner
PETG blister tray with Tyvek lid and outer foil pouch.
Any differences between the Arthrex 3.9 mm SwiveLock Anchor and the
predicate devices are considered minor and do not raise different
questions of safety or effectiveness. |
| Conclusion | The Arthrex 3.9 mm SwiveLock Anchor is substantially equivalent to the
predicate devices in which the basic design features and intended use are
the same. Any differences between the proposed Arthrex 3.9 mm
SwiveLock Anchor and the predicate devices are considered minor and do
not result in new or different questions of 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 device. |