(108 days)
The Knotless SutureTak Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure Hip: Capsular Repair, Acetabular Labral repair
The Knotless SutureTak Anchors are "tap-in" suture anchors with a ribbed profile and a proximally placed external suture eyelet. The anchors are preloaded with Arthrex Suture and are offered preassembled on a driver/inserter, for single use. The Knotless SutureTak Anchors are manufactured from either PEEK or bioabsorbable materials. The PEEK anchor was originally cleared under K120155 for indications in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. The indication for the PEEK anchor was expanded to include Joint Capsule Closure under K171020. The bioabsorbable version of the cleared Arthrex Knotless SutureTak Anchor is made of the same material as the Arthrex PushLock cleared under K101679.
This document is a 510(k) Pre-market Notification for a medical device, not a study report for an AI/ML device. Therefore, it does not contain the information required to answer your prompt. The questions you posed—regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device—are not applicable to this submission, which is for physical surgical anchors.
Specifically, the document pertains to:
- Device Name: Knotless SutureTak Anchors
- Device Type: Surgical anchors for suture or tissue fixation in orthopedic applications.
- Purpose of Submission: To obtain additional indications for use (Lateral Epicondylitis Repair) and introduce a bioabsorbable version of an already cleared device, demonstrating substantial equivalence to predicate devices.
There is no mention of any AI or machine learning component, diagnostic capabilities, or a study involving human readers or algorithm-only performance. The "Performance Data" section explicitly states that "Pull-out and degradation testing was conducted to demonstrate that the Knotless SutureTak Anchors perform statistically equivalent to the predicate device. Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications." This confirms that the performance evaluation was mechanical and material-based, not AI/ML model validation.
Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, study design, sample sizes for AI/ML validation, expert adjudication, or MRMC studies based on the provided text.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 22, 2018
Arthrex, Inc. Ivette Galmez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K180594
Trade/Device Name: Knotless SutureTak Anchors Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: May 23, 2018 Received: May 25, 2018
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requrements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
{1}------------------------------------------------
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sarah B. Nelson -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Knotless SutureTak Anchors
Indications for Use (Describe)
The Knotless SutureTak Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Unar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers
Foot/Ankle: Lateral Stabilization. Medial Stabilization. Achilles Tendon Repair. Metatarsal Ligament Repair. Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure
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}------------------------------------------------
1. 510(k) Summary or 510(k) Statement
| Date Prepared | June 21, 2018 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Ivette Galmez |
| Senior Regulatory Affairs Specialist | |
| 1-239-643-5553, ext. 71263 | |
| Ivette.galmez@arthrex.com | |
| Name of Device | Knotless SutureTak Anchors |
| Common Name | Suture Anchor |
| Product Code | MAI, MBI |
| Classification Name | 21 CFR 888.3030: Fastener, Fixation, Biodegradable, Soft Tissue |
| 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener | |
| Regulatory Class | II |
| Predicate Device | K171020: Arthrex Knotless SutureTak Anchor |
| K101679: Arthrex PushLock Anchors | |
| K063478: DePuy Mitek VERSALOK Anchor | |
| K140855: Arthrex SutureTak Suture Anchors | |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain Lateral |
| Epicondylitis Repair indications for the Arthrex Knotless SutureTak Anchor cleared | |
| under K171020. This submission also introduces a bioabsorbable version of the | |
| cleared Arthrex Knotless SutureTak Anchor. | |
| Device Description | The Knotless SutureTak Anchors are "tap-in" suture anchors with a ribbed profile and |
| a proximally placed external suture eyelet. The anchors are preloaded with Arthrex | |
| Suture and are offered preassembled on a driver/inserter, for single use. | |
| The Knotless SutureTak Anchors are manufactured from either PEEK or bioabsorbable | |
| materials. The PEEK anchor was originally cleared under K120155 for indications in | |
| the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. The indication for the | |
| PEEK anchor was expanded to include Joint Capsule Closure under K171020. The | |
| bioabsorbable version of the cleared Arthrex Knotless SutureTak Anchor is made of | |
| the same material as the Arthrex PushLock cleared under K101679. | |
| Indications for Use | The Knotless SutureTak Anchors are intended to be used for suture or tissue fixation |
| in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are | |
| listed below: | |
| Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure Hip: Capsular Repair, Acetabular Labral repair | |
| Performance Data | Pull-out and degradation testing was conducted to demonstrate that the KnotlessSutureTak Anchors perform statistically equivalent to the predicate device.Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that thedevice meets pyrogen limit specifications. |
| Conclusion | The Knotless SutureTak Anchors are substantially equivalent to the predicate devicein which the basic design features and intended uses are the same. Any differencesbetween the subject device and the predicate device are considered minor and donot raise new or different questions of safety or effectiveness.Based on the indications for use, technological characteristics, and the summary ofdata submitted, Arthrex Inc. has determined that the proposed devices aresubstantially equivalent to the currently marketed predicate device. |
{4}------------------------------------------------
§ 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.