(259 days)
The Arthrex SutureTak Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
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
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular repair, Acetabular Labral repair
The Arthrex SutureTak Suture Anchors share the same design features, materials, and intended use as the predicates. The anchors are composed of Polyetheretherketone (PEEK), or PLDLA/βTCP and are preloaded on a driver with nonabsorbable suture. The anchors range from 2.0mm – 3.0mm in diameter and 4.9mm – 14.5mm in length.
The provided document is a 510(k) summary for the Arthrex SutureTak Suture Anchors. This document describes the device, its intended use, and claims substantial equivalence to predicate devices based on design, materials, and intended use. It also mentions testing data to support performance.
However, the document does not contain the detailed acceptance criteria and the study results in the format requested, particularly for an AI/ML powered device. The "acceptance criteria" discussed in this document refer to the criteria for demonstrating substantial equivalence to predicate medical devices, rather than performance metrics for an AI/ML algorithm.
Specifically, the document lacks the following information for an AI/ML device study:
- A table of acceptance criteria and reported device performance: While the document states "the submitted tensile testing, fatigue testing, and degradation testing data demonstrates that the performance of the proposed devices meets or exceeds the predicate device for the desired indications," it does not provide a table with specific acceptance criteria and detailed performance metrics. The device in question is a physical suture anchor, not an AI/ML algorithm, so typical AI performance metrics like sensitivity, specificity, AUC, etc., are not applicable here.
- Sample size used for the test set and data provenance: No such information is provided as this is not an AI/ML study.
- Number of experts used to establish ground truth and their qualifications: Not applicable for this type of device submission.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance study: Not applicable in the context of an AI/ML algorithm's standalone performance. The document describes pre-market testing for a physical device.
- Type of ground truth used: Not applicable in the AI/ML context. Performance is based on physical property testing (tensile, fatigue, degradation).
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory submission for a physical medical device (suture anchors) and therefore does not contain the information requested for describing the acceptance criteria and study proving an AI/ML device meets those criteria.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2014
Arthrex. Incorporated Mr. David L. Rodgers Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108
Re: K140855
Trade/Device Name: Arthrex SutureTak Suture Anchors Regulation Number: 21 CFR 888.3080 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: November 17, 2014 Received: November 19, 2014
Dear Mr. Rodgers:
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 (reporting of medical
{1}------------------------------------------------
Page 2 - Mr. David L. Rodgers
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the Arthrex logo, which includes the company name and a graphic of scissors cutting a suture. Next to the logo, the text "TRADITIONAL 510(K): ARTHREX SUTURETAK SUTURE ANCHORS" is displayed. This text indicates that the product, Arthrex SutureTak Suture Anchors, has received traditional 510(k) clearance.
2.4 INDICATIONS FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K140855
Device Name
Arthrex SutureTak Suture Anchors
Indications for Use (Describe)
The Arthrex SutureTak Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
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
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
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)
Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
PSC Publishing Services (301) 443-674
{3}------------------------------------------------
1.1510K SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared | December 12, 2014 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | David L RogersRegulatory AffairsArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 71924Fax: 239/598.5508Email: david.rogers@arthrex.com |
| Trade Name | Arthrex SutureTak Suture Anchors |
| Common Name | Suture Anchor |
| Product Code, | MAI, MBI |
| Classification Name, CFR | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliancesand accessories |
| Predicate Device | K112237: Arthrex MicroSuture AnchorsK110660: Arthrex BioComposite SutureTakK091844: Arthrex Bio-Composite SutureTak Suture AnchorsK061863: Arthrex Corkscrew, Corkscrew FT, Bio-Corkscrew, and Bio Corkscrew FTSuture Anchors |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain clearance forthe Arthrex SutureTak Suture Anchors for indications in the foot, ankle, knee,hand, wrist, elbow, shoulder, and hip. |
| Device Description | The Arthrex SutureTak Suture Anchors share the same design features, materials,and intended use as the predicates. The anchors are composed ofPolyetheretherketone (PEEK), or PLDLA/βTCP and are preloaded on a driver withnonabsorbable suture. The anchors range from 2.0mm – 3.0mm in diameter and4.9mm – 14.5mm in length. |
| Intended Use | The Arthrex SutureTak suture anchors are intended to be used for suture (softtissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, andhip.Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shiftor Capsulolabral ReconstructionFoot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendontransfers, Mid-foot reconstructionKnee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial BandTenodesisHand/Wrist: Scapholunate Ligament Reconstruction, Carpal LigamentReconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexorand Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendontransfersElbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral LigamentReconstructionHip: Capsular repair, Acetabular Labral repair |
| SubstantialEquivalence Summary | The Arthrex SutureTak Suture Anchors is substantially equivalent to the predicatedevices, in which the basic design features and intended uses are the same. Anydifferences between the Arthrex SutureTak Suture Anchors and the predicatesare considered minor and do not raise questions concerning safety andeffectiveness. |
| The submitted tensile testing, fatigue testing, and degradation testing datademonstrates that the performance of the proposed devices meets or exceeds thepredicate device for the desired indications. | |
| Based on the indication for use, technological characteristics, and the summary ofdata submitted, Arthrex, Inc. has determined that the Arthrex SutureTak SutureAnchors is substantially equivalent to currently marketed predicate devices. |
{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.