(24 days)
The Arthrex BioComposite SutureTak is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder. Specific indications are listed below and are size appropriate per patient needs:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
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 Reconstruction, 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.
The Arthrex BioComposite SutureTak is a 2.0mm biocomposite suture anchor with a molded-in suture eyelet. The anchor is loaded on a driver and pre-loaded polyester suture.
The provided text describes a 510(k) submission for the Arthrex BioComposite SutureTak device. The study described focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. It does not involve human readers, AI, or traditional clinical study methodologies for diagnostic accuracy.
Here's the information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ultimate load strength of the proposed devices after 16 weeks of degradation meets or exceeds the minimum acceptance criteria. | "The submitted mechanical testing data demonstrated that the ultimate load strength of the proposed devices after 16 weeks of degradation meets or exceeds the minimum acceptance criteria." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes mechanical testing. The text does not specify the sample size for the mechanical testing (e.g., how many anchors were tested) nor the provenance of this testing data (e.g., which lab conducted it). It is implied to be a prospective mechanical test conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The study is a mechanical test of device performance, not a diagnostic accuracy study requiring expert human interpretation or ground truth establishment in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method was described as this was a mechanical test.
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 conducted. This device is a medical implant, and the study described focused on its mechanical properties for regulatory clearance, not on human-AI diagnostic performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component to this device or study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth or evaluation metric was the "minimum acceptance criteria" for ultimate load strength after 16 weeks of degradation, which is a physical performance target derived from engineering and regulatory standards for medical implants, not clinical ground truth.
8. The sample size for the training set
Not applicable. There is no training set mentioned or implied for this mechanical validation study.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned or implied for this mechanical validation study.
{0}------------------------------------------------
K 110660 (1/1)
Arthrex SPECIAL 510(k): Arthrex BioComposite SutureTak
MAR 3 1 2011
4 510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | March 2, 2011 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Courtney SmithRegulatory Affairs Project ManagerArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1720Fax: 239/598.5508Email: csmith@arthrex.com |
| Trade Name | Arthrex BioComposite SutureTak |
| Common Name | Suture Anchor |
| Product Code - | HWC - Screw, fixation, bone |
| Classification Name | MAI - Fastener, fixation, biodegradable, soft tissue |
| Predicate Devices | K091844: Arthrex BioComposite SutureTak Anchors |
| Device Description andIntended Use | The Arthrex BioComposite SutureTak is a 2.0mm biocompositesuture anchor with a molded-in suture eyelet. The anchor isloaded on a driver and pre-loaded polyester suture.The Arthrex BioComposite SutureTak family is intended to beused for suture or tissue fixation in the foot, ankle, knee, hand,wrist, shoulder, and elbow. Please see indications for use formfor specific indications. |
| Substantial EquivalenceSummary | The Arthrex BioComposite SutureTak is substantiallyequivalent to the Arthrex BioComposite SutureTak Anchors(K091844), in which the basic features, materials and intendeduses are the same. Any differences between the BioCompositeSutureTak and the predicate are considered minor and do notraise questions concerning safety and effectiveness.The submitted mechanical testing data demonstrated that theultimate load strength of the proposed devices after 16 weeks ofdegradation meets or exceeds the minimum acceptance criteria.Based on the indication for use, technological characteristics, andthe comparison to the predicate devices, Arthrex, Inc. hasdetermined that the Arthrex BioComposite SutureTak issubstantially equivalent to currently marketed predicate devices. |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, with three lines running through the eagle's body. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Arthrex, Inc. % Courtney Smith Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
MAR 3 1 2911
Re: K110660
Trade/Device Name: Arthrex BioComposite SutureTak Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: MAI, HWC Dated: March 02, 2011 Received: March 09, 2011
Dear Courtney Smith:
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. Ilsting 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.
{2}------------------------------------------------
Page 2 - Courtney Smith
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) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm111800.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours.
Mark N. Melkers Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Arthreach SPECIAL 510(k): Arthrex BioComposite SutureTak
3 Indications for Use Form
Indications for Use
510(k) Number:
K110660 (1/1)
Device Name:
Arthrex BioComposite SutureTak
Indications For Use:
The Arthrex BioComposite SutureTak is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder. Specific indications are listed below and are size appropriate per patient needs:
| Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. |
|---|---|
| Shoulder: | Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis,Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift orCapsulolabral Reconstruction. |
| Hand/Wrist: | Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction,Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and ExtensorTendons at the PIP, DIP and MCP joints for all digits, Digital Tendon Transfers. |
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, MetatarsalLigament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-footreconstruction. |
| Knee: | Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, PatellarTendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. |
Prescription Use _ X_AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE I of 1
for m. melkerson
(Division Sign-Off) (Division Surgical, Orthopedic, and Restorative Devices
510(k) Number K110660
§ 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.