(168 days)
No
The device description focuses on the mechanical properties and materials of a suture anchor and its inserter. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The performance studies described are mechanical tests, not algorithmic performance evaluations.
No
The device is a fixation device (suture anchor) used for tissue fixation during surgical repairs, not a device that provides therapy for a disease or condition.
No
The device is described as an "all-suture" soft-tissue fixation device used for suture or tissue fixation in orthopedic repairs, not for diagnosing conditions.
No
The device description clearly describes a physical suture anchor made of polyester and UHMWPE, preloaded on a physical inserter made of nitinol and ABS plastic. It is a hardware device for tissue fixation.
Based on the provided information, the Arthrex FiberTak Suture Anchor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The Arthrex FiberTak Suture Anchor is a surgical implant used for fixing sutures or tissue within the body during surgical procedures. It is a mechanical device used for structural support and repair.
The description clearly indicates it's an implantable device used in surgical procedures, not for testing biological samples.
N/A
Intended Use / Indications for Use
The Arthrex FiberTak Suture Anchor 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:
- o Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
- 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, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
- 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
Product codes
MBI
Device Description
The Arthrex FiberTak Suture Anchor is an "all-suture" soft-tissue fixation device with an expandable push-in design. The anchor and connected sutures are impacted into a pilot hole. The sutures are then manually tensioned to set the anchor by "bulging" the suture sleeve within the pilot hole. Once the anchor is set, the suture is passed around the soft tissue and tied in a knot to complete the repair. The device is provided sterile intended for single use. The anchor is constructed from a hollow braid of polyester. A blue and white striped suture comprised of UHMWPE (white) and Polyester (blue) is assembled through the hollow braid. The striped suture component is designated as TigerWire CL. The device comes preloaded on a disposable inserter. The inserter is made from surgical grade nitinol and ABS plastic. The FiberTak Suture may be sold separately or in a kit with implantation instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot/ankle, knee, hand/wrist, elbow, and shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The submitted mechanical testing demonstrates that the pull-out strength of the proposed devices meets or exceeds the pull-out strength of the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 13, 2014
Arthrex, Incorporated Ms. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108
Re: K140476
Trade/Device Name: Arthrex FiberTak Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: July 24, 2014 Received: July 28, 2014
Dear Ms. 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, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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,
Lori A. Wiggins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.5 INDICATIONS FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-01 Expiration Date: December 31, 201 See PRA Statement on last page.
510(k) Number (if known)
Device Name
Arthrex FiberTak Suture Anchor
Indications for Use (Describe)
The Arthrex FiberTak Suture Anchor 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:
- o Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
- 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, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
- 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
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)
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)
Page 1/1
FORM FDA 3881 (9/13)
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2.2 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared | April 21, 2014 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Courtney Smith |
| Regulatory Affairs Manager | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 1720 | |
| Fax: 239/598.5508 | |
| Email: csmith@arthrex.com | |
| Trade Name | Arthrex FiberTak Suture Anchor |
| Common Name | Soft Tissue Fixation Device |
| Product Code -Classification Name | MBI |
| CFR | Fastener, fixation, nondegradable, soft tissue |
| 21 CFR 888.3040 | |
| Predicate Device | K112237: Arthrex MicroSuture Anchor |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted |
| to obtain clearance for the Arthrex FiberTak Suture | |
| Anchor. | |
| Device Description | The Arthrex FiberTak Suture Anchor is an "all-suture" |
| soft-tissue fixation device with an expandable push-in | |
| design. The anchor and connected sutures are impacted | |
| into a pilot hole. The sutures are then manually | |
| tensioned to set the anchor by "bulging" the suture | |
| sleeve within the pilot hole. Once the anchor is set, the | |
| suture is passed around the soft tissue and tied in a knot | |
| to complete the repair. | |
| The device is provided sterile intended for single use. The | |
| anchor is constructed from a hollow braid of polyester. A | |
| blue and white striped suture comprised of UHMWPE | |
| (white) and Polyester (blue) is assembled through the | |
| hollow braid. The striped suture component is | |
| designated as TigerWire CL. The device comes preloaded | |
| on a disposable inserter. The inserter is made from | |
| surgical grade nitinol and ABS plastic. The FiberTak | |
| Suture may be sold separately or in a kit with | |
| implantation instrumentation. | |
| Intended Use | The Arthrex FiberTak Suture Anchor 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: | |
| • Elbow: Biceps Tendon Reattachment, Ulnar or Radial | |
| Collateral Ligament Reconstruction | |
| • Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP |
|
| Substantial Equivalence Summary | The indications for use of the proposed Arthrex FiberTak
Suture Anchor are identical to the predicate device.
The submitted mechanical testing demonstrates that the
pull-out strength of the proposed devices meets or
exceeds the pull-out strength of the predicate devices.
Based on the indication for use, technological
characteristics, and the summary of data submitted,
Arthrex, Inc. has determined that the FiberTak Suture
Anchor is substantially equivalent to currently marketed
predicate devices. |
4