(95 days)
No
The device description and performance studies focus on mechanical properties and materials, with no mention of AI or ML.
No.
The device is intended for suture or tissue fixation, which is a supportive role in surgical repair rather than a direct therapeutic action to treat a disease or condition. Its function is mechanical stabilization of tissue.
No
The device description indicates that FiberTak DR is a surgical fixation device used for "suture or tissue fixation" in various anatomical sites, not for diagnosing medical conditions. It performs a therapeutic function by securing tissue and is evaluated based on its mechanical pull-out strength rather than diagnostic metrics like sensitivity or specificity.
No
The device description clearly describes a physical implantable device (an "all-suture" soft-tissue fixation device) made of polyester, UHWMPE, and a disposable inserter made of stainless steel and ABS plastic. This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- FiberTak DR Function: The description clearly states that FiberTak DR is a device used for "suture or tissue fixation" within the body during surgical procedures. It is an implantable device used to repair or reconstruct ligaments and tendons.
The information provided about the device's intended use, description, materials, and performance testing all point to it being a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
FiberTak DR 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 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
FiberTak DR 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 or though soft tissue and tied in a knot; or the repair can be completed in a knotless fashion when used in combination with Arthrex SwiveLock Anchors (K101823).
FiberTak DR is constructed from a hollow braid of polyester with a suture component combination assembled through the hollow braid. The suture component can be made from either UHWMPE or a polyblend of UHMWPE and Polyester. The anchor configuration of FiberTak DR is similar to the predicate device, except that it combines suture and tape within the same anchor. FiberTak DR is available in three models with combinations in the color of its suture components. FiberTak DR comes preloaded on a disposable inserter made from stainless steel (ASTM F899) whereas the predicate inserter is made of nitinol. The handle of the inserters is made of ABS plastic. FiberTak DR may be sold separately or in a kit with implantation instrumentation. The proposed FiberTak DR is provided sterile for single use.
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, 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
The submitted mechanical testing demonstrates that the pull-out strength of the proposed FiberTak DR exceeds the pull out strength of the predicate device. In addition, the pull out displacements recorded meet the criteria established by the predicate devices and therefore of no clinical relevance. Furthermore, the biocompatibility and packaging/shelf life for the subject device were reviewed and determined to be acceptable due to its similarities in material and packaging.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 10, 2016
Arthrex, Incorporated Ms. Ivette Galmez Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K160319
Trade/Device Name: FiberTak DR Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: April 20, 2016 Received: April 21, 2016
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 Parts 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/ResourcesforYou/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
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INDICATIONS FOR USE 2.5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
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
FiberTak DR
Indications for Use (Describe)
FiberTak DR 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 Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
· Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PP, 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)
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."
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2.1 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared | April 12, 2016 |
|---|---|
| Manufacturer/Distributor/ | |
| Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Ivette Galmez |
| Regulatory Affairs Specialist | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 71263 | |
| Fax: 239/598.5508 | |
| Email: igalmez@arthrex.com | |
| Trade Name | FiberTak DR |
| Common Name | Soft Tissue Fixation Device |
| Product Code - | |
| Classification Name | |
| CFR | MBI |
| Fastener, fixation, nondegradable, soft tissue | |
| 21 CFR 888.3040 | |
| Predicate Device | K151230: Arthrex FiberTak Anchors |
| Purpose of Submission | This special 510(k) premarket notification is submitted to obtain |
| clearance for FiberTak DR. | |
| Device Description | FiberTak DR 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 or though soft tissue and tied in a knot; or the repair can | |
| be completed in a knotless fashion when used in combination | |
| with Arthrex SwiveLock Anchors (K101823). | |
| FiberTak DR is constructed from a hollow braid of polyester with | |
| a suture component combination assembled through the hollow | |
| braid. The suture component can be made from either UHWMPE | |
| or a polyblend of UHMWPE and Polyester. The anchor | |
| configuration of FiberTak DR is similar to the predicate device, | |
| except that it combines suture and tape within the same anchor. | |
| FiberTak DR is available in three models with combinations in the | |
| color of its suture components. FiberTak DR comes preloaded on | |
| a disposable inserter made from stainless steel (ASTM F899) | |
| whereas the predicate inserter is made of nitinol. The handle of | |
| the inserters is made of ABS plastic. FiberTak DR may be sold | |
| separately or in a kit with implantation instrumentation. The | |
| proposed FiberTak DR is provided sterile for single use. | |
| Intended Use | FiberTak DR 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 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 | |
| Substantial Equivalence | |
| Summary | The proposed FiberTak DR is similar to the predicate device in |
| which the basic design features (all-suture anchor); the materials | |
| and intended use are the same. | |
| The submitted mechanical testing demonstrates that the pull-out | |
| strength of the proposed FiberTak DR exceeds the pull out | |
| strength of the predicate device. In addition, the pull out | |
| displacements recorded meet the criteria established by the | |
| predicate devices and therefore of no clinical relevance. | |
| Furthermore, the biocompatibility and packaging/shelf life for | |
| the subject device were reviewed and determined to be | |
| acceptable due to its similarities in material and packaging. | |
| Based on the indication for use, technological characteristics, and | |
| the summary of data submitted, Arthrex, Inc. has determined | |
| that FiberTak DR is substantially equivalent to currently marketed | |
| predicate devices. |
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