(22 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical suture anchor, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as an "all-suture" soft tissue device intended for fixation of suture to bone, used in various orthopedic repair procedures. It is a mechanical fixation device, not one that delivers therapy or treats a disease in a therapeutic manner.
No
Explanation: The device description and intended use clearly state that this is a surgical anchor used for fixation of suture to bone in various joints. It is a therapy device, not a diagnostic one.
No
The device description clearly states it is a physical "all-suture" soft tissue device constructed from polyester and UHWMPE, preloaded on a disposable inserter. It is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of suture (soft tissue) to bone" in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implantable device (suture anchor) made of polyester and UHMWPE, used for mechanical fixation.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on mechanical strength, biocompatibility, and bacterial endotoxin levels, which are relevant for an implantable surgical device, not an IVD.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical tool used for repair within the body.
N/A
Intended Use / Indications for Use
The Arthrex Knotless FiberTak Biceps Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
· Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
· Shoulder: Rotator Cuff 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, Joint Capsule Closure
·Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair.
Product codes
MBI
Device Description
The proposed Arthrex Knotless FiberTak Biceps Suture Anchor is an "all-suture" soft tissue device intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.
The anchor is constructed from a hallow braid of polyester with pre-loaded suture components composed of UHWMPE or a polyblend of UHMWPE and polyester. The anchor is preloaded on a disposable inserter and is sold sterile single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, foot/ankle, knee, hand/wrist, elbow, and hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Cyclic Pull-out testing was performed on the subject device and compared to the predicate device to demonstrate that the modifications do not negatively impact mechanical strength or stiffness. Biocompatibility testing was performed to support the use of surgical marker which resulted in additional contact materials to the device.
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains two logos. On the left is the Department of Health and Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 15, 2022
Arthrex Inc. Kelsey Roberts Sr. Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K222161
Trade/Device Name: Arthrex Knotless FiberTak Biceps Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI
Dear Kelsey Roberts:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter sent on August 11, 2022. Specifically, FDA is updating this SE Letter because the original letter had an incorrect date (August 11, 2020) as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Laura Rose, Ph.D., OHT6: Office of Orthopedic Devices, by phone at (301) 348-1947, or email at Laura.Rose@fda.hhs.gov.
Sincerely,
Melissa A. Ramcharan -
S
For,
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image shows 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 the FDA logo, which 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.
August 11, 2020
Arthrex Inc. Kelsey Roberts Sr. Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K222161
Trade/Device Name: Arthrex Knotless FiberTak Biceps 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 20, 2022 Received: July 20, 2022
Dear Kelsey Roberts:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
2
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Melissa A. Ramcharan -5
For,
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222161
Device Name
Arthrex Knotless FiberTak Biceps Suture Anchor
Indications for Use (Describe)
The Arthrex Knotless FiberTak Biceps Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
· Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
· Shoulder: Rotator Cuff 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, Joint Capsule Closure
·Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon 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) |
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510(k) Summary
| Date Prepared | August 1, 2022 | |
|---|---|---|
| 510(k) Number | K222161 | |
| Submitter | Arthrex Inc. | |
| 1370 Creekside Boulevard | ||
| Naples, FL 34108-1945 | ||
| Contact Person | Kelsey N. Roberts | |
| Sr. Regulatory Affairs Specialist | ||
| 1-239-643-5553, ext. 72257 | ||
| Kelsey.Roberts@arthrex.com | ||
| Name of Device | Arthrex Knotless FiberTak Biceps Suture Anchor | |
| Common Name | Smooth or threaded metallic bone fixation fastener | |
| Product Code | MBI | |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener | |
| Regulatory Class | II | |
| Predicate Device | K203268: Arthrex FiberTak Suture Anchor | |
| Reference Device | K193503: Arthrex SwiveLock Suture Anchor | |
| Purpose of Submission | This Special 510(k) premarket notification is submitted as a line extension of the | |
| Arthrex FiberTak Suture Anchor devices cleared under K203268. | ||
| Device Description | The proposed Arthrex Knotless FiberTak Biceps Suture Anchor is an "all-suture" soft | |
| tissue device intended to be used for fixation of suture (soft tissue) to bone in the | ||
| shoulder, foot/ankle, knee, hand/wrist, elbow, and hip. |
The anchor is constructed from a hallow braid of polyester with pre-loaded suture
components composed of UHWMPE or a polyblend of UHMWPE and polyester. The
anchor is preloaded on a disposable inserter and is sold sterile single use. | |
| Comparison Summary
of Technological
Characteristics and
Modifications
Proposed | The proposed device is a line extension to the predicate device. The proposed and
predicate device (K203268) have the same basic design, intended use, packaging,
shelf life, biocompatibility profile, and sterilization. Differences between the
proposed device and the predicate include instrumentation, surgical technique, an
additional #2 Suture, and an additional contact material.
The proposed Arthrex Knotless FiberTak Biceps Suture Anchor is substantially
equivalent to the predicate device in which the basic design features and intended
uses are the same. Any differences between the proposed device and the predicate
device are considered minor and do not raise new or different questions concerning
safety or effectiveness. | |
| Indications for Use | The Arthrex Knotless FiberTak Biceps Suture Anchor is intended for fixation of suture
(soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in
the following procedures:
• 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, Joint Capsule Closure
•Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair. |
| Performance Data | | Cyclic Pull-out testing was performed on the subject device and compared to the predicate device to demonstrate that the modifications do not negatively impact mechanical strength or stiffness. Biocompatibility testing was performed to support the use of surgical marker which resulted in additional contact materials to the device. |
| | | Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications. |
| Conclusion | | The Arthrex Knotless FiberTak Biceps Suture Anchor is substantially equivalent to the predicate device in which the basic design features and intended use are the same. Any differences between the Arthrex proposed device and the predicate device are considered minor and do not raise and different questions concerning safety or effectiveness. Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex Inc. has determined that the proposed device is substantially equivalent to the currently marketed predicate device. |
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