(91 days)
No
The device description and intended use focus on the physical properties and surgical applications of sutures, with no mention of AI or ML. The performance studies are mechanical and biological, not related to algorithmic performance.
No.
The device is a cerclage suture intended for soft tissue approximation, ligation, and bone fixation for various orthopedic applications, not for therapy or treatment directly.
No
This device is described as a cerclage suture intended for soft tissue approximation and ligation, and for bone fixation in various surgical procedures. It is a physical implant used for repair and reconstruction, not for diagnosis.
No
The device description clearly describes a physical suture made of UHMWPE and polyester materials, assembled on an HDPE card or ABS loader. There is no mention of software as a component or the primary function of the 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 that the device is for "soft tissue approximation and or ligation" and "bone fixation cerclage" in various surgical procedures. This involves direct interaction with the patient's body during surgery.
- Device Description: The device is described as a "flat braided suture assembled in a loop configuration" made of UHMWPE and polyester materials. This is a physical implantable device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) during surgical procedures.
N/A
Intended Use / Indications for Use
Arthrex FiberTape and TigerTape cerclage sutures are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.
When used as bone fixation cerclage the sutures are intended for:
- · Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty
- · Sternotomy indications including the "rewiring" of osteomized sternums
- · Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring
- Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft)
·Repair of long bone fractures due to trauma or reconstruction
Product codes
HTN, HWC, JDQ, GAT
Device Description
The proposed Arthrex FiberTape and TigerTape Cerclage devices are available as a flat braided suture assembled in a loop configuration. Cerclage is assembled on an HDPE card or on an ABS loader. The devices are manufactured from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester materials. These materials are identical to those cleared in K170206. For the loop assembly, the looped end of the suture is tied as a hitch over a sheath that secures a double loop.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, bone (trochanteric, sternum, olecranon, ankle, patella, shoulder, glenoid, long bone)
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)
Tensile and pressure distribution testing was performed on the subject device and compared to the predicate device to demonstrate that the modifications do not negatively impact mechanical strength. 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
Not Found
§ 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.
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August 22, 2022
Image /page/0/Picture/1 description: The image contains 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.
Arthrex Inc. Kelsey Roberts Sr. Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K221485
Trade/Device Name: Arthrex FiberTape and TigerTape Cerclage Sutures Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN, HWC, JDQ, GAT Dated: May 20, 2022 Received: May 24, 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.
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
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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 medical devices and radiation-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,
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
Enclosure
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Indications for Use
510(k) Number (if known) K221485
Device Name
Arthrex FiberTape and TigerTape cerclage sutures
Indications for Use (Describe)
Arthrex FiberTape and TigerTape cerclage sutures are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.
When used as bone fixation cerclage the sutures are intended for:
- · Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty
- · Sternotomy indications including the "rewiring" of osteomized sternums
- · Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring
- Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft)
·Repair of long bone fractures due to trauma or reconstruction
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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 22, 2022 |
|---|---|
| 510(k) Number | K221485 |
| 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 FiberTape and TigerTape Cerclage Sutures |
| Common Name | Bone Fixation Cerclage, Suture |
| Product Code | HTN |
| HWC | |
| JDQ | |
| GAT | |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and |
| accessories | |
| 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener | |
| 21 CFR 888.3010: Bone Fixation Cerclage | |
| 21 CFR 878.5000: Nonabsorbable Poly(ethylene) Terephthalate Surgical Suture | |
| Regulatory Class | II |
| Predicate Device | K183232 Double ENDOBUTTON Fixation Device |
| Reference Device | K170206 Arthrex FiberTape Cerclage |
| K122374 Arthrex Suture | |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain the indication of |
| anterior glenoid bone loss using the Laterjet or bone block procedure (allograft or | |
| autograft) for the Arthrex FiberTape and TigerTape Cerclage Sutures. | |
| Device Description | The proposed Arthrex FiberTape and TigerTape Cerclage devices are available as a flat |
| braided suture assembled in a loop configuration. Cerclage is assembled on an HDPE | |
| card or on an ABS loader. The devices are manufactured from a polyblend of Ultra | |
| High Molecular Weight Polyethylene (UHMWPE) and polyester materials. These | |
| materials are identical to those cleared in K170206. For the loop assembly, the | |
| looped end of the suture is tied as a hitch over a sheath that secures a double loop. | |
| Comparison Summary | |
| of Technological | |
| Characteristics and | |
| Modifications | |
| Proposed | The proposed devices have the same technological characteristics (device design, |
| sterilization, and biocompatibility). The proposed device modification consists of the | |
| additional indication of anterior glenoid bone loss using the Laterjet or bone block | |
| procedure. |
The Arthrex FiberTape and TigerTape cerclage sutures are 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 | Arthrex FiberTape and TigerTape cerclage sutures are intended for use in soft tissue
approximation and or ligation. These sutures may be incorporated, as components,
into surgeries where constructs including those with allograft or autograft tissues are
used for repair.
When used as bone fixation cerclage the sutures are intended for:
• Trochanteric reattachment after trochanteric osteotomy following total hip
arthroplasty |
| | • Sternotomy indications including the “rewiring” of osteomized sternums • Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring - Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft) •Repair of long bone fractures due to trauma or reconstruction |
| Performance Data | Tensile and pressure distribution testing was performed on the subject device and compared to the predicate device to demonstrate that the modifications do not negatively impact mechanical strength. Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications. |
| Clinical Literature | Clinical literature was provided to justify the testing conditions and acceptance criteria of the subject Arthrex Cerclage Sutures. |
| Conclusion | The Arthrex FiberTape and TigerTape Cerclage Sutures are 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 raised questions concerning safety and 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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