(28 days)
No
The device description and intended use are solely focused on the physical properties and surgical applications of sutures, with no mention of AI or ML capabilities.
Yes
The device is intended for use in soft tissue approximation and ligation, and for providing fixation during the healing process after various surgical procedures, which are therapeutic actions.
No
The device is a suture used for soft tissue approximation, ligation, and bone fixation, and there is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly states the device is a physical suture made of polyblend materials, not software.
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 sutures are for "soft tissue approximation and or ligation" and "bone fixation cerclage." These are surgical procedures performed directly on the patient's body.
- Device Description: The device is described as "flat braided sutures assembled in a loop configuration" made from specific materials. This is a physical implantable device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory analysis.
The device described is a surgical implant used for mechanical support and repair within the body.
N/A
Intended Use / Indications for Use
Arthrex FiberTape and TigerTape 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
- To provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption.
Product codes (comma separated list FDA assigned to the subject device)
HTN, HWC, JDQ, GAT
Device Description
The proposed Arthrex FiberTape and TigerTape Cerclage Sutures are available as flat braided sutures assembled in a loop configuration. The devices are manufactured from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE), polyester, and nylon materials. These materials are identical to those cleared in K221485 and K170206. For the loop assembly, the looped end of the suture is tied as a hitch over a sheath that secures a double loop or tied over the post of an ABS loader. The proposed Arthrex FiberTape and TigerTape Cerclage Sutures may be used with or without the cleared Arthrex Dog Bone Button (K220947).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Trochanteric, Sternum, Olecranon, Ankle, Patella, Shoulder, Anterior Glenoid, Long bone, Acromioclavicular
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 testing data, ultimate load and cyclic displacement, demonstrates that the Arthrex FiberTape and TigerTape Cerclage Sutures are substantially equivalent to the predicate device Arthrex Knotless AC Repair Devices (K220947). 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K220947 Arthrex Knotless AC Repair Devices
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K221485 Arthrex FiberTape and TigerTape Cerclage Sutures, K170206 Arthrex FiberTape Cerclage
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
§ 888.3030 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 6, 2023
Arthrex Inc. Ruth Segall Regulatory Affairs Specialist I 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K232755
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: September 7, 2023 Received: September 8, 2023
Dear Ruth Segall:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pm.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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and
1
21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medicaldevice-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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-devices/deviceadvice-comprehensive-regulatory-assistance/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,
Christopher Ferreira -S
for
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K232755
Device Name Arthrex FiberTape and TigerTape Cerclage Sutures
Indications for Use (Describe)
Arthrex FiberTape and TigerTape 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
- · To provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption.
| 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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K232755 Page 1 of 4
510(k) Summary
| Date Prepared | October 6, 2023 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Ruth Segall |
| Regulatory Affairs Specialist I | |
| 1-239-598-4302, ext. 71764 | |
| Ruth.Segall@arthrex.com | |
| Trade Name | Arthrex FiberTape and TigerTape Cerclage Sutures |
| Common Name | Bone Fixation Cerclage, Suture and Washer |
| Product Code | HTN - Primary Product Code |
| 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 |
| Primary Predicate Device | K220947 Arthrex Knotless AC Repair Devices |
| Reference Devices | K221485 Arthrex FiberTape and TigerTape Cerclage |
| Sutures | |
| K170206 Arthrex FiberTape Cerclage | |
| Purpose of Submission | This special 510(k) premarket notification is submitted |
| to obtain the additional indication to provide fixation | |
| during the healing process following syndesmotic | |
| trauma, such as fixation of acromioclavicular separation | |
| due to coracoclavicular ligament disruption for the | |
| Arthrex FiberTape and TigerTape Cerclage Sutures. | |
| Device Description | The proposed Arthrex FiberTape and TigerTape |
| Cerclage Sutures are available as flat braided sutures | |
| assembled in a loop configuration. The devices are | |
| manufactured from a polyblend of Ultra High Molecular | |
| Weight Polyethylene (UHMWPE), polyester, and nylon | |
| materials. These materials are identical to those cleared | |
| in K221485 and K170206. For the loop assembly, the | |
| looped end of the suture is tied as a hitch over a sheath | |
| that secures a double loop or tied over the post of an | |
| ABS loader. The proposed Arthrex FiberTape and | |
| TigerTape Cerclage Sutures may be used with or | |
| without the cleared Arthrex Dog Bone Button | |
| (K220947). | |
| 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 | |
| • To provide fixation during the healing process | |
| following syndesmotic trauma, such as fixation of | |
| acromioclavicular separation due to coracoclavicular | |
| ligament disruption. | |
| Performance Data | The submitted testing data, ultimate load and cyclic |
| displacement, demonstrates that the Arthrex FiberTape | |
| and TigerTape Cerclage Sutures are substantially | |
| equivalent to the predicate device Arthrex Knotless AC | |
| Repair Devices (K220947). Bacterial endotoxin per EP | |
| 2.6.14/USP was conducted to demonstrate that | |
| the device meets pyrogen limit specifications. | |
| Technological Comparison | Compared to the predicate device Arthrex Knotless AC |
| Repair Devices (K220947) and reference devices Arthrex | |
| FiberTape and TigerTape Cerclage Sutures (K221485) | |
| and Arthrex FiberTape Cerclage (K170206), the | |
| proposed Arthrex FiberTape and TigerTape Cerclage | |
| Sutures have identical materials, fundamental scientific | |
| technology, packaging, sterility, shelf-life, and MRI | |
| safety labeling. | |
| The proposed device is an all-suture cerclage construct | |
| that may be used with up to one button for the surgical | |
| technique; whereas the predicate device is a suture | |
| construct used with two metal buttons (either pre- | |
| assembled or attached). | |
| Based on the intended use, fundamental scientific | |
| technology, and the data provided in this Special 510(k), | |
| Arthrex has determined that the proposed Arthrex | |
| FiberTape and TigerTape Cerclage Sutures are | |
| substantially equivalent to the predicate device Arthrex | |
| Knotless AC Repair Devices, K220947 and reference | |
| devices, Arthrex FiberTape and TigerTape Cerclage | |
| Sutures, K221485 and Arthrex FiberTape Cerclage, | |
| K170206. Any differences between the proposed device | |
| and predicate device are considered minor and do not | |
| raise different questions concerning safety and | |
| effectiveness. | |
| 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 | |
| identical. 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 |
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5
6
| determined that the proposed device is substantially |
|---|
| equivalent to the currently marketed predicate device. |