(295 days)
No
The device description and performance studies focus on the material properties and mechanical performance of a suture, with no mention of AI or ML technologies.
No
The device is a cerclage suture used for soft tissue approximation, ligation, and bone fixation in various surgical procedures, primarily for repair and reattachment, not for treating or curing a disease or condition.
No
The device description and intended use indicate it is a surgical cerclage suture used for approximation, ligation, and fixation of soft tissue and bone, not for diagnosis.
No
The device description clearly states it is a physical suture made of braided 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 describes the device's function in soft tissue approximation, ligation, and bone fixation cerclage during surgical procedures. This involves direct interaction with the patient's body for structural support and repair.
- Device Description: The description details a suture made of specific materials, designed for physical manipulation and placement within the body.
- 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 screening.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body for surgical repair.
N/A
Intended Use / Indications for Use
The Arthrex FiberTape Cerclage suture is 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 a bone fixation cerclage the suture is intended for:
- Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty.
- Sternotomy indications including the "rewiring" of osteotomized sternums.
- Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring.
- Repair of long bone fractures due to trauma or reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
JDQ, GAT
Device Description
The Arthrex FiberTape Cerclage suture is available as a flat braided suture or assembled in a loop configuration. The Arthrex FiberTape Cerclage suture is braided from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester materials identical to those used in other cleared Arthrex sutures (K032245, K041553 and K122374). For the loop assembly, the looped end of the suture is tied as a hitch over a sheath that secures a double looped suture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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, fatigue strength, tensile force, creep and knot strength demonstrates that the Arthrex FiberTape Cerclage is substantially equivalent to the cleared DSM Biomedical DPR Cable and the Kinamed ISO-Elastic Cerclage System. Wear testing with particle analysis and comparative testing demonstrated no statistical significant differences between the proposed Arthrex FiberTape Cerclage and the cleared DSM Biomedical DPR Cable.
Bacterial Endotoxins Test was performed in accordance to USP 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.
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.
K102834, K032245, K041553, K122374
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
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
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November 15, 2017
Arthrex, Inc. Ms. Ivette Galmez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K170206
Trade/Device Name: Arthrex FiberTape Cerclage Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: JDQ, GAT Dated: October 18, 2017 Received: October 19, 2017
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 Mav 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for
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
510(k) Number (if known) K170206
Device Name
Arthrex FiberTape Cerclage
Indications for Use (Describe)
The Arthrex FiberTape Cerclage suture is 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 a bone fixation cerclage the suture is intended for:
- · Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty.
- · Sternotomy indications including the "rewiring" of osteotomized sternums.
- · Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring.
- · Repair of long bone fractures due to trauma or reconstruction.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary 1.
| Date Prepared | November 13, 2017 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Ivette Galmez |
| Senior Regulatory Affairs Specialist | |
| 1-239-643-5553, ext. 71263 | |
| lvette.galmez@arthrex.com | |
| Name of Device | Arthrex FiberTape Cerclage |
| Common Name | Bone Fixation Cerclage, Suture |
| Product Code | JDQ, GAT |
| Classification Name | 21 CFR 888.3010: Bone Fixation Cerclage |
| 21 CFR 878.5000: Nonabsorbable Poly(ethylene) Terephthalate Surgical Suture | |
| Regulatory Class | ll |
| Predicate Device | K143716: DSM Biomedical DPR Cable |
| Reference Predicate | K102834: ISO-Elastic Cerclage System |
| K032245: Arthrex FiberTape Family | |
| K041553: Arthrex Suture Grafting Kit | |
| K122374: Arthrex Suture | |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain clearance for the |
| Arthrex FiberTape Cerclage sutures for use as bone fixation cerclage. This Arthrex | |
| FiberTape Cerclage submission is comprised of four suture devices, two of which | |
| (FiberTape® and TigerTape™) have been previously cleared in K032245, K041553 and | |
| K122374. | |
| Device Description | The Arthrex FiberTape Cerclage suture is available as a flat braided suture or |
| assembled in a loop configuration. The Arthrex FiberTape Cerclage suture is braided | |
| from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and | |
| polyester materials identical to those used in other cleared Arthrex sutures (K032245, | |
| K041553 and K122374). For the loop assembly, the looped end of the suture is tied as | |
| a hitch over a sheath that secures a double looped suture. | |
| Intended Use | The Arthrex FiberTape Cerclage suture is 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 suture is 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 | |
| • Repair of long bone fractures due to trauma or reconstruction | |
| Substantial Equivalence | |
| Summary | The Arthrex FiberTape Cerclage suture is substantially equivalent to the predicate |
| devices, in which the basic design features and intended uses are the same. Any | |
| differences between the Arthrex FiberTape Cerclage and the predicates are considered | |
| minor and do not raise new questions concerning safety and effectiveness. | |
| The submitted testing data, fatigue strength, tensile force, creep and knot strength | |
| demonstrates that the Arthrex FiberTape Cerclage is substantially equivalent to the | |
| cleared DSM Biomedical DPR Cable and the Kinamed ISO-Elastic Cerclage System. | |
| Wear testing with particle analysis and comparative testing demonstrated no | |
| statistical significant differences between the proposed Arthrex FiberTape Cerclage | |
| and the cleared DSM Biomedical DPR Cable. | |
| Bacterial Endotoxins Test was performed in accordance to USP to demonstrate | |
| that the device meets pyrogen limit specifications. | |
| Based on the indication for use, the technological characteristics, and the summary of | |
| data submitted, Arthrex, Inc. has determined that the Arthrex FiberTape Cerclage | |
| suture is substantially equivalent to currently marketed predicate devices. |
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