(141 days)
No
The 510(k) summary describes a physical surgical suture device and its mechanical properties, with no mention of software, algorithms, or any AI/ML related terms or functionalities.
Yes.
The device is intended for soft tissue approximation and/or ligation, as well as bone fixation cerclage in various surgical applications, including fracture repair and reattachment, which are therapeutic interventions.
No
The device is a surgical suture intended for tissue approximation and ligation, particularly in bone fixation applications. It is used for repair and reconstruction, not for diagnosing medical conditions.
No
The device description clearly states it is a physical medical device (sutures assembled on a loader) made of materials like UHMWPE, Bismuth Trioxide, and polyester. It is 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 a "non-absorbable braided suture" used for physical repair and fixation within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is a surgical implant used for mechanical support and repair within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Arthrex Radiopaque FiberTape 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 autograff 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 (comma separated list FDA assigned to the subject device)
JDQ, GAT
Device Description
The Arthrex Radiopaque FiberTape Cerclage sutures are non-absorbable braided sutures assembled on an ABS loader. The Radiopaque FiberTape Cerclage implant is hitched around the post of the ABS loader which allows the nitinol wire to pass through the knot. The devices are manufactured from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) which incorporates Bismuth Trioxide (Bi2O3), and polyester materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Trochanteric, sternotomy, olecranon, ankle, patella, shoulder, glenoid, long bone fractures.
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, tensile strength, cyclic displacement, and creep displacement, demonstrates that the Arthrex Radiopaque FiberTape Cerclage sutures are substantially equivalent to the additional predicate device DSM Biomedical DRP Cable (K143716).
Bacterial Endotoxins Test (BET) was performed on the Arthrex Radiopaque FiberTape Cerclage Sutures per EP 2.6.14/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.
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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August 24, 2023
Arthrex, Inc Stacy Valdez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K230976
Trade/Device Name: Arthrex Radiopaque FiberTape Cerclage sutures Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: JDQ, GAT Dated: July 24, 2023 Received: July 25, 2023
Dear Stacy Valdez:
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
1
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,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal 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) K230976
Device Name
Arthrex Radiopaque FiberTape cerclage sutures
Indications for Use (Describe)
Arthrex Radiopaque FiberTape 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 autograff 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) | |
|---|---|
| * | 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 | 07/24/2023 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Stacy Valdez |
| Senior Regulatory Affairs Specialist | |
| 1-239-643-5553, ext. 72010 | |
| Stacy.valdez@arthrex.com | |
| Name of Device | Arthrex Radiopaque FiberTape Cerclage sutures |
| Common Name | Bone Fixation Cerclage |
| Product Code | JDQ (Primary), GAT |
| Classification Name | 21 CFR 888.3010: Bone Fixation Cerclage (Primary) |
| 21 CFR 878.5000: Nonabsorbable Poly(ethylene) Terephthalate | |
| Regulatory Class | II |
| Predicate Device | K221485: Arthrex FiberTape and TigerTape Cerclage Sutures |
| Additional Predicate Device | K143716: DSM Biomedical DRP Cable |
| Reference Device(s) | K170206: Arthrex FiberTape Cerclage |
| K193575: Arthrex SutureTape | |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain |
| clearance for the Arthrex Radiopaque FiberTape Cerclage Sutures. | |
| Device Description | The Arthrex Radiopaque FiberTape Cerclage sutures are non-absorbable |
| braided sutures assembled on an ABS loader. The Radiopaque FiberTape | |
| Cerclage implant is hitched around the post of the ABS loader which | |
| allows the nitinol wire to pass through the knot. The devices are | |
| manufactured from a polyblend of Ultra High Molecular Weight | |
| Polyethylene (UHMWPE) which incorporates Bismuth Trioxide (Bi2O3), | |
| and polyester materials. | |
| Indications for Use | Arthrex Radiopaque FiberTape 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 | The submitted testing data, tensile strength, cyclic displacement, and
creep displacement, demonstrates that the Arthrex Radiopaque
FiberTape Cerclage sutures are substantially equivalent to the additional
predicate device DSM Biomedical DRP Cable (K143716). |
| | Bacterial Endotoxins Test (BET) was performed on the Arthrex
Radiopaque FiberTape Cerclage Sutures per EP 2.6.14/USP to |
| | |
| | demonstrate that the device meets pyrogen limit specifications. |
| Technological Comparison | Compared to the primary predicate device Arthrex FiberTape and
TigerTape Cerclage Sutures (K221485) and additional predicate device
DSM Biomedical DPR Cable (K143716), the proposed Arthrex
Radiopaque FiberTape Cerclage sutures have the same fundamental
scientific technology, design, packaging, sterility, shelf-life, and MRI
safety labeling. The proposed Arthrex Radiopaque FiberTape Cerclage
sutures contain UHMWPE which incorporates Bismuth Trioxide (Bi2O3);
whereas the primary predicate device Arthrex FiberTape and TigerTape
Cerclage sutures (K221485) do not contain Bismuth Trioxide (Bi2O3).
However, the Cerclage sutures cleared under additional predicate device
DSM Biomedical DPR Cable (K143716) contain UHMWPE which
incorporates Bismuth Trioxide (Bi2O3). |
| | Any differences between the proposed devices and the predicate
devices are considered minor and do not raise new or different
questions concerning safety or effectiveness. |
| Conclusion | The Arthrex Radiopaque FiberTape 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 proposed
device and the predicate device are considered minor and do not raise
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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