(214 days)
The Arthrex SutureTape 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 tissues are used for repair.
Arthrex SutureTape is a suture made of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester, and may include nylon. The proposed suture is braided flat with round ends, and is available in precut lengths in straight and loop configurations, and with or without needles. Arthrex SutureTape is packaged sterile for single use. New colorant additives meet the requirements of 21 CFR 73.1015 and 21 CFR 74.3054.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "Arthrex SutureTape." This document details the regulatory clearance for a surgical suture and focuses on demonstrating substantial equivalence to previously cleared devices.
Crucially, this document does not describe acceptance criteria for an AI/ML-based device or a study proving that an AI/ML device meets such criteria. It pertains to a physical medical device (suture) and its mechanical and biocompatibility testing. Therefore, I cannot extract the information required to answer your prompt regarding acceptance criteria and study details for an AI/ML device.
The information you are asking for, such as sample size for a test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth, and training set details, are specific to the validation of AI/ML systems, particularly in medical imaging or diagnostic contexts. This document is about a surgical suture.
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July 24, 2020
Arthrex Inc. Ivette Galmez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K193575
Trade/Device Name: Arthrex SutureTape Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: June 25, 2020 Received: June 26, 2020
Dear Ivette 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 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
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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 (OS) 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,
Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control 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) K193575
Device Name
Arthrex SutureTape
Indications for Use (Describe)
The Arthrex SutureTape 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 tissues are used for 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 1.
| Date Prepared | July 21, 2020 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Ivette GalmezSenior Regulatory Affairs Specialist1-239-643-5553, ext. 71263ivette.galmez@arthrex.com |
| Name of Device | Arthrex SutureTape |
| Common Name | Soft Tissue Fixation Device |
| Product Code | GAT |
| Classification Name | 21 CFR 878.5000: Non-absorbable poly(ethylene terephthalate) surgical suture |
| Regulatory Class | Class II |
| Predicate Device | K171296: SutureTape |
| Reference Device | K122374: Arthrex SutureK041553: Arthrex Suture Grafting KitK032245: Arthrex FiberTape Family |
| Purpose of Submission | This 510(k) premarket notification is submitted to obtain clearance for ArthrexSutureTape suture with new colorant additives per 21 CFR 73.1015 and 21 CFR74.3054. |
| Device Description | Arthrex SutureTape is a suture made of Ultra High Molecular Weight Polyethylene(UHMWPE) and polyester, and may include nylon. The proposed suture is braided flatwith round ends, and is available in precut lengths in straight and loop configurations,and with or without needles. Arthrex SutureTape is packaged sterile for single use.New colorant additives meet the requirements of 21 CFR 73.1015 and 21 CFR74.3054. |
| Indications for Use | Arthrex SutureTape is intended for use in soft tissue approximation and or ligation.These sutures may be incorporated, as components, into surgeries where constructsincluding those with allograft or autograft tissues are used for repair. |
| Performance Data | Mechanical testing demonstrated that the strength of the proposed ArthrexSutureTape (straight pull, knot pull and needle pull) met the criteria established bythe predicate device.Biocompatibility testing was conducted on the proposed Arthrex SutureTape inaccordance with ISO 10993-1:2018.Bacterial Endotoxin test was conducted in accordance with ANSI/AAMIST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14 to demonstrate that theproposed device meets pyrogen limit specifications. |
| Conclusion | The Arthrex SutureTape is substantially equivalent to the predicate device in whichthe basic design features, materials, manufacturing and intended uses are the same.Any differences between the proposed device and the predicate device areconsidered minor and do not raise questions concerning safety or effectiveness.Based on the indications for use, technological characteristics, and the summary ofdata submitted, Arthrex Inc. has determined that the proposed device is substantiallyequivalent to the currently marketed predicate devices. |
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.