Who is the manufacturer of Arthrex SutureTape?

Arthrex, Inc. filed the 510(k) submission for Arthrex SutureTape (K221354).

What is the FDA product code for Arthrex SutureTape?

GAT. It is classified under 21 CFR 878.5000 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Arthrex SutureTape?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like Arthrex SutureTape?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Arthrex SutureTape

K221354 · Arthrex, Inc. · GAT · Sep 9, 2022 · General, Plastic Surgery

Device Facts

Record ID	K221354
Device Name	Arthrex SutureTape
Applicant	Arthrex, Inc.
Product Code	GAT · General, Plastic Surgery
Decision Date	Sep 9, 2022
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.5000
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Arthrex SutureTape is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft tissues are used for repair.

Device Story

Arthrex SutureTape is a non-absorbable surgical suture designed for soft tissue approximation and ligation. The device features a flat braided tape portion transitioning to a round-braided suture tail. It is used by surgeons in clinical settings to secure soft tissue or as a component in surgical constructs involving allograft or autograft tissues. The tape portion provides high tensile strength, while the tail facilitates handling. The device is supplied sterile in various configurations, including pre-cut lengths and swaged needles. By providing a secure, high-strength fixation method, the suture assists in tissue repair and healing. It is a line extension of existing SutureTape products, maintaining established surgical techniques and material compositions.

Clinical Evidence

Bench testing only. Performance data includes knot pull tensile strength testing for the tape portion (meeting USP size 2 standards) and the suture tail (meeting USP 2-0 standards). Needle pull tensile strength meets USP size 2-0 standards. Bacterial Endotoxins Test (BET) performed per ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, and EP 2.6.14 confirms compliance with pyrogen limit specifications.

Technological Characteristics

Non-absorbable surgical suture composed of UHMWPE, polyester, and nylon yarns. Includes cyanoacrylate and dyes (D&C Blue No. 6, Logwood Black). Features a flat braided tape section and round-braided tail. Supplied sterile. Testing conducted per USP standards for tensile strength and ANSI/AAMI ST72:2011/(R)2016 for endotoxins.

Indications for Use

Indicated for soft tissue approximation and ligation in surgical procedures, including those utilizing allograft or autograft tissues.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Arthrex SutureTape (K171296)

Reference Devices

Arthrex SutureTape (K193575)
Arthrex Suture (K122374)

Related Devices

K171296 — SutureTape · Arthrex, Inc. · May 26, 2017
K193575 — Arthrex SutureTape · Arthrex, Inc. · Jul 24, 2020
K071622 — ARTHREX FIBERWIRE · Arthrex, Inc. · Jul 3, 2007
K150584 — Stryker Suture Tape · Stryker · Aug 13, 2015
K122374 — ARTHREX SUTURE (UHMWPE) · Arthrex, Inc. · Sep 25, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". September 9, 2022 Arthrex Inc. Lai Saeteurn Regulatory Affairs Specialist II 1370 Creekside Boulevard Naples, Florida 34108-1945 Re: K221354 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 17, 2022 Received: June 21, 2022 Dear Lai Saeteurn: 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 {1}------------------------------------------------ 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, for Deborah Fellhauer 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K221354 Device Name Arthrex SutureTape Indications for Use (Describe) The Arthrex SutureTape is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft tissues are used for repair. Type of Use (Select one or both, as applicable) | <svg height="12" width="12"> <path d="M1 1 L11 1 L11 11 L1 11 Z" fill="none" stroke="black" stroke-width="1"></path> <path d="M2 2 L10 10 M2 10 L10 2" stroke="black" stroke-width="1"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) | <svg height="12" width="12"> <path d="M1 1 L11 1 L11 11 L1 11 Z" fill="none" stroke="black" stroke-width="1"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | X | Prescription Use (Part 21 CFR 801 Subpart D) _] Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary | Date Prepared | September 9, 2022 | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 | | Contact Person | Lai Saeteurn Regulatory Affairs Specialist II 1-239-598-4302 Ext. 71764 Lai.Saeteurn@Arthrex.com | | Name of Device | Arthrex SutureTape | | Common Name | Suture | | Product Code | GAT | | Classification Name | 21 CFR 878.5000: Nonabsorbable poly(ethylene terephthalate) surgical suture | | Regulatory Class | II | | Predicate Device | K171296: Arthrex SutureTape | | Reference Devices | K193575: Arthrex SutureTape K122374: Arthrex Suture | | Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain clearance for the Arthrex 0.9 mm SutureTape sutures as a line extension to the Arthrex SutureTape. | | Device Description | The Arthrex SutureTape is comprised of non-absorbable sutures made of a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester yarns but may also include nylon yarns. The Arthrex 0.9 mm SutureTape is a 0.9 mm-wide tape suture with a round braided suture tail that is smaller than the tape portion. The tape and tail portion of the suture are implantable while the suture tail is not intended to be knotted. The flat tape portion of the Arthrex 0.9 mm SutureTape suture meets or exceeds USP performance standards for knot pull tensile strength for size 2 non-absorbable surgical sutures. The suture tail portions of the Arthrex 0.9 mm SutureTape suture meet the performance standards for USP 2-0 non-absorbable surgical suture, except for an oversize in diameter. The Arthrex 0.9 mm SutureTape is supplied sterile, in pre-cut lengths, in various loop configurations, and in some cases, with various swaged needles and with stiffened ends. The Arthrex 0.9 mm SutureTape is available non-dyed, dyed, and fully or partially striped. Dyes may include D&C Blue No. 6 and Logwood Black. Suture strands that are dyed with Logwood black are made of nylon. Additional material for the Arthrex 0.9 mm SutureTape includes cyanoacrylate. | | Indications for Use | The Arthrex SutureTape is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissues are used for repair. | | Performance Data | The flat tape portion of the Arthrex 0.9 mm SutureTape suture meets or exceeds USP performance standards for knot pull tensile strength for size 2 non- absorbable surgical sutures. The suture tail portions of the Arthrex 0.9 mm SutureTape suture meet the performance standards for USP 2-0 non-absorbable surgical suture, except for an oversize in diameter. The attached needle at the suture tail portion of the Arthrex 0.9 mm SutureTape suture meets or exceeds USP performance standards for needle pull tensile strength for size 2-0 non- absorbable surgical sutures. | | | Bacterial Endotoxins Test (BET) was performed on the representative samples utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14 to demonstrate that the proposed device meets pyrogen limit specifications. | | Technological Comparison | The Arthrex 0.9 mm SutureTape suture is a line extension to the predicate device. In comparison to the predicate device, the Arthrex 0.9 mm SutureTape suture share the same basic design features (e.g., flat braided with round-braided suture tails, non-USP size), fundamental scientific technology, intended use, materials (e.g., yarns, dyes, additive), shelf life, surgical technique, manufacturing, packaging, and sterilization processes as the predicate device. However, the Arthrex 0.9 mm SutureTape suture has a tape width and suture tail diameter range smaller than that of the predicate. | | Conclusion | The Arthrex 0.9 mm SutureTape devices are substantially equivalent to the predicate device in which the basic design features, materials, manufacturing, and intended use are the same. Any differences between the proposed and predicate devices are considered minor and do not raise questions concerning safety or effectiveness. Based on the indication or use, technological characteristics, and the tensile test data submitted, Arthrex Inc. has determined that the proposed device is substantially equivalent to the currently marketed predicate device. | {4}------------------------------------------------