(122 days)
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.
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.
This document describes the 510(k) premarket notification for the Arthrex SutureTape, specifically the K221354 submission for the 0.9 mm SutureTape as a line extension. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against acceptance criteria for a new type of AI/medical imaging device.
Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test and training sets) are not applicable to this type of regulatory submission because it's a materials science and mechanical performance comparison for a medical device (suture), not an AI/imaging diagnostic device.
However, I can extract the relevant "acceptance criteria" and "reported device performance" based on the provided text, focusing on the mechanical and performance standards for sutures.
Acceptance Criteria and Reported Device Performance for Arthrex SutureTape
This submission (K221354) is for a line extension of the Arthrex SutureTape device, specifically the 0.9 mm SutureTape. The "proof" of meeting acceptance criteria is demonstrated through mechanical performance testing against established USP (United States Pharmacopeia) standards for surgical sutures and comparison to a legally marketed predicate device (K171296: Arthrex SutureTape).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (USP Performance Standard) | Reported Device Performance (Arthrex 0.9 mm SutureTape) |
|---|---|
| Knot Pull Tensile Strength (for tape portion): Meets or exceeds USP standards for Size 2 non-absorbable surgical sutures. | 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. |
| Tensile Strength (for braided suture tail portion): Meets or exceeds USP standards for Size 2-0 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. |
| Needle Pull Tensile Strength (for attached needle): Meets or exceeds USP standards for Size 2-0 non-absorbable surgical sutures. | 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. |
| Pyrogenicity: Meets pyrogen limit specifications. | Bacterial Endotoxins Test (BET) was performed...to demonstrate that the proposed device meets pyrogen limit specifications. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (N numbers) for the mechanical performance tests (tensile strength, BET). It states that "representative samples" were used for the Bacterial Endotoxins Test. The data provenance is implied to be from internal testing conducted by Arthrex Inc., a U.S.-based company. The studies are prospective in the sense that they are conducted specifically for this regulatory submission to demonstrate compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. Ground truth for mechanical devices like sutures is established through standardized laboratory testing (e.g., USP methods) rather than expert consensus on diagnostic images.
4. Adjudication Method for the Test Set
This is not applicable. No human adjudication is involved in evaluating the mechanical properties of a suture.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This submission is for a surgical suture, not an AI or imaging diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithmic device.
7. The Type of Ground Truth Used
The ground truth used for performance evaluation is USP (United States Pharmacopeia) performance standards for surgical sutures and comparison to the mechanical and physical properties of a legally marketed predicate device. This is a form of objective, standardized laboratory measurement rather than clinical outcomes or expert consensus.
8. The Sample Size for the Training Set
This is not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. This is not an AI/machine learning device that requires a training set.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study proving the Arthrex 0.9 mm SutureTape meets acceptance criteria is primarily a series of bench tests and laboratory evaluations designed to demonstrate that the device's mechanical properties and safety aspects (like pyrogenicity) conform to well-established industry standards (USP) and are substantially equivalent to a pre-existing, legally marketed predicate device. The key performance indicators evaluated were:
- Knot pull tensile strength of the flat tape portion.
- Tensile strength of the braided suture tail portion.
- Needle pull tensile strength of any attached needles.
- Bacterial Endotoxins Test (BET) for pyrogenicity.
The conclusion is that "Any differences between the proposed and predicate devices are considered minor and do not raise questions concerning safety or effectiveness," and based on "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." This demonstrates that the new line extension performs as expected for its intended use as a surgical suture.
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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
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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
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) | 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)
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510(k) Summary
| Date Prepared | September 9, 2022 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Lai SaeteurnRegulatory Affairs Specialist II1-239-598-4302 Ext. 71764Lai.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 SutureTapeK122374: Arthrex Suture |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain clearance for theArthrex 0.9 mm SutureTape sutures as a line extension to the ArthrexSutureTape. |
| Device Description | The Arthrex SutureTape is comprised of non-absorbable sutures made of apolyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyesteryarns but may also include nylon yarns.The Arthrex 0.9 mm SutureTape is a 0.9 mm-wide tape suture with a roundbraided suture tail that is smaller than the tape portion. The tape and tailportion of the suture are implantable while the suture tail is not intended to beknotted. The flat tape portion of the Arthrex 0.9 mm SutureTape suture meetsor exceeds USP performance standards for knot pull tensile strength for size 2non-absorbable surgical sutures. The suture tail portions of the Arthrex 0.9 mmSutureTape suture meet the performance standards for USP 2-0 non-absorbablesurgical suture, except for an oversize in diameter.The Arthrex 0.9 mm SutureTape is supplied sterile, in pre-cut lengths, in variousloop configurations, and in some cases, with various swaged needles and withstiffened ends. The Arthrex 0.9 mm SutureTape is available non-dyed, dyed, andfully 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. Additionalmaterial for the Arthrex 0.9 mm SutureTape includes cyanoacrylate. |
| Indications for Use | The Arthrex SutureTape is intended for use in soft tissue approximation and/orligation. The suture may be provided individually or be incorporated as acomponent, into surgeries where constructs including those with allograft orautograft tissues are used for repair. |
| Performance Data | The flat tape portion of the Arthrex 0.9 mm SutureTape suture meets orexceeds USP performance standards for knot pull tensile strength for size 2 non-absorbable surgical sutures. The suture tail portions of the Arthrex 0.9 mmSutureTape suture meet the performance standards for USP 2-0 non-absorbablesurgical suture, except for an oversize in diameter. The attached needle at thesuture tail portion of the Arthrex 0.9 mm SutureTape suture meets or exceedsUSP performance standards for needle pull tensile strength for size 2-0 non-absorbable surgical sutures. |
| Bacterial Endotoxins Test (BET) was performed on the representative samplesutilizing the Kinetic Chromogenic Method 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. | |
| TechnologicalComparison | 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 sutureshare the same basic design features (e.g., flat braided with round-braided suturetails, 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, theArthrex 0.9 mm SutureTape suture has a tape width and suture tail diameterrange smaller than that of the predicate. |
| Conclusion | The Arthrex 0.9 mm SutureTape devices are substantially equivalent to thepredicate device in which the basic design features, materials, manufacturing,and intended use are the same. Any differences between the proposed andpredicate devices are considered minor and do not raise questions concerningsafety or effectiveness.Based on the indication or use, technological characteristics, and the tensile testdata submitted, Arthrex Inc. has determined that the proposed device issubstantially equivalent to the currently marketed predicate device. |
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§ 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.