(216 days)
The Arthrex BioSuture is intended for 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.
The proposed Arthrex BioSuture is a braided construct made of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester and coated with collagen coating. The proposed suture is braided flat with round ends and may be available in precut lengths in straight and loop configurations. The Arthrex BioSuture is packaged sterile for single use. The Arthrex BioSuture is a line extension to the Arthrex Bio-Suture consisting of a new size.
The provided document is a 510(k) summary for the Arthrex BioSuture, a surgical suture. It details the device's indications for use, technological characteristics, and conformity to established standards through performance testing. However, the document does not describe a study involving an AI/ML device, human readers, or any of the specific criteria typically associated with such studies (e.g., sample size for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, or training set details).
This document focuses on demonstrating substantial equivalence to predicate devices for a physical medical device (suture) through mechanical testing and comparison of attributes.
Therefore, most of the requested information regarding AI/ML device acceptance criteria and studies cannot be extracted from this document.
Here's an attempt to answer the questions based only on the provided text, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (What was tested against) | Reported Device Performance (Arthrex BioSuture) |
|---|---|
| Strength of the proposed Arthrex BioSuture met the established acceptance criteria (implicitly, this refers to the strength of predicate devices for comparison) | Mechanical testing (straight pull, knot pull) demonstrated that the strength of the proposed Arthrex BioSuture met the established acceptance criteria. |
| Pyrogen limit specifications (in accordance with ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14) | Bacterial Endotoxins Test (BET) was performed on representative samples utilizing the Kinetic Chromogenic Method to demonstrate that the proposed device meets pyrogen limit specifications. |
| Substantially equivalent to predicate devices (K112899, K140019) in terms of overall design, configuration, intended use/indications, surgical technique, fundamental scientific technology, sterility, materials, packaging, and manufacturing process. | The Arthrex BioSuture is substantially equivalent to the predicate devices with minor dimensional modifications and no change to intended use or function. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only states "representative samples" for the Bacterial Endotoxins Test and generally mentions "mechanical testing."
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is not an AI/ML study involving human expert ground truth. The "ground truth" here is based on physical material properties and established industry standards for sutures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/ML study involving human expert ground truth adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This document describes a submission for a surgical suture, not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document is for a physical medical device (suture), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" or reference for comparison described in this document is based on:
- Established physical and mechanical properties of surgical sutures: Primarily tensile strength (straight pull, knot pull) as defined by internal acceptance criteria and implicitly compared to predicate devices.
- Regulatory standards: Specifically pyrogen limits as outlined in ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14.
- Characteristics of legally marketed predicate devices: For demonstrating substantial equivalence in design, materials, manufacturing, and performance.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires a training set.
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10/27/2022
Arthrex Inc. Stacy Valdez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples. Florida 34108-1945
Re: K220880
Trade/Device Name: Arthrex BioSuture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: September 2, 2022 Received: September 7, 2022
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 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,
Deborah Fellhauer RN, BSN 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)
Device Name Arthrex BioSuture
Indications for Use (Describe)
The Arthrex BioSuture is intended for 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) |
escription 303 (Part 21 CFR 301 Subpart B)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Date Prepared | October 17, 2022 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Stacy ValdezSenior Regulatory Affairs Specialist1-239-643-5553, ext. 72010stacy.valdez@arthrex.com |
| Name of Device | Arthrex BioSuture |
| Common Name | Suture |
| Product Code | GAT |
| Classification Name | 21 CFR 878.5000: Nonabsorbable poly(ethylene terephthalate) surgical suture |
| Regulatory Class | II |
| Primary Predicate Device | K112899: Arthrex Bio-Suture |
| Additional Predicate Device | K140019: Arthrex BioSuture |
| Reference Devices | K193575: Arthrex SutureTapeK122374: Arthrex SutureK041553: Arthrex Suture Grafting KitK032245: Arthrex FiberTape FamilyK021434: Arthrex FiberWire Family, USP Size Sutures |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtainclearance for the Arthrex BioSuture. |
| Device Description | The proposed Arthrex BioSuture is a braided construct made of Ultra HighMolecular Weight Polyethylene (UHMWPE) and polyester and coatedwith collagen coating. The proposed suture is braided flat with roundends and may be available in precut lengths in straight and loopconfigurations. The Arthrex BioSuture is packaged sterile for single use.The Arthrex BioSuture is a line extension to the Arthrex Bio-Sutureconsisting of a new size. |
| Indications for Use | The Arthrex BioSuture is intended for soft tissue approximation and orligation. These sutures may be incorporated, as components, intosurgeries where constructs, including those with allograft or autografttissues, are used for repair. |
| Performance Data | Mechanical testing (straight pull, knot pull) was conducted todemonstrate that the strength of the proposed Arthrex BioSuture metthe established acceptance criteria. |
| Technological Comparison | Bacterial Endotoxins Test (BET) was performed on the representativesamples utilizing the Kinetic Chromogenic Method in accordance withANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14 todemonstrate that the proposed device meets pyrogen limit specifications.The Arthrex BioSuture is substantially equivalent to the predicate devicescleared under K112899 and K140019 in which the overall design andconfiguration of the suture, intended use/indications, surgical technique,fundamental scientific technology, sterility, materials, packaging andmanufacturing process are identical. |
| diameter than the predicate devices cleared under K112899. | |
| The Arthrex BioSuture is labeled with a 4-year shelf life; whereas thepredicate devices cleared under K112899 are labeled with a 2-year shelflife. However, the additional predicate devices cleared under K140019are labeled with a 4-year shelf life. | |
| The Arthrex BioSuture has been evaluated for MR Safe labeling; whereasthe predicate devices cleared under K112899 were not evaluated for MRSafe labeling. The needles are not implantable and therefore have notbeen evaluated for MR Safety. | |
| The Arthrex BioSuture is a line extension to the predicate devices, whichinclude minor dimensional modifications with no change to intended useor function. Any differences between the Arthrex BioSuture and thepredicate devices are considered minor and do not raise differentquestions of safety or effectiveness. | |
| Conclusion | The Arthrex BioSuture is substantially equivalent to the predicate devicein which the overall design and configuration of the suture, the intendeduse/indications, surgical technique, fundamental scientific technology,sterility, materials, packaging, and manufacturing process remainidentical to the primary predicate Arthrex Bio-Suture (K112899) andadditional predicate Arthrex BioSuture (K140019). Any differencesbetween the proposed device and the predicate device are consideredminor and do not raise different questions concerning safety oreffectiveness. |
| Mechanical testing (straight pull, knot pull) demonstrated that thestrength of the proposed Arthrex BioSuture is substantially equivalent tothat of the predicate device for the desired indications. | |
| Based on the indications for use, technological characteristics, and thesummary of data submitted, Arthrex Inc. has determined that theproposed device is substantially equivalent to the currently marketedpredicate 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.