(62 days)
The Arthrex SoftStitch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears and fixation of prosthetic or biologic material to soft tissues in minimally invasive and open surgical procedures such as rotator cuff repairs.
The Arthrex SoftStitch consists of a suture implant and an implant delivery inserter. The implant is a polyester sheath preloaded on a barbed suture manufactured from #1 USP nylon monofilament. The polyester sheath is coated with beeswax.
The provided document is an FDA 510(k) clearance letter and a 510(k) summary for the Arthrex SoftStitch device. It pertains to a surgical suture and implantable retention device, not an AI-powered diagnostic tool. Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI performance metrics, ground truth, expert adjudication, or MRMC studies is not applicable and cannot be extracted from this document.
The document details the substantial equivalence of the modified Arthrex SoftStitch to a previously cleared predicate device (K190707) and a reference device (K203117). The performance data cited focuses on mechanical strength (tensile testing) and biocompatibility (bacterial endotoxin testing), which are standard for medical devices like sutures, but not relevant to AI/ML device performance.
Therefore, I cannot fulfill the request as the provided text does not contain information about the development and validation of an AI-powered medical device.
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September 14, 2022
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Arthrex, Inc Kelsey N. Roberts Sr. Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K222078
Trade/Device Name: Arthrex SoftStitch Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: July 13, 2022 Received: July 14, 2022
Dear Kelsey N. Roberts:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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:
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma 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) K222078
Device Name
Arthrex SoftStitch
Indications for Use (Describe)
The Arthrex SoftStitch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears and fixation of prosthetic or biologic material to soft tissues in minimally invasive and open surgical procedures such as rotator cuff repairs.
Type of Use (Select one or both, as applicable)
| 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 1, 2022 |
|---|---|
| 510(k) Number | K222078 |
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Kelsey N. RobertsSr. Regulatory Affairs Specialist1-239-643-5553, ext. 72257Kelsey.Roberts@arthrex.com |
| Name of Device | Arthrex SoftStitch |
| Common Name | Fastener, fixation, nondegradable soft tissue |
| Product Code | GAT |
| Classification Name | 21 CFR 878.5000 – Nonabsorbable poly(ethylene terephthalate) surgical suture |
| Regulatory Class | ll |
| Primary Predicate Device | K190707: Arthrex SoftStitch |
| Reference Device | K203117: TissueTak Device |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to expand theindications of the Arthrex SoftStitch to include Rotator Cuff Augmentation. |
| Device Description | The Arthrex SoftStitch consists of a suture implant and an implant deliveryinserter. The implant is a polyester sheath preloaded on a barbed suturemanufactured from #1 USP nylon monofilament. The polyester sheath is coatedwith beeswax. |
| Comparison Summary ofTechnologicalCharacteristics and | The proposed and predicate device (K190707) have the same basic design,intended use, packaging, shelf life, biocompatibility profile, and sterilization. |
| Modifications Proposed | The proposed Arthrex SoftStitch is substantially equivalent to the predicatedevice in which the basic design features and intended uses are the same. Anydifferences between the proposed device and the predicate device areconsidered minor and do not raise new or different questions concerning safetyor effectiveness. |
| Indications for Use | The Arthrex SoftStitch is an implantable suture retention device which facilitatespercutaneous or endoscopic soft tissue repairs, including the repair of meniscaltears and fixation of prosthetic or biologic material to soft tissues in minimallyinvasive and open surgical procedures such as rotator cuff repairs. |
| Performance Data | Tensile testing was performed on the subject device and compared to thereference device to demonstrate that the modifications do not negatively impactmechanical strength.Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate thatthe device meets pyrogen limit specifications. |
| Conclusion | The Arthrex SoftStitch is substantially equivalent to the predicate device in whichthe basic design features and intended use are the same. Any differencesbetween the Arthrex proposed device and the predicate device are consideredminor and do not raise questions concerning safety and effectiveness. Based onthe indications for use, technological characteristics, and the summary of datasubmitted, Arthrex Inc. has determined that the proposed device is substantiallyequivalent to the currently marketed predicate device. |
§ 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.