(108 days)
The Arthrex LoopLocTM Knotless Suture is intended for soft-tissue approximation for hip capsular closure.
The Arthrex LoopLoc™ Knotless Suture is an all-suture device intended for use in soft-tissue approximation for hip capsular closure. This device is composed of a nonabsorbable suture implant and shuttling suture that are braided polyblend sutures (Arthrex size #2) made of ultra-high molecular weight polyethylene (UHMWPE) and polyester (PET) sutures, and preloaded on a single-use high-density polyethylene (HDPE) card with a disposable suture threader made of low-density polyethylene (LDPE), stainless steel, and Nitinol wire.
This 510(k) premarket notification is for the Arthrex LoopLoc™ Knotless Suture. The submission does not describe an AI medical device or an algorithm-driven diagnostic tool. Therefore, the information requested regarding acceptance criteria and study design for an AI/algorithm-based device, such as ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, is not applicable to this submission.
The acceptance criteria and supporting study for the Arthrex LoopLoc™ Knotless Suture are focused on demonstrating its physical performance and biocompatibility as a surgical suture, rather than diagnostic accuracy or algorithmic performance.
Here's the relevant information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document broadly states that the device meets performance specifications and is substantially equivalent to predicate devices. Specific quantitative acceptance criteria and detailed reported performance values are not explicitly laid out in a table format within this summary, but rather described in terms of testing conducted and conclusions drawn.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | - Maintains knotless integrity. |
| - Withstands cyclic loads greater than anticipated during the rehabilitation period following arthroscopic hip surgery. | |
| Biocompatibility | - Meets pyrogen limit specifications (demonstrated through Bacterial endotoxin per EP 2.6.14/USP <85>). |
| Substantial Equivalence | - Has the same intended use, materials, biocompatibility profile, packaging configuration, shelf-life, and sterilization method as cleared predicate devices. |
| - Technological differences are considered minor and mitigated by cyclic and ultimate load testing. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Cyclic and ultimate load testing" and "Bacterial endotoxin per EP 2.6.14/USP <85>" but does not specify the sample sizes used for these tests. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified, as these are bench tests on manufactured devices, not clinical data from patients.
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 a medical device (suture) and the testing involves mechanical and biocompatibility assessments, not a diagnostic or AI-driven system requiring expert consensus for "ground truth." The "ground truth" here is objective physical and chemical properties and performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a diagnostic device or a study involving human interpretation of data for ground truth establishment.
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
Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" would be the direct measurement of physical properties (e.g., load to failure, cyclic fatigue resistance) performed according to established engineering standards relevant to surgical sutures. For the biocompatibility testing (bacterial endotoxin), the "ground truth" is whether the endotoxin levels meet predefined specifications. These are objective measurements rather than subjective assessments requiring expert consensus or pathology.
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
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October 25, 2021
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Arthrex, Inc. Lai Saeteurn Regulatory Affairs Specialist II 1370 Creekside Boulevard Naples, Florida 34108
Re: K212146
Trade/Device Name: Arthrex LoopLocTM Knotless Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: July 27, 2021 Received: July 28, 2021
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 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 medical devices and radiation-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,
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
Submission Number (if known)
Device Name
Arthrex LoopLoc™ Knotless Suture
Indications for Use (Describe)
The Arthrex LoopLoc™ Knotless Suture is intended for soft-tissue approximation for hip capsular closure.
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
| Date Prepared | October 19, 2021 |
|---|---|
| Contact Details | Arthrex, Inc.1370 Creekside Boulevard Naples FL 34108 US239-598-4302Ms. Lai SaeteurnLai.Saeteurn@Arthrex.com |
| Device Trade Name | Arthrex LoopLoc™ Knotless Suture |
| Common Name | Nonabsorbable poly (ethylene terephthalate) surgical suture |
| Classification Name | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Regulation Number | 878.5000 |
| Product Code | GAT |
| Predicate Device | K122374: Arthrex SutureK041553: Arthrex Suture Grafting Kit |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for theArthrex LoopLoc™ Knotless Suture. |
| Device Description | The Arthrex LoopLoc™ Knotless Suture is an all-suture device intended for use in soft-tissue approximation for hip capsular closure. This device is composed of anonabsorbable suture implant and shuttling suture that are braided polyblendsutures (Arthrex size #2) made of ultra-high molecular weight polyethylene(UHMWPE) and polyester (PET) sutures, and preloaded on a single-use high-densitypolyethylene (HDPE) card with a disposable suture threader made of low-densitypolyethylene (LDPE), stainless steel, and Nitinol wire. |
| Indications for Use | The Arthrex LoopLoc™ Knotless Suture is intended for soft-tissue approximation forhip capsular closure. |
| Indications for UseComparison | The Arthrex LoopLoc™ Knotless Suture is indicated for hip capsular closure whereasthe predicate devices are indicated for soft tissue approximation and/or ligation.However, the intended use, soft tissue approximation, remains unchanged. |
| TechnologicalComparison | The Arthrex LoopLoc™ Knotless Suture has the same intended use, materials,biocompatibility profile, packaging configuration, shelf-life, and sterilization methodas the cleared predicate devices. Any technological differences between theproposed and predicate devices are considered minor and can be mitigated by cyclicand ultimate load testing performed using clinically relevant parameters. Therefore,the proposed device is substantially equivalent to the predicate devices. |
| Non-Clinical and/orClinical Tests Summary& Conclusions | Cyclic and ultimate load testing was conducted on the Arthrex LoopLoc™ KnotlessSuture and submitted in this Traditional 510(k).Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that thedevice meets pyrogen limit specifications.The test data demonstrates that the proposed device can maintain knotless integrityand withstand cyclic loads greater than anticipated during the rehabilitation periodfollowing arthroscopic hip surgery. The specific hip capsular closure indication doesnot increase risk greater than the previously cleared general soft tissueapproximation with respect to improper selection and use, suture breakage, andadverse tissue reaction. Therefore, the proposed device is substantially equivalent tothe cleared Arthrex suture devices for soft tissue approximation.Based on the intended use, technological characteristics, and the bench testingsubmitted, 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.