(108 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the suture, with no mention of AI or ML.
No.
The device is a suture intended for soft-tissue approximation, not for actively treating a disease or condition.
No
The device description clearly states its purpose is "soft-tissue approximation for hip capsular closure," which is a treatment or repair function, not a diagnostic one.
No
The device description clearly states it is an "all-suture device" composed of physical materials like UHMWPE, PET, HDPE, LDPE, stainless steel, and Nitinol wire, and performance studies involve physical load testing. There is no mention of software as a component or the primary function of the device.
Based on the provided information, the Arthrex LoopLoc™ Knotless Suture is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "soft-tissue approximation for hip capsular closure." This describes a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a suture and associated components used for surgical repair. It does not involve analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or other substances to detect or measure analytes.
Therefore, the Arthrex LoopLoc™ Knotless Suture is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex LoopLocTM Knotless Suture is intended for soft-tissue approximation for hip capsular closure.
Product codes (comma separated list FDA assigned to the subject device)
GAT
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Cyclic and ultimate load testing was conducted on the Arthrex LoopLoc™ Knotless Suture and submitted in this Traditional 510(k). Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications. The test data demonstrates that the proposed device can maintain knotless integrity and withstand cyclic loads greater than anticipated during the rehabilitation period following arthroscopic hip surgery. The specific hip capsular closure indication does not increase risk greater than the previously cleared general soft tissue approximation with respect to improper selection and use, suture breakage, and adverse tissue reaction. Therefore, the proposed device is substantially equivalent to the cleared Arthrex suture devices for soft tissue approximation. Based on the intended use, technological characteristics, and the bench testing submitted, Arthrex, Inc. has determined that the proposed device is substantially equivalent to the currently marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
October 25, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
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
1
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
2
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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3
510(k) Summary
| Date Prepared | October 19, 2021 |
|---|---|
| Contact Details | Arthrex, Inc. |
| 1370 Creekside Boulevard Naples FL 34108 US | |
| 239-598-4302 | |
| Ms. Lai Saeteurn | |
| Lai.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 Suture |
| K041553: Arthrex Suture Grafting Kit | |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for the |
| Arthrex 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 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. | |
| Indications for Use | The Arthrex LoopLoc™ Knotless Suture is intended for soft-tissue approximation for |
| hip capsular closure. | |
| Indications for Use | |
| Comparison | The Arthrex LoopLoc™ Knotless Suture is indicated for hip capsular closure whereas |
| the predicate devices are indicated for soft tissue approximation and/or ligation. | |
| However, the intended use, soft tissue approximation, remains unchanged. | |
| Technological | |
| Comparison | The Arthrex LoopLoc™ Knotless Suture has the same intended use, materials, |
| biocompatibility profile, packaging configuration, shelf-life, and sterilization method | |
| as the cleared predicate devices. Any technological differences between the | |
| proposed and predicate devices are considered minor and can be mitigated by cyclic | |
| and ultimate load testing performed using clinically relevant parameters. Therefore, | |
| the proposed device is substantially equivalent to the predicate devices. | |
| Non-Clinical and/or | |
| Clinical Tests Summary | |
| & Conclusions | Cyclic and ultimate load testing was conducted on the Arthrex LoopLoc™ Knotless |
| Suture and submitted in this Traditional 510(k). | |
| Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the | |
| device meets pyrogen limit specifications. | |
| The test data demonstrates that the proposed device can maintain knotless integrity | |
| and withstand cyclic loads greater than anticipated during the rehabilitation period | |
| following arthroscopic hip surgery. The specific hip capsular closure indication does | |
| not increase risk greater than the previously cleared general soft tissue | |
| approximation with respect to improper selection and use, suture breakage, and | |
| adverse tissue reaction. Therefore, the proposed device is substantially equivalent to | |
| the cleared Arthrex suture devices for soft tissue approximation. | |
| Based on the intended use, technological characteristics, and the bench testing | |
| submitted, Arthrex, Inc. has determined that the proposed device is substantially | |
| equivalent to the currently marketed predicate devices. |