(97 days)
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No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI/ML or data-driven analysis.
No.
The device facilitates soft tissue repair by deploying implants and suture; it does not directly treat a disease or condition itself.
No
Explanation: The device is described as an implantable suture retention device used for repairing meniscal tears, not for diagnosing conditions. Its function is to facilitate soft tissue repairs by deploying implants and suture.
No
The device description clearly states it is a "hand held, disposable device" that deploys "implants and suture," indicating it is a physical, hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The ConMed Linvatec Sequent™ Meniscal Repair Device is an implantable suture retention device used to physically repair meniscal tears. It is a surgical tool and implant, not a device that analyzes biological samples.
- Intended Use: The intended use clearly states it "facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears." This is a therapeutic/surgical function, not a diagnostic one.
The information provided describes a surgical device used for repair, not a device used for testing or diagnosis.
N/A
Intended Use / Indications for Use
The ConMed Linvatec Sequent™ Meniscal Repair Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.
Product codes
GAT, MBI
Device Description
The ConMed Linvatec Sequent™ Meniscal Repair Device is an all-inside meniscal repair device that sequentially deploys implants and suture. This device allows the surgeon to generate multiple stitches in order to create fixation points along a soft tissue tear. The hand held, disposable device, provided sterile for single use, is removed at the end of the repair leaving behind a suture/implant construct. The implant encompasses a cleat which retains the suture and allows the knotless feature.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
ConMed Linvatec conducted verification and validation testing including cyclic loading characteristics, ultimate fixation strength of meniscal repairs, functional system testing, material degradation, risk analysis and packaging/transportation qualification. Based on this testing, we have determined that the device is safe and effective and performs as well as or better than the legally marketed predicate devices identified in Section D of this summary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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510(k) SUMMARY ConMed Linvatec
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec is hereby submitting the 510(k) Summary of Safety and Effectiveness for the 510(k) Number