(29 days)
The Smith & Nephew ULTRA FAST-FIX Meniscal Repair Systems and ULTRA FAST-FIX AB Meniscal Repair Systems are intended for use as suture retention devices to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair and gastrostomy.
The Smith & Nephew ULTRA FAST-FIX and ULTRA FAST-FIX AB Meniscal Repair Systems are all-inside meniscal repair devices. Each device includes two implants, pre-tied with #0 nonabsorbable suture pre-loaded into a needle delivery system. The FAST-FIX Meniscal Repair System is provided sterile for single use only.
The provided text describes the 510(k) summary for the ULTRA FAST-FIX Meniscal Repair System and ULTRA FAST-FIX AB Meniscal Repair System. It does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria.
Instead, it states that the device is "substantially equivalent" to predicate devices (Smith & Nephew FAST-FIX and FAST-FIX AB Meniscal Repair Systems) in terms of intended use, fundamental scientific technology, and performance. The summary mentions "Performance testing demonstrates that the soft tissue repair achieved using ULTRA FAST-FIX and ULTRA FAST-FIX AB is substantially equivalent to repair achieved with currently marketed meniscal repair devices. Performance testing also affirms that ULTRA FAST-FIX and ULTRA FAST-FIX AB offer substantially equivalent suture sliding characteristics compared to the predicate FAST-FIX and FAST-FIX AB devices."
However, it does not provide:
- A table of specific acceptance criteria and reported device performance values.
- Sample sizes for test sets, data provenance, or details about the study design.
- Information about expert involvement for ground truth, adjudication methods, or MRMC studies.
- Details about standalone algorithm performance if relevant (this is a medical device, not an AI/algorithm).
- The type of ground truth used, or sample sizes and ground truth establishment for a training set.
The document focuses on establishing substantial equivalence to previously cleared devices rather than presenting detailed performance data against pre-defined acceptance criteria for a new type of study.
§ 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.