(20 days)
The Manan™ Accura needle is intended for use as a needle localization of breast lesions.
This needle is made in various gauges from 20 to 21 ga, and in various lengths from 3 to 15 cm. It is composed of an outer cannula essentially identical to the standard hypodermic needle and an inner stylet spring wire with an overbent tip.
The provided document is a 510(k) summary for the Manan™ Accura Needle, a spring hook localization needle. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about studies related to device performance or acceptance criteria in the context of a diagnostic AI device.
Therefore, I cannot provide the requested information, such as acceptance criteria, reported device performance, details of a study with sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set size. This document describes a physical medical device (a needle) and not an AI or diagnostic software.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.