(75 days)
The Ivalon® Instrument Wipe and PVA Knife Cleaning Block are used to clean surgical instruments and knives.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Ivalon Instrument Wipe and Ivalon Knife Cleaning Block. It does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria.
The document is a notification of an administrative change related to a previous substantial equivalence (SE) determination, and the initial SE letter itself. These documents confirm that the devices are substantially equivalent to devices marketed prior to May 28, 1976, or reclassified devices, and therefore can be marketed. They discuss regulatory compliance such as annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
Therefore, I cannot provide the requested information as it is not present in the given text.
§ 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.