(156 days)
Neuro sponge drains are used during surgery to protect brain tissue from trauma, absorb fluids and to act as a filter to aspirate.
Not Found
The provided documents are FDA letters regarding the 510(k) premarket notification for the "Ultracell Suction Sponge" (K972633 and K972634). These documents do not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
The letters from the FDA specifically state that the devices are substantially equivalent to legally marketed predicate devices, allowing them to proceed to market. This type of FDA clearance (510(k)) generally relies on demonstrating substantial equivalence to a predicate device rather than on the detailed clinical performance data often required for new higher-risk devices or premarket approval (PMA).
Therefore, based solely on the provided text, I cannot complete the requested tables and information. The document focuses on regulatory approval based on substantial equivalence, not on the detailed technical or clinical study data.
§ 886.4790 Ophthalmic sponge.
(a)
Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.