(175 days)
The Medline Surgical Sponge Scanning System is intended to be used to augment current sponge counting practice by providing a means to electronically detect potentially retained springes,
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Medline Surgical Sponge Scanning System. It does not contain information about acceptance criteria, study design, or device performance metrics.
Therefore, I cannot answer your request based on the provided input. The document mainly states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing.
§ 880.2740 Surgical sponge scale.
(a)
Identification. A surgical sponge scale is a nonelectrically powered device used to weigh surgical sponges that have been used to absorb blood during surgery so that, by comparison with the known dry weight of the sponges, an estimate may be made of the blood lost by the patient during surgery.(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 § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.