(56 days)
The Invuity® Eigr™ Surgical Illumination System is intended to provide surgical site illumination from a high intensity light source.
Not Found
The provided document is a 510(k) clearance letter for the Invuity® Eigr™ Surgical Illumination System. It indicates that the device is substantially equivalent to a predicate device and is intended to provide surgical site illumination.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).
Therefore, it is not possible to answer the user's request based on the provided text. The document is solely a regulatory approval letter and does not include the technical study details requested.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.