(16 days)
The Disposable Light Handle is a sterile product. It is intended to be used as an accessory to Surgical Lamps. This Disposable Handle provides a sterile interface between the operating room Surgical Lamp (non-sterile), and the Surgeon or Scrub Nurse (sterile)
Not Found
This document, an FDA 510(k) clearance letter for the "Disposable Light Handle and Adaptor," does not contain information about acceptance criteria for device performance, nor does it describe any study (clinical or otherwise) that proves the device meets such criteria.
The letter is a regulatory document confirming that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This means the FDA believes the new device is as safe and effective as a device already on the market, based on the information provided in the 510(k) submission.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, not on specific performance metrics or studies in the format you described.
§ 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.