(51 days)
The Scintillant light is intended to provide localized illumination of surgical sites.
The Scintillant Surgical Light is intended to provide localized illumination of surgical sites.
The Scintillant Surgical Light is an untethered, self-contained medical lighting device that allows illumination inside the surgical field. The light can be hand-held and is provided with accessories which allow it to be attached to almost any surgical tool or instrument.
The light is provided sterile and is battery powered. The light consists of light-emitting diode (LED) mounted on the end of a flexible wand. A single button turns the light on and off. A battery and circuit board are contained in the device handle.
This is a 510(k) premarket notification for the Scintillant Surgical Light, a surgical lamp. The provided documents establish substantial equivalence to predicate devices, but do not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary (K071180) merely states that:
- The Scintillant Surgical Light is an untethered, self-contained medical lighting device for illumination inside the surgical field.
- It's hand-held, sterile, battery-powered, and uses an LED on a flexible wand.
- Its intended use is to provide localized illumination of surgical sites.
- It is technologically similar to predicate devices (AtriCure Dissector, Light Port Surgical Illuminator, VersaLight Multi-Function Surgical Illuminator, LightMat Surgical Illuminator), all being sterile, hand-held, battery-powered surgical field illuminating devices with the same overall intended use.
- The conclusion is that the device is as safe and effective as the predicate device and does not raise any new questions regarding safety and effectiveness.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text. The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies with defined acceptance criteria and performance metrics for all new devices.
§ 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.