(49 days)
The LT-300 Digital Colposcope is intended for the magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and select areas for biopsy. The image can be viewed on a color screen or computer monitor and printed on a color printer. The device is intended to be used in hospitals and clinics.
Not Found
This document, primarily a 510(k) clearance letter and an "Indications for Use" statement, does not contain the detailed study information or acceptance criteria for the LT-300 Video Colposcope.
The provided text only states that the device is "substantially equivalent" to legally marketed predicate devices. This substantial equivalence determination typically relies on demonstrating that the new device has the same intended use as a predicate device and has similar technological characteristics (or, if different, that the differences do not raise new questions of safety and effectiveness).
Therefore, I cannot provide the requested information from the given text. A 510(k) summary or the full 510(k) submission would be required to find details about performance testing, acceptance criteria, study methodologies, and ground truth establishment.
§ 884.1630 Colposcope.
(a)
Identification. A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.(b)
Classification. Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.