(154 days)
The ENT LaserVision is a device to be used in conjunction with the UN-L25 CO2 Laser in The ENI Laser Vision is a device to be used far computer membrane and Myringotomy .
Laser Otoscope, Device Model: ENT LaserVision
The provided text is a 510(k) premarket notification letter from the FDA to Union Medical USA regarding their ENT LaserVision device. This document primarily focuses on regulatory approval and does not contain the detailed information necessary to answer the questions about acceptance criteria and study design.
Specifically, the document states:
- It is a 510(k) review, which determines "substantial equivalence" to a legally marketed predicate device, rather than requiring new clinical efficacy or performance studies in the same way a PMA would.
- The device is a "Laser surgical instrument for use in general and plastic surgery and in dermatology" (K012071) and is classified as II.
- The "Indications for Use" for the ENT LaserVision are "to be used in conjunction with the UN-L25 CO2 Laser in The ENI Laser Vision is a device to be used far computer membrane and Myringotomy." This is a typo, and it likely intends to say "for tympanic membrane and Myringotomy".
Since this is a substantial equivalence determination, rigorous clinical trials with acceptance criteria, sample sizes, ground truth establishment, or expert reviews are typically not required as they would be for a PMA or novel device. The FDA's letter confirms substantial equivalence based on the information provided in Union Medical USA's 510(k) submission, which would compare the new device's technological characteristics and performance (e.g., laser power, wavelength, safety features) to a predicate device.
Therefore, I cannot extract the requested information from the provided text. The document does not describe a study that sets acceptance criteria or proves the device meets them in the way the questions imply for AI/diagnostic devices.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.