(27 days)
The MegaBeam Endocular Probe and Aspirating Endocular Probe are intended for intraocular photocoagulation with or without simultaneous aspiration/ irrigation as an adjunct to vitrectomy surgery. Specific indications include the treatment of proliferative vitreoretinopathy, tractional retinal detachments, proliferative diabetic retinopathy, and various retinal vascular tumors.
The provided text explicitly states that no performance testing was included in the submission for the MegaBeam Endocular Probe and Aspirating Endocular Probe. The submission relies on the established and documented performance of its predicate devices due to similar components, design, and only a small change in tip size (19 gauge to 25 gauge).
Therefore, there is no information available in the provided document to answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, or ground truth establishment for this particular device submission.
The relevant sentence is: "Since the performance of the MegaBeam Endocular Probe and Aspirating Endocular Probe is well established and documented no performance testing is being specifically included in this submission."
§ 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.