(90 days)
The family of IRIS Medical EndoProbe handpieces is intended for use in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye, the aspiration function is indicated for use when unwanted fluid is present in the eye causing refraction or scattering of the laser beam from the intended treatment site, and the illumination function is indicated for use to illuminate the interior of the eye. The handpieces are offered in straight or angled styles, and with a universal SMA connector that allows the family of EndoProbe handpieces to be used with compatible laser systems, such as IRIS Medical and Lumenis. The handpieces are cleared for use for the particular indications of the laser system to which they are attached.
The family of IRIS Medical EndoProbe handpieces is comprised of the following main components: a universal SMA style input connector, a glass fiber optic protected by a PVC (vinyl) jacket, a handle, and a medical grade stainless steel needle. The Illuminating EndoProbe has an additional illumination fiber optic with jacket.
This 510(k) premarket notification for the IRIS Medical® EndoProbe® Handpieces does not describe a study that uses acceptance criteria and reports device performance.
Instead, this submission focuses on demonstrating substantial equivalence to predicate devices already on the market. This means the manufacturer is asserting that their device is as safe and effective as existing legally marketed devices, primarily by comparing their intended use, materials, and performance characteristics to those predicates.
Therefore, I cannot provide the requested information about acceptance criteria, a performance study, sample sizes, ground truth, or MRMC studies, as these elements are not presented in this 510(k) summary.
The document states: "The family of IRIS Medical EndoProbe handpieces shares similar indications for use, materials, and similar performance characteristics as, and thus is substantially equivalent to, the currently marketed predicate devices." This is the core argument for clearance, rather than presenting a performance study against specific acceptance criteria.
§ 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.