(23 days)
Contact Transscleral Cyclophotocoagulation (CYC) for the reduction of intra ocular pressure (IOP) in glaucoma patients. This ocular contact probe to be used with marketed (approved) infrared lasers for this procedure. Ablation of the Ciliary Body in glaucoma patients.
The TSX Probe consists of three basic parts; handgrip, tip and focusing lens and is a presterilized (Ethylene Oxide) disposable contact probe. Its tip is a clear amber medical plastic that is angled to match the curvature of the human eye and therefore allows for the placement of the probe vertically, closest to the limbus. The angle of the contact tip (distal end) conforms to the curvature of the eye. The three-meter 600 um fiber plugs into an HGM SmartScan™ laser or other SMA connection compatible device allows the physician to perform noninvasive contact CYC with marketed (approved) infrared lasers.
The provided text is a 510(k) summary for the TSX Probe, a laser delivery device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document. The 510(k) submission primarily focuses on establishing substantial equivalence to an existing legally marketed device, not on presenting detailed performance study results against specific acceptance criteria.
The submission is essentially a declaration that the TSX Probe is similar enough to the Iris G-Probe that it doesn't require a new, full pre-market approval process. It highlights similarities in fiber size, intended use (reduction of IOP in glaucoma patients via CYC), and compatibility with existing lasers.
The information you're asking for would typically be found in a more comprehensive clinical trial report or a detailed performance validation study, which is not included in this 510(k) summary.
§ 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.