(36 days)
Intended for use in the treatment of ocular pathology in both the posterior and anterior segments.
Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:
- proliferative and nonproliferative diabetic retinopathy .
- macular edema .
- choroidal neovascularization .
- branch and central retinal vein occlusion .
- age-related macular degeneration .
- . lattice degeneration
- retinal tears and detachments .
- iridotomy, iridectomy and trabeculoplasty in angle closure and open angle . glaucoma.
The PASCAL Photocoagulator is an integrated system comprising of solid state aiming and treatment lasers, control electronics, graphical user interface, slit-lamp and table. It is intended for use in the treatment of ocular pathology in both the posterior and anterior segments.
The proposed PASCAL Photocoagulator includes design modifications to the performance specifications, available scan patterns, outer housing and software to enhance product performance. No changes to the laser or the product safety have been made. The PASCAL Photocoagulator maintains the same indication for use as the predicate device, the PASCAL Photocoagulator (K043486).
The provided text does not contain information about acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) premarket notification for the PASCAL Photocoagulator, seeking substantial equivalence to a predicate device.
The relevant sections indicate:
- Intended Use and Product Description: The device is intended for use in the treatment of ocular pathology.
- Substantial Equivalence: The manufacturer asserts that the proposed PASCAL Photocoagulator is substantially equivalent to a predicate device (K043486) in terms of function, intended use, and physical characteristics.
- Testing in Support of Substantial Equivalence Determination: "All necessary bench testing was conducted on the proposed PASCAL Photocoagulator to support a determination of substantial equivalence to the predicate device."
This documentation focuses on establishing equivalence rather than demonstrating performance against specific clinical acceptance criteria through a dedicated study. Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth, expert involvement, adjudication, or MRMC/standalone studies is not provided in the given text.
§ 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.