(90 days)
The Clarus Straight Firing Laser Fiber and the Clarus Side Firing Lasers Fiber are for use in general, urological, OB-GYN, orthopedic, and ENT laser surgical procedures for cutting, vaporizing, or coagulating in any soft tissue application for which Ho:YAG lasers have been cleared.
This 510(k) submission is a modification of the existing Clarus Model 1150 Lascr Fiber previously filed as K922881 and found to be substantially equivalent by the FDA on November 16, 1992. The original 510(k) device was a single-use, straight firing laser fiber with a fiber indicated for laser disc decompression where the laser is used to remove inner disc material. The laser fiber core ranges from 380 -- 600 microns. The modifications represented by this submission are the addition of a reusable fiber, a side firing version (Model 1160), increased indications for any soft tissue application for which Ho:YAG lasers have been cleared, and an increased laser fiber core size range from 200 – 1000 microns.
The Model 1150 Clarus Straight Firing Fiber is identical in materials, methods of manufacture, sterilization, and dimensions to the currently marketed Clarus Model 1150 Laser Fiber (K922881) with the following exceptions. These exceptions are: making the fiber assembly reusable, increasing the range of the laser fiber core size from 380 - 600 microns to 200 - 1000 microns, and the indications for use. The distal end is polished flat and the laser energy is transmitted in a forward direction. The low OH fiber is terminated on the proximal end with a standard compatible laser connector. These devices consist of an optical fiber, which may be contained in a catheter tube, cannula. needle, handpiece or handle.
The Model 1160 Clarus Side Firing Laser Fiber is built identical to the Model 1150 Clarus Straight Firing Fiber listed above with the following exceptions. The exceptions being that the entire working length of the fiber is in a protective sheath and the distal end is polished at an angle, and then terminated in a quartz. cap. The distal tip includes an exit beam indicator that is easily visible to the operator when the fiber is placed through an endoscope. On the proximal end, the low OH fiber is terminated with a standard compatible laser connector.
The Clarus Model 1150 Straight Firing and the Clarus Model 1160 Side Firing Laser Fibers are supplied sterile (ETO) and are intended for reuse.
The Clarus Straight Firing and the Clarus Side Firing Laser Fibers may be used both intraoperatively and percutaneously through regulatory cleared delivery systems.
The provided text does not contain information related to acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
The document is a 510(k) summary for laser fibers, detailing general information, predicate devices, intended use, and device description. It also includes the FDA's substantial equivalence letter. There is no mention of a clinical or performance study with defined acceptance criteria.
Therefore, I cannot fulfill your request for these specific details based on the provided input.
§ 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.