(90 days)
The reusable MegaBeam Fiber Optic Delivery System is intended to vaporize, coagulate, and incise and excise tissue. The MegaBeam Fiber Optic Delivery System is also intended to be used in lithotripsy procedures with a Ho:YAG laser system. The reusable MegaBeam Fiber Optic Delivery System is an accessory to a Ho:YAG laser system.
The reusable MegaBeam Fiber Optic Delivery System is intended for use as an accessory to a Ho:YAG laser system to vaporize, coagulate, and incise and excise tissue, including lithrotripsy. The MegaBeam Fiber Optic Delivery System is also intended to be used in lithotripsy procedures with Ho:YAG laser systems.
The reusable MegaBeam Fiber Optic Delivery System has similar technological characteristics as its predicate devices. First, CeramOptec's reusable MegaBeam Fiber Optic Delivery System is intended for use with a Ho:YAG laser system. The Coherent SlimLine Delivery System also are intended for use with a Ho:YAG laser, and the company's cleared, disposable fiber optic delivery systems have been cleared for use with 1.44 YAG, Ho:YAG, KTP, Argon and Diode lasers.
Second, CeramOptec's reusable MegaBeam Fiber Optic Delivery System's fiber optical tip has a similar material composition as its predicate devices. Third, the reusable MegaBeam Fiber Optic Delivery System is available in four sizes: 200 micron, 365 micron, 550 micron and 1000 micron. The cleared Coherent SlimLine Laser Delivery System is available in the identical four sizes, and the cleared disposable MegaBeam Fiber Optic Delivery System is available in sizes ranging from 200 micron to 1200 micron.
Fourth, the reusable MegaBeam Fiber Optic Delivery System is available in the same tip shapes and handpiece configurations as the company's cleared disposable MegaBeam Fiber Optic Delivery System. Further, both the reusable MegaBeam Fiber Optic Delivery System and the predicate devices are prepackaged sterile and fit lasers which employ SMA 905 connectors or lasers which have suitable adapters to allow SMA 905 connectors to be used.
Finally, as with the Coherent's SlimLine Laser Delivery System, the reusable MegaBeam Fiber Optic Delivery System can be reused once the optical fiber tip is properly cleaned, inspected, stripped, and cleaved.
The provided 510(k) summary for CeramOptec's MegaBeam Fiber Optic Delivery System states "Performance Data: None required."
This indicates that no specific acceptance criteria or studies demonstrating device performance were deemed necessary for this particular device's clearance. The clearance was based on demonstrating substantial equivalence to predicate devices, rather than on new performance data.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details because these were not part of the submission for this 510(k) clearance.
§ 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.