(57 days)
For use in removing smoke from laser and/or electrosurgical procedures.
Edge Systems Sterile Tubing (Accessory Device Name:
This document is a 510(k) clearance letter from the FDA to Edge Systems Corporation for their "Edge Systems Sterile Tubing" device. It does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.
Therefore, I cannot fulfill your request for the detailed information outlined (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set size/ground truth establishment).
The document merely states that the device is substantially equivalent to legally marketed predicate devices for its intended use: "For use in removing smoke from laser and/or electrosurgical procedures." This clearance is based on the device meeting general controls provisions and compliance with Good Manufacturing Practice for Medical Devices.
§ 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.