(79 days)
The FlexGuard Family of sheath's are intended for use in surgical procedures using flexible scopes and other approved flexible or rigid fiber optic delivery devices, to protect the working channel from damage when a laser fiber is introduced and also to provide irrigation to the surgical site when used for incision, ablation, vaporization and coagulation of soft tissue with any approved laser with a wavelength from 532nm to 2100nm in medical specialties including: Urology, Gasteroenterology, Thoracic, Head and Neck, Pulmonary, Gynecology, ENT and General Surgery
The FlexGuard is a family of flexible sheaths that are used to protect the working channel of a flexible scope or surgical device from mechanical damage when the laser fiber is introduced into the working channel. The tip of the FlexGuard is allowed to protrude approx 3mm beyond the laser fiber, this assembly is then inserted into the working channel of the scope. The FlexGuard Family is designed to work with a range of laser fibers from 200 micron to 600 micron diameter. It consists of: Flexible Sheath Fiber clamp/Yee piece
The provided text is a 510(k) summary for the FlexGuard device and a clearance letter from the FDA. It does not contain information about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of an AI/ML device.
The FlexGuard is a family of flexible sheaths designed to protect flexible scopes or surgical devices from mechanical damage when a laser fiber is introduced. It is a physical medical device, not an AI/ML diagnostic or prognostic tool. Therefore, the questions about acceptance criteria, study design parameters (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), and ground truth establishment (pathology, outcomes data) as they relate to AI/ML device performance are not applicable to this submission.
The document discusses the device's intended use, its components, and its substantial equivalence to a predicate device, which is typical for a 510(k) submission for a non-AI/ML device.
§ 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.