(87 days)
Fiber One is a fiber optic delivery device intended for use with the GreenLight™ XPS Laser System for its FDA cleared indications for use.
Fiber One is a fiber optic delivery device that is supplied as a sterile, single-use device. Fiber One is intended for use with the GreenLight XPS Laser System for its FDA cleared indications for use. It can access the tissue in multiple planes. Fiber One is a liquid cooled delivery device which enables the delivery of up to 180W of power and aids in maintaining a clear environment at the fiber cap.
Fiber One features a side firing mechanism delivering up to 180W of 532nm light to tissue. Fiber One can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Fiber One will deliver 532nm laser energy from a compatible laser console (GreenLight XPS Laser System) to tissue during surgical procedures, including photoselective vaporization of the prostate for benign prostatic hyperplasia (BPH).
The provided text describes a medical device, "Fiber One," and its 510(k) premarket notification. However, it does not contain any information regarding specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies as requested in your prompt.
The document focuses on:
- Device Information: Description of Fiber One as a fiber optic delivery device for use with the GreenLight XPS Laser System.
- Predicate Device: Stating substantial equivalence to the 2090 Fiber (K062719).
- Intended Use and Indications for Use: General surgical applications and specifically for photoselective vaporization of the prostate for BPH.
- Substantial Equivalence Determination: Mentioning "bench and animal testing" but without details of the studies, their results, or how they meet specific acceptance criteria.
- FDA Clearance Letter: Confirming the 510(k) clearance based on substantial equivalence.
Therefore, I cannot populate the table or answer most of your specific questions from the provided text. The document states "All necessary bench and animal testing was conducted on Fiber One to support a determination of substantial equivalence to the predicate device," but it does not elaborate on what that testing entailed, what the acceptance criteria were, or the performance outcomes.
If you have other documents that provide technical reports, study designs, or performance data for Fiber One, I would be able to extract the requested information.
§ 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.