(59 days)
The Laser Ureteral Catheter is intended for protection and delivery of a laser fiber in the urinary tract.
The Laser Ureteral Catheter is a single lumen catheter available in a diameter of 7.1 French and a length of 40 centimeters. The Laser Ureteral Catheter is manufactured from polyethylene tubing, with a proximal female Luer lock adapter and connector cap, and male Luer lock adapter and connector cap with a cap seal. The device is provided sterile and intended for one-time use.
The provided document is a 510(k) summary for the Cook Incorporated Laser Ureteral Catheter. It describes the device, its indications for use, and its comparison to predicate and reference devices, along with performance and biocompatibility data. However, it does not contain a detailed study proving the device meets specific acceptance criteria with the information requested for AI/ML device studies. This document pertains to a physical medical device, not an AI/ML powered device.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies in the context of an AI/ML device. The document explicitly states:
- No AI/ML Component: The device described, a "Laser Ureteral Catheter," is a physical medical device for protecting and delivering a laser fiber in the urinary tract. There is no mention of any AI or machine learning components.
- Performance Data Scope: The "Performance Data" section discusses:
- Compatibility and Dimensional Testing
- Tensile Strength
- Radiopacity
- Kink Radius
- Biocompatibility (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity)
These tests are standard for physical medical devices and do not involve the types of studies or metrics (e.g., AUC, sensitivity, specificity for classification tasks, or error rates for predictive tasks) relevant to AI/ML device evaluations.
Thus, a table of acceptance criteria and reported device performance in the context of AI/ML, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies, is not present in this document because it is not applicable to the device type.
§ 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.