(124 days)
The Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices are intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as:
Submucous myomas
Endometrial Polyps
Retained products of conception
The Myosure Hysteroscopic Tissue Removal System consists of the following procedural components which are identical to those found in the predicate TRUCLEAR Morcellator System:
- Tissue Removal Drive System
- Tissue Removal Device
The Myosure Hysteroscopic Tissue Removal System uses mechanical resection to remove endometrial polyps and submucous myomas hysteroscopically from the uterus. Mechanical resection allows the surgeon to have precise control of the locations and extent of tissue resected by drawing the targeted tissue into the cutting window under suction while the inner blade cuts the tissue. There have been no major changes in design or materials in the subject Myosure System or its associated tissue removal devices since their market clearance.
This document is a 510(k) Summary for the Myosure Hysteroscopic Tissue Removal System. It describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or software.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device for the purpose of market clearance for an electromechanical medical device, not on evaluating the performance of an AI system against specific metrics.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. 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 § 884.9.