(214 days)
The Conceptus FTCM System is intended for use in selective catheterization/cannulation of the fallopian tubes in order to evaluate proximal tubal occlusion or patency under direct visualization.
The FTCM System combines well-established procedures of HSG, co-axial catheterization and microendoscopy. The FTCM System is composed of the following components: Soft Seal Cervical Catheter, Soft Torque Uterine Catheter and Accessory Valve, and/or Articulating Tip Hysteroscope, Variable Softness Catheter, guidewires: the Robust Guidewire, the Traveler Guidewire, the Supple Guidewire and the Pirouette Guidewire, and a Microendoscope with Eyepiece.
The provided text describes a medical device, the FTCM System, and states its intended use. However, it does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria.
The document focuses on:
- Device Description: Detailed breakdown of each component of the FTCM System (Catheters, Hysteroscope, Guidewires, Microendoscope, Eyepiece).
- Indications for Use: What the device is intended for (selective catheterization/cannulation of fallopian tubes to evaluate occlusion or patency under direct visualization).
- Substantial Equivalence: A statement that the FTCM System is substantially equivalent to a previous system (Conceptus FTC System) based on "comparative performance testing" related to "force required to navigate the fallopian tube model" and further "performance testing and clinical data."
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving the device meets them based on the provided text. The text mentions "comparative performance testing" and "clinical data" but gives no specifics about the acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement for those tests.
§ 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.