(51 days)
The GYNECARE MORCELLEX Tissue Morcellator is intended for gynecologic, urologic and general surgical endoscopic use by trained professionals in hospital environments and ambulatory surgery centers.
The GYNECARE MORCELLEX Tissue Morcellator is indicated for cutting, coring, and extracting tissue during operative laparoscopy including laparoscopic general surgical procedures, laparoscopic urologic procedures, and laparoscopic gynecologic procedures.
The GYNECARE MORCELLEX™ Tissue Morcellator is a single-use device. The device is inserted into the patient with the use of the provided single-use obturator. The device allows tissue to be grasped with a standard grasping instrument extended through its central lumen. The tissue can be drawn up inside the device's central lumen into the inner stationary sheath as the exposed blade cuts the tissue. The physician can activate the GYNECARE MORCELLEX™ Tissue Morcellator via a foot pedal or via the dual-function Blade Guard / Activation Trigger on the device's detachable handle. The device can operate in either coring or peeling mode based on the degree of exposure of the blade and placement of the rotatable coreguard. The device is packaged with a single-use reducer cap to allow the optional use of a 5mm instrument.
The provided text describes a 510(k) summary for the GYNECARE MORCELLEX™ Tissue Morcellator, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a dedicated study proving a device meets specific performance criteria.
The "Performance Data" section explicitly states: "The bench testing data, including insertion and extraction forces, provided in this 510(k) demonstrates that the corrective action on the device design addresses the root cause of device failure." This indicates testing was done related to a "root cause of device failure" for a previous version of the device (K061050), and not necessarily to establish new performance criteria for the current device's intended use in comparison to a defined clinical or performance benchmark.
Furthermore, the "Clinical Data" section states: "This 510(k) does not rely on clinical data to demonstrate substantial equivalence."
Therefore, based solely on the provided text, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria, as such a study with the specified details (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance) is not described.
The document primarily focuses on demonstrating that the technological characteristics of the current device are identical to its predicate, and that previous bench testing (related to a corrective action) was sufficient for the 510(k) clearance process.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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.