(90 days)
Indicated for cutting, coring and extracting tissue in operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures such as nephrectomy, and laparoscopic gynecologic procedures such as myomectomy and hysterectomy.
The modified Laparoscopic Morcellator is comprised of two major components: the Laparoscopic Morcellator and the Motor Drive Unit (MDU). The Gynecare Laparoscopic Morcellator is a disposable device which is provided sterile. It is essentially a rotating, cylindrical (tubular) razor blade, with a blade guard, which allows tissue to be grasped with a standard grasper type instrument extending through the central lumen of the device and then drawn up inside the rotating cutter as the cutter cuts with a coring action. The cutting is powered by the Gynecare Laparoscopic Motor Drive Unit (MDU) via a flexible drive cable (see drawing). The physician can turn the Gynecare Laparoscopic Morcellator on and off via a foot pedal. The direction and speed of rotation are controlled on the face of the MDU by a nurse outside the sterile field. The variable-speed, reversible MDU is an integral part of the Gynecare Laparoscopic Morcellator since it drives the rotation of the cutter/Morcellator at a controlled speed and torque. The Gynecare Motor Drive Unit provides a user-selectable speed range at which to drive (rotate) the cutter/Morcellator. The torsional output of the motor is sufficient at all speeds to drive the cutter while cutting tough tissue. The direction of rotation of the motor is user-selectable.
The provided text describes the 510(k) summary for the Gynecare Laparoscopic Morcellator. However, it explicitly states that no performance data, nonclinical laboratory data, or clinical data were deemed necessary to support this premarket notification. The submission relies on substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details (sample size, provenance, experts, adjudication, MRMC, standalone performance), or ground truth establishment.
The document only states:
| Information | Description |
|---|---|
| Predicate Device Name: | Gynecare Laparoscopic Morcellator |
| Technological Characteristics: | The modified device has identical technological characteristics to the predicate device. |
| Performance Data: | Nonclinical laboratory was deemed unnecessary. |
| Clinical Data: | No clinical data was deemed necessary to support this premarket notification; however, published literature is available to support the use of a laparoscopic morcellation device for laparoscopic hysterectomies. |
| Conclusions: | Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug, and Cosmetic Act. |
Since no new performance data was generated for this 510(k) submission, the requested details about acceptance criteria and the study proving device performance are not available in the provided text. The approval was based on the device being substantially equivalent to an existing legally marketed device.
§ 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.