(125 days)
The Medrobotics Flex® Robotic System is intended to provide robot-assisted control of the Flex® Transabdominal Drive.
The Flex® Transabdominal Drive is intended to be used with ancillary equipment for endoscopic surgery. The Flex® Transabdominal Drive is indicated to provide robot-assisted visualization within the thoracic and abdominal cavities including female reproductive organs.
This instrument must not be used for observation of the heart and must not contact the heart or any area near the heart. This instrument must not contact with any device or therapeutic accessory that contacts the heart or any area near the heart.
The Flex® Robotic System and Flex® Transabdominal Drive make up the Flex Robotic Transabdominal System. The system includes three (3) major components: Flex Console; Flex Cart/Base; and Flex Transabdominal Drive with camera. The Flex console is the primary user interface for controlling functionality of the Flex Transabdominal System. The Flex Cart/Base positions and manipulates the Flex Transabdominal Drive. The Flex Camera is a sterile, reusable component that is attached to the Flex Transabdominal Drive. The Flex Transabdominal Drive is attached to the Flex Base and is introduced to the patient through a commercially available trocar. The physician provides input to manipulate the Flex Transabdominal Drive via the Physician Controller located on the Flex Console. The input from the Physician Controller generates the desired motion in the Flex Base resulting in driving and articulation of the endoscope inside the patient's anatomy. Manipulation of available camera controls allows the physician to achieve appropriate visualization of the target site. The Flex® Robotic Transabdominal System is an operatorcontrolled flexible endoscope that provides the benefits of both a rigid endoscope and a computer-assisted controller. The Flex® Robotic Transabdominal System is a software-controlled device. The Flex® Robotic Transabdominal System allows for the endoscope to be introduced via an operator-controlled user interface easily providing visualization of structures in the thoracic and abdominal cavities, including female reproductive organs. Visualization is provided by a 3D camera attached at the distal end of the endoscope. The Flex® Robotic Transabdominal System is intended for professional use only in a hospital setting. The Flex® Robotic System is provided non-sterile and reusable. The Flex® Transabdominal Drive is provided sterile through EtO sterilization and is intended for single patient use. The patient-contacting components of the proposed system are all composed of biocompatible materials.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Medrobotics Flex® Robotic System and Flex® Transabdominal Drive, guided by your requested information points.
Important Note: The provided document is a 510(k) summary for a medical device. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a novel device's effectiveness through large-scale clinical trials in the same way a drug or a Class III device might. Therefore, many of your requested points (like MRMC studies, training set details for AI, and explicit "acceptance criteria" presented as targets for the device's performance vs. reported performance) are not typically included in this type of submission. The "acceptance criteria" for a 510(k) device are generally that it performs comparably or better than the predicate device in relevant non-clinical tests.
Description of Acceptance Criteria and Study:
The Medrobotics Flex® Robotic System and Flex® Transabdominal Drive (collectively, the Flex® Robotic Transabdominal System) demonstrated substantial equivalence to its predicate device, the Olympus LTF-190-10-3D, Endoeye Flex 3D Deflectable Videoscope [K123365], through a series of non-clinical performance tests. The acceptance criteria are implicitly met by demonstrating that the device performs equivalently or acceptably within established medical device standards and compared to the predicate.
1. A table of acceptance criteria and the reported device performance
As explained, a 510(k) emphasizes substantial equivalence through comparison to a predicate device and adherence to recognized standards. The following table extracts relevant performance characteristics and reported values. Explicit "acceptance criteria" are not given as numerical targets in this document, but rather a demonstration of performance consistent with the predicate and relevant standards.
| Characteristic | Acceptance Criteria (Implied / Comparator) | Reported Device Performance (Flex® Transabdominal System) |
|---|---|---|
| Resolution | Comparable to predicate; meets medical endoscope standards (BS ISO 8600-1) | 12.5 lp/mm @ 30mm; 5.5 lp/mm @ 80mm |
| Working Distance | Meets clinical needs for laparoscopic visualization (implicitly 30-80mm) | 30 – 80 mm |
| Distortion | Acceptable for clear visualization; meets medical endoscope standards (BS ISO 8600-1) |
§ 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.