(139 days)
The intended use of the New Device is to establish a path of entry for minimally invasive instruments. The instrument is intended for creating secondary ports under direct visualization.
The TRISTAR TM LP Trocar with Low Profile Threaded Sleeve has application in thoracic, general, gynecologic, or other minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments. The instrument is intended for insertion under direct visualization for secondary port locations.
The TRISTAR TM LP Trocar with Low Profile Threaded Sleeve consists of two main sub-assemblies: an obturator sub-assembly and a sleeve sub-assembly.
The obturator consists of a sharp pyramidal tip and a spring loaded safety shield. The safety shield is designed to cover the pyramidal tip to protect internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered.
The sleeve subassembly has an inner gasket seal and an outer gasket seal to maintain pneumoperitoneum when instrumentation is inserted and withdrawn through cannula during a surgical procedure. Integral threads along the outside diameter of the cannula portion of the sleeve provide a retention mechanism to stabilize the sleeve in tissue.
The TRISTAR TM LP Trocar with Low Profile Threaded Sleeve shall be provided in a variety of sizes from 3mm to 12mm in diameter and 65mm to 150mm in length.
This device is designed to create secondary trocar sites and is labeled to be used only under direct visualization of the insertion site.
This document is a 510(k) summary for a medical device (TRISTAR LP Trocar with Low Profile Threaded Sleeve) and does not describe a study involving an AI/ML powered device. Therefore, it does not contain the specific information required to answer the prompt. The provided text outlines the device description, intended use, indications, and mentions pre-clinical laboratory evaluations to ensure acceptable performance compared to a predicate device.
Specifically, the document states:
- Performance data: "Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. The studies demonstrated acceptable performance to the Predicate Device in mating the obturator with the sleeve, insertion into the operative cavity, removal of the obturator from the sleeve, security of the sleeve in tissue, and maintenance of pneumoperitoneum of the operative space."
However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts.
- Adjudication method.
- MRMC comparative effectiveness study with effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size.
- How ground truth for the training set was established.
This information is typically found in submissions for AI/ML devices, not for a traditional mechanical surgical instrument as described here.
§ 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.