(357 days)
The Alexis® Contained Extraction System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation via an abdominal or vaginal approach.
The Alexis® Contained Extraction System is a sterile, single use tissue bag with a guard system component. The polyurethane tissue bag consists of a flexible ring, tabs, strap with a snap fastener, and an attached tether It is available in two models GTB14 and GTB17 with the following dimensions and volumes:
| Model | Ring Diameter | Volume |
|---|---|---|
| GTB14 | 14 cm | 3,400 mL |
| GTB17 | 17 cm | 6,500 mL |
The tissue bag is used to contain and isolate specimens for surgical removal and/or manual morcellation. The strap with snap fastener maintains the folded bag and flexible ring in a collapsed state during insertion. After the device is fully inserted and deployed into the abdominal or pelvic cavity, the opening of the bag returns to its original, circular shape, facilitating placement of the specimen in the bag. When the specimen is ready for removal and/or manual morcellation, the tether, tabs, and strap are used to maneuver the ring to the surface of the extraction site.
If the specimen requires manual morcellation. the ring may be repeatedly flipped to shorten the bag and consequently bring the specimen closer to the extraction site.
The guard system consists of a guard and a self-retaining retractor. The guard is composed of a coiled polyethylene material that conforms to the extraction site. The self-retaining retractor consists of two polyurethane rings connected by a polyurethane sheath and a tether attached to the inner ring. It helps anchor the guard at the extraction site. The guard system provides a robust barrier between the bag and sharp instruments.
The Alexis® Contained Extraction System can be inserted and retrieved either through an abdominal incision or through the vaginal canal and colpotomy. In both cases, manual morcellation is performed extracorporeally at the extraction site.
The provided text describes a 510(k) summary for the Alexis® Contained Extraction System. This notification focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific performance metrics and acceptance criteria for a new AI/software device.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample size for test sets (including provenance, expert qualifications, and adjudication methods), MRMC studies, standalone performance, ground truth establishment, and training set details cannot be extracted from the provided text.
The document details engineering tests related to the physical device's characteristics (biocompatibility, sterilization, shelf life, and functional performance) to support its substantial equivalence to an existing device, as opposed to clinical performance data against defined metrics for a diagnostic or AI-driven system.
The "Discussion of Performance Data" section refers to:
- Biocompatibility: Evaluation in accordance with ISO 10993-1 and FDA guidance.
- Sterilization/Shelf Life: Validation performed in accordance with ISO 11135-2.
- Functional Performance: Design Verification testing for various physical attributes (e.g., integrity of tissue bag, tether, guard system, resistance to penetration, ability to maintain a closed system, specimen capture). This also included "simulated use testing with the subject device in both an abdominal bench model and a vaginal bench model."
However, these are engineering and safety tests typical for a physical medical device, not performance studies as would be conducted for a diagnostic algorithm or AI system.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.