(146 days)
The Beacon Bag Specimen Retrieval Bag System consists of a family of impervious bags that are sterile, single use, disposable devices having applications as a receptacle for the safe encapture and removal of tissue specimens, organs and calculi during laparoscopic surgical procedures that can be used alone or with a dedicated introducer system.
The Beacon Bag Specimen Retrieval Bags are comprised of an introducer tube with a blunt tip, flexible fiber reinforced plastic bag with a large, easily accessible opening. With the blunt tip the instruments can be introduced percutaneously to the intended surgical site directly through an opening in the abdomen or through a conduit cannula/trocar for sizes under 16 mm, after which the working portion of the instrument can be deployed. The deployment systems consists of either a push/pull rod with thumb ring (similar to a syringe), finger ring handle, or a back handle and a push button with an internal push rod, all instruments have a blunt tip nose used for direct insertion into the abdomen. In the fully deployed condition, the bag opening is maintained in an open position by metallic rings. A suture with a slipknot and perforations of the bag under where the bag is attached to the rings facilitates closure of the specimen bag after the specimen has been collected into the bag, the suture or purse string is connected to an external part (string ring).. The specimen bag has a series of perforations around the perimeter so when the purse string suture is pulled and the bag starts to cinch and separates from the metallic rings, this is accomplished by pulling the external string ring.
The larger sized Beacon Bag Specimen Retrieval Bags, 16mm and 20mm come with a side access tube which allows for additional access into the bag without compromising the integrity of the bag opening to visualize the specimen inside the bag. This is accomplished by using a 5 mm or less sized instruments and scopes to be introduced directly into the bag for additional visualization and manipulation where required.
The provided text describes a 510(k) premarket notification for the Beacon Bag Specimen Retrieval Bag System. This is a medical device clearance document, not a clinical study report for an AI model. Therefore, the document does not contain the information requested regarding acceptance criteria and study proving an AI device meets those criteria.
Specifically, the document discusses:
- Acceptance Criteria for a Physical Device: The document states "The Beacon Bag Specimen Retrieval Bag utilizes technologies that are currently found in legally marketed predicate devices. Based upon testing and comparison with the predicate devices, the Beacon Surgical Specimen retrieval bag system presents no additional adverse indications or results. We have found that the Beacon Bag Specimen Retrieval Bag system does not present any new risks to the patient and that it is safe and performs within its design specifications." This indicates the acceptance criteria are related to safety, performance within design specifications, and equivalence to predicate devices, which are typical for traditional medical devices.
- Study Proving Device Meets Criteria: The document mentions "The devices components being utilized from the predicate device K111845 have been subjected to and passed a variety of bench tests along with sterilization and aging. Additionally, the critical functions of the device have been tested for verification under protocol's BS-0101 and BS-0102 and have met the stated requirements." This refers to bench testing for a physical medical device, not a study involving AI model evaluation.
Therefore, I cannot provide the requested information in the form of the table and the detailed study parameters because the source material does not describe a study related to an AI device's performance against acceptance criteria. The document is for a physical specimen retrieval bag, not an AI or software as a medical device.
§ 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.