(23 days)
The specimen retrieval bag has application for safe, convenient removal of tissue specimens such as the appendix, an ectopic pregnancy, gallbladder, gallstones, lymph nodes, ovaries, small sections of bowel and other tissue structures.
The ReliaCatch™ 10mm Specimen Retrieval Bag and ReliaCatch™ 12mm Specimen Retrieval Bag consist of a long cylindrical tube and a rip-stop nylon bag that encapsulates and contains specimens for removal from the body cavity. The device contains a handle used to retract and deploy the bag. The specimen bag is designed for introduction and use through all appropriately sized trocar sleeves.
The provided text describes a 510(k) premarket notification for the ReliaCatch Specimen Retrieval Bag, comparing it to a predicate device. However, it does not contain the detailed acceptance criteria for the device's performance, nor does it present a study proving the device meets specific acceptance criteria in a structured manner.
The document primarily focuses on establishing substantial equivalence to a predicate device based on device description, intended use, and a general summary of performance data. It lists types of performance tests conducted but does not provide the quantitative acceptance criteria or the specific results.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or training set information. This information is not present in the provided document.
The document states:
- "Summary of testing includes description of test methods, sample size, acceptance criteria, and pass/fail results. Objective acceptance criteria were defined for each test."
- "Performance testing included: Leak Rate Evaluation, Trocar Insertion Force, Trocar Removal Force, Pouch Deployment Force, Pouch Retraction Force, Pouch Cinch Force, Pouch Burst Pressure, Human Factors/Usability"
This indicates that such information exists but is not detailed within this FDA letter or the included 510(k) summary.
§ 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.