(85 days)
The family of impervious bags for endoscopic retrieval of tissue are single-use The family of importantes for the collection and extraction and extraction of tissue during laparoscopic surgical procedures. The family includes three sizes of impervious bags for the endoscopic retrieval of tissue: NUBERT (a new bag for the endoscopic retrieval of tissue), ALBERT (a large bag for the endoscopic retrieval of tissue), and HUBERT (a huge bag for the endoscopic retrieval of tissue).
Single-use disposable device used as a receptacle for the collection and extraction of tissue during laparoscopic surgical procedures.
This document appears to be a 510(k) summary for a medical device (laparoscopic specimen retrieval bags). It does not contain the kind of detailed study information (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, etc.) that would be required to answer your specific questions about device performance and its proof through a study.
The provided text focuses on:
- Administrative details: Applicant, contact person, preparation date, trade name, common name, classification, predicate devices.
- Device description: Single-use disposable device for tissue collection and extraction during laparoscopy.
- Intended Use: Specifies the purpose and the different sizes of the bags.
- Substantial Equivalence: States that the device is substantially equivalent in design and materials to predicate devices.
- FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence.
- Indications for Use form: Reiterates the intended use.
Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria and the study proving device performance because that information is not present in the provided text.
This type of 510(k) submission typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive de novo clinical study data with specific performance metrics and acceptance criteria for this particular device's clinical efficacy. While performance testing (e.g., burst strength, material compatibility) would have been conducted for the submission, the specific details of those tests (acceptance criteria, sample sizes, ground truth, etc., as you've requested) are not usually included in the public 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.