(140 days)
The "TissueBags" are intended for safe collection and removal of specimen, such as appendix, gallbladder, myoma, cysts, ovaries, fibroid tumours and other tissues, and calculi during surgical procedures.
The TissueBags are intended as receptacles for safe collection and removal of specimen during surgical procedures. Removal is accomplished by positioning the bag that serves as a receptacle for the specimen, close to the specimen that is intended to be removed. The bag opens, and the feeding-mouth is kept open automatically. Closure of the filled bag is done either by pulling back the complete device, or by pulling back an integrated purse string only.
The TissueBags comprise various types of retrieval bags, which share similarities of the basic functional principle, materials, Sterile-Barrier-Packaging, delivery status and sterilisation method. The TissueBags differ in the size of their bag (loading capacity), the availability of an integrated handle, respectively the need for being connected to an A.M.I.-dock Applicator pre-operatively and the possibility to disconnect the filled bag from the instrument.
Each TissueBag consists of a bag, a suspension mechanism, a protection sleeve and a handle, that is either an integrated part of the device or attached in terms of an A.M.I.dock Applicator. One type of the TissueBags is additionally equipped with a purse string.
All TissueBags are designed to be applicable with 10 mm ports for minimally invasive surgery. They are disposable, delivered sterile as single use devices. Their Sterile-Barrier-Packaging consists of two independently sealed pouches made from Tyvek and PET-foil. Sterilisation by means of Radiation guarantees a Sterility Assurance Level of 10° Biocompatibility evaluation has shown the TissueBags to meet the requirements of ISO 10993-1.
This document does not contain the information required to populate the table and answer the questions related to acceptance criteria and device performance studies. The provided text is a 510(k) summary for a medical device called the "A.M.I. TissueBag System," and it primarily focuses on:
- Device description: How the TissueBag functions and its components.
- Comparison to a predicate device: Stating substantial equivalence in design, principle, and clinical effectiveness to a previously marketed device.
- Regulatory information: Classification, regulation number, and FDA's determination of substantial equivalence.
- Indications for Use: The intended surgical procedures and types of specimens the device is designed for.
There is no mention of specific acceptance criteria, performance metrics, a study to demonstrate these criteria are met, sample sizes, expert involvement, or any form of clinical or standalone algorithm performance evaluation. The document states that "The TissueBags provoke no new safety or effectiveness issues when used as intended," implying reliance on the predicate device's established safety and effectiveness rather than new performance studies for this specific 510(k).
Therefore, I cannot provide the requested information from the given text.
However, if you would like to see a hypothetical example of how this information would be presented if it were available for a different type of device (e.g., an AI-powered diagnostic device), please let me know.
§ 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.