(29 days)
The US Endoscopy Endoscopic Suture Cutter Device is intended to be used in conjunction with an endoscope to grasp and cut suture in the GI tract.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device called "The US Endoscopy Endoscopic Suture Cutter Device." This type of document primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for market.
Crucially, 510(k) notifications do not typically include detailed studies or acceptance criteria for device performance in the way that a PMA (Pre-Market Approval) or clinical trial report would. The 510(k) process focuses on demonstrating substantial equivalence, often through bench testing, materials characterization, and comparisons to predicate devices, rather than extensive clinical efficacy studies with specific performance metrics and acceptance criteria.
Therefore, based solely on the provided text, it is not possible to provide the requested information about acceptance criteria and the study proving the device meets them. The document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Information on experts used to establish ground truth or their qualifications.
- Adjudication methods.
- MRMC comparative effectiveness study details or effect sizes.
- Standalone algorithm performance (as this is a physical medical device, not an AI algorithm).
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the clearance was based on substantial equivalence, not on meeting specific, pre-defined performance acceptance criteria from a comprehensive study detailed in this document.
To find the kind of information requested, one would typically need to refer to the full 510(k) submission itself (which is often voluminous and not publicly released in its entirety), or any associated clinical trial publications if they were part of the submission (though for 510(k)s, clinical data is often not required or is limited).
In summary, the provided text does not contain the information needed to answer the prompt.
§ 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.