(17 days)
Used as accessories in general laparoscopic diagnostic and surgical procedures for manipulating tissue (grasping, cutting, coagulating, dissecting and suturing).
The Allegiance Modular Endoscopy Laparoscopic Scissors, Grasping Forceps, Dissectors and Needle Holders are composed of a reusable handle and shaft assembly and a removable tip assembly. These instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures.
I am sorry, but based on the provided text, there is no detailed information about the acceptance criteria or a specific study proving the device meets those criteria.
The document is a 510(k) premarket notification for "Modular Endoscopy Laparoscopic Scissors, Grasping Forceps, Dissectors and Needle Holders." It states that:
- "All materials used in the composition of the Modular Endoscopy Laparoscopic Scissors, Grasping Forceps, Dissectors and Needle Holders were subjected to performance and physical tests to evaluate the safety, effectiveness and reliability of the device. All test results were acceptable." (Page 1, "Summary of Testing")
However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts, their qualifications, or adjudication methods for ground truth.
- Whether a multi-reader, multi-case (MRMC) comparative effectiveness study was done.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document serves as an FDA clearance letter and a summary of substantial equivalence to a predicate device, rather than a detailed technical report of device performance testing.
§ 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.