(43 days)
The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated for use with a flexible endoscope to aid in endoscopic insertion and advancement during diagnostic and therapeutic lower GI flexible endoscopy.
The device described in this 510(k) consists of a sterile, single use, flexible overtube designed for use with currently marketed flexible endoscopes in the lower & I tract.
I am sorry, but based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria using performance metrics. This document is a 510(k) Premarket Notification summary for the Endo-Ease Endoscopic Overtube.
The document states that substantial equivalence was based on:
- design characteristics
- comparison to legally marketed predicate devices
- performance testing which "consisted of destructive tensile testing of the helix and collars."
This 510(k) summary focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing detailed clinical study results with specific acceptance criteria and performance metrics typically found in efficacy studies.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The provided text describes a regulatory submission for a medical device (Endoscopic Overtube) and its clearance, which primarily relies on demonstrating equivalence to existing devices through design and specific engineering performance tests (destructive tensile testing), not clinical or diagnostic accuracy studies.
§ 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.