(143 days)
The disposable Overtube is a device used in conjunction with an endoscope for foreign body removal or endoscopic procedures requiring multiple insertions of the endoscope into the upper gastrointestinal tract.
The Endoscope Caps are intended to keep suitable endoscopic view field during endoscopic procedures.
The BAROnova Retrieval Kit includes the following products:
- BAROnova Overtube Set (Overtube with a mated Obturator and • Seal Cap)
- Endoscope Cap Set (Endoscope Caps, Small and Large) ●
- Push Tube ●
The BAROnova Overtube Set (BAROnova Overtube) consists of a non-sterile, polymer extrusion with a metallic coil reinforcement, atraumatic tip and handle, in addition to a mated Obturator made of flexible PVC with a tapered tip, and a flexible polymer seal cap. The BAROnova Endoscope Cap Set (BAROnova Endoscope Caps) consists of two non-sterile, plastic caps for use with standard endoscopes. The Endoscope Caps are provided in two sizes to accommodate a range of standard endoscope sizes. The Push Tube (Class I, regulated under 876.4730 - Manual Gastroenterology-Urology-Urology Surgical Instrument and Accessories) and the Endoscope Cap Sizing Guide (Class I, regulated under 876.1500 - Endoscope and Accessories), are optional accessories included in the Retrieval Kit for use with the BAROnova Overtube and BAROnova Endoscope Caps respectively. The Push Tube is a non-sterile, plastic probe with a handle, which may be used to facilitate removal of foreign objects through the BAROnova Overtube. The Endoscope Sizing Cap Guide is an optional accessory for the BAROnova Endoscope Caps to assist the user in selecting the correct size Cap.
The provided text describes a 510(k) summary for the BAROnova Retrieval Kit, which includes an Overtube and Endoscope Caps. The purpose of this document is to demonstrate "substantial equivalence" to legally marketed predicate devices.
The information provided does not contain any details about an AI/algorithm-based device, nor does it discuss acceptance criteria and a study that proves an AI device meets those criteria. The document focuses entirely on the physical characteristics, intended use, and performance of traditional medical devices (an overtube and endoscope caps) and their comparison to predicate devices for regulatory clearance.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance for an AI device.
- Sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods for an AI test set.
- Details on MRMC studies or effect sizes for AI assistance.
- Details on standalone algorithm performance.
The document describes non-clinical testing for mechanical, biocompatibility, and simulated use data for the physical devices (BAROnova Overtube and Endoscope Caps), confirming they "perform as intended and that no new issues of safety and effectiveness are introduced" when compared to their predicates. This is a standard regulatory pathway for physical medical devices and does not involve AI performance metrics.
§ 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.