(97 days)
The SmartStart™ air/water valve is intended be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The SmartStart™ suction valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
The device is intended for single-use, and is supplied sterile, single-use air/water and suction valves help prevent potential safety risks and eliminate the need for manual cleaning and reprocessing. These valves easily incorporate into infection prevention policies as a single patient use item. The air/water valve is designed to be attached to the air/water port of the endoscope and the suction valve to the suction port of the endoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the endoscopic image, while the activation of the air/water valve allows the user to control air and water flow to assist in cleansing the lens during procedures.
The provided document is a 510(k) premarket notification for the SmartStart™ Air/Water and Suction Valves. It aims to demonstrate substantial equivalence to predicate devices, rather than establishing de novo performance criteria. Therefore, this document does not contain the information requested in the prompt regarding acceptance criteria and the comprehensive study details for a device meeting those criteria.
Specifically, the document focuses on demonstrating that the SmartStart™ valves perform similarly to already approved devices. It does not provide:
- A table of distinct acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the device's clinical performance.
- Details of a study proving the device meets specific performance acceptance criteria beyond basic physical and functional tests (like air/water flow and leakage).
- Information on sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types for clinical efficacy.
- Details regarding training sets for an AI/algorithm-based device, as this is a medical device and not an AI-driven software.
The performance testing section (8.3) mentions "acceptance criteria for air flow, water flow and leakage," but it does not specify what those criteria are or provide detailed results from a study that quantifies the device's performance against these criteria. It simply states that the device "will perform in accordance with the acceptance criteria."
This type of submission relies on comparative analysis with existing predicate devices, focusing on technical characteristics, indications for use, and a limited set of non-clinical performance and safety tests (sterilization, shelf-life, biocompatibility, and basic functional tests).
§ 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.