(22 days)
The Seal Single Use Biopsy Valve is intended to provide access for endoscopic device passage and exchange, help maintain insufflation, minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provide access for irrigation.
The Seal™ Single-Use Biopsy Valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The Seal™ Single Use Biopsy Valve provides sealable access via the working channel port of an endoscope for surgical instruments. The valve consists of an attached cap and valve body with a circular opening. The cap is pre-perforated, and ensures instrument access and removal is tight and leak-free.
The valve is designed with a hollow body with a distal end that attaches to the inlet port of the working channel. The valve body provides a flexible diaphragm seal that separates the body into a proximal chamber and distal chamber. The distal chamber secures onto the endoscope, while the proximal chamber secures the cap. Instruments are inserted through the cap and chambers, through the diaphragm seal, and into the endoscope. The diaphragm seal is configured such that a seal is formed due to deformation of the elastomer around an instrument when it is inserted through the opening, preventing fluids from passing through the biopsy valve.
The cap serves two primary functions. One function of the cap is to provide an additional seal around surgical instruments to prevent leakage. The second function is to allow modification of pressure during insufflation by opening the cap, allowing gasses to flow from the endoscope, and out of the biopsy valve.
The provided text does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding study design elements such as sample sizes, expert involvement, or ground truth establishment.
The text is a 510(k) summary for the Boston Scientific Seal Single Use Biopsy Valve, outlining its intended use, technological characteristics, and a statement that bench testing was performed.
Here's what can be extracted:
- Device Name: Seal Single Use Biopsy Valve
- Intended Use: To provide access for endoscopic device passage and exchange, help maintain insufflation, minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provide access for irrigation.
- Performance Data Mentioned:
- Bench testing for air and water leak testing, device insertion and removal, and scope compatibility.
- Biocompatibility testing (cytotoxicity, sensitization, and irritation testing).
- Result of Performance Data: The device "passed all Bench testing" and "passed all Biocompatibility testing."
However, none of the specific details requested in your prompt regarding acceptance criteria values, performance metrics, study design specifics (sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types and establishment, training set details) are present in the provided document.
§ 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.