(61 days)
The DEFENDO™ Disposable Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
The DEFENDO™ Disposable Suction Valve is a disposable device that attaches to the suction cylinder of an endoscope. When the valve is depressed, the suction function on the endoscope is activated, allowing for the suctioning of fluid through the stem of the valve where it flows into the Suction Pump Canister.
Here's a breakdown of the acceptance criteria and the study details for the DEFENDO™ Disposable Suction Valve, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|
| Connection to the endoscope: The valve must connect to the endoscope by aligning valve with port and pressing down. Must not be cumbersome to attach. | The force required to connect the BMI suction valve (100305) and the ease of installation was similar to the predicate (Olympus® MH-443). Alignment with the port notches was comparable. Test results showed "Smooth" for all 10 tests of the BMI 100305, matching the "Smooth" results of the predicate. | Pass |
| Priming time to Suction Canister: The device must be comparable to the predicate device in terms of being able to supply water within a reasonable time frame (priming time). | The average priming time for the BMI 100305 was 3.92 seconds (SD 0.163) over 10 tests, compared to the predicate's average of 4.16 seconds (SD 0.147) over 8 tests. The results indicate no significant difference between the two units. | Pass |
| Material Quantity Removed: The device must be comparable to the predicate device in terms of the amount of water removed in the defined time frame. | The average material removed for the BMI Suction Valve was 512.2 grams (SD 11.25) over 8 samples (10 tests each), compared to the predicate's average of 528.5 grams (SD 13.61) over 8 samples (10 tests each). The difference was |
§ 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.