(356 days)
The KSEA Endomat® LC pump provide suction during Genral and Urological examination and procedures.
The Karl Storz Endomat® LC Pump is a suction pump device which is use to provide suction during General and Urological examination / procedures.
I apologize, but the provided text from the FDA 510(k) Pre-Market Notification does not contain information related to the acceptance criteria, study details, or performance of the Endomat® LC Pump model Number 20 3303 20.
The document primarily focuses on:
- The FDA's decision regarding substantial equivalence to a predicate device.
- Regulatory information and compliance requirements for the device.
- The intended use/indications for use of the device: "The KSEA Endomat® LC Pump provides suction during General and Urological examination and procedures."
- A brief description of the device as a "suction pump device which is use to provide suction during General and Urological examination / procedures."
It explicitly states, "The minor differences between the Karl Storz Endomat® LC Suction Pump and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices." This suggests that the substantial equivalence was based on similarities to existing devices, and a specific clinical performance study with acceptance criteria, as one might find for a novel or significantly different device, is not detailed here.
Therefore, I cannot provide the requested table and study details.
§ 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.