(39 days)
The KSEA MVM 3.3 mm Microendoscope is designed to be used by qualified surgeons and physicians for general endoscopic and laparoscopic surgical procedures.
This instrument is indicated for use during general endoscopic and laparoscopic surgical procedures, and, using additional accessories, to perform-variousdiagnostic and therapeutic procedures.
The KSEA MVM 3.3 mm Microendoscope is comprised of a video module, and a endoscope module. The endoscope module is a rigid, panoramic telescope which utilizes rod lens technology. The video module is an imaging device which connects to a camera control unit. The body contact portions of the KSEA MVM 3.3 mm Microendoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
The provided 510(k) summary for the Karl Storz MVM 3.3 mm Microendoscope does not contain information about acceptance criteria or a study proving the device meets said criteria.
The document is a standard 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance criteria and associated studies for a novel or significantly modified device. The key elements discussed in the provided text are:
- Applicant and Device Identification: Karl Storz Endoscopy - America, Inc., MVM 3.3 mm Microendoscope.
- Indication: General endoscopic and laparoscopic surgical procedures.
- Device Description: Comprised of a video module and an endoscope module, made of surgical grade stainless steel.
- Substantial Equivalence: Claimed by virtue of same basic features, design, and intended uses as predicate devices. The minor differences are stated not to raise new issues of safety and effectiveness.
- Regulatory Status: Communication from FDA confirming substantial equivalence and allowing marketing.
Therefore, I cannot provide the requested table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.
§ 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.