(61 days)
The KSEA MVM 7.5 French Choledochoscope is designed to be used by qualified surgeons and physicians for general cholecystic and choledochal surgical procedures.
This instrument is indicated for examination of the gall bladder and bile duct, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The KSEA MVM 7.5 French Choledochoscope is comprised of a video module, and a endoscope module. The endoscope module is a flexible, fiber optic endoscope. The video module is an imaging device which connects to a camera control unit. The body contact portions of the KSEA MVM 7.5 French Choledochoscope are composed of medical grade polyurethane, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
This 510(k) submission for the KSEA MVM 7.5 French Choledochoscope does not contain information regarding detailed acceptance criteria or a study proving the device meets said criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel performance testing data. The key points from the provided text are:
- Device Identification: KSEA MVM 7.5 French Choledochoscope
- Indication: Used by qualified surgeons and physicians for general cholecystic and choledochal surgical procedures, including examination of the gall bladder and bile duct, and, with accessories, various diagnostic and therapeutic procedures.
- Device Description: Comprised of a video module and a flexible, fiber optic endoscope module.
- Substantial Equivalence Claim: The device is substantially equivalent to predicate devices because basic features, design, and intended uses are the same. Minor differences are claimed to raise no new issues of safety and effectiveness as they do not affect performance, function, or intended use.
Therefore, I cannot provide the requested information in the table or address the specific study parameters for the following reasons:
- No Acceptance Criteria or Performance Data: The document states that "minor differences... raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices," but it does not specify what those "performance" criteria are, nor does it provide any data to support this claim for the new device.
- Focus on Substantial Equivalence: This type of submission relies on the performance of a predicate device to establish safety and effectiveness. It typically does not involve a new, detailed performance study with acceptance criteria for the new device itself, unless there are significant technological differences.
- No Clinical Study Details: There is no mention of a clinical study, test sets, ground truth, expert opinions, or any other elements that would be part of a robust performance study.
In summary, based solely on the provided text, the information required to answer your questions is not present. The 510(k) summary is a regulatory document asserting equivalence, not a detailed technical report of device performance testing against predefined acceptance criteria.
§ 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.