(20 days)
The KSEA Laparocam 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 laparcascopic surgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The KSEA Laparocam is comprised of a rigid telescope with an integral CCD chip. The body contact portions of the KSEA Laparocam 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.
This 510(k) summary for the Karl Storz Laparocam is a premarket notification for a medical device seeking substantial equivalence to existing devices. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The document primarily focuses on establishing the device's substantial equivalence to predicate devices based on "basic features, design and intended uses." It states that "The minor differences between the KSEA Laparocam and the predicate devices 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."
Therefore, I cannot provide the requested information from the provided text. The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance.
- Number of experts used or their qualifications.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about a standalone (algorithm only) performance study.
- The type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
§ 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.