(179 days)
The MIST Panoramic Laparoscope is intended to be used by trained physicians for the illumination and direct visualization of body cavities, hollow organs and canals during diagnostic and general surgical procedures.
The MIST Panoramic Laparoscope is a rigid laparoscope intended for the illumination and direct visualization of body cavities, hollow organs and canals for the purpose of diagnosis of diseases and/or minimally invasive general surgeries.
The MIST Panoramic Laparoscope is a rigid, fiber-optic laparoscope. No working channel is provided.
The devices are re-usable, and will be sold non-sterile with instruction for cleaning, sterilization, and re-use.
This 510(k) summary for the MIST Panoramic Laparoscope does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
This document is a premarket notification for a medical device (a rigid laparoscope) to the FDA, asserting its substantial equivalence to a previously marketed device (Comeg Endoscopes under K862275). It does not present de novo performance data from a new study with explicit acceptance criteria.
Here's why the requested information is not available in these documents:
- Substantial Equivalence (510(k)) Process: The 510(k) pathway is primarily about demonstrating that a new device is as safe and effective as a legally marketed predicate device, often by showing similar technological characteristics and intended use. It typically doesn't require the same level of new clinical study data with specific performance metrics and acceptance criteria that a PMA (Premarket Approval) or a de novo classification might.
- Focus of the Document: This submission focuses on:
- Identifying the device and its intended use.
- Identifying a predicate device.
- Stating that the subject device is "identical in intended use and materials" and has "no differences in the characteristics" compared to the predicate.
- Providing basic information like cleaning and sterilization instructions.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a detailed performance study based on the provided text. The document explicitly states: "There are no differences in the characteristics of the MIST Panoramic Laparoscope and the predicate devices. The MIST devices are identical to the predicate." This implies that the performance is presumed to be the same as the predicate device, and no new study was conducted to establish new performance 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.