(197 days)
The MIST Micro Interchangeable Scope System ™ 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 Micro Interchangeable Scope Systems are rigid, two piece fiber-optic endoscopes intended for the illumination and direct visualization of body cavities, hollow organs and canals during general diagnostic procedures.
The MIST Micro Interchangeable Scope System ™ is a two piece, rigid, fiberoptic laparoscope. The universal eyepiece (MicroView Handle)) may be used with several variable sizes of shafts. No working channel is provided.
The devices are re-usable, and will be sold non-sterile with instruction for cleaning, sterilization, and re-use.
The provided text is a 510(k) summary for a medical device (MIST Micro Interchangeable Scope System) and does not describe a study involving acceptance criteria, device performance metrics, or AI. Instead, it describes a substantial equivalence determination for a physical medical device. Therefore, I cannot extract the requested information as it is not present in the given text.
Here's why and what the document does discuss:
- 510(k) Summary: This document's primary purpose is to demonstrate "substantial equivalence" of a new medical device to a legally marketed predicate device. This is a regulatory pathway in the US.
- Substantial Equivalence: MIST claims its device is substantially equivalent to the Galileo Endoscope (K962116) in intended use and materials, noting the primary difference is that the MIST system is a two-piece device.
- Device Description: The MIST Micro Interchangeable Scope System is a two-piece, rigid, fiberoptic laparoscope with an interchangeable universal eyepiece and various shaft sizes, used for illumination and direct visualization during diagnostic and general surgical procedures.
In summary, the provided text does not contain any of the following information:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details about training sets.
- Information about experts establishing ground truth or adjudication methods.
- Any mention of AI, MRMC studies, or standalone algorithm performance.
- Specific ground truth types (e.g., pathology, outcomes data).
The document is purely a regulatory submission for a physical medical device, not a performance study of a device, especially not one involving AI or detailed clinical trial results.
§ 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.