(75 days)
THE EASTGATE TRADING PERSONAL MONITOR CAN BE USED FOR ANY PROCEDURE THAT REQUIRES A VIDEO DISPLAY. IT IS DESIGNED TO SIT ON THE BRIDGE OF THE NOSE. IN THIS POSITION A MEDICAL PERSON IS ABLE TO SEE THE MONITOR PICTURE AND THE SURROUNDING AREA AT THE SAME TIME.
THE PERSONAL MONITOR IS PROVIDED WITH ACCESSORIES TO PLUG INTO ANY VIDEO OUTPUT. IT CAN BE USED BY ITSELF OR IN CONJUNCTION WITH OTHER VIDEO MONITORS.
AS AN EXAMPLE IN ENDOSCOPIC SURGERY THE DOCTOR WOULD ATTACH THE VIDEO FEED TO THE REGULAR MONITOR DEVICE. BY DOING THIS THE DOCTOR COULD VIEW THE PATIENT AND THE CAMERA IMAGE AT THE SAME TIME.
AS THIS MONITOR HAS A UNIVERSAL VIDEO PLUG IT COULD BE ATTACHED TO ANY MEDICAL DEVICE WITH A VIDEO OUTPUT.
THE PERSONAL MONITOR IS A BIOCULAR VIDEO MONITOR. DISPLAY-BIOCULAR, SINGLE LCD RESOLUTION-180,000 PIXEL OPITCAL SYSTEM-ACHROMATIC FIELD OF VIEW-18.750 DIAGONAL BRIGHTNESS 20FL CONTRAST 200:1 EYE RELIEF 28MM INTER-PUPILARY DISTANCE 58MM-77 MM ADJUSTABLE HORIZONTAL ANGULAR RESOLUTION 3,37 INTERFACE NTSC/PAL COMPOSITE POWER 7-9V DC FOCUS ADJUSTMENT- NO MONITOR BLOCK WT- 36 GRAMS MONITOR BLOCK SIZE-9.5X4X3.5CM MOUNTING EYEGLASSES. SEE THROUGH-NO SEE-AROUND-YES CONTROLLER NIT WT-80 GRMS ONTROLLER UNIT SIZE-2.0X11X5 CM &BLE DISTANCE OPTIONAL
The provided text is a 510(k) summary for the EASTGATE TRADING CORP. Personal Monitor. It describes the device, its intended use, and states that it is substantially equivalent to two previously marketed monitors (ALBATECH PERSONAL MONITOR K-981-999 and MEDIVISION PERSONAL MONITOR K-961-343).
However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for the device.
The 510(k) summary focuses on demonstrating substantial equivalence based on technological characteristics and intended use, rather than presenting a detailed performance study with acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on 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.