(310 days)
The camera is intended to digitally capture images for micro-surgery, pathology, micro-biology, ophthalmology and general surgery applications. Upon capturing the image, it is stored in the memory of the PCMCIA Card in the camera. User may utilize the audio function of the camera to record patient, exam or any other pertinent identification information. The Camera is connected to the computer via the high speed serial bus (IEEE 1394) cable interface. The images are viewed, selected and then downloaded using Twain Compliant" Driver for PCs and Adobe Photoshop Plug-in Software for MACINTOSH based systems. The user will be able to annotate and format the images and add information prior to transmission and/or archiving. The camera is capable of both lossy and lossless data compression. The operator is instructed in the manual to utilize only lossless data compression for medical applications.
Not Found
This document is a 510(k) clearance letter from the FDA for the Kodak Pro-Medical Digital Camera System. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications related to the device's imaging quality or diagnostic accuracy.
The letter focuses on the regulatory clearance for marketing the device and its intended uses, which are:
"The camera is intended to digitally capture images for micro-surgery, pathology, micro-biology, ophthalmology and general surgery applications. Upon capturing the image, it is stored in the memory of the PCMCIA Card in the camera. User may utilize the audio function of the camera to record patient, exam or any other pertinent identification information. The Camera is connected to the computer via the high speed serial bus (IEEE 1394) cable interface. The images are viewed, selected and then downloaded using Twain Compliant" Driver for PCs and Adobe Photoshop Plug-in Software for MACINTOSH based systems. The user will be able to annotate and format the images and add information prior to transmission and/or archiving. The camera is capable of both lossy and lossless data compression. The operator is instructed in the manual to utilize only lossless data compression for medical applications."
Therefore, I cannot provide the requested information based on the provided text. To answer your questions, I would need a different type of document, such as a clinical study report, a technical performance study, or a more detailed section of the 510(k) submission that discusses the performance evaluation of the device.
§ 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.