(102 days)
The Confocal Endoscopic Imaging System (CEIS) is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical track accessed by legally marketed video endoscopes (equipped with a confocal laser imaging module), during endoscopic medical examination procedures. The system is applied when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
The Optiscan Confocal Endoscopic Imaging System (CEIS) is a software controlled device which is intended for use as a required accessory with a legally marketed and compatible video endoscope system that is equipped with confocal imaging module.
The Confocal Endomicroscopy Imaging System (CEIS) consists of three main units.
- The Control Unit (CEIS-CU) together with its monitor, keyboard, and footswitch, 1. is a computer based unit which performs the instrument control, and image capture and processing functions of the CEIS.
- The Optical Unit (CEIS-OU) a specialised endomicroscope interface unit which 2. performs the laser illumination and fluorescence detection functions of the CEIS.
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- The Isolation Transformer.
A video endoscope equipped with a confocal imaging module is connected to the CEIS-OU. Under control by the endoscopist, the CEIS-OU transmits visible laser light into the connected endoscope. The endoscope transmits this light to and then subsequently receives return light signals from the subject tissue. The returned light is detected by the CEIS-OU and converted into an electrical signal. The detected signal is sent to the System Computer (CEIS-CU) which processes the confocal image information for display on the system monitor, and allows still images of the tissue to be captured and stored.
The provided document is a 510(k) summary for the Optiscan Confocal Endoscopic Imaging System (CEIS). It details the device's description, intended use, and comparison to predicate devices for substantial equivalence. However, it explicitly states:
"The submission for substantial equivalence was not based on an assessment of clinical performance data."
Therefore, the document does not contain information regarding:
- Acceptance criteria for device performance.
- A study that proves the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Expert involvement for ground truth establishment or adjudication methods.
- Any multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- The type of ground truth used.
The 510(k) submission for the Optiscan CEIS focused on demonstrating substantial equivalence to a predicate device (Pentax Confocal Laser System, K042740) based on similar intended use, indications, and technological characteristics, rather than on clinical performance assessment.
§ 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.