(266 days)
The PENTAX Medical Video Colonoscope EC34-i10cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes, but is not restricted to, the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel. This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 5kg of body weight.
The PENTAX Medical Video Colonoscope EC38-110cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes, but is not restricted to, the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel. This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 20kg of body weight.
The PENTAX Medical Video Upper GI Scope EG29-i10c is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, and duodenum.
This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in patient populations with greater than 20kg of body weight.
The PENTAX Medical Video Processor EPK-i5500c is intended to be used with the PENTAX Medical camera heads, endoscopes, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation. It processes signals transmitted from a video endoscope into images that are displayed on an inspection monitor. This processor has air/water pump function.
This device includes PENTAX i-scan™, a digital, post-processing imaging enhancement technology. i-scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.
PENTAX Medical Video Processor EPK-i5500c
The PENTAX Medical Video Processor EPK-i5500c consists of a video system, monitor and ancillary equipment. This processor is intended for endoscopic diagnostic, treatment and video observation. The PENTAX Medical Video Processor EPK-i5500c contains a contrast enhancement feature: PENTAX i-scan technology. All visualization is done with the white light mode first. White light (RGB) illuminates the tissue and transfers the captured light through the Complementary MOS (CMOS) of the video scope. Note that the white light visualization mode is always used first by the physician. For i-scan image enhancement, the modification of the combination of RGB components for each pixel occurs when the i-scan function is turned on in the PENTAX Medical Video Processor EPK-i5500c. The resulting i-scan image is then displayed on the observation monitor. The EPK-i5500c is compatible with PENTAX Medical endoscopes EG29-i10c, EC34-i10cL and EC38-i10cL.
PENTAX Medical Video Upper GI Scope EG29-i10c
The PENTAX Medical Video Upper GI Scope EG29-i10c is used with PENTAX Medical Video Processor EPK-i5500c.The PENTAX Medical Video Upper GI Scope EG29-i10c is composed of the following main parts: an Insertion Portion, Control Body and Scope Connector. The Insertion Portion is inserted into the body cavity of patient. The Insertion Portion includes the Distal End and Bending Section. The Objective Lens, Light Guide, Instrument Channel, Air/Water Nozzle, and Water Jet Nozzle are located on the Distal End of the Insertion Portion. The Control Body is held by the user's hand. The Control Body includes the Angulation Control Knob, Angulation Lock Knob/Lever, Air/Water Cylinder, Suction Cylinder, Remote Control Button, Magnification Control Lever, and Instrument Channel Inlet. The Air/Water Feeding Valve is attached to the Air/Water Cylinder, and the Suction Control Valve is attached to the Suction Cylinder. The Inlet Seal is attached to the Instrument Channel Inlet. The Scope Connector is connected to the Video Processor via an Electrical Contacts. The Bending Section is bent by the Angulation Control Knob to operate the endoscope angulation. The Angulation Lock Knob/Lever is used to adjust the rotation torque of the Angulation Control Knob. The Air/Water Feeding System is used to deliver the air and water to the Objective Lens from the Air/Water Nozzle. When the hole at the top of Air/Water Feeding Valve is covered, air is delivered. When the Air/Water Feeding Valve is pushed, the water is delivered. The Suction Control System is used to suction the fluid and air in body cavity from the Instrument Channel. When the Suction Control Valve is pushed, the fluid and air are suctioned. The Remote Button is used to operate the function of video processor and external device from the control body, as necessary. Endotherapy Device such as Biopsy Forceps is inserted from the Instrument Channel Inlet into the body cavity through the instrument channel. The Water Jet System is used to stream forward the sterile water from Water Jet Nozzle. The Light Guide of the Distal End is used to illuminate the body cavity with LEDs. The CMOS built into the Distal End receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the Monitor.
PENTAX Medical Video Colonoscopes EC34-i10cL and EC38-i10cL
The PENTAX Medical Video Colonoscopes EC34-i10cL and EC38-i10cL are used with PENTAX Medical Video Processor EPK-i5500c. The endoscopes are composed of the following main parts: an Insertion Portion, Control Body and Scope Connector. The Insertion Portion is inserted into the body cavity of patient. The Insertion Portion includes the Distal End and Bending Section. The Objective Lens, Light Guide, Instrument Channel, Air/Water Nozzle, and Water Jet Nozzle are located on the Distal End of the Insertion Portion. The Control Body is held by the user's hand. The Control Body includes the Angulation Control Knob, Angulation Lock Knob/Lever, Air/Water Cylinder, Suction Cylinder, Remote Button, Suction Selector Cylinder, and Instrument Channel Inlet. The Air/Water Feeding Valve is attached to the Air/Water Cylinder, and the Suction Control Valve is attached to the Suction Cylinder. The Suction Channel Selector is attached to the Suction Selector Cylinder. The Inlet Seal is attached to the Instrument Channel Inlet. The Scope Connector is connected to the Video Processor via an Electrical Contacts. The Bending Section is bent by the Angulation Control Knob to operate the endoscope angulation. The Angulation Lock Knob/Lever is used to adjust the rotation torque of the Angulation Control Knob. The Air/Water Feeding System is used to deliver the air and water to the Objective Lens from the Air/Water Nozzle. When the hole at the top of Air/Water Feeding Valve is covered, the air is delivered. When the Air/Water Feeding Valve is pushed, the water is delivered. The Suction Control System is used to suction the fluid and air in body cavity from the Instrument Channel. When the Suction Control Valve is pushed, the fluid and air are suctioned. The endoscopes have two channels; the primary channel and secondary one. Suction Channel Selector is used to switch between the primary and secondary channels as necessary. The Remote Button is used to operate the function of video processor and external device from the control body, as necessary. Endotherapy Device such as Biopsy Forceps is inserted from the Instrument Channel Inlet into the body cavity through the instrument channel. The Water Jet System is used to stream forward the sterile water from Water Jet Nozzle. The Light Guide of the Distal End is used to illuminate the body cavity with LEDs. The CMOS built into the Distal End receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is, displayed on the Monitor.
The provided document is a 510(k) Pre-market Notification from the FDA regarding several PENTAX Medical devices. It outlines the substantial equivalence to predicate devices based on intended use, technological characteristics, and performance testing. However, the document does not contain information about a study that describes acceptance criteria for an AI device, the device's performance against those criteria, or details regarding ground truth establishment, expert adjudication, or MRMC studies for an AI component.
The only mention of "AI" or "imaging enhancement technology" related to AI is:
"This device includes PENTAX i-scan™, a digital, post-processing imaging enhancement technology. i-scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling."
This statement describes a feature of the PENTAX Medical Video Processor EPK-i5500c, but the document does not provide any specific study details, acceptance criteria, or performance metrics for this "i-scan" technology as if it were a separate AI device requiring standalone validation. The 510(k) summary focuses on the substantial equivalence of the entire endoscopy system (processor and scopes) to previous PENTAX models, citing general performance testing like "Optical Characterization," "Backflow Prevention," "Compatibility," and "Product Life," along with standard regulatory considerations such as reprocessing, biocompatibility, software, EMC, and electrical safety.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them from the provided text for an AI component. The document is primarily a regulatory filing asserting substantial equivalence of hardware devices, not a detailed performance study of a specific AI feature.
§ 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.