(57 days)
No
The document describes a standard video colonoscope and video processor. There is no mention of AI, ML, or any advanced image analysis beyond basic color frame compilation for display.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended to provide "therapeutic access to" the Lower Gastrointestinal Tract. The "Device Description" also mentions two working channels for introducing biopsy devices or other devices, and that the instrument is supplied with two biopsy forceps, supporting its therapeutic capabilities.
No
The device provides visualization of the lower gastrointestinal tract and access for therapeutic procedures, but it does not perform any analysis or interpretation of data to arrive at a diagnosis. Its function is to display images for a human to interpret.
No
The device description clearly outlines hardware components such as a flexible insertion tube, control body, umbilicus, light carrying bundles, CCD, working channels, and biopsy forceps. While it mentions a "software controlled device" (the Video Processor), the primary device being described is a physical colonoscope with integrated hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The EC-3840TL Video Colonoscope is used to visualize and provide therapeutic access to the lower gastrointestinal tract within the body. It does not perform tests on samples taken from the body.
- Intended Use: The intended use clearly states visualization and therapeutic access to the Lower Gastrointestinal Tract.
- Device Description: The description details how the device captures images inside the body and displays them. It doesn't mention any analysis of biological samples.
Therefore, the EC-3840TL Video Colonoscope is an in vivo diagnostic and therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EC-3840TL, Video Colonscope, is intended to provide visualization (via a video monitor) of, and therapeutic access to, the Lower Gastrointestinal Tract. The Lower Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems; Large Bowel. The instrument is introduced per rectally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.
Product codes
FDF
Device Description
The EC-3840TL, Video Colonoscope, must be used with a Video Processor (a software controlled device). The endoscope has a flexible insertion tube, a control body, and umbilicus. The umbilious provides connection to the video processor. The control body includes controls for up/ downl left/ right angulation, air/water delivery, suction, forward water jet, two (2) accessory inlet ports, and suction channel selector. The device contains light carrying bundles, to illuminate the body cavity, and a charge couple device (CCD) to collect image data. The instrument contains two (2) working channels through which biopsy devices, or other devices, may be introduced (the instrument is supplied with two biopsy forceps). The Video Processor contains a 300 watt xenon lamp which provides white light that is filtered, via a Red, Green, Blue color wheel, and is focused at the connected video endoscope lightguide prong The endoscope light carrying bundles present the color strobes to the body cavity and the CCD collects image data for each strobe of color. The video processor stores the CCD information until all three color strobes are completed and a full color frame is compiled. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
video
Anatomical Site
Lower Gastrointestinal Tract, Large Bowel
Indicated Patient Age Range
Adult and Pediatric patient populations
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The submission for substantial equivalence was not based on an assessment of clinical performance data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(K) SUMMARY EC-3840TL, VIDEO COLONOSCOPE DEVICE: DE PREPARED BY: PAUL SILVA DATE SUMMARY PREPARED: 06-14-96
1. SUBMITTER INFORMATION: Pentax Precision Instrument Corporation 30 Ramland Road Orangeburg, NY, 10962 TEL: (914)-365-0700
2. NAME OF DEVICE:
EC-3840TL, Video Colonoscope Trade Name: Classification Name: Colonoscope, Gastro- Urology (78FDF), 876.1500
PREDICATED DEVICE(S) INFORMATION: 3.
| 1. EC-3800TL, Video Colonoscope | Pentax | K951579 |
|---|---|---|
| 2. EPM-3300, Video Processor | Pentax | K934918 |
4. DEVICE DESCRIPTION:
The EC-3840TL, Video Colonoscope, must be used with a Video Processor (a software controlled device). The endoscope has a flexible insertion tube, a control body, and umbilicus. The umbilious provides connection to the video processor. The control body includes controls for up/ downl left/ right angulation, air/water delivery, suction, forward water jet, two (2) accessory inlet ports, and suction channel selector. The device contains light carrying bundles, to illuminate the body cavity, and a charge couple device (CCD) to collect image data. The instrument contains two (2) working channels through which biopsy devices, or other devices, may be introduced (the instrument is supplied with two biopsy forceps). The Video Processor contains a 300 watt xenon lamp which provides white light that is filtered, via a Red, Green, Blue color wheel, and is focused at the connected video endoscope lightguide prong The endoscope light carrying bundles present the color strobes to the body cavity and the CCD collects image data for each strobe of color. The video processor stores the CCD information until all three color strobes are completed and a full color frame is compiled. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.
ട്. INTENDED USE:
The EC-3840TL, Video Colonscope, is intended to provide visualization (via a video monitor) of, and therapeutic access to, the Lower Gastrointestinal Tract. The Lower Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems; Large Bowel. The instrument is introduced per rectally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.
6. COMPARISON TO PREDICATED DEVICE(S):
The submission for substantial equivalence included EC-3840TL literature including specifications, the identification of standard set components, and identification of optional accessories, comparision tables were provides to illustrate the comparisons to the predicated devices. The submission for substantial equivalence was not based on an assessment of clinical performance data.