(62 days)
No
The summary describes a standard video colonoscope and video processor with no mention of AI or ML capabilities for image analysis, diagnosis, or other functions. The image processing described is basic color compilation and display.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device provides "therapeutic access to, the Lower Gastrointestinal Tract." Additionally, the "Device Description" mentions that the instrument contains a working channel through which "biopsy devices, or other devices, may be introduced" and is "supplied with two biopsy forceps," indicating its use for therapeutic procedures.
Unsure.
While the device is used for visualization and therapeutic access, it's not explicitly stated that it is used to diagnose a medical condition.
No
The device description clearly details hardware components such as a flexible insertion tube, control body, umbilicus, light carrying bundles, CCD, working channel, and biopsy forceps. It also mentions a separate Video Processor with a xenon lamp and color wheel. This is a hardware device with associated software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide visualization and therapeutic access to the Lower Gastrointestinal Tract. This is a direct examination of the body, not an analysis of samples taken from the body.
- Device Description: The device is a colonoscope, which is used to directly view the inside of the colon. It uses light and a camera to capture images.
- No mention of analyzing samples: The description focuses on the mechanics of the colonoscope and the video processing of the images. There is no mention of collecting or analyzing biological samples (like blood, urine, tissue, etc.) which is the core function of an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for direct visualization and intervention within the body.
N/A
Intended Use / Indications for Use
The EC-3840L/F, Video Colonoscope, 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-3840LF, Video Colonoscope (L or F in model number denotes length), must be used with a Video Processor (a software controlled device). The endoscope has a flexible insertion tube, a control body, and umbilicus The umbilicus provides connection to the video processor. The control body includes controls for up/ down/ left/ right angulation, air/water delivery, suction, Forward Water Jet, and an accessory inlet port. The device contains light carrying bundles, to illuminate the body cavity, and a charge couple device (CCD) to collect image data. The instrument contains a working channel 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
K 961570
JUN 24 1998
EC-3840L/F, VIDEO COLONOSCOPE DEVICE: PAUL SILVA DATE SUMMARY PREPARED: 06-14-96 PREPARED BY:
- SUBMITTER INFORMATION: Pentax Precision Instrument Corporation 30 Ramland Road Orangeburg, NY, 10962 TEL: (914)-365-0700
2. NAME OF DEVICE:
EC-3840L/F, Video Colonoscope Trade Name: Classification Name: Colonoscope, Gastro- Urology (78FDF), 876.1500
3. PREDICATED DEVICE(S) INFORMATION:
| 1. EC-3800L, Video Colonoscope | Pentax | K951574 |
|---|---|---|
| 2. EPM-3300, Video Processor | Pentax | K934918 |
DEVICE DESCRIPTION: 4.
The EC-3840LF, Video Colonoscope (L or F in model number denotes length), must be used with a Video Processor (a software controlled device). The endoscope has a flexible insertion tube, a control body, and umbilicus The umbilicus provides connection to the video processor. The control body includes controls for up/ down/ left/ right angulation, air/water delivery, suction, Forward Water Jet, and an accessory inlet port. The device contains light carrying bundles, to illuminate the body cavity, and a charge couple device (CCD) to collect image data. The instrument contains a working channel 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.
ર. INTENDED USE:
The EC-3840L/F, Video Colonoscope, 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.
Q. COMPARISON TO PREDICATED DEVICE(S):
The submission for substantial equivalence included EC-38400L/F literature including specifications, the identification of standard set components, and identification of optional accessories, comparison tables were provided to illustrate the comparisons to the predicated devices. The submission for substantial equivalence was not based on an assessment of clinical performance data.