(352 days)
No
The device description focuses on standard video endoscopy technology and does not mention any AI or ML components or capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The 'Intended Use / Indications for Use' states that the device is intended to provide "therapeutic access to, the Lower Gastrointestinal Tract."
Yes
The device is described as providing "optical visualization" and collecting "image data" of the Lower Gastrointestinal Tract, which is used to observe "indications consistent with the requirement for the procedure". This aligns with the purpose of diagnostics, which involves identifying or determining the nature of a disease or condition.
No
The device description clearly outlines hardware components such as a flexible insertion tube, control body, umbilicus, light carrying bundles, a CCD, and a working channel. It also mentions a required Video Processor which contains a xenon lamp and color wheel. While the Video Processor is software-controlled, the device itself is a physical instrument with multiple hardware components.
Based on the provided information, the EC-3800L, Video Colonoscope, is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This involves directly examining the inside of the body.
- Device Description: The device is a colonoscope, which is an instrument used for internal examination. It uses light and a CCD to capture images of the internal anatomy.
- Lack of In Vitro Testing: IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue). This device is used inside the body for direct visualization and intervention.
The device is a medical device used for diagnostic and therapeutic procedures performed in vivo (within the living body), not in vitro (in a test tube or laboratory setting).
N/A
Intended Use / Indications for Use
The EC-3800L, Video Colonoscope, is intended to provide optical visualization 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
78FDF
Device Description
The EC-3800L, 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 umbilicus provides connection to the video processor. The control body includes controls for up/ down/ left/ right angulation, air/water delivery, suction, CO2 delivery, 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
optical visualization
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
The submission for substantial equivalence was not based on an assessment of clinical performance data.
Key Metrics
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
N1351
510(K) SUMMARY DEVICE: --EC-3800L, VIDEO COLONOSCOPE DATE SUMMARY PREPARED: 02/04/95 PREPARED BY: PAUL SILVA
SUBMITTER INFORMATION: 】.
Pentax Precision Instrument Corporation 30 Ramland Road Orangeburg, NY, 10962 TEL: (914)-365-0700
MAN 2 1 1950
2. NAME OF DEVICE:
EC-3800L, Video Colonoscope Trade Name: Classification Name: Colonoscope, Gastro- Urology (78FDF), 876.1500
3. PREDICATED DEVICE(S) INFORMATION:
| 1. FC-38LA, Fiber Colonoscope | Pentax | K822846 |
|---|---|---|
| 2. VB-1530/ 1830, Video Bronchoscope | Pentax | K934920 |
| 3. EPM-3300, Video Processor | Pentax | K934918 |
4. DEVICE DESCRIPTION:
The EC-3800L, 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 umbilicus provides connection to the video processor. The control body includes controls for up/ down/ left/ right angulation, air/water delivery, suction, CO2 delivery, 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.
న. INTENDED USE:
The EC-3800L, Video Colonoscope, is intended to provide optical visualization 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.
(). COMPARISON TO PREDICATED DEVICE(S):
The submission for substantial equivalence included EC-3800L 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.
KS048