(352 days)
Not Found
No
The device description focuses on standard video endoscopy technology and image processing for display, with no mention of AI or ML algorithms for image analysis, diagnosis, or other functions.
No
The device is primarily for optical visualization and diagnostic access, with "therapeutic access" referring to the ability to introduce other devices for therapeutic procedures, rather than being a therapeutic device itself.
Yes
The device provides "optical visualization of... the Lower Gastrointestinal Tract", which is a form of medical imaging used for diagnostic purposes. It also allows for "therapeutic access," implying that it can be used to identify and potentially treat conditions, further supporting its diagnostic function. The presence of a "CCD to collect image data" and the ability to detect "indications consistent with the requirement for the procedure" also point to its diagnostic capabilities.
No
The device description clearly outlines significant hardware components including a flexible insertion tube, control body, umbilicus, light carrying bundles, CCD, working channel, and a video processor with a xenon lamp. While the video processor is described as "software controlled," the device as a whole is a physical instrument with integrated hardware for visualization and therapeutic access.
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 optical 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 sigmoidoscope, which is used to directly view the inside of the sigmoid colon. It uses light and a CCD to capture images of the tissue. While it has a working channel for introducing devices like biopsy forceps, the primary function described is visualization and therapeutic access within the body.
- Lack of IVD Characteristics: An IVD device typically analyzes biological samples (blood, urine, tissue, etc.) outside of the body to provide information about a patient's health status. This device does not perform such analysis.
The device is a medical device used for direct examination and intervention within the body, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The ES-3800, Video Sigmoidoscope, is intended to provide optical visualization of, and therapeutic access to, the Lower Gastrointestinal Tract (extent of exam, sigmoid colon). 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
78FAM
Device Description
The ES-3800, Video Sigmoidoscope, must be used with a Video Processor (a software controlled device) The endoscope has a flexible insertion tube, a control body, and umuilicus. 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
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical visualization
Anatomical Site
Lower Gastrointestinal Tract (extent of exam, sigmoid colon), 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.
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DAVINI DUNNIVEARD ES-3800, VIDEO SIGMOIDOSCOPE DEVICE: D FREPARED BY: DATE SUMMARY PREPARED: 02/04/95
1. SUBMITTER INFORMATION: Pentax Precision Instrument Corporation 30 Ramland Road Orangeburg, NY, 10962 TEL: (914)-365-0700
MAR 2 1 1500
2. NAME OF DEVICE:
Trade Name: ES-3800. Video Sigmoidoscope Classification Name: Sigmoidoscope, flexible (78FAM), 876.1500
3. PREDICATED DEVICE(S) INFORMATION:
| 1. FS-34, Fiber Sigmoidoscope | Pentax | K792341 |
|---|---|---|
| 2. VB-1530/ 1830, Video Bronchoscope | Pentax | K934920 |
| 3. EPM-3300, Video Processor | Pentax | K934918 |
4. DEVICE DESCRIPTION:
The ES-3800, Video Sigmoidoscope, must be used with a Video Processor (a software controlled device) The endoscope has a flexible insertion tube, a control body, and umuilicus. 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.
న్. INTENDED USE:
The ES-3800, Video Sigmoidoscope, is intended to provide optical visualization of, and therapeutic access to, the Lower Gastrointestinal Tract (extent of exam, sigmoid colon). 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 ES-3800 literature including specifications, the identification of standard set components, and identification of optional accessories, comparisinon 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.
KS044