EG-3800T, VIDEO GASTROSCOPE
Device Facts
| Record ID | K962460 |
|---|---|
| Device Name | EG-3800T, VIDEO GASTROSCOPE |
| Applicant | Pentax Precision Instrument Corp. |
| Product Code | FDS · Gastroenterology, Urology |
| Decision Date | Sep 16, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Intended Use
The EG-3800T, Video Gastroscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes, but is not limited to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Small Bowel. The instrument is introduced per orally when indications consistent with the requirement for procedure(s) are observed in Adult and Pediatric patient populations.
Device Story
EG-3800T is a video gastroscope for upper GI tract visualization and therapy. Input: optical images captured via CCD sensor; illumination provided by 300W xenon lamp in external video processor. Operation: light transmitted via fiber bundles; CCD collects image data synchronized with RGB color wheel strobes; video processor compiles full-color frames. Output: real-time video displayed on monitor. Used in clinical settings by physicians. Features flexible insertion tube, angulation controls, air/water delivery, suction, and two working channels for biopsy forceps. Benefits: enables minimally invasive diagnostic and therapeutic access to GI organs.
Clinical Evidence
No clinical data; substantial equivalence based on bench testing and technical comparison.
Technological Characteristics
Flexible video gastroscope with CCD imaging sensor and fiber optic illumination. Connects to external video processor (300W xenon lamp, RGB color wheel). Features two working channels, angulation controls, air/water/suction ports. System requires software-controlled video processor for image compilation and display.
Indications for Use
Indicated for adult and pediatric patients requiring optical visualization and therapeutic access to the upper gastrointestinal tract, including the esophagus, stomach, duodenum, and small bowel.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- FG-36TA, Fiber Gastroscope Pentax (K833924)
- EC-3800TL, Video Colonoscope Pentax (K951579)
- EPM-3300, Video Processor Pentax (K934918)
Related Devices
- K962897 — EG-3400, VIDEO GASTROSCOPE · Pentax Precision Instrument Corp. · Oct 4, 1996
- K961564 — EG-2940, VIDEO GASTROSCOPE · Pentax Precision Instrument Corp. · Jul 9, 1996
- K232997 — EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 · Olympus Medical Systems Corporation · Jun 19, 2024
- K963056 — ED-3410, VIDEO DUODENOSCOPE · Pentax Precision Instrument Corp. · Oct 10, 1996
- K023401 — EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE · Pentax Precision Instrument Corp. · Feb 11, 2003
