ED-3410, VIDEO DUODENOSCOPE
Device Facts
| Record ID | K963056 |
|---|---|
| Device Name | ED-3410, VIDEO DUODENOSCOPE |
| Applicant | Pentax Precision Instrument Corp. |
| Product Code | FDT · Gastroenterology, Urology |
| Decision Date | Oct 10, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Intended Use
The ED-3410, Video Duodenoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to, the Upper Gastrointestinal Tract and Biliary Tract. The Upper Gastrointestinal Tract and Biliary Tract includes, but is not limited to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile Duct, Hepatic Duct, and Cystic Duct. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.
Device Story
Flexible video duodenoscope; used for visualization and therapeutic access to upper GI and biliary tracts. Input: light reflected from body cavity captured by CCD sensor. Operation: requires connection to external video processor; processor uses 300W xenon lamp with RGB color wheel; CCD collects sequential color strobes; processor compiles full-color frames for monitor display. Features: angulation controls, air/water delivery, suction, elevator control, accessory inlet for biopsy forceps. Used in clinical settings by physicians. Output: real-time video feed on monitor; assists physician in diagnostic and therapeutic interventions. Benefits: enables minimally invasive visualization and access to GI/biliary structures.
Clinical Evidence
No clinical data; submission based on bench testing and technical specifications comparison.
Technological Characteristics
Flexible insertion tube with CCD imaging sensor and fiber optic light bundles. Requires external video processor with 300W xenon lamp and RGB color wheel. Includes manual controls for angulation, suction, and elevator mechanism. Connectivity: proprietary umbilicus connection to video processor.
Indications for Use
Indicated for optical visualization and therapeutic access to the Upper Gastrointestinal Tract (esophagus, stomach, duodenum) and Biliary Tract (common bile, hepatic, and cystic ducts) in adult and pediatric patients requiring such procedures.
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
- FD-34A, Fiber Duodenoscope Pentax (K832006)
- VB-1530/ 1830, Video Bronchoscope Pentax (K934920)
- EPM-3300, Video Processor Pentax (K934918)
Related Devices
- K961568 — ED-344OT · Pentax Precision Instrument Corp. · Jul 9, 1996
- K152257 — Fujifilm Duodenoscope Model ED-530XT · Fujifilm Medical Systems U.S.A, Inc. · Jul 21, 2017
- K961564 — EG-2940, VIDEO GASTROSCOPE · Pentax Precision Instrument Corp. · Jul 9, 1996
- K163614 — PENTAX Medical ED34-i10T, Video Duodenoscope · Pentax Medical · Sep 20, 2017
- K161222 — PENTAX MEDICAL ED-3490TK, Video Duodenoscope · Pentax Medical · Feb 7, 2018
