ED-344OT
Device Facts
| Record ID | K961568 |
|---|---|
| Device Name | ED-344OT |
| Applicant | Pentax Precision Instrument Corp. |
| Product Code | FDT · Gastroenterology, Urology |
| Decision Date | Jul 9, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Intended Use
The ED-3440T, Video Duodenoscope, is intended to provide 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 restricted 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; features insertion tube, control body, umbilicus. Inputs: light via fiber bundles; image data via CCD. Operation: connects to external video processor with 300W xenon lamp; RGB color wheel filters light; CCD captures sequential color strobes; processor compiles full-color frames for monitor display. Includes working channel for biopsy forceps/accessories; controls for angulation, air/water, suction, elevator lever. Used in clinical settings by physicians for diagnostic/therapeutic procedures in upper GI/biliary tracts. Output: real-time video visualization for physician guidance during interventions. Benefits: enables minimally invasive access and visualization of internal anatomy.
Clinical Evidence
No clinical data; substantial equivalence based on bench testing and technical specifications.
Technological Characteristics
Flexible endoscope with CCD imaging sensor and fiber optic illumination. Connects to external video processor (300W xenon lamp, RGB color wheel). Features working channel, angulation controls, air/water/suction ports. Software-controlled video processing.
Indications for Use
Indicated for adult and pediatric patients requiring visualization and therapeutic access to the upper gastrointestinal tract and biliary tract, including the esophagus, stomach, duodenum, common bile duct, hepatic duct, and cystic duct.
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
- EC-3800L, Video Colonoscope Pentax (K951574)
- FD-34A, Fiber Duodenoscope Pentax (K832006)
- EPM-3300 Pentax (K934918)
Related Devices
- K963056 — ED-3410, VIDEO DUODENOSCOPE · Pentax Precision Instrument Corp. · Oct 10, 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
