EVIS 140 SYSTEM
Device Facts
| Record ID | K954451 |
|---|---|
| Device Name | EVIS 140 SYSTEM |
| Applicant | Olympus America, Inc. |
| Product Code | FET · Gastroenterology, Urology |
| Decision Date | Mar 29, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The EVIS 140 System is specifically designed for endoscopic diagnosis, treatment, and photo and video documentation in combination with Olympus endoscopes, various accessories and ancillary equipment within the upper and lower digestive tract including esophagus, stomach, pancreatic duct, biliary duct, duodenum, small intestine, rectum and colon.
Device Story
Video endoscopy system; captures visual images of upper/lower GI tract via Olympus endoscopes; processes signals for display, photo, and video documentation; used in clinical settings by physicians; provides real-time visualization to assist in diagnosis and treatment; facilitates documentation of endoscopic procedures.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Video endoscopy system comprising processor, endoscopes, and ancillary equipment. System utilizes electronic imaging sensors for video signal acquisition. Designed for integration with existing Olympus endoscopic accessories.
Indications for Use
Indicated for patients requiring endoscopic diagnosis, treatment, and imaging of the upper and lower digestive tract, including esophagus, stomach, pancreatic duct, biliary duct, duodenum, small intestine, rectum, and colon.
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
- Olympus EVS Video Endoscopy System (K853585)
- Olympus EVIS 200 System - Bronchoscopy (K931154)
Related Devices
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- K974493 — FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES · Fiegert-Endotech Medizintechnik GmbH · Mar 31, 1998
- K982409 — VES 1501-M · Angiolaz, Inc. · Aug 21, 1998
- K180341 — FUJIFILM 600 Series Endoscope EG-600WR v2 · Fujifilm Corporation · Aug 3, 2018
