← Product Code [FET](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FET) · K954451 # EVIS 140 SYSTEM (K954451) _Olympus America, Inc. · FET · Mar 29, 1996 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FET/K954451 ## Device Facts - **Applicant:** Olympus America, Inc. - **Product Code:** [FET](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FET.md) - **Decision Date:** Mar 29, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **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. ## Regulatory 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](/device/K853585.md)) - Olympus EVIS 200 System - Bronchoscopy ([K931154](/device/K931154.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 1. 754457 MAY 29 1996 # 510 (k) SUMMARY ## OLYMPUS EVIS 140 VIDEO ENDOSCOPY SYSTEM | Device Name: | Olympus EVIS 140 System, associated endoscope, and ancillary equipment and endoscopic accessories | | --- | --- | | Common/Usual Name: | Olympus EVIS 140 System | | Classification Name: | Endoscope and Accessories | | Predicate Devices: | Olympus EVS Video Endoscopy System (K853585) Olympus EVIS 200 System - Bronchoscopy (K931154) Refer to Subsection I-A for additional list of predicate devices. | | Submitted By: (Contact Person) | Mr. Barry Sands Olympus America Inc. Endoscope Division Two Corporate Center Drive Melville, New York 11747-3157 (516) 844-5474 | | Summary Preparation Date: | January 16, 1996 | ## Statement of 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. The intended use of EVIS 140 System and associated endoscopes are identical to the currently marketed EVS System which was cleared for marketing in the 510(k) # K853585. Both systems are used for observation, photo and video documentation of the images within the upper and lower GI tract. Thus, when compared to the predicate device, Olympus EVIS 140 System does not raise any questions regarding the safety of the subject device. 118 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FET/K954451](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FET/K954451) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com