← Product Code [FFS](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFS) · K970217 # VISTA ILLUMINATION SYSTEM (K970217) _Vista Medical Technologies, Inc. · FFS · Apr 2, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFS/K970217 ## Device Facts - **Applicant:** Vista Medical Technologies, Inc. - **Product Code:** [FFS](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFS.md) - **Decision Date:** Apr 2, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Intended Use The Vista Illumination System is intended to provide visible light for illumination of various rigid and flexible endoscopes, laparoscopes, cameras, and headlamps,etc. It is intended for use in all types of endoscopic and endoscopic assisted procedures, as well as visualization of the evacuated cardiac chamber. ## Device Story Vista Illumination System; Xenon light source unit; fiberoptic cable. Provides visible light for rigid/flexible endoscopes, laparoscopes, video cameras, headlamps. Features dual ports with independent attenuator controls; intensity level indicators; system/lamp fault LEDs; LCD lamp life display. Fiberoptic cable produces uniform beam profile; includes adapters for Storz, ACMI, Wolfe; core diameters 0.1mm-1mm; 10-foot length. Used in clinical settings for endoscopic procedures; operated by physicians/clinical staff. Benefits patient by providing necessary illumination for visualization during minimally invasive surgery. ## Clinical Evidence Bench testing only. Compliance with IEC 601-1 (General Safety Requirements for Medical Electrical Equipment), IEC 601-1-2 (Electrical Magnetic Compatibility), and UL 544 (Standards for Safety, Medical and Dental Equipment). ## Technological Characteristics Xenon light source; fiberoptic cable delivery. Dual ports with independent attenuators. LED indicators for system/lamp status; LCD for lamp life. Fiber core diameters 0.1mm-1mm. Adapters for Storz, ACMI, Wolfe. Standards: IEC 601-1, IEC 601-1-2, UL 544. ## 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 - Cogent Light Illuminator 10010 Xenon Light Source and Fiberoptic Cable ([K933405](/device/K933405.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} Vista Medical Technologies Westborough, MA K 970 217 510(k) Notification Illumination System January 1997 APR - 2 1997 510(k) SUMMARY January, 1997 ## COMPANY NAME AND ADDRESS Vista Medical Technologies 134 Flanders Road Westborough, MA 01581 ## CONTACT PERSON Martin Newman Director of Regulatory Affairs and Quality Assurance Telephone: (508) 366-3668 Fax: (508) 366-1543 ## DEVICE TRADE NAME Vista Illumination System ## COMMON NAME Xenon Light Source for Endoscopic Procedures ## PREDICATE DEVICE Device Name: Cogent Light Illuminator 10010 Xenon Light Source and Fiberoptic Cable Classification: Illuminator, Fiberoptic for Endoscope Manufacturer: Cogent Light Technologies, Inc. 650 S. San Vicente Blvd. Los Angeles, CA 90048-4620 510(k)#: K933405 510(k) 28 {1} Vista Medical Technologies Westborough, MA 510(k) Notification Illumination System January 1997 ## DEVICE DESCRIPTION The Vista Illumination System, is a Xenon Light Source illumination system consisting of a light source unit which houses the lamp and a fiberoptic cable. The system provides visible light for illumination of rigid or flexible endoscopes, laparoscopes, video cameras, headlamps,etc. The light source has 2 ports which are provided with independent attenuator controls and separate light output intensity level indicators. The front panel contains dual intensity level indicators as well as system fault and lamp fault LED's. The LED's will light if the lamp fails to start or fails during use for any reason. There is a LCD on the front panel that provides an indication of lamp life. The fiberoptic cable produces a uniform beam profile from a single fiber. There are three different adapters to allow connection to various endoscopic devices currently available. The thread types are for Storz, ACMI and Wolfe. Custom adapters are available. The fiber is available in core diameter of 0.1mm to 1mm with a standard cable length of 10 feet. ## INTENDED USE The Vista Illumination System is intended to provide visible light for illumination of various rigid and flexible endoscopes, laparoscopes, cameras, and headlamps,etc. It is intended for use in all types of endoscopic and endoscopic assisted procedures, as well as visualization of the evacuated cardiac chamber. ## PERFORMANCE DATA IEC 601-1 "General Safety Requirements for Medical Electrical Equipment" IEC 601-1-2 "Electrical Magnetic Compatibility" UL 544 "Standards for Safety, Medical and Dental Equipment" 510(k) 29 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFS/K970217](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFS/K970217) **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