VISTA ILLUMINATION SYSTEM
Device Facts
| Record ID | K970217 |
|---|---|
| Device Name | VISTA ILLUMINATION SYSTEM |
| Applicant | Vista Medical Technologies, Inc. |
| Product Code | FFS · Gastroenterology, Urology |
| Decision Date | Apr 2, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
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.
Indications for Use
Indicated for illumination of rigid and flexible endoscopes, laparoscopes, cameras, and headlamps during endoscopic and endoscopic-assisted procedures, including visualization of the evacuated cardiac chamber.
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
- Cogent Light Illuminator 10010 Xenon Light Source and Fiberoptic Cable (K933405)
Related Devices
- K962365 — XENON LIGHTSOURCE · Dsp Worldwide · Jul 18, 1996
- K971057 — COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM · Cogent Light Technologies, Inc. · Mar 28, 1997
- K992050 — LUMENON XENON LIGHT SOURCE · Walter Lorenz Surgical, Inc. · Sep 14, 1999
- K062895 — XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII · Dutch Ophthalmic Research Center International BV · Oct 13, 2006
- K962595 — KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS · KARL STORZ Endoscopy-America, Inc. · Sep 4, 1996
