ENDO VIP
Device Facts
| Record ID | K963323 |
|---|---|
| Device Name | ENDO VIP |
| Applicant | Richard Wolf Medical Instruments Corp. |
| Product Code | GCJ · Gastroenterology, Urology |
| Decision Date | Nov 21, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
Intended Use
Video Image Processor ENDO VIP 5588 is a video contrast enhancer and is used in connection with a video system. It enhances the detail definition of medical video images. It is used as an accessory during diagnostic and therapeutic interventions in video endoscopy and video microscopy.
Device Story
ENDO VIP 5588; video contrast enhancer; connects between video camera and monitor; processes Y/C video signals (NTSC/PAL) in real-time; enhances detail definition of medical video images; manual 3-step enhancement control; used in video endoscopy and microscopy; assists clinicians in visualizing diagnostic/therapeutic interventions.
Clinical Evidence
No clinical tests performed. Bench testing conducted per IEC601-1, IEC601-1-2, and UL2601-1 standards.
Technological Characteristics
Digital video processor; Y/C video signal input/output; NTSC/PAL compatible; real-time processing; manual 3-step enhancement control; fixed algorithm with user-variable parameters; electrical safety per IEC601-1, IEC601-1-2, UL2601-1.
Indications for Use
Indicated for use as an accessory during diagnostic and therapeutic interventions in video endoscopy and video microscopy to enhance detail definition of medical video images.
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
- Karl Storz video image processor (unspecified model)
Related Devices
- K962260 — REAL-TIME VIDEO CONTRAST ENHANCER · Digivision, Inc. · Sep 9, 1996
- K130929 — ZMED VP4000 · Zmed, Inc. · Apr 12, 2013
- K173679 — PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes · Pentax of America, Inc. · Jul 3, 2018
- K982397 — VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM · Angiolaz, Inc. · Sep 10, 1998
- K991416 — ENDOSCOPIC CAMERA · Genzyme Surgical Product (Genzyme Biosurgery) · Jul 20, 1999
