VISTA MINI CAMERA SYSTEM
Device Facts
| Record ID | K970369 |
|---|---|
| Device Name | VISTA MINI CAMERA SYSTEM |
| Applicant | Oktas |
| Product Code | GCJ · Gastroenterology, Urology |
| Decision Date | Apr 14, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
Intended Use
The device is intended for use in endoscopic procedures and all types of video assisted procedures, including anterior spinal and general thoracic procedures and as an aid in visualization of the evacuated cardiac chamber.
Device Story
Vista Mini Camera system; video camera for endoscopic procedures; inputs optical images from body cavities/organs via endoscope; transforms optical input to electronic video signal via camera control unit (CCU); outputs video to monitors or head-mounted displays; used in OR by surgeons/physicians; aids visualization during minimally invasive surgery; facilitates surgical navigation and procedure monitoring; benefits patient through improved visualization during endoscopic/video-assisted interventions.
Clinical Evidence
Bench testing only. Compliance with IEC 601-1 (general safety), IEC 601-1-2 (EMC), IEC 601-2-18 (endoscopic safety), ISO 10993 (biocompatibility), and UL544 (medical equipment safety). Optical performance data provided.
Technological Characteristics
Video endoscope system; consists of camera head and camera control unit (CCU); compatible with standard light sources and video monitors/head-mounted displays. Complies with IEC 601-1, IEC 601-1-2, IEC 601-2-18, ISO 10993, and UL544 standards.
Indications for Use
Indicated for patients undergoing endoscopic or video-assisted surgical procedures, including anterior spinal, general thoracic, and cardiac chamber visualization.
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
- 3D Scope Three Dimensional Medical VideoSystem (K923160, K961182)
- Oktas Video Endoscope System with Zoom (K946171)
- Zeiss EndoLive™ Stereo Endoscope (K950988)
Related Devices
- K971373 — VISTA SINGLE CHIP VIDEO CAMERA · Vista Medical Technologies, Inc. · May 20, 1997
- K161017 — True HD 3MOS Camera System · Conmed Corporation · May 9, 2016
- K990635 — VISTA STEREOSCOPE SYSTEM · Vista Medical Technologies, Inc. · May 19, 1999
- K970214 — 3 DIMENSIONAL VIDEO ENDOSCOPE · Oktas · Apr 14, 1997
- K243008 — Arthrex NanoScope System · Arthrex, Inc. · Jan 22, 2025
