3 DIMENSIONAL VIDEO ENDOSCOPE
Device Facts
| Record ID | K970214 |
|---|---|
| Device Name | 3 DIMENSIONAL VIDEO ENDOSCOPE |
| 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 all types of endoscopic and endoscopic assisted procedures, including general thoracic and as an aid in visualization of the evacuated cardiac chamber.
Device Story
3D Video Endoscope System; integrated endoscope and video camera. Inputs: optical images from body cavities/organs. Transformation: captures stereoscopic video signals for processing by Camera Control Unit. Output: 3D video feed displayed on external monitors or head-mounted displays (HMD). Used in OR/clinical settings by physicians. Facilitates visualization during minimally invasive procedures; aids surgical navigation; enhances depth perception via 3D imaging. Compatible with standard light sources and rack-mounted systems.
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 UL 544. Optical test data provided to verify imaging performance.
Technological Characteristics
Integrated endoscope and camera control unit. Connectivity: compatible with external light sources, monitors, and HMDs. Standards: IEC 601-1, IEC 601-1-2, IEC 601-2-18, ISO 10993, UL 544. Form factor: handheld endoscope with rack-mountable control unit.
Indications for Use
Indicated for patients undergoing endoscopic or endoscopic-assisted procedures, including general thoracic surgery and 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
- 3D Scope Three Dimensional Medical VideoSystem (K923160, K961182)
- Oktas Video Endoscope System with Zoom (K946171)
- Zeiss EndoLive™ Stereo Endoscope (K950988)
Related Devices
- K013952 — INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM · Intuitive Surgical, Inc. · Feb 28, 2002
- K990635 — VISTA STEREOSCOPE SYSTEM · Vista Medical Technologies, Inc. · May 19, 1999
- K020301 — MODIFICATION TO VISTA STEREOSCOPE SYSTEM · Vista Medical Technologies, Inc. · Feb 12, 2002
- K183675 — 3D Visualization System · Scivita Medical Technology Co., Ltd. · Sep 25, 2019
- K152619 — Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) · Prosurg, Inc. · Apr 29, 2016
