← Product Code [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ) · K970214 # 3 DIMENSIONAL VIDEO ENDOSCOPE (K970214) _Oktas · GCJ · Apr 14, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K970214 ## Device Facts - **Applicant:** Oktas - **Product Code:** [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ.md) - **Decision Date:** Apr 14, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for 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. ## 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 - 3D Scope Three Dimensional Medical VideoSystem ([K923160](/device/K923160.md), [K961182](/device/K961182.md)) - Oktas Video Endoscope System with Zoom ([K946171](/device/K946171.md)) - Zeiss EndoLive™ Stereo Endoscope ([K950988](/device/K950988.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 510(k) Notification 3Dimensional Video Endoscope January 1997 APR 14 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 3D Video Endoscope ## COMMON NAME Video Endoscope System ## PREDICATE DEVICE 1. Device Name: 3D Scope Three Dimensional Medical VideoSystem Classification: Camera, Television, Endoscopic, without audio Manufacturer: American Surgical Technologies 300 Billerica Rd Chelmsford, MA 01824 510(k) #: K923160 and K961182 2. Device Name: Oktas Video Endoscope System with Zoom Classification: Endoscopes and Accessories - 21 CFR 876.1500 Manufacturer: Oktas 134 Flanders Rd Westborough, MA 01581 510(k) #: K946171 510(k) 38 {1} Vista Medical Technologies Westborough, MA 510(k) Notification 3Dimensional Video Endoscope January 1997 3. Device Name: Zeiss EndoLive™ Stereo Endoscope Classification: Endoscopes and Accessories - 21 CFR 876.1500 Manufacturer: Carl Zeiss, Inc. Thomwood, NY 10594 510(k) #: K950988 ## DEVICE DESCRIPTION The 3D Video Endoscope System is a device used to allow observation in body cavities, organs, or canals through manmade or natural orifices. It is designed 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. The product is an integrated endoscope and video camera. The system will be supplied as a 3D Video Endoscope and Camera Control Unit. The device is designed to work with commercially available light sources, and video monitors or head mounted displays (HMD). Additionally the device can be mounted in a rack and used as one module of a rack mounted system. ## 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. ## PERFORMANCE DATA | IEC 601-1 | "General Safety Requirements for Medical Electrical Equipment" | | --- | --- | | IEC 601-1-2 | "Electrical Magnetic Compatibility" | | IEC 601-2-18 | "Safety of Endoscopic Equipment" | | ISO 10993 | "Biological Evaluation of Medical Devices" | | UL 544 | "Standard for Safety Medical and Dental Equipment" | | Optical Test Data | | 510(k) 39 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K970214](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K970214) **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