← Product Code [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ) · K961182 # 3D SCOPE (K961182) _Oktas · GCJ · Jul 19, 1996 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K961182 ## Device Facts - **Applicant:** Oktas - **Product Code:** [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ.md) - **Decision Date:** Jul 19, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use The 3D SCOPE™ is designed to aid in visualization for general endoscopic and laparoscopic procedures including general thoracic, and as an aid in visualization and examination of the evacuated cardiac chambers. ## Device Story 3D SCOPE™ is a three-dimensional medical video system used for visualization during endoscopic, laparoscopic, and thoracic surgeries. Device provides 3D visual feedback to surgeons to assist in surgical navigation and examination of internal structures, including evacuated cardiac chambers. System operates as an endoscopic camera; provides real-time video output to a display for physician viewing. Used in OR settings by surgeons to enhance depth perception during minimally invasive procedures. No hardware or software modifications made to the previously cleared device; submission solely adds clinical indication for cardiac chamber examination. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on the identical technological characteristics and intended use as the predicate device. ## Technological Characteristics Endoscopic television camera system; 3D visualization capability. No modifications to materials, energy source, or connectivity from predicate device (K923160). ## 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 Video System ([K923160](/device/K923160.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} K961182 JUL 19 1996 510(K) SUMMARY July 1, 1996 COMPANY NAME AND ADDRESS Vista Medical Technologies 5451 Avenida Encinas, Suite A Carlsbad, CA. 92008 CONTACT PERSON Debbie Iampietro Director of Regulatory Affairs and Quality Assurance Telephone (508) 366-8882 Fax: (508) 366-8858 DEVICE TRADE NAME 3D SCOPE™ COMMON NAME Laparoscopic Video System PREDICATE DEVICE 1. Device Name: 3D Scope Three Dimensional Medical Video System Classification: Camera, Television, Endoscopic, without audio Manufacturer: American Surgical Technologies 300 Billerica Rd Chelmsford, MA 01824 510(k) #: K923160 DEVICE DESCRIPTION This 510(k) submission is for the addition of an indication for use of the currently marketed, cleared device 3D SCOPE™ Three Dimensional Medical Video System. 510(k) #: K923160. The primary application cleared for the AST 3D SCOPE™ is general endoscopic surgery and laparoscopic procedures. This includes general thoracic procedures. This submission is to add to the indications for use: examination of the evacuated cardiac chambers. {1} # INTENDED USE The 3D SCOPE™ is designed to aid in visualization for general endoscopic and laparoscopic procedures including general thoracic, and as an aid in visualization and examination of the evacuated cardiac chambers. # DEVICE COMPARISON 1. Device Name: 3D SCOPE™ Three Dimensional Medical Video System Classification: Camera, Television, Endoscopic, without audio Manufacturer: American Surgical Technologies 300 Billerica Rd Chelmsford, MA 01824 510(k) #: K923160 The device is not modified in any way except for the added indication for use. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K961182](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K961182) **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. 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