← Product Code [FCW](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCW) · K970598 # INTEGRATED VISUALIZATION SYSTEM (K970598) _Urohealth, Inc. · FCW · Mar 12, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCW/K970598 ## Device Facts - **Applicant:** Urohealth, Inc. - **Product Code:** [FCW](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCW.md) - **Decision Date:** Mar 12, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Intended Use The IVS is used in providing illumination for endoscopic procedures and transmitting an image from an endoscope to a viewing monitor, which is integral to the system. ## Device Story Integrated Visualization System (IVS) combines light source, CCD camera, and 10.4" flat panel monitor in single 7-pound unit; used in endoscopic procedures. Device provides illumination via 24W light source (5460°K color temperature) and transmits endoscopic images to integrated monitor. Immersible camera head requires ≤1 lux. Operated by clinicians in clinical settings to visualize internal anatomy during procedures; assists in real-time surgical/diagnostic decision-making by providing direct visual feedback. ## Clinical Evidence Bench testing only; no clinical data provided. Biocompatibility testing not applicable as device components do not contact patient or body fluids. ## Technological Characteristics Integrated unit containing 24W light source (5460°K), CCD camera, and 10.4" flat panel monitor. Camera head is immersible. Weight: ~7 lbs. No patient-contacting materials. ## 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 - Welch Allyn Hi - Lux Illuminator ([K951647](/device/K951647.md)) - Integrated Video System (unknown) - Camera, Accessory to endoscope ([K963046](/device/K963046.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} K970598/S001 8172 510(k) Notification Integrated Visualization System February 17, 1997 # 510(k) SUMMARY ## COMPANY NAME AND ADDRESS UROHEALTH Systems, Inc. 3050 Redhill Ave. Costa Mesa, CA. 92626 ## CONTACT PERSON Ronald H. Bergeson Corporate Director, Regulatory Affairs Telephone (714) 708-7748, ext. 248 Fax (714) 708-7795 ## DEVICE TRADE NAME Integrated Visualization System ## COMMON NAME Light Source, Camera, and Monitor in one unit ## PREDICATE DEVICE 1. Device Name: Welch Allyn Hi - Lux Illuminator Classification: II Manufacturer: Welch Allyn 510(k) #: K951647 2. Device Name: Integrated Video System Classification: II Manufacturer: BEI Medical Systems Company, Inc. 510(k) #: unknown 3. Device Name: Camera, Accessory to endoscope Classification: I Manufacturer: Corin U.S.A. 510(k) #: K963046 DEVICE DESCRIPTION 000057 {1} 16970598 p2012 510(k) Notification Integrated Visualization System February 17, 1997 UROHEALTH Systems, Inc. Costa Mesa, CA The Integrated Visualization System is comprised of a light source, CCD camera, and 10.4" flat panel monitor, all housed in a single unit weighing approximately seven pounds. It has an immersible camera head with minimum illumination requirements of ≤1 lux. The light source uses 24 watts and outputs a color temperature of 5460°K. ## INDICATIONS FOR USE The IVS is used in providing illumination for endoscopic procedures and transmitting an image from an endoscope to a viewing monitor, which is integral to the system. ## BIOCOMPATIBILITY The materials and components of the proposed Integrated Visualization System do not have patient or body fluid contact and therefore biocompatibility testing is not applicable. 000058 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCW/K970598](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCW/K970598) **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