INTEGRATED VISUALIZATION SYSTEM
Device Facts
| Record ID | K970598 |
|---|---|
| Device Name | INTEGRATED VISUALIZATION SYSTEM |
| Applicant | Urohealth, Inc. |
| Product Code | FCW · Gastroenterology, Urology |
| Decision Date | Mar 12, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
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.
Indications for Use
Indicated for use in endoscopic procedures requiring illumination and image transmission to a viewing monitor.
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
- Welch Allyn Hi - Lux Illuminator (K951647)
- Integrated Video System (unknown)
- Camera, Accessory to endoscope (K963046)
Related Devices
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- K071292 — VIEW MD OFFICE SYSTEM, MODEL 41066.5540 · Richard Wolf Medical Instruments Corp. · Jul 19, 2007
- K971373 — VISTA SINGLE CHIP VIDEO CAMERA · Vista Medical Technologies, Inc. · May 20, 1997
- K123359 — OVS1 VIDEO SYSTEM · Olive Medical Corp. · Dec 19, 2012
- K022490 — KSEA MEDI PACK · KARL STORZ Endoscopy-America, Inc. · Sep 29, 2003
