LSI VIDEOSCOPIC DISPLAY SYSTEM

K963919 · Lsi Solutions · GCJ · Jan 8, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K963919
• Device Name: LSI VIDEOSCOPIC DISPLAY SYSTEM
• Applicant: Lsi Solutions
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jan 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The LSI Videoscopic Display System produces high quality video images for use in a wide range of medical applications, including surgery, microscopy and endoscopy.

Device Story

LSI Videoscopic Display System utilizes Texas Instruments Digital Micromirror Projector technology to project video images onto a sterile, disposable plastic screen positioned within the surgical field. Device intended for use in surgery, microscopy, and endoscopy. Surgeon and surgical staff view projected images directly within the sterile field to facilitate visualization during procedures. System accepts standard 1.0V p-p, 75 ohms video input. Benefits include improved image accessibility and viewing ergonomics for the surgical team compared to traditional monitors.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital Micromirror Projector technology; 800 (H) x 600 (V) active pixels; 1.0V p-p, 75 ohms video input; 120V/230V AC power; includes sterile disposable plastic screen for surgical field placement; dimensions 8.04" x 12.2" x 16.38"; weight 28.5 lbs.

Indications for Use

Indicated for use in medical applications requiring video image display, including surgery, microscopy, and endoscopy.

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

• Sony Trinitron Color Video Monitor, Model Number PVM-1343MD (K5885042)

Submission Summary (Full Text)

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K963919
JAN 8 1997

# Premarket Notification [510(k)] Summary

LSI Solutions
2144 Brighton-Henrietta Town Line Road
Rochester, NY 14623
Phone: [phone]
Fax: [phone]
Contact: Jude S. Sauer, M.D.

September 27, 1996

**Trade Name:** LSI Videoscopic Display System
**Common Name:** Color Video Monitor
**Classification Name:** Surgical Camera and Accessories (per 21 CFR Section 878.4160)
**Predicate Device:** The legally marketed device (predicate) to which substantial equivalence is claimed is the Sony Trinitron Color Video Monitor, Model Number PVM-1343MD (K5885042).
**Description:** The LSI Videoscopic Display System utilizes advanced video projection technology to display an image on a sterile, disposable screen appropriately positioned within the surgical field.
**Intended Use:** The LSI Videoscopic Display System produces high quality video images for use in a wide range of medical applications, including surgery, microscopy and endoscopy.

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Comparison:

Summary of the technological characteristics of how this device compares to the predicate device:

| Specification | LSI Videoscopic Display System (Model 001) | Sony Color Video Monitor (PVM-1343MD) |
| --- | --- | --- |
| Indications For Use | The LSI Videoscopic Display System produces high quality video images for use in a wide range of medical applications, including surgery, microscopy and endoscopy. | The PVM-1343MD Color Video Monitor produces high quality video images for use in a wide range of medical applications, including surgery, microscopy, endoscopy and A/V. |
| Diagonal Picture Measure (in.) | 14 | 13 |
| Sterile Disposables | Plastic screen for placement in the surgical field. | None |
| Image Source | Texas Instruments Digital Micromirror Projector | SMPTE C (American standard phosphor) |
| Resolution | 800 (H) x 600 (V) active pixels | 2000 Characters (50 characters/line x 25 lines) >600 (H) TV lines |
| Video Input | 1.0V p-p, 75 ohms | 1.0V p-p, 75 ohms |
| Audio input | Phono jack | Phono jack |
| Power Requirements | 120V AC at 60 Hz
230V AC at 50 Hz | 110-130 V AC at 50-60 Hz |
| Power Consumption | 600 W (approx.) | 99W (approx.) |
| Dimensions (in.) | 8.04 (H) x 12.2 (W) x 16.38 (D) | 13.5 (H) x 13.63 (W) x 16.25 (D) |
| Weight (lb.) | 28.5 | 36.4 |

Summary:

The LSI Videoscopic Display System is a safe and effective device which is equivalent to the Sony Color Video Monitor (PVM-1343MD). The LSI Videoscopic Display System has a slightly larger screen when measured diagonally with 800 horizontal lines of resolution versus 600 horizontal lines of resolution for the Sony device. In addition the LSI Videoscopic Display System projects the video image into the surgical field, on a sterile screen, where it may be more easily viewed by the surgeon and others.