HEAD MOUNTED DISPLAY

K961800 · Vista Medical Technologies, Inc. · GCJ · Sep 11, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K961800
• Device Name: HEAD MOUNTED DISPLAY
• Applicant: Vista Medical Technologies, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Sep 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Vista Head Mounted Display System is designed to display video images while mounted on the users head.

Device Story

Head-mounted display (HMD) system for endoscopic surgery; provides binocular field display to allow surgeon to view surgical site and operating field simultaneously. Inputs: standard NTSC or PAL video signals (CVBS or S-Video) from endoscopic cameras. Processing: controller unit drives active matrix liquid crystal displays (LCDs) mounted on headgear. Output: visual display of endoscopic images directly in surgeon's field of view. Used in OR by surgeons; allows viewing without turning away from surgical site. Benefits: maintains surgeon's focus on patient; provides natural 'look down' visualization; supports simultaneous use of up to four HMDs and two standard monitors. Serves as backup to direct visualization or standard 2D monitors.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Active matrix liquid crystal display (LCD) technology; head-mounted form factor; controller station for signal processing; supports NTSC/PAL, CVBS, and S-Video (Y,C) inputs; wired connection between HMD and controller; supports monocular and stereo endoscope inputs; allows use of corrective eyewear.

Indications for Use

Indicated for use by surgeons as a component of a visualization system during endoscopic surgery to display video images.

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

• 3DSCOPE™ Three Dimensional Medical Video System (K923160)
• Crystal Eyes View/Record and Playback Controllers with Eyewear and Emitters (K944254)

Submission Summary (Full Text)

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SEP 11 1996
K961800
510(K) SUMMARY
July 31, 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 [phone]
Fax: [phone]

DEVICE TRADE NAME
Head Mounted Display

COMMON NAME
Stereo Viewing Monitor
Display for Endoscopic Visualization

PREDICATE DEVICE

1. Device Name: 3DSCOPE™ Three Dimensional Medical Video System
Classification: Camera, Television, Endoscopic, without audio
Manufacturer: American Surgical Technologies
300 Billerica Rd
Chelmsford, MA 01824
510(k) #: K923160

2. Device Name: Crystal Eyes View/Record and Playback Controllers with Eyewear and Emitters
Classification: Endoscope and Accessories, Class II per 21 CFR 876.1500
Manufacturer: Oktas
134 Flanders Rd.
Westborough, MA 01581
510(k) #: K944254

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# DEVICE DESCRIPTION

The Head Mounted Display (HMD) System is a binocular field display, occupying a large portion of the normal straight ahead field of view. This display is intended to be used as a component of a visualization system for use in endoscopic surgery. Traditional video-endoscopic surgery images are displayed on a TV monitor. This requires the surgeon to maintain contact with the traditional monitor and remain in position with it at all times. Having to turn away from the monitor causes the surgeon to lose sight of what is being accessed. The HMD system enables the surgeon to see the surgical site as well as the general operating field with the lateral and 45 degree look down vision, without having to look away, thus providing the means to present the endoscopic picture in a more natural and acceptable look down location with respect to the patient. This also provides a safe back up, the physician can resort to either direct visualization or utilize the back up 2D video monitor. The HMD takes a standard signal and displays it on two small electronic image display devices called liquid crystal display (LCD). It can be connected to any standard video generating equipment.

The HMD consists of an image generating array, eyepiece, and electronics. The image generating array is an active matrix liquid crystal display (LCD). These elements are mounted on a lightweight and compact headgear which fits comfortably on the user's head. The remaining electronics are housed separately in a controller station. The HMD communicates with the controller by a lightweight, durable, flexible cable. The HMD can be driven by both monocular and stereo endoscopes.

The HMD Controller will accept NTSC, PAL with CVBS, or S Video (Y,C) video input. Interfaces to external and remote data sets, power supplies and drivers for the LCD and backlight are included in the controller. A maximum of four (4) HMDs and two (2) standard video monitors can be driven simultaneously with the single controller.

# INTENDED USE

The Vista Head Mounted Display System is designed to display video images while mounted on the users head.

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# DEVICE COMPARISON

The HMD system is similar to the display component of the 3DSCOPE™, Three Dimensional Medical Video System which received clearance from FDA in December 1992, (K923160). The 3DSCOPE™ Stereo Display is a high resolution, high speed, multi-synch RGB full color video display monitor. The liquid crystal screen switches its circular polarization from left to right in precise synchronization (120 Hz) with the left and right images that appear on the Stereo Display. When the left image appears on the Stereo Display, the liquid crystal shutter switches to the left polarized state.

The HMD system accepts mono or binocular input from the endoscope and passes the input to the LCD matrix. The small number of elements, compactness and low weight enable this technology to be incorporated into a head mounted display. Most endoscopes are optical and attached to the video system which can feed the video electronic imager rather than an optical image from the endoscope itself to the HMD.

Corrective eyewear may be worn with this device as the HMD provides large eye relief.