MEDVISION PERSONAL MONITOR

K961343 · Medvision, Inc. · GCJ · Mar 13, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K961343
• Device Name: MEDVISION PERSONAL MONITOR
• Applicant: Medvision, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Mar 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The MedVision Personal Monitor Models A and Models B are intended to display video image while mounted on the user's head.

Device Story

Device is a head-mounted display (HMD) for endoscopic surgery; inputs standard video signals from endoscopic camera systems; controller unit demodulates signals and drives display electronics; projects high-resolution color video image onto surgeon's retina via lens/mirror system; monoscopic binocular viewing; see-around design allows peripheral vision; used in surgical settings by surgeons; maintains endoscopic image in line of sight regardless of head orientation; improves hand-eye coordination by reducing decoupling between instrument movement and visual display; benefits include enhanced surgeon focus and reduced cognitive load during complex endoscopic manipulations.

Clinical Evidence

No clinical data. Bench testing only; device complies with IEC-601-1, IEC-601-2, and IEC 10004-3 standards.

Technological Characteristics

Monoscopic binocular HMD; Model A uses TFT LCD; Model B uses AMEL display; includes monitor block, eyeglasses with polycarbonate lenses, and controller box; lens/mirror projection system; 9V DC power; non-sterile; connectivity via standard video input; shielded cable transmission.

Indications for Use

Indicated for surgeons performing endoscopic procedures to display video images within the user's line of sight.

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

• Head Mounted Display (K961800)

Submission Summary (Full Text)

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MedVision Inc.
North Brunswick, NJ
February 1, 1997

MAR 13 1997 K961343

# Section 2

## 510 (k) Summary

**Device Trade Name**
MedVision Personal Monitor Models A and B

**Common /Usual Name**
Head Mounted Display
Virtual Display Device

**Classification Name**
Accessory to Endoscopes

**Contact Person:**
Miklos S. Ruschak
MedVision Inc.
257 Kempsey Drive
North Brunswick, NJ 08902

Telephone: [phone]
Fax: [phone]

**Predicate Device**
Trade Name: Head Mounted Display
Manufacturer: Vista medical Technologies
5451 Avenida Encinas, Suite A
Carlsbad, CA 92008
510 (k)#: K961800

Summary Preparation Date: February 1, 1997

**Statement of Intended Use**
The MedVision Personal Monitor Models A and Models B are intended to display video image while mounted on the user's head.

**Device Description**
In endoscopic procedures the conventional video monitors are placed away from the site of the operation. As a result, the surgeon has to constantly divide his/her attention between the conventional monitor that shows the endoscopic image and the site of the operation. The remote location of the monitor and its orientation in the surgical setting have an effect on both the doctor's perception of the surgical field, and the difficulties encountered when interacting with it. Much of the difficulty encountered by a surgeon when learning the techniques videoendoscopy, relate to the disconnection between instrument movements on the video monitor and their hand movements. With the displacement and axial rotation of the monitor, the doctor must relearn the image to tissue relationship at each procedure, and with each manipulation of the camera. With

{1}

MedVision Inc.
North Brunswick, NJ

this decoupled image, the hand-eye coordination of the doctor suffers. For example, with a 90 degree rotation of the camera, an intended movement South North direction, will result in a display movement in an East to West direction, presenting the doctor with a working field that is difficult to comprehend.

The MedVision Personal Monitors project a high resolution color video image that appears in a the surgeon's line of sight in a viewing angle comparable to watching a 26" television from 2 meters (6.5 feet) away. The video image is see-around; it blocks only the area the image appears, otherwise users are free to view the surrounding environment. The MedVision Personal Monitors provide an added convenience to surgeons compared to conventional monitors. They enables the surgeon to maintain the endoscopic image in the surgeon's line of site regardless of where he/she is looking. The MedVision Personal Monitor Model A and Model B can receive video signals from any video source. The signals are converted in the controller unit into signals the driving electronics of LCD/AMEL displays require.

The MedVision Personal Monitors (MPM) Model A and Model B are monoscopic binocular displays with a relatively narrow field of view. The MPMs take standard video signals and display them on a small TFT LCD display (Model A) or AMEL display (Model B) that can be connected to any standard video source. The MPM consists of a monitor block, eyeglasses and controller box. The monitor block contains the display, for MPM Model A only, a backlight and its driver for the LCD, and a system of lenses and mirrors that project the display image onto the retina of the eyes. The light beams coming from the display are reflected in two directions by dividing mirrors placed in front of the display. The monitor block has a mounting slot that fits into the vertical nose piece of the eyeglasses. The controller box contains the video input demodulator unit and the driving electronics of the LCD/AMEL display. The LCD/AMEL direct display control signals are sent through a flexible shielded cable to the displays.

The eyeglasses have adjustable temple pieces and each unit comes with a commercially available 9V DC adaptor with low EMI.

All components and accessories of the device are marketed as non-sterile.

## Device Comparison

The MedVision Personal monitor Models A and B are substantially equivalent to the display component of Vista Medical Technologies' Head Mounted Display, which received clearance from FDA on September 11, 1996 (K 961800). The MedVision Personal Monitor Model A and Model B are binocular monoscopic displays with a single LCD display (Model A) and single AMEL display (Model B). The Vista Medical Technologies' Head Mounted Display has two AMLCDs and it is a monoscopic/stereoscopic display. While the predicate device has large field of view and low apparent resolution, the MedVision Personal Monitors have relatively narrow field of view and relatively higher and apparent resolution. The MedVision Personal Monitors are monoscopic displays that do not need the large virtual distance, large field of view to create the stereoscopic immersion as opposed to Vista's HMD. The tradeoff for the large field of view is the reduction in apparent resolution.

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MedVision Inc.
North Brunswick, NJ

# Safety

The MedVision Personal Monitors Model A and Model B are designed, manufactured and tested in compliance with IEC-601-1, IEC-601-2, and IEC 10004-3.

The eyeglasses will have polycarbonate lenses to ensure high resistance to impact and scratch.

When compared to the predicate device the MedVision Personal Monitors Model A and Model B do not incorporate any significant change in intended use and technological characteristics that could affect the safety or effectiveness.