VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE

K991303 · Vista Medical Technologies, Inc. · GCJ · Jul 12, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K991303
• Device Name: VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE
• Applicant: Vista Medical Technologies, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jul 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Vista ORPC with Infomatix IntraOp Software is designed to display video images while mounted on the users' head. These video images can be captured, redisplayed as still images, and exported to removable media. The ORPC with Infomatix IntraOp software is designed to be used as a personal replacement for surgical monitors.

Device Story

Head-mounted display (HMD) system for endoscopic visualization; displays real-time video images to surgeon. System inputs include endoscopic video sources; auxiliary control inputs via touchscreen, mouse/touchpad, remote keypad, or voice control. Features include image capture, picture-in-picture review of last captured image, and export to CD-RW. System allows VGA monitor output for desktop interface or HMD view. Used in surgical settings by physicians; provides personal monitor replacement to facilitate visualization during procedures.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and UL2601-1 standards.

Technological Characteristics

Head-mounted display system; auxiliary input interfaces (touchscreen, mouse, keypad, voice control); CD-RW storage; VGA output; electrical power source. Compliant with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and UL2601-1.

Indications for Use

Indicated for use by clinicians as a head-mounted personal display system for viewing endoscopic video images during surgical procedures, replacing traditional surgical monitors.

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

• Vista Head Mounted Display System With Infomatix Software, Version 1.0 (K973436)

Submission Summary (Full Text)

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JUL 11:2 1999.
JUL 11:2 Wista Medical Technologies
Wedical Westly wough MA Westborough MA

510(k) Notification Vista ORPC with Infomatix™ IntraOp Software April 1999

# 510(K) SUPPLEMENT SUMMARY April 1999

Kq91303

# COMPANY NAME AND ADDRESS

Vista Medical Technologies 134 Flanders Road Westborough, MA. 01581

## CONTACT PERSON

Vicki Anastasi Regulatory Affairs Manager Telephone [phone] [phone] Fax:

### DEVICE TRADE NAME

Vista ORPC with Infomatix IntraOp

COMMON NAME

Stereo Viewing Monitor Display for Endoscopic Visualization

### PREDICATE DEVICE

Vista Head Mounted Display System With Infomatix Software, Version 1.0 K973436 Vista Medical Technologies, Inc. 134 Flanders Road Westborough, MA 01581

When compared to the originally submitted device, the Vista ORPC with Informatix IntraOp Software does not incorporate any significant change in intended use, method of operation, material or design that could effect the safety or effectiveness of the subject device.

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# DEVICE DESCRIPTION

The Vista ORPC System with IntraOp software now features the capability to control the image display with auxiliary input devices such as a touchscreen, mouse/touchpad, and a remote keypad, as well as with voice control. Color, hue, contrast and brightness for the video sources are now adjusted via the auxilliary input devices. Another new feature of the device is the capability to capture intra-operative static images of what is being displayed on the HMD. The last captured image can be displayed to the HMD as a picture-in-picture for review. The captured images can also be exported to a CD data storage disk via a CD-RW device. The capture and display last capture functions can be operated via voice control or the auxilliary input devices. The export feature is controlled via mouse, or the touchscreen. The system also allows the VGA monitor to display what is being seen in the HMD or the user interface controls on the desktop.

## INTENDED USE

The Vista ORPC with Infomatix IntraOp Software is designed to display video images while mounted on the users' head. These video images can be captured, redisplayed as still images, and exported to removable media. The ORPC with Infomatix IntraOp software is designed to be used as a personal replacement for surgical monitors.

### PERFORMANCE DATA

The Vista Head Mounted Display System was designed and will be tested in compliance with the requirements of the following standards:

| IEC 60601-1 | General requirements for safety. |
|---------------|-----------------------------------------------------------------------------------------------|
| IEC 60601-1-1 | Collateral standard: Safety requirements for<br>medical electrical systems. |
| IEC 60601-1-2 | Collateral standard: Electromagnetic<br>compatibility requirements and tests. |
| UL2601-1 | Standard for Safety, Medical Electrical Equipment, Part 1:<br>General Requirements for Safety |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 12 1999

Ms. Vicki S. Anastasi Regulatory Affairs Manager Vista Medical Technologies, Inc. 134 Flanders Road Westborough, Massachusetts 01581

K991303 Re:

> Trade Name: Vista ORPC with Infomatix IntraOp Software Regulatory Class: II Product Code: GCJ Dated: April 15, 1999 Received: April 16, 1999

Dear Ms. Anastasi:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Vicki S. Anastasi

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

not available

Device Name:

Vista ORPC with Infomatix IntraOp Software

Indications for Use:

The Vista ORPC with Infomatix IntraOp Software is designed to display video images while mounted on the users' head. These video images can be captured, redisplayed as still images, and exported to removable media. The ORPC with Infomatix IntraOp software is designed to be used as a personal replacement for surgical monitors.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|---------------------|--|

| Division of General Restorative Devices | K991303 |
|-----------------------------------------|---------|
| 510(k) Number | |

| Prescription Use | <div style="text-align:center;">X</div> | or | Over-The-Counter Use | |
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