VISTA STEREOSCOPE SYSTEM

K990635 · Vista Medical Technologies, Inc. · GCJ · May 19, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990635
• Device Name: VISTA STEREOSCOPE SYSTEM
• Applicant: Vista Medical Technologies, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Vista StereoScope System is intended for use in endoscopic procedures and all types of video assisted procedures, including general endoscopic and laparoscopic, thoracic, anterior and posterior spinal and as an aid in visualization of cardiac structures.

Device Story

Vista StereoScope System is a video camera and endoscope system for visualization in body cavities, organs, or canals. System components include a camera head, stereo endoscope, and 3D camera control unit (CCU). It interfaces with external light sources and video monitors or head-mounted displays. Operated by physicians in clinical settings, the device provides 3D visualization to assist in surgical navigation and anatomical assessment during endoscopic and video-assisted procedures. It facilitates minimally invasive surgery by providing enhanced depth perception, potentially improving surgical precision and patient outcomes.

Clinical Evidence

Bench testing only. The device was evaluated for compliance with IEC 601-1 (General Safety), IEC 601-1-2 (EMC), IEC 601-2-18 (Endoscopic Equipment Safety), UL 2601-1 (General Safety), and ISO 10993 (Biological Evaluation). No clinical data provided.

Technological Characteristics

System comprises a camera head, stereo endoscope, and 3D CCU. Operates as a video-based endoscopic visualization system. Complies with IEC 601-1, IEC 601-1-2, IEC 601-2-18, UL 2601-1, and ISO 10993 standards. Designed for integration with external light sources and display monitors.

Indications for Use

Indicated for patients undergoing endoscopic and video-assisted procedures, including general endoscopic, laparoscopic, thoracic, anterior and posterior spinal procedures, and visualization of cardiac structures.

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

• Zeiss Endolive System (K931478, K950985)
• Vista 3D Video Endoscope (K970214)

Submission Summary (Full Text)

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Vista Medical Technologies Westborough MA

510(k) Notification Vista StereoScope System February 1999

MAY 1 9 1999

# 510(K) SUMMARY February 1999

#### COMPANY NAME AND ADDRESS

Vista Medical Technologies 134 Flanders Road Westborough, MA. 01581

### CONTACT PERSON

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

### DEVICE TRADE NAME

Vista StereoScope System

### COMMON NAME

Video Camera and Endoscope System

### PREDICATE DEVICE

- 1. Zeiss Endolive System Device Name: Class II Classification: Manufacturer: Carl Zeiss, Inc. 305 College Road East Princeton, New Jersey 08540 K931478 and K950985 510(k) #:
- 2. Device Name: Vista 3D Video Endoscope Classification; Class II Manufacturer: Vista Medical Technologies 134 Flanders Road Westborough, MA 01581 K970214 510(k) #:

K990635

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When compared to the predicate devices, the Vista StereoScope System 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.

## DEVICE DESCRIPTION

The Vista StereoScope System is a device used to allow observation in body cavities, organs, or canals through manmade or natural orifices. It is designed for use in all types of endoscopic and endoscopic assisted procedures. The system will be supplied as a Vista StereoScope Camera Head, Vista Stereo Endoscope and a 3D Camera Control Unit (CCU). The device is designed to work with commercially available light sources and video monitors or head mounted displays.

## INTENDED USE

The Vista StereoScope System is intended for use in endoscopic procedures and all types of video assisted procedures, including general endoscopic and laparoscopic, thoracic, anterior and posterior spinal and as an aid in visualization of cardiac structures.

## PERFORMANCE DATA

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

| IEC 601-1<br>Equipment | General Safety Requirements for Medical Electronic |
|------------------------|------------------------------------------------------------------------------------------------|
| IEC 601-1-2 | Electromagnetic Compatibility Requirements and Tests |
| IEC 601-2-18 | Safety of Endoscopic Equipment |
| UL 2601-1 | Standard for Safety, Medical Electrical Equipment, Part<br>1: General Requirements for Safety |
| ISO 10993 | Biological Evaluation of Medical Devices |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2

MAY 1 9 1999

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

Re: K990635 Trade Name: Vista Stereoscope System Regulatory Class: II Product Code: GCJ Dated: February 25, 1999 Received: February 26, 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,

Salih M. Wittke, Ph.D., M.D.

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 K 99 b 63 ﮐﺎ

Device Name:

Vista StereoScope System

Indications for Use:

The Vista StereoScope System is intended for use in endoscopic procedures and all types of video assisted procedures, including general endoscopic and laparoscopic, thoracic, anterior and posterior spinal and as an aid in visualization of cardiac structures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General Restorative Devices

| 510(k) Number | K990635 |
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| Prescription Use (Per 21 CFR 801.109) | X | or | Over-The-Counter Use | |
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