VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100

K021290 · Vista Medical Technologies, Inc. · GCJ · Jun 28, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K021290
• Device Name: VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100
• Applicant: Vista Medical Technologies, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jun 28, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

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

Device Story

Vista Visualization System provides endoscopic visualization for surgical procedures. System components: Vista StereoScope (camera head, endoscope, camera control unit) and Head Mounted Display (HMD) with processor. Operates by capturing optical images via endoscope, processing signals, and displaying video to surgeon via HMD or external monitor. Used in OR by surgeons for minimally invasive procedures; facilitates navigation and visualization of internal anatomy. Benefits include enhanced visualization during complex surgeries like bariatric, thoracic, and spinal procedures. System integrates with standard light sources and light guides.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological characteristics.

Technological Characteristics

System comprises camera head, endoscope, camera control unit, HMD, and HMD processor. Interfaces with standard light sources, light guides, and video monitors. Class II device (Product Code GCJ).

Indications for Use

Indicated for patients undergoing endoscopic or video-assisted surgical procedures, including general endoscopic, laparoscopic, bariatric, thoracic, anterior/posterior spinal, and cardiac structure visualization.

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 StereoScope System (K020301)
• Head Mounted Display System (K973436)
• ORPC with Infomatix IntraOp Software (K991303)

Submission Summary (Full Text)

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JUN 2 8 2002

# 7) 510(k) Summary

K021290

510(k) Summary for Vista Visualization System

#### A. Sponsor

Vista Medical Technologies 134 Flanders Road Westborough, MA 01581

## B. Contact Name

Graham A. L. Baillie Manager, Quality Assurance and Service Vista Medical Technologies Phone: [phone] ext. 8279 Facsimile: [phone]

#### C. Device Name

Vista Visualization System

#### D. Predicate Device(s)

Vista StereoScope System (K020301); Head Mounted Display System (K973436); ORPC with Infomatix IntraOp Software (K991303).

# E. Device Description

The Vista Visualization System is 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 including bariatric surgeries. The system consists of the Vista StereoScope System (camera head, endoscope and a camera control unit), and the Head Mounted Display System (HMD with HMD processor). The system is designed to work with commercially available light sources, light guides, and video monitor displays.

#### F. Intended Use

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

## G. Substantial Equivalence

The proposed Vista Visualization System is substantially equivalent to the currently legally marketed Vista devices in terms of intended use, operating principle, basic design, and shelf life. The addition of a specific indication for bariatric surgery does not affect the intended diagnostic affect or safety and effectiveness.

Vista Medical Technologies

134 Flanders Road Westborough MA 01581

Ph 508 366-3668 508 366-1543

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 8 2002

Mr. Graham Baillie Vista Medical Technologies, Inc. 134 Flanders Road Westborough, Massachusetts 01581

Re: K021290

Trade/Device Name: Vista Visualization System, Model 9000 Regulation Number: 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: GCJ Dated: April 22, 2002 Received: April 23, 2002

Dear Mr. Baillie:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Graham Baillie

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Stupt Rhodes

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

Enclosure

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9) Indications for Use Statement

Statement of Intended Use

,KO21290 510(k) Number (if Known):

Device Name:

Vista Visualization System

Indications For Use:

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

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use (Optional Format 1-2-96)

Styt Rhodes

OR

Division Sign-Off Division of General, Restorative and Neurological Devices

KO21290 510(k) Number_

Confidential and Proprietary to Vista Medical Technologies