VISTA MINI CAMERA SYSTEM

K970369 · Oktas · GCJ · Apr 14, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970369
• Device Name: VISTA MINI CAMERA SYSTEM
• Applicant: Oktas
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Apr 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The device is intended for use in endoscopic procedures and all types of video assisted procedures, including anterior spinal and general thoracic procedures and as an aid in visualization of the evacuated cardiac chamber.

Device Story

Vista Mini Camera system; video camera for endoscopic procedures; inputs optical images from body cavities/organs via endoscope; transforms optical input to electronic video signal via camera control unit (CCU); outputs video to monitors or head-mounted displays; used in OR by surgeons/physicians; aids visualization during minimally invasive surgery; facilitates surgical navigation and procedure monitoring; benefits patient through improved visualization during endoscopic/video-assisted interventions.

Clinical Evidence

Bench testing only. Compliance with IEC 601-1 (general safety), IEC 601-1-2 (EMC), IEC 601-2-18 (endoscopic safety), ISO 10993 (biocompatibility), and UL544 (medical equipment safety). Optical performance data provided.

Technological Characteristics

Video endoscope system; consists of camera head and camera control unit (CCU); compatible with standard light sources and video monitors/head-mounted displays. Complies with IEC 601-1, IEC 601-1-2, IEC 601-2-18, ISO 10993, and UL544 standards.

Indications for Use

Indicated for patients undergoing endoscopic or video-assisted surgical procedures, including anterior spinal, general thoracic, and cardiac chamber 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

• 3D Scope Three Dimensional Medical VideoSystem (K923160, K961182)
• Oktas Video Endoscope System with Zoom (K946171)
• Zeiss EndoLive™ Stereo Endoscope (K950988)

Submission Summary (Full Text)

{0}

Vista Medical Technologies Westborough MA
APR 14 1997
510K Notification
Vista Mini Cameras
January 1997
K970369
510(K) SUMMARY
January 1997

## COMPANY NAME AND ADDRESS

Vista Medical Technologies
134 Flanders Road
Westborough, MA. 01581

## CONTACT PERSON

Martin Newman
Director of Regulatory Affairs and Quality Assurance
Telephone [phone]
Fax: [phone]

## DEVICE TRADE NAME

Vista Mini Camera(s)

## COMMON NAME

Video Endoscope System

## PREDICATE DEVICE

1. Device Name: 3D Scope Three Dimensional Medical VideoSystem
Classification: Camera, Television, Endoscopic, without audio
Manufacturer: American Surgical Technologies
300 Billerica Rd
Chelmsford, MA 01824
510(k) #: K923160, K961182

2. Device Name: Oktas Video Endoscope System with Zoom
Classification: Endoscopes and Accessories - 21 CFR 876.1500
Manufacturer: Oktas
134 Flanders Rd
Westborough, MA 01581
510(k) #: K946171

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{1}

Vista Medical Technologies Westborough MA
510K Notification
Vista Mini Cameras January 1997

3. Device Name: Zeiss EndoLive™ Stereo Endoscope
Classification: Endoscopes and Accessories - 21 CFR 876.1500
Manufacturer: Carl Zeiss, Inc.
Thomwood, NY 10594
510(k) #: K950988

## DEVICE DESCRIPTION

The Vista Mini Camera System is a device used to allow observation in body cavities, organs, or canals through manmade or natural orificies. It is designed for use in endoscopic procedures and all types of video assisted procedures, including anterior spinal and general thoracic procedures and as an aid in visualization of the evacuated cardiac chamber. The product is a video camera. The system will be supplied as a Vista Mini Camera, intended to be used with a Vista 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 device is intended for use in endoscopic procedures and all types of video assisted procedures, including anterior spinal and general thoracic procedures and as an aid in visualization of the evacuated cardiac chamber.

## PERFORMANCE DATA

The Vista Mini Camera System was designed and tested in compliance with the requirements of the following standards:

| IEC 601-1 | General Safety requirements for Medical Electronic Equipment |
| --- | --- |
| IEC 601-1-2 | Electromagnetic Compatibility Requirements and Tests |
| IEC 601-2-18 | Safety of Endoscopic Equipment |
| ISO 10993 | Biological Evaluation of Medical Devices |
| UL544 | Standard for Safety, Medical and Dental Equipment |
| | Optical Test Data |

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