VISTA SINGLE CHIP VIDEO CAMERA

K971373 · Vista Medical Technologies, Inc. · FET · May 20, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971373
• Device Name: VISTA SINGLE CHIP VIDEO CAMERA
• Applicant: Vista Medical Technologies, Inc.
• Product Code: FET · Gastroenterology, Urology
• Decision Date: May 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The device is intended for use in all types of endoscopic and endoscopic assisted procedures. The Vista Single Chip Camera System is intended for use with optical endoscopes to provide a video image of the target area.

Device Story

Vista Single Chip Video Camera System consists of a camera head and camera control unit (CCU). Device connects to commercially available light sources, endoscope couplers, and video monitors or head-mounted displays. System captures visual data from body cavities, organs, or canals via endoscopes. Physician operates system during endoscopic procedures to visualize target anatomy on external displays. Output provides real-time video feedback to assist in surgical or diagnostic navigation. Device facilitates minimally invasive visualization, aiding clinical decision-making during procedures.

Clinical Evidence

Bench testing only. Compliance with IEC 601-1 (General Safety), IEC 601-1-2 (EMC), and UL544 (Medical/Dental Equipment Safety) standards, plus optical test data.

Technological Characteristics

Single-chip video camera system comprising a camera head and CCU. Designed for integration with standard light sources, C-mount couplers, and video monitors. Operates as an electronic imaging device. Complies with IEC 601-1, IEC 601-1-2, and UL544 standards.

Indications for Use

Indicated for use in all types of endoscopic and endoscopic assisted procedures to provide a video image of the target area. No specific patient population, age, or gender restrictions are defined.

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

• Oktas (K946171)
• Olympus OTV-S5 Video System (K955404)

Submission Summary (Full Text)

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MAY < 0 1997

Vista Medical Technologies Westborough MA

510(k) Vista Single Chip Video Camera April 1997

# 510(K) SUMMARY April 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 [phone] Telephone Fax: [phone]

#### DEVICE TRADE NAME

Vista Single Chip Video Camera System

COMMON NAME

Video Camera System

### PREDICATE DEVICE

| 1. Device Name:<br>Classification: | Oktas<br>Endoscopes and Accessories -<br>21 CFR 876.1500 |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Oktas<br>134 Flanders Rd<br>Westborough, MA 01581 |
| 510(k) #: | K946171 |
| 2. Device Name:<br>Classification :<br>Manufacturer: | Olympus OTV-S5 Video System<br>Endoscope and Accessories<br>Olympus<br>Endoscope Division<br>Two Corporate Center Drive<br>Melville, New York 11747-3157 |
| 510(k) #: | K955404 |

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Vista Medical Technologies Westborough MA

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510(k) Notification

Vista Single Chip Video Camera

April 1997

When compared to the predicate devices, the Vista Single Chip Video Camera 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 Single Chip Video Camera 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 product is a video camera. The system will be supplied as a Vista Single Chip Video Camera Head and a Camera Control Unit (CCU). The device is designed to work with commercially available light sources, V&C mount endoscope couplers and video monitors or head mounted displays.

# INTENDED USE

The device is intended for use in all types of endoscopic and endoscopic assisted procedures.

# PERFORMANCE DATA

The Vista Single Chip Video Camera was designed and will be 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 |
| UL544 | Standard for Safety Medical and Dental Equipment |
| | Optical Test Data |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### 20 1997 MAY

Mr. Martin Newman Director of Regulatory Affairs and ... .................. Quality Assurance Vista Medical Technologies, Inc. 134 Flanders Road Westborough, Massachusetts 01581

**Re:** K971373

Vista Single Chip Video Camera System Dated: May 8, 1997 Received: May 9, 1997 Regulatory class: II 21 CFR §876.1500/Product code: 78 KOG

Dear Mr. Newman:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

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,

William Yin, Ph.D.

Lillian Yin, Ph. Director, Division of Reproduc Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

L.S.A.T.

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510(k) Number (if known): K971373 Vista Single Chip Video Camera System. ---------Device Name: ... . . . . . . . . . .

Indications for Use:

The Vista Single Chip Camera System is intended for use with optical endoscopes to provide a video image of the target area.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter R. Adkins
(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

or

510(k) Number K971373

Prescription Use _ / (Per 21 CFR 801.109)

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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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