SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTRAORAL CAMERA, SPECTRA VU HDDI SV I INTRAORAL CAMERA,

K984332 · International Technology Concepts · EIA · Apr 29, 1999 · Dental

Device Facts

• Record ID: K984332
• Device Name: SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTRAORAL CAMERA, SPECTRA VU HDDI SV I INTRAORAL CAMERA,
• Applicant: International Technology Concepts
• Product Code: EIA · Dental
• Decision Date: Apr 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

Intraoral images captured and displayed by the cameras are intended to be used to aid in patient education, enhancement of defect detection, and for image storage. These are not intended to aid in dental surgical procedures.

Device Story

SpectraVu Family of Intraoral Camera Systems captures intraoral images for dental patient education and defect detection. System comprises power supply, digital camera processor, circuit boards, light source, optical/electronic cables, and ergonomic handpiece with autoclavable sleeve. Device operates by capturing images over wide focal range; images displayed on television monitor, computer, or printed. Used in general dental offices by dental professionals. Provides enlarged view of oral cavity; allows image storage for future reference. Benefits include improved patient communication and enhanced visualization of dental conditions. Not intended for surgical procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and intended use.

Technological Characteristics

System includes power supply, digital camera processor, circuit boards, light source, and ergonomic handpiece. Features include variable focal length optical lens system, digital on-board image storage, and S-Video/computer output. Handpiece includes autoclavable metallic sleeve tip with glass optical window; compatible with disposable plastic sleeves. EMC approved.

Indications for Use

Indicated for use in dentistry to provide a view of the oral cavity and contents to aid in patient education, demonstration of conditions, and identification of defects. Not for use as an operative device.

Regulatory Classification

Identification

A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.

Predicate Devices

• Ultracam II (K941452)

Submission Summary (Full Text)

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4/29/99

129184332

AUSTIN W. BREWIN, M.D. Piedmont Consulting Group 6114 LaSalle Avenue, Suite 330, Oakland, CA 94611 USA 510-547-1211 Phone and Fax e-mail [e-mail]

25 November 1998

## 510(k) Summary as required by section 807.92(c)

Submitted by the contact person: Austin Brewin, M.D. Piedmont Consulting Group 6114 LaSalle Avenue, Oakland, CA 94611 Phone, Fax: [phone]

- The Device: ●
Trade Name: SpectraVu Family of Intraoral Camera Systems manufactured and marketed by International Technology Concepts (ITC/SpectraVu) of 11501 Dublin Boulevard, Dublin, CA 94568. Phone: [phone] Fax: [phone] Common Name: Intraoral video camera Classification Name: Dental Operative Unit and Accessories (76 EIA)

- Equivalent legally marketed device: . Ultracam II, made by Ultrac, Inc, a division of Dental Vision Direct, Inc. The 510(k) number assigned for this equivalent system is K941452.
- Summary of technological similarities between the SpectraVu and UltraCam systems: .

| Feature: | SpectraVu | UltraCam |
|-----------------------------------|-----------|-------------|
| Used for dental patient education | Yes | Yes |
| General dental office use | Yes | Yes |
| Ergonomic, portable design | Yes | Yes |
| Portable and fixed models | Yes | Yes |
| Built-in back-up battery | Yes | Yes |
| Accurate optical lens system | Yes | Yes |
| Variable focal lengths | Yes | Yes |
| Integrated camera-light cable | Yes | Yes |
| Digital, on-board image storage | Yes | Yes |
| High resolution image | Yes | Yes |
| Accurate color image | Yes | Yes |
| Display single or multiple images | Yes | Yes |
| Computer or S-Video output | Yes | Yes |
| On the unit control | Yes | Yes |
| Handpiece image capture control | Yes | Yes |
| Autoclavable window sleeves | Yes | No |
| EMC approved | Yes | UL Approved |

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- Summary Description of the Device: The SpectraVu Family of Intraoral Camera Systems . consist of a power supply, digital camera processor, circuit boards, a light source, optical and electronic cables, and an ergonomic hand piece with an autoclavable sleeve containing an optical system. The components are capable of capturing images over a wide focal range. The images can be displayed on a television monitor, in a computer or may be printed out.
- Intended use of the device: Intraoral images captured and displayed by the cameras are . intended to be used to aid in patient education, enhancement of defect detection, and for image storage. These are not intended to aid in dental surgical procedures.
- The Spectra Vu Family of Intraoral Camera Systems provides intraoral images, and are not . substantially different from currently marketed devices such as the UltraCam systems.

Respectfully submitted,

B. leum

Austin Brewin, M.D.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with a bird-like figure above them. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1999

International Technology Concepts C/O Austin W. Brewin, M.D. Piedmont Consulting Group 6114 LaSalle Avenue, Suite 330 Oakland, California 94611

Re: K984332 Spectra Vu 1000 Series Intraoral Camera, Trade Name: Spectra Vu 2000 Series Requlatory Class: I Product Code: EIA Dated: March 15, 1999 Received: March 23, 1999

Dear Dr. Brewin:

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 The general controls provisions of the Act 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 requlations 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.

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Page 2 - Dr. Brewin

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 requlation entitled, "Misbranding by reference to ene regaracron Chercica) Titblanding II 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,

Timothy A. Ulatowski
Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number K 984332

## 13. Statement of indications for use:

The SpectraVu Family of Intracral Cameras are intended for use in dentistry to provide a view of the oral cavity and contents as an aid in explaining and demonstrating conditions to patients. These also provide an enlarged view of areas for the dentist to better identify defects. Images can be stored for future reference.

These cameras are not intended for use as an operative device. The camera and components are not manufactured to be sterile, however the metallic sleeve tip with the glass optical window is designed to be sterilized between uses, and/or may be protected by commercially available plastic disposable sleeves,

Susan Runge

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K184332

Prescription DEVICE

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